business plan medical device sales

Medical Device Business Plan Template

Written by Dave Lavinsky

Medical Device Business Plan

You’ve come to the right place to create your Medical Device business plan.

We have helped over 1,000 entrepreneurs and business owners create business plans and many have used them to start or grow their Medical Device businesses.

Below is a template to help you create each section of your Medical Device business plan.

Executive Summary

Business overview.

MediTech LLC is a medical device company that sells Class I medical devices to hospitals, clinics, and other establishments in the medical industry. We manufacture a long list of devices including surgical instruments, syringes, and bandages. We know that patients can’t receive quality care if medical professionals don’t have good tools. Therefore, our mission is to provide the best medical devices in the industry so that all hospitals and clinics can provide the best care possible.

MediTech LLC is founded by Sarah Nelson. Sarah has considerable experience as a surgeon and used hundreds of medical devices throughout her career. She knows exactly what it takes to make high quality medical products and has made it her mission to create the best medical devices in the industry. Her expertise and knowledge of the industry will give us a considerable advantage over the competition.

Product Offering

MediTech LLC sells a long list of Class I medical devices. Class I medical devices are low risk devices and are unlikely to cause any harm to users. These include bandages, surgical tools, bedpans, gloves, and surgical masks. Our product list will grow and change depending on which devices are in high demand.

Customer Focus

MediTech LLC will primarily serve hospitals, clinics, and other medical organizations. Some products will be sold in stores to the public, including bandages, gloves, and face masks.

Management Team

MediTech LLC was founded by Sarah Nelson, a licensed and experienced surgeon. While working in the medical industry, she was frustrated by the quality of the medical devices she used. Her hospital routinely purchases low quality devices to save costs and this would affect the quality of her care. She researched what it would take to make higher quality versions of these products and decided to start a company that provides better quality devices for an affordable cost.

Success Factors

MediTech LLC will be able to achieve success by offering the following competitive advantages:

• We will provide the best quality medical devices in the industry. Our devices will help improve the quality of care that our clients give their patients.
• MediTech will price all of its products moderately so all of our clients and customers can afford them.
• Our founder has years of experience as a surgeon in the medical industry, bringing a vast amount of medical knowledge to the table. This will help us create perfect medical devices and products that all medical professionals will be eager to use.

Financial Highlights

MediTech LLC is currently seeking $1,400,000 to launch. The funding will be dedicated to the facility build out, purchase of initial equipment, working capital, marketing costs, and startup overhead expenses. The breakout of the funding is below:

• Facility design/build: $500,000
• Equipment: $200,000
• Six months of overhead expenses (payroll, rent, utilities): $400,00
• Initial supplies and inventory: $100,000
• Marketing and advertising: $100,000
• Working capital: $100,000

The following graph below outlines the pro forma financial projections for MediTech LLC.

Company Overview

Who is meditech llc.

MediTech LLC sells high-quality Class I medical devices to the medical industry. Our management team knows from experience that patients can’t receive the best care possible if physicians aren’t using the best tools. However, many medical organizations order lower quality devices in order to save on costs. At MediTech LLC, we are committed to making the best medical devices in the industry that are more affordable than the competition.

  MediTech LLC produces a long list of medical devices for the medical industry. These include bandages, surgical masks, gloves, surgical instruments, and bedpans. All of our products are Class I devices, meaning they present a low risk to the user.

MediTech LLC is founded by Sarah Nelson. Sarah has considerable experience as a surgeon and used hundreds of medical devices throughout her career. She knows exactly what it takes to make high quality medical products and has made it her mission to create the best medical devices in the industry. Her expertise and connections in the industry will ensure that MediTech LLC achieves its mission.

MediTech LLC History

Sarah Nelson founded and incorporated MediTech LLC as an LLC in June 2023. Though the company is currently running out of a small rented office, it will move to a large warehouse once the lease is finalized.

Since incorporation, MediTech LLC has achieved the following milestones:

• Developed the company’s name, logo, and website
• Determined equipment and fixture requirements
• Identified and established relationships with potential clients and suppliers
• Begun recruiting key employees

MediTech LLC Services

MediTech LLC manufactures and sells Class I medical devices. These include (but are not limited to) the following:

• Surgical instruments
• Non-electric wheelchairs
• Stethoscopes
• Surgical masks

Industry Analysis

The medical industry is dependent on the access to high-quality medical devices and products. From gloves and masks to EKG machines, every device used in the care of patients needs to be high quality and always in working order. Devices that are poor quality or don’t work properly can cause significant problems when being used to care for patients.

Medical devices are categorized into three classes. Class I devices are devices that pose very little risk to the user. These items include bandages, surgical instruments, and gloves. Class II devices are intermediate risk devices. These include intravenous pumps and CT machines. Class III devices are high risk and require a great amount of regulation. These devices are also critical to sustaining life. These include pacemakers and brain stimulators.

According to Fortune Business Insights, the medical device industry is valued at $539 billion and is expected to grow at a CAGR of 5.9%. Medical devices are constantly in high demand and are essential for the success of the medical industry. Therefore, now is a great time to start a new medical device company.

Customer Analysis

Demographic profile of target market.

Customer Segmentation

The company will primarily target the following customer segments:

• Medical clinics

Competitive Analysis

Direct and indirect competitors.

MediTech LLC will face competition from other companies with similar business profiles. A description of each competitor company is below.

Smith & Smith

Smith & Smith is a large corporation that sells thousands of products, including cosmetics, hygiene products, and certain medical devices. The medical devices they primarily produce include bandages, ointments, and low risk surgical and physician instruments. They sell many of their products to the general public (such as simple wound care devices) but also sell some devices to the medical industry. They will be a major competitor since they sell primarily Class I devices. However, they currently do not produce as many medical devices as MediTech LLC plans to produce, which gives us an advantage in the market.

MedMonitor is a medical device company that manufactures Class III medical devices. Some of their products include breast implants, pacemakers, implanted prosthetics, and defibrillators. They do sell some Class I and Class II products, such as gloves, wound care items, and surgical masks, but they are not a major manufacturer of these products. As such, we expect that MedMonitor will only be a minor competitor in the market.

MedSource is the source for most of the medical industry’s Class II medical devices. They produce a long list of devices including syringes, testing kits, contact lenses, and blood pressure cuffs. They do produce some products that can be categorized as Class I devices, but their product list does not overlap too much with ours. As such, we expect that MedSource will only be a minor competitor.

Competitive Advantage

MediTech LLC enjoys several advantages over its competitors. These advantages include the following:

• Management : Sarah Nelson has been extremely successful working in the medical industry and will be able to use her previous experience to design and manufacture the best medical devices in the industry.
• Relationships : Sarah knows many of the local leaders, business managers, and other influencers in the medical industry. These relationships will help her have access to quality materials and create an initial clientbase.
• Affordability : Thanks to Sarah’s connections within the industry, we are able to access high-quality materials for our products for an affordable cost. As a result, we can price all our products more moderately than the competition.

Marketing Plan

Brand & value proposition.

The MediTech LLC brand will focus on the company’s unique value proposition:

• High quality medical devices
• Affordable pricing
• Client-focused service

Promotions Strategy

The promotions strategy for MediTech LLC is as follows:

Social Media Marketing

Social media is one of the most cost-effective and practical marketing methods for improving brand visibility. MediTech LLC will use social media to develop engaging content in terms of the company’s product offerings. Engaging with prospective consumers and businesses on social media platforms like Facebook, Instagram, Twitter, and LinkedIn will also help understand changing customer needs.

Website/SEO

MediTech LLC will invest in developing a professional website that displays all of the products offered by the company. It will also invest in SEO so that the company’s website will appear at the top of search engine results.

Direct Mail

MediTech LLC will blanket businesses with direct mail pieces. These pieces will provide general information on MediTech LLC, offer discounts, and/or provide other incentives for companies to buy our products.

Advertisement

Advertisements in print publications like newspapers, magazines, etc., are an excellent way for businesses to connect with their audience. MediTech LLC will advertise its products in popular magazines and news dailies. Obtaining relevant placements in industry magazines and journals will also help in increasing brand visibility.

MediTech LLC’s pricing will be moderate, so clients feel they receive great value when purchasing our products.

Operations Plan

The following will be the operations plan for MediTech LLC. Operation Functions:

• Sarah Nelson will be the CEO of MediTech LLC. She will oversee the general operations and executive aspects of the business.
• Sarah is joined by Rebecca Smith who will act as the warehouse manager. She will train and manage the staff as well as oversee general production of our products.
• Sarah will hire an Administrative Assistant, Marketing Manager, and Accountant, to handle the administrative, marketing, and bookkeeping functions of the company.
• Sarah will also hire several employees to manufacture our products and maintain the equipment and machinery.

Milestones:

MediTech LLC will have the following milestones completed in the next six months.

• 02/202X Finalize lease agreement
• 03/202X Design and build out MediTech LLC
• 04/202X Hire and train initial staff
• 05/202X Kickoff of promotional campaign
• 06/202X Launch MediTech LLC
• 07/202X Reach break-even

Sarah Nelson is a former surgeon who is familiar with the most popular medical devices in the industry. She knows better than anyone that low quality products means low quality care for patients. As a surgeon, she was often disappointed with the quality of the medical devices she used. Her hospital would routinely choose the cheapest options to save costs. This resulted in more problems and low quality care being delivered to her patients. She is now passionate about starting her own company that provides high quality medical devices for an affordable cost.

Though Sarah has never run a business of her own, she has worked in the medical industry long enough to gain an in-depth knowledge of the operations (e.g., running day-to-day operations) and the business (e.g., staffing, marketing, etc.) sides of the industry. She will also hire several professionals to help her run other aspects of the business she is unfamiliar with.

Financial Plan

Key revenue & costs.

The key revenues for MediTech LLC will come from the sale of our medical devices and products.

The major cost drivers for the company will include manufacturing costs, overhead expenses, labor expenses, and marketing costs.

Funding Requirements and Use of Funds

• Six months of overhead expenses (payroll, rent, utilities): $400,000

Key Assumptions

The following outlines the key assumptions required in order to achieve the revenue and cost numbers in the financials and pay off the startup business loan.

• Number of wholesale contracts:
• Year 5: 100
• Average order value: $5,000

Financial Projections

Income statement.

Balance Sheet

Cash Flow Statement

Medical Device Business Plan FAQs

What is a medical device business plan.

A medical device business plan is a plan to start and/or grow your medical device business. Among other things, it outlines your business concept, identifies your target customers, presents your marketing plan and details your financial projections.

You can easily complete your Medical Device business plan using our Medical Device Business Plan Template here .

What are the Main Types of Medical Device Businesses? 

There are a number of different kinds of medical device businesses , some examples include: Class 1 medical device, Class 2 medical device, and Class 3 medical device.

How Do You Get Funding for Your Medical Device Business Plan?

Medical Device businesses are often funded through small business loans. Personal savings, credit card financing and angel investors are also popular forms of funding.

What are the Steps To Start a Medical Device Business?

Starting a medical device business can be an exciting endeavor. Having a clear roadmap of the steps to start a business will help you stay focused on your goals and get started faster.

1. Develop A Medical Device Business Plan - The first step in starting a business is to create a detailed medical device business plan that outlines all aspects of the venture. This should include potential market size and target customers, the services or products you will offer, pricing strategies and a detailed financial forecast. 

2. Choose Your Legal Structure - It's important to select an appropriate legal entity for your medical device business. This could be a limited liability company (LLC), corporation, partnership, or sole proprietorship. Each type has its own benefits and drawbacks so it’s important to do research and choose wisely so that your medical device business is in compliance with local laws.

3. Register Your Medical Device Business - Once you have chosen a legal structure, the next step is to register your medical device business with the government or state where you’re operating from. This includes obtaining licenses and permits as required by federal, state, and local laws.

4. Identify Financing Options - It’s likely that you’ll need some capital to start your medical device business, so take some time to identify what financing options are available such as bank loans, investor funding, grants, or crowdfunding platforms.

5. Choose a Location - Whether you plan on operating out of a physical location or not, you should always have an idea of where you’ll be based should it become necessary in the future as well as what kind of space would be suitable for your operations.

6. Hire Employees - There are several ways to find qualified employees including job boards like LinkedIn or Indeed as well as hiring agencies if needed – depending on what type of employees you need it might also be more effective to reach out directly through networking events.

7. Acquire Necessary Medical Device Equipment & Supplies - In order to start your medical device business, you'll need to purchase all of the necessary equipment and supplies to run a successful operation.

8. Market & Promote Your Business - Once you have all the necessary pieces in place, it’s time to start promoting and marketing your medical device business. This includes creating a website, utilizing social media platforms like Facebook or Twitter, and having an effective Search Engine Optimization (SEO) strategy. You should also consider traditional marketing techniques such as radio or print advertising. 

Learn more about how to start a successful medical device business:

• How to Start a Medical Device Company

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Medical Device Business Plan

Published Nov.06, 2023

Updated Apr.23, 2024

By: Brandi Marcene

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Table of Content

Medical Device Business Plan Sample

A medical device business plan is a document that outlines how to start and run a successful company that produces and sells products that diagnose, treat, or prevent diseases or injuries. Navigating the vast and expanding medical device sector presents thrilling opportunities alongside complex hurdles. A well-crafted business plan illuminates the route to success. Articulate your vision, milestones, tactics, and budgetary forecasts.

A business plan should also demonstrate how you will stand out from the crowd, satisfy users, adhere to regulations, and uphold ethical standards. A medical billing business plan is a specific type of medical device business plan that focuses on how to provide billing and coding services for healthcare providers.

In this article, we will provide you with a medical device business plan sample that you can use as a template or a reference for your business plan. We will cover the following sections:

• Executive Summary
• Company Overview
• Industry Analysis
• Customer Analysis
• Competitive Analysis
• Marketing Plan
• Operations Plan

Management Team

• Financial Plan

Executive Summary Section of Our Medical Device Business Plan

Business overview.

Medix is a medical device company that develops and sells innovative and affordable devices for diabetes management. We aim to enhance the well-being and health results of those managing diabetes. We aim to offer user-friendly and dependable products that assist in tracking and regulating blood sugar levels.

Products and Services

Medix offers two main products:

• Medix Glucometer – A smart glucose meter that connects to a mobile app via Bluetooth and provides accurate and instant readings of blood glucose levels.
• Medix Patch – A wearable patch that continuously measures blood glucose levels through the skin without needing finger pricks or test strips.

Customer Focus

Medix focuses on serving people with diabetes, seeking convenient and affordable solutions to manage their condition. According to the IDF Diabetes Atlas 10th edition report , 537 million adults (20-79 years) live with diabetes – 1 in 10. Experts predict that this number will rise to 643 million by 2030 and 783 million by 2045. Therefore, there is a huge demand for effective and accessible diabetes care products.

Leo Clark and Aria Bennett, two experienced entrepreneurs with biomedical engineering and business administration backgrounds, founded Medix. Leo is the CEO and head of product development, while Aria is the COO and head of marketing and sales. A team of qualified engineers, designers, developers, marketers, salespeople, and advisors supports them.

Success Factors

Medix has several competitive advantages that will enable it to succeed in the medical device industry:

• Innovation with cutting-edge technology to create novel devices
• High standards of quality and safety in every aspect of devices
• Customer satisfaction by providing user-friendly devices
• Social impact by addressing a major health problem globally

Financial Highlights

Medix seeks $5 million in seed funding to launch its products and scale its operations. The company projects to generate $1.2 million in revenue in the first year, $3.6 million in the second year, and $10.8 million in the third year, with a gross margin of 60% and a net profit margin of 20%. The company expects to break even in the second year and reach a valuation of $50 million by the end of the third year.

Company Overview Section of Our Medical Device Sales Business Plan

Who is Medix Medical Supply?

Medix dedicates itself to developing and selling innovative, affordable, and reliable devices for diabetes management. Our products help people with diabetes to monitor and control their blood glucose levels with ease and effectiveness, leading to better health outcomes and an improved quality of life.

Medix Medical Supply History

Medix is a company that provides innovative solutions for diabetes care. It was founded by Leo Clark and Aria Bennett in 2023, who both personally experienced the challenges and frustrations of living with diabetes. These challenges included frequent finger pricks, expensive test strips, inaccurate readings, and complicated insulin injections.

They started Medix with their personal funds and an incubator grant to address these issues. Medix developed two products – the Medix Glucometer and the Medix Patch – to make diabetes monitoring and treatment easier, more accurate, and more affordable.

The Medix products have received regulatory approvals from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). They are now ready for launch in the US and European markets. For more information, please refer to our dentistry business plan .

Legal Structure

Medix, an LLC registered in Delaware, USA, has obtained ownership by Leo Clark (60%) and Aria Bennett (40%). Additionally, the company has applied for a patent for its products in the US Patent and Trademark Office (USPTO).

Industry Analysis Section of Our Medical Device Business Plan

The medical device industry is one of the world’s most innovative and dynamic sectors. Fortune Business Insights reported that the global medical device market was valued at $512.29 billion in 2022 and can grow from $536.12 billion in 2023 to $799.67 billion by 2030, at a CAGR of 5.9%.

The medical device industry is driven by several factors, such as:

• The increasing prevalence of diseases and the aging population
• The rising demand for minimally invasive and personalized treatments
• The advancement of technology and digitalization
• The emergence of new markets and segments

Customer Analysis Section of Our Medical Supply Business Plan

Demographic profile of target market.

Medix’s target market is the US market, which ranks third for the highest number of people with diabetes. We target diabetic people looking for convenient, affordable solutions to manage their condition. 

According to the National Diabetes Statistics Report by CDC, here are some interesting stats about why the US market is best for Medix:

• 37.3 million people have diabetes (11.3% of the US population)
• 28.7 million people are diagnosed, including 28.5 million adults
• 8.5 million people are undiagnosed (23.0% of adults)
• 96 million people aged 18 years or older have prediabetes (38.0% of the adult US population)
• 26.4 million people aged 65 years or older (48.8%) have prediabetes

The demographic profile of our target market is as follows:

• Age – We target all ages, mainly the young and middle-aged, who are tech-savvy and have more money to spend. A CDC report says 34.1 million adults aged 18 years or older—or 13.0% of all US adults—have diabetes.
• Gender – We target both males and females, as diabetes does not discriminate by gender. A NIDDK (NIH) report says a higher percentage of men (41%) than women (32%) have prediabetes.
• Income – We target all income levels, mainly the low and middle-income who need better healthcare solutions. An NCBI (NIH) report says 80% of the adults worldwide with diabetes live in low- and middle-income countries (LMICs).

Customer Segmentation

Based on our market research and customer feedback, we have identified four main customer segments for our products:

• Segment A – Tech-savvy innovators who value quality, performance, and convenience. They share their views online.
• Segment B – Cost-conscious buyers who seek affordable and effective products. They trust their peers’ recommendations.
• Segment C – Health-conscious improvers who want products that motivate and support them. They join online health communities.
• Segment D – Compliance-driven users need products that ensure safety, security, and simplicity. They depend on their health providers and caregivers.

The table below summarizes our findings:

Based on the table, we have decided to target segments A and B as our primary segments, and segments C and D as our secondary segments.

Competitive Analysis Section of Our Medical Equipment Producer Business Plan

Direct and indirect competitors.

Our direct competitors are other medical device companies that offer similar or substitute surgical medical equipment for diabetes management. Some of the major players in this category are:

1. Abbott – A global healthcare company that offers a range of products for diabetes care with mobile apps for real-time data and insights.

• Strong brand recognition
• Global presence
• Innovation capabilities
• Customer loyalty

Weaknesses:

• Limited availability
• Technical issues

2. Dexcom – A medical device company specializing in CGMs for diabetes management. These devices use sensors to record and transmit data to a receiver or a smartphone.

• High accuracy
• Reliability
• Convenience
• Customer satisfaction
• Short sensor lifespan
• Skin irritation

3. Medtronic – A medical technology company that offers a range of durable medical equipment for diabetes care, such as insulin pumps, CGMs, and APSs. The system connects to a mobile app to monitor and control settings.

• Leadership position
• Advanced technology
• Clinical evidence
• Customer support
• Safety concerns
• Regulatory hurdles
• Competition

Our indirect competitors are other healthcare providers or solutions that offer alternative or complementary ways to manage diabetes, such as medications, diet plans, exercise programs, coaching services, etc. Refer to our hospital business plan to learn more.

Competitive Advantage

Medix’s unique value proposition and competitive advantage over its competitors are:

• Medix is more innovative
• Medix is more convenient
• Medix is more versatile
• Medix is more affordable
• Medix is more user-friendly

Marketing Plan Section of Our Medical Device Business Plan

Promotions strategy.

We will promote our products using online and offline channels to attract and retain customers. Our promotional mix consists of:

• Advertising – Online platforms (e.g., Google Ads, Facebook Ads) and offline media (e.g., newspapers, billboards) to deliver relevant and engaging messages.
• Public Relations – Press releases, media interviews, podcasts, webinars, etc., to generate positive publicity and exposure. Social media platforms (e.g., Facebook, Twitter) to interact and communicate with customers and stakeholders.
• Sales Promotion – Discounts, coupons, free samples, free trials, referrals, loyalty programs, etc., to stimulate sales and repeat purchases. Contests, sweepstakes, giveaways, etc., to create excitement and buzz.
• Personal Selling – Direct sales, telemarketing, email marketing, etc., to contact and persuade customers to buy our products. Online platforms (e.g., Amazon, eBay, Shopify) to sell our products directly.

We will use a value-based pricing strategy that reflects the value and benefits of our products and our competitive advantage. We will also offer competitive pricing that matches or undercuts our competitors’ prices.

We will charge $100 for each Medix Glucometer and $50 for each Medix Patch. We will also generate recurring revenue from the sales of test strips ($0.5 each) and insulin cartridges ($10 each). We estimate that each customer will use an average of 100 test strips and 12 insulin cartridges per year.

Operations Plan Section of Our Medical Device Business Plan

Operation functions.

We do these core activities to offer our products and services to our customers:

• Product Development – We research, design, test, and improve our products using agile methods, customer feedback, market trends, and tools like GitHub, Jira, Figma, etc.
• Manufacturing – We produce our products on a large scale and high quality by outsourcing to a reliable contract manufacturer.
• Distribution – We deliver our products to our customers quickly and cheaply using direct and indirect channels in different regions or countries.
• Customer Service – We support and assist our customers before, during, and after their purchase using various channels and methods.

Milestones and Timeline

We have these specific goals and objectives to track our progress and success in our operation functions:

• June 2024: Complete R&D, testing, prototyping of products
• September 2024: Obtain regulatory approvals and certifications
• December 2024: Launch marketing campaign and product launch in the US
• March 2025: Market research for Europe entry
• December 2025: Launch Europe marketing, market entry
• March 2026: Invest in production capacity
• June 2026: Expand manufacturing workforce
• December 2026: Evaluate production, increase to 100k units/month

Management Team Section of Our Medical Device Business Plan

Founders and co-founders.

Leo Clark, a biomedical engineer with type 1 diabetes, and Aria Bennett, the daughter of a type 2 diabetic and a business administrator, founded Medix. Leo is responsible for the product development function, while Aria leads the marketing and sales function. Both have several years of experience working in their respective fields and personal and professional experience with diabetes.

Other Key Team Members

• Alice Lee – Our chief engineer
• Bob Chen – Our chief developer
• Carol Wang – Our chief designer
• Dave Jones – Our chief marketer
• Emma Smith – Our chief salesperson

Financial Plan Section of Our Medical Device Business Plan

Key revenue and costs.

Medix’s main sources of revenue, along with pricing, are:

• Medix Glucometer – $100 for each Glucometer
• Medix Patch – $50 for each Patch
• Test Strips – $0.5 for each test strip
• Insulin Cartridge – $10 for each cartridge

We estimate that each customer will use an average of 100 test strips and 12 insulin cartridges per year.

Medix’s main categories of expenses are:

• Cost of Goods Sold (COGS) – Our main cost of goods sold is the cost of materials, components, parts, and additional supplies. We estimate that the COGS per unit is $40 for the Medix Glucometer, $20 for the Medix Patch, $0.1 for the test strip, and $2 for the insulin cartridge.
• Operating Expenses (OPEX) – Our main operating expenses are the costs we incur for running and operating our business, such as salaries, rent, utilities, marketing, advertising, R&D, etc. Our OPEX will be 40% of our revenue in the first year, 35% in the second year, and 30% in the third year.

Funding Requirements and Use of Funds

Funding Requirements – We seek $5 million in seed funding to launch our products and scale our operations. We have already raised $500,000 from our savings and a small grant from a local incubator. We need an additional $4.5 million to cover our expenses for the next 18 months until we reach the break-even point.

Use of Funds – We will use the funds for the following purposes as highlighted in the below chart:

Key Assumptions

• Market size for our products is 10% of the total number of people with diabetes in the US and Europe
• Market share is projected to grow from 107,000 customers in 2024 to 444,000 customers in 2026
• Sales volume is projected to grow from 321,000 units in 2024 to 1.33 million units in 2026
• Gross margin is projected to be 60% in all three years
• Net margin is projected to grow from 20% in 2024 to 30% in 2026

Financial Projections

Based on the above assumptions, we have prepared the following financial projections for the next three years:

Income Statement

OGSCapital – Your Partner for Medical Device Startup Success

With over a decade of experience, at OGSCapital, we have helped various entrepreneurs craft winning business plans. Our consultants provide end-to-end support – from market research and competitor analysis to realistic profitability forecasts. We understand the medical device industry inside-out, including regulations, manufacturing, and distribution.

Whether you need help with your hospital feasibility study , medical equipment manufacturing business plan, or medical supply store business plan, we tailor our approach to your specific product and goals. Partner with us to launch your startup on the path to profitability and rapid growth.

Frequently Asked Questions

How to start a medical device business.

A strategic business plan is a key ingredient in a startup medical device company. But that alone won’t cut it – the company also requires a talented group of professionals, structured product development procedures, a plan for meeting regulatory guidelines, and effective marketing tactics. A distributor or a medical equipment supplier can help distribute the devices.

How profitable are medical devices?

The medical equipment industry is booming with high growth potential. The average operating margin for medical equipment and supplies companies averages 2.87%. The medical device market will grow at a CAGR of 5.5% to 5.9% from 2022 to 2030.

How do I market my medical device?

As highlighted in our Medical Clinic Business Plan , some popular marketing channels to market a medical device include online platforms, social media, trade shows, conferences, webinars, publications, referrals, and testimonials. A medical equipment rental company can also help market the device.

OGSCapital’s team has assisted thousands of entrepreneurs with top-rate business plan development, consultancy and analysis. They’ve helped thousands of SME owners secure more than $1.5 billion in funding, and they can do the same for you.

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Medical Device Business Plan Template

Written by Dave Lavinsky

Medical Device Business Plan

Over the past 20+ years, we have helped over 500 entrepreneurs and business owners create business plans to start and grow their medical device companies.

If you’re unfamiliar with creating a medical device business plan, you may think creating one will be a time-consuming and frustrating process. For most entrepreneurs it is, but for you, it won’t be since we’re here to help. We have the experience, resources, and knowledge to help you create a great business plan.

In this article, you will learn some background information on why business planning is important. Then, you will learn how to write a medical device business plan step-by-step so you can create your plan today.

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What is a Medical Device Business Plan?

A business plan provides a snapshot of your medical device business as it stands today, and lays out your growth plan for the next five years. It explains your business goals and your strategies for reaching them. It also includes market research to support your plans.

Why You Need a Business Plan for a Medical Device Business

If you’re looking to start a medical device business or grow your existing medical device company, you need a business plan. A business plan will help you raise funding, if needed, and plan out the growth of your medical device business to improve your chances of success. Your medical device business plan is a living document that should be updated annually as your company grows and changes.

Sources of Funding for Medical Device Businesses

With regards to funding, the main sources of funding for a medical device business are personal savings, credit cards, bank loans, and angel investors. When it comes to bank loans, banks will want to review your business plan and gain confidence that you will be able to repay your loan and interest. To acquire this confidence, the loan officer will not only want to ensure that your financials are reasonable, but they will also want to see a professional plan. Such a plan will give them the confidence that you can successfully and professionally operate a business. Personal savings and bank loans are the most common funding paths for medical device companies.

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How to write a business plan for a medical device business.

If you want to start a medical device business or expand your current one, you need a business plan. The guide below details the necessary information for how to write each essential component of your medical device business plan.

Executive Summary

Your executive summary provides an introduction to your business plan, but it is normally the last section you write because it provides a summary of each key section of your plan.

The goal of your executive summary is to quickly engage the reader. Explain to them the kind of medical device business you are running and the status. For example, are you a startup, do you have a medical device business that you would like to grow, or are you operating an established medical device business that you would like to sell?

Next, provide an overview of each of the subsequent sections of your plan.

• Give a brief overview of the medical device industry.
• Discuss the type of medical device business you are operating.
• Detail your direct competitors. Give an overview of your target customers.
• Provide a snapshot of your marketing strategy. Identify the key members of your team.
• Offer an overview of your financial plan.

Company Overview

In your company overview, you will detail the type of medical device business you are operating.

For example, you might specialize in one of the following types of medical device businesses:

• Class 1 medical device: This type of medical device is one that poses low risk to end-users and does not have too many regulatory controls. Stethoscopes and tongue depressors are some examples of Class 1 medical devices.
• Class 2 medical device: This type of medical device could pose higher risk to end-users than Class 1, thus requiring the company to submit a Premarket Notification 510(k) form to the FDA before the product can be sold. Examples of Class 2 medical devices include catheters and surgical tools.
• Class 3 medical device: This type of medical device poses more of a risk to the end-user than Class 1 or Class 2 devices. For this reason, companies selling Class 3 devices must go through a more stringent FDA approval before the product can be sold. Examples of Class 3 devices include cochlear implants and pacemakers.

In addition to explaining the type of medical device business you will operate, the company overview needs to provide background on the business.

Include answers to questions such as:

• When and why did you start the business?
• What milestones have you achieved to date? Milestones could include the number of customers served, the number of products sold, or reaching $X amount in revenue, etc.
• Your legal business Are you incorporated as an S-Corp? An LLC? A sole proprietorship? Explain your legal structure here.

Industry Analysis

In your industry or market analysis, you need to provide an overview of the medical device industry.

While this may seem unnecessary, it serves multiple purposes.

First, researching the medical device industry educates you. It helps you understand the market in which you are operating.

Secondly, market research can improve your marketing strategy, particularly if your analysis identifies market trends.

The third reason is to prove to readers that you are an expert in your industry. By conducting the research and presenting it in your plan, you achieve just that.

The following questions should be answered in the industry analysis section of your medical device business plan:

• How big is the medical device industry (in dollars)?
• Is the market declining or increasing?
• Who are the key competitors in the market?
• Who are the key suppliers in the market?
• What trends are affecting the industry?
• What is the industry’s growth forecast over the next 5 – 10 years?
• What is the relevant market size? That is, how big is the potential target market for your medical device business? You can extrapolate such a figure by assessing the size of the market in the entire country and then applying that figure to your local population.

Customer Analysis

The customer analysis section of your medical device business plan must detail the customers you serve and/or expect to serve.

The following are examples of customer segments: individuals, schools, families, and corporations.

As you can imagine, the customer segment(s) you choose will have a great impact on the type of medical device business you operate. Clearly, individuals would respond to different marketing promotions than corporations, for example.

Try to break out your target customers in terms of their demographic and psychographic profiles. With regards to demographics, including a discussion of the ages, genders, locations, and income levels of the potential customers you seek to serve.

Psychographic profiles explain the wants and needs of your target customers. The more you can recognize and define these needs, the better you will do in attracting and retaining your customers.

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Competitive Analysis

Your competitive analysis should identify the indirect and direct competitors your business faces and then focus on the latter.

Direct competitors are other medical device businesses.

Indirect competitors are other options that customers have to purchase from that aren’t directly competing with your product or service. This includes alternative medical devices and other types of medical device retailers. You need to mention such competition as well.

For each such competitor, provide an overview of their business and document their strengths and weaknesses. Unless you once worked at your competitors’ businesses, it will be impossible to know everything about them. But you should be able to find out key things about them such as

• What types of customers do they serve?
• What type of medical device business are they?
• What is their pricing (premium, low, etc.)?
• What are they good at?
• What are their weaknesses?

With regards to the last two questions, think about your answers from the customers’ perspective. And don’t be afraid to ask your competitors’ customers what they like most and least about them.

The final part of your competitive analysis section is to document your areas of competitive advantage. For example:

• Will you make it easier for customers to acquire your product?
• Will you offer products or services that your competition doesn’t?
• Will you provide better customer service?
• Will you offer better pricing?

Think about ways you will outperform your competition and document them in this section of your plan.  

Marketing Plan

Traditionally, a marketing plan includes the four P’s: Product, Price, Place, and Promotion. For a medical device business plan, your marketing strategy should include the following:

Product : In the product section, you should reiterate the type of medical device company that you documented in your company overview. Then, detail the specific products or services you will be offering. For example, will you provide surgical instruments, implants, or test kits?

Price : Document the prices you will offer and how they compare to your competitors. Essentially in the product and price sub-sections of your plan, you are presenting the products you offer and their prices.

Place : Place refers to the site of your medical device company. Document where your company is situated and mention how the site will impact your success. For example, is your medical device business located in a busy retail district, a business district, a standalone building, or purely online? Discuss how your site might be the ideal location for your customers.

Promotions : The final part of your medical device marketing plan is where you will document how you will drive potential customers to your location(s). The following are some promotional methods you might consider:

• Advertise in local papers, radio stations and/or magazines
• Reach out to websites
• Distribute flyers
• Engage in email marketing
• Advertise on social media platforms
• Improve the SEO (search engine optimization) on your website for targeted keywords

Operations Plan

While the earlier sections of your business plan explained your goals, your operations plan describes how you will meet them. Your operations plan should have two distinct sections as follows.

Everyday short-term processes include all of the tasks involved in running your medical device business, including answering calls, meeting with potential customers, scheduling shipments, billing customers and collecting payments, etc.

Long-term goals are the milestones you hope to achieve. These could include the dates when you expect to acquire your Xth customer, or when you hope to reach $X in revenue. It could also be when you expect to expand your medical device business to a new city.  

Management Team

To demonstrate your medical device business’ potential to succeed, a strong management team is essential. Highlight your key players’ backgrounds, emphasizing those skills and experiences that prove their ability to grow a company.

Ideally, you and/or your team members have direct experience in managing medical device businesses. If so, highlight this experience and expertise. But also highlight any experience that you think will help your business succeed.

If your team is lacking, consider assembling an advisory board. An advisory board would include 2 to 8 individuals who would act as mentors to your business. They would help answer questions and provide strategic guidance. If needed, look for advisory board members with experience in managing a medical device business.  

Financial Plan

Your financial plan should include your 5-year financial statement broken out both monthly or quarterly for the first year and then annually. Your financial statements include your income statement, balance sheet, and cash flow statements.

Income Statement

An income statement is more commonly called a Profit and Loss statement or P&L. It shows your revenue and then subtracts your costs to show whether you turned a profit or not.

In developing your income statement, you need to devise assumptions. For example, will you keep 300 devices on-hand and will sell and restock your inventory every 3 months? And will sales grow by 2% or 10% per year? As you can imagine, your choice of assumptions will greatly impact the financial forecasts for your business. As much as possible, conduct research to try to root your assumptions in reality.

Balance Sheets

Balance sheets show your assets and liabilities. While balance sheets can include much information, try to simplify them to the key items you need to know about. For instance, if you spend $50,000 on building out your medical device business, this will not give you immediate profits. Rather it is an asset that will hopefully help you generate profits for years to come. Likewise, if a lender writes you a check for $50,000, you don’t need to pay it back immediately. Rather, that is a liability you will pay back over time.

Cash Flow Statement

Your cash flow statement will help determine how much money you need to start or grow your business, and ensure you never run out of money. What most entrepreneurs and business owners don’t realize is that you can turn a profit but run out of money and go bankrupt.

When creating your Income Statement and Balance Sheets be sure to include several of the key costs needed in starting or growing a medical device business:

• Cost of equipment and office supplies
• Payroll or salaries paid to staff
• Business insurance
• Other start-up expenses (if you’re a new business) like legal expenses, permits, computer software, and equipment

Attach your full financial projections in the appendix of your plan along with any supporting documents that make your plan more compelling. For example, you might include your business location lease or a list of medical devices in your inventory.

Medical Device Business Plan Template PDF

You can download our medical device business plan PDF to help you get started on your own business plan.

Writing a business plan for your medical device business is a worthwhile endeavor. If you follow the template above, by the time you are done, you will truly be an expert. You will understand the medical device industry, your competition, and your customers. You will develop a marketing strategy and will understand what it takes to launch and grow a successful medical device business.  

Don’t you wish there was a faster, easier way to finish your Medical Device business plan?

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Since 1999, Growthink has developed business plans for thousands of companies who have gone on to achieve tremendous success.   Click here to see how a Growthink business planning consultant can create your business plan for you.

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Medical Sales 30-60-90 Day Plan: An Overview and Examples

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A commonly overlooked component of the medical sales interview process is the development of a  30-60-90 Day Plan tailored specifically to medical sales.

In this article, we'll review what a 30-60-90 Day Plan is, how to structure it specifically for medical sales, and finally, conclude with some examples.

What is a  30-60-90 Day Plan?

It is highly recommended that you complete a 30-60-90 Day Plan for each role you apply to in medical sales.  The purpose of this document is to outline what you plan to accomplish during your first 30 days, 60 days, and 90 days on the job. The action plan that you set forth needs to strike a balance between being ambitious yet realistic.

The Recruiter or Hiring Manager will most likely not ask you for the 30-60-90 Day Plan outright during the recruiting process.  Why?  It is often implied that the interviewee applying for a sales role knows to craft it. Secondly, the Hiring Manager wants to see if you take the initiative to go the extra mile to secure the role. 

Prior to your first round interview with the Hiring Manager, send across a PowerPoint or Microsoft Word document containing your 30-60-90 Day Plan to demonstrate that you are:

• Proactive go-getter
• A logical thinker who has a concrete plan to hitting your numbers
• Clear on the expectations of the role

 Your plan should focus on addressing the following:

• Administrative Tasks
• Relationship Development
• Knowledge Development (products, accounts, industry)
• Opportunity Identification
• Risk Mitigation

Each action point that you set forth in your plan should address one of the following points above.

The Structure of the Plan

The structure of your plan is flexible; however, we recommend that you include 5 subsections: 

Let's dive deeper into each section:

Fiscal Year Goals

This section describes 2-3 action points that you plan to accomplish during the first fiscal year on the job. Your fiscal year goals should be ambitious yet practical.

Examples include:

• Finish the year at [XXX] % to plan
• Gain a comprehensive understanding of surgical techniques, instruments, and trays

Five Year Goals

This section describes 2-3 action points that you plan to accomplish during the five years on the job. Ideally, this section should focus on aggressive growth — sales growth and professional growth.

• Attain quota [Years] out of [Years] years
• Grow market share so that [Territory Name] is a top performing territory in the [Division Name] division

30 Day Plan

30 Day Plan should be actionable and realistic for the first month on the job. List out 5-7 bullet points or short sentences in this section. We recommend that you focus on addressing quick wins — training, administrative, and unfinished deals. Furthermore, you should focus on familiarizing yourself with your products, accounts, and surgeons (or purchaser).

• Force rank accounts based on FY [XX] projected revenue
• Profile Surgeons in territory — compile education, certifications, awards

60 Day Plan

60 Day Plan focus on following through, cementing relationships, and identifying opportunities.  List out 5-7  bullet  points or short sentences in this section. W e recommend that you piece together a prospecting plan outlining: key targets, clinical messaging, follow up schedule, and objection handling.

• Quantify prospecting model to determine:
• # of cases per surgeon per month
• Average # of trials per successful close
• Design competitive defense plan identifying surgeons that require the most service

90 Day Plan

Your 90 Day Plan should be laser-focused on zeroing in on closing deals.  List out 5-7  bullet  points or short sentences in this section.  You should outline how to plan to convert competitor accounts to your products and how you plan to follow up on leads. Additionally, include verbiage on how you plan to continue to build upon your current account and industry knowledge.

• Grow market share at existing accounts:
• Develop pricing proposals and pricing incentives (eg: consignments, discounts)
• Identify cross-selling opportunities
• Continue to advance Clinical Knowledge
• Stay current with new surgical techniques by watching procedures online for [Surgery #1] , [Surgery #2] , and [Surgery #3]

For more details, templates, and examples for each section of the 30-60-90 Day Plan, view our Breaking Into Medical Sales All-In Course .

Megan Moore

August 13, 2022

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Medical Equipment Business Plan

Start your own medical equipment business plan

MedNexis, Inc.

Executive summary executive summary is a brief introduction to your business plan. it describes your business, the problem that it solves, your target market, and financial highlights.">.

MedNexis, Inc. (the company) is a medical device development company that has designed and patented medical devices which it plans to produce and market. A magnetic muscle stimulator/field generator has been designed with the participation of leading medical personnel and biomedical engineers. One patent is initially incorporated.

Allopathic Medicine

One market addresses the unanswered need of atrophy prevention/treatment in conditions resulting in patient immobilization for greater than two weeks. After two weeks of immobilization, the average muscle loses over 30% of its mass, resulting in an increased time to complete recovery. A new and innovative design, dubbed the MedStim system, has been created to answer this need for an effective, easy-to-use atrophy prevention/treatment device. The number of indications for this device is expected to rise as further research on the benefits of pulsed magnetic fields unfolds. For example, pulsed field magnetism has recently been shown in controlled studies to be an effective treatment in accelerating the healing of skeletal fractures.

The market for magnetic stimulation devices in allopathic medicine is existent, but in the embryonic stages and subject to explosive growth once the technology proves cost-effective. This potential market has reached an estimated 4.2 million patients in the United States. The new and innovative device designed to target this market has been named the MedStim system.

Alternative Medicine

Another market addresses an unanswered need in the alternative medicine market for a device which will provide a more powerful and consistent therapeutic magnetic field. Dynamic magnetic field therapy (the treatment of soft tissue with variable magnetic pulses) is currently thought to have beneficial effects on circulation, immune system function, wound healing, etc., in the alternative healthcare sector and these effects are thought to be proportional to the strength of the magnetic field generated. The new and innovative design created to answer this need for a more powerful therapeutic magnetic field in alternative medicine has been named the TheraMag system. This market is in existence and is expected to have the potential of approximately 40 million customers in the United States on our starting date.

Patent applications on the company’s first market entries have been filed using a patent agent specializing in biomedical device patents. MedNexis’ technology utilizes the principal that a current in a coil will generate a magnetic field which will, in turn, generate a current in any conductive material within this field. This model is currently effectively applied in diagnostic studies in which single nerves are stimulated with magnetism for diagnostic purposes alone. Using this model, and considering the human nerve to be the conductive material, MedNexis has developed an electromagnetic device which will painlessly stimulate human muscles to contract. Applications of this technology are numerous, with the following devices being those initially marketed:

MedNexis’ patented device will be tailored to effectively stimulate muscle. This will require larger electrical currents, greater functionality, and a wider range of settings. This device will be marketed for mainstream, allopathic medicine

TheraMag- MedNexis’ patented device will bathe tissue in a magnetic field without causing contraction of the muscle. This device will be marketed for alternative applications.

MedNexis will target the following two markets: allopathic and alternative medicine. In order to effectively distance the two products from possible negative connotations associated with alternative medicine in the field of allopathic medicine, the two devices will be given separate and distinct names: MedStim for the allopathic medicine device and TheraMag for the alternative medicine device.

MedStim will be distributed through channels dominated by large distributors and strategic association with these players will be key to gaining acceptance in this market. Furthermore, physicians will demand randomized, controlled study data, the production of which will be the focus of the bulk of MedNexis’ early efforts in this market.

TheraMag will be distributed to alternative medicine centers which are less centralized and direct sales will also be possible. Less scientific proof is required by this market, and entrance will be immediate once the FDA issues an Investigational Device Exemption.

Regulatory Issues

Through obtaining an Investigational Device Exemption and clearly labeling the product “For Investigational Use Only,” FDA regulations will be satisfied and market entrance will be expedited. Acceptance of these products based on successful research results will drastically increase demand and allow for expansion to foreign markets

Major Milestones

Animal stage Research and Development underway, early Year One.

• Extend patent coverage to Australia, Europe and Canada, middle Year One
• Human clinical trials underway, middle Year Two.
• Research studies published, end of Year Two.
• TheraMag for sale, end of Year One.
• MagnaStim for sale, labeled as ‘For Investigational Use Only’, end of Year Two.
• Profitability established by Year Four.

Competitive Advantage

While the MagnaStim and TheraMag devices are effective and user-friendly, with multiple home healthcare applications, all the competing devices currently on the market are only partially effective or difficult and awkward to use for the recommended therapeutic treatment. MedNexis will use its patented designs to fill the need in the market for an easier to use, more effective magnetic stimulator/field generator.

Based on detailed financial projections, if the company receives the $750,000 in funding, it will operate profitably by Year 3. The company projects $23.5 million in sales with a formidable net profit in Year 3, with projections based on penetration of less than 3% in any market segment.

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Medical Equipment Business Plan

If you are planning to start a new manufacturing business, the first thing you will need is a business plan. Use our Lanzor – medical equipment manufacturing business plan example created using Upmetrics business plan software to start writing your business plan in no time.

Before you start writing your business plan for your new medical equipment manufacturing business, spend as much time as you can reading through some examples of manufacturing business plans.

Reading some sample business plans will give you a good idea of what you’re aiming for, and also it will show you the different sections that different entrepreneurs include and the language they use to write about themselves and their business plans.

We have created this medical equipment business plan example for you to get a good idea about how a perfect manufacturing business plan should look like and what details you will need to include in your stunning business plan.

Medical Equipment Business Plan Example Outline

This is the standard medical equipment manufacturing business plan outline which will cover all important sections that you should include in your business plan.

• Market and Opportunity
• Commercialized Products
• Products Under Development
• Competition
• Competitive Advantages
• Marketing and Distribution
• Frank Martin
• Evgeny Shaman
• Kimberly Patric
• Robert Stoddard
• Board of Directors
• Scientific Advisory Board and Clinical Investigators
• Professional Services
• Projected Revenue
• Projected Net Income
• Coronary Artery Disease (CAD)
• Diagnosing CAD
• Treating CAD
• Catheter-Based Procedures
• SmartFlowTM Console
• SmartFlow CFR/FFR Module
• SmartFlow Multiple lesionTM Module
• SmartFlow PTC Module
• SmartFlow@ Pressure Guide Wire (Consumable Product)
• SmartFlow Renal
• Myocardial Perfusion (Distal Vascular Bed)
• Product Acquisitions
• Intellectual Property
• Number of Cath Labs
• Number of Cam Procedures
• Spending on Oath Lab Equipment
• Patient Base
• Economic Impact
• Market Potential
• Interest in Physiologic Data
• Direct Competitors
• Indirect Competitors
• Summary of Competitive Advantages
• Pricing Strategy
• Sales and Marketing Strategy
• Sales Forecast
• Regulatory Approval
• Reimbursement
• Manufacturing and Distribution
• Market Risks
• Competitive Risks
• R&D Risks
• Legal Risks
• History and Structure
• Office Locations
• Evgeny Shalman
• Dov Gal, D.V.M.
• Gideon Tolkowsky
• Hillel Bachrach
• Shmuel Einav
• Takashi Akasaka
• Rafael Beyar
• Bernard De Bruyne
• Organization Chart
• Key Open Positions
• General Assumptions and Notes
• Revenue Assumptions
• Expense Assumptions
• Summary Income Statement($000)
• Capital Requirements a Use of Proceeds
• Exit Strategy

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After getting started with Upmetrics , you can copy this medical equipment business plan example into your business plan and modify the required information and download your medical equipment business plan pdf and doc file. It’s the fastest and easiest way to start writing your business plan.

Download a sample medical equipment business plan

Need help writing your business plan from scratch? Here you go;  download our free medical equipment business plan pdf  to start.

It’s a modern business plan template specifically designed for your medical equipment business. Use the example business plan as a guide for writing your own.

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About the Author

Vinay Kevadiya

Vinay Kevadiya is the founder and CEO of Upmetrics, the #1 business planning software. His ultimate goal with Upmetrics is to revolutionize how entrepreneurs create, manage, and execute their business plans. He enjoys sharing his insights on business planning and other relevant topics through his articles and blog posts. Read more

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• February 9, 2023

Medical Device Sales: 9 Strategies for Success in 2023

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The medical field is growing.

The OECD  recently said that spending on healthcare across the globe is now 8.8% of GDP. Furthermore, the organization predicts it will outpace the GDP by 2030.

This is great news for those in medtech sales! But to truly capitalize on this growth, you must ensure your team is well trained and equipped with the right tools.

What does this look like? You must experiment with different strategies and software platforms to see what works best for your team. And your reps need to adopt an omnichannel process that uses all of the medical device sales channels at their disposal. If you do these two things, you’ll succeed.

We want to help you with this process. So in this article, we’ll outline the numerous challenges modern medical device sales reps face. Then we’ll show you how to overcome them by sharing 9 tips to increase medical device sales. Let’s dive in!

Modern challenges for medical device sales reps

Let’s start by looking at the five challenges you and your team face. Each threatens to derail your medical device sales process in some way. The five challenges are:

Building customer relationships

You know the stat: it’s five times more expensive  to acquire a new customer than it is to retain an existing one. So it makes sense to build strong relationships with your target audience and prioritize retention over various metrics.

Unfortunately, most doctors are incredibly busy. Very few will give your reps the time to pitch products effectively and make sales.

Understanding and explaining complex products

Challenge number two: the actual products you and your team sell.

Medical devices are intricate pieces of technology built to remedy complicated ailments. This fact often puts reps in an incredibly difficult situation.

First, they have to understand the medical conditions their products help cure. Then they have to learn how said products work. Finally, they must convey all of this information to knowledgeable prospects, who will likely ask detailed questions.

And we haven’t even talked about the ever-changing laws, regulations, and standards that plague the medical field. It’s a lot to deal with regularly.

Adapting to an omnichannel sales process

As of August 2021, only 58% of physicians  want to meet with medical sales reps face-to-face. That means that a huge portion of your target audience would rather communicate with your reps via phone, email, and/or video conference.

What does this mean for your sales team? You must adopt omnichannel medical device sales strategies to succeed in 2023 and beyond.

If your reps don’t use every channel they can to connect with doctors, they won’t make enough sales. But adjusting to this new reality can be challenging.

Increased competition

Your sales team also faces more competition than ever before.

There are a lot of companies trying to get into medtech sales. To meet and exceed your sales goals, you must devise ways to beat these competitors.

It won’t be easy, though. As mentioned earlier, fewer doctors accept in-person meetings. To build winning relationships—the kind that other reps can’t break apart—you need to use all of the medical device sales channels at your disposal. But again, transitioning to this sales model won’t be a walk in the park.

Expected personalization in the sales process

Finally, modern physicians expect personalized sales pitches.

They want to know about the products and services that solve their  pain points. That’s it. Reps that waste their time with anything else will quickly get the boot.

Sadly, not every medical device sales rep is trained to deliver personalized pitches. Many are encouraged to memorize a specific script. Then deliver said scrip, word for word, to potential customers. This method won’t cut it in years to come if you expect to separate yourself from the competition.

The shift to a hybrid sales model

We’ve mentioned it a few times, but we’ll say it again: most doctors are open to remote interaction with medtech sales reps. Many actually prefer it.

To succeed in this field , you and your team must shift to a hybrid sales model.

What does this hybrid approach look like? It will look slightly different for every customer your reps talk to. Why? Because a hybrid approach accounts for the customer’s preferred communication channels, then attempts to use them.

For example, Doctor A might be too busy to meet with reps in-person, but a quick email, which they can read on the weekend, maybe a perfect way to connect.

Doctor B, on the other hand, hates crowded inboxes and is quick to delete messages. Call their office on the phone, however, and you’ll likely talk to a lovely receptionist who will schedule you for an in-person meeting in the next few weeks.

An omnichannel approach is key to a strong medical device sales process in 2023. You need to meet physicians where they want to be met to close deals.

9 ways to increase medical device sales

Now that we’ve covered the challenges that medtech sales reps face and the hybrid shift the industry is currently experiencing let’s talk strategy. Here are 9 tips to help you overcome the challenges above and succeed in medical device sales.

Define your ideal customer profile

First, decide who you’re going to sell medical devices to .

When you know who your ideal customer is, you can target these professionals, boost your productivity levels, and increase your chances of success.

Once you’ve defined who you’ll sell to, create an ideal customer profile (ICP) and give it to your reps. Not familiar with the term? An ICP is a fictional representation of an individual or company that will benefit most from your products.

Your ICP should include geographical and financial information, as well as the top goals and pain points that your ideal customers have/deal with.

Provide specialized product training

Next, teach your reps everything they need to know about the products you sell.

This will probably be a gargantuan task, as most medical devices are complex. Still, it must be done if you want your reps to make sales consistently.

When your reps have a firm grasp of the products you sell, educate them on the ailments said devices were created to cure. It wouldn’t hurt to teach them about competing products and the medical field in general, either.

Focus on the patient benefits

Doctors care for patients. They’re interested in products that help them do this more effectively. Your reps should keep this in mind during their sales pitches.

Whenever your reps talk with physicians, they should lead the conversation with patient  benefits. How will the devices your company sells reduce pain? How will they speed up recovery time? These are essential questions to answer.

Using this strategy will make your reps seem more empathetic. It will also cut straight to the physician’s goals: improving the lives of the people they care for.

Highlight the economic benefits too

Patient benefits are essential, so we suggest leading your sales pitches with them. But let’s be real, economic benefits are important, too.

Your reps will close more deals if they can make the products they sell more financially appealing. How can doctors save money by purchasing your products?

We’re not just talking about limited-time deals here. (Though, a discount offer can help move the needle.) We’re talking about long-term economic benefits. Will your product help physicians bring in more patients or something similar?

If so, make sure your sales reps stress these benefits during their presentations, too.

Use a multichannel sales strategy

Different doctors like to engage with medtech sales reps in different ways. By adopting a multichannel sales strategy, you can cater to everyone’s preferences.

Don’t worry, it’s not hard to do. Tools like SPOTIO make multichannel  comms  a piece of cake. Our platform, for example, will automatically capture contact data for reps. They’ll never have to manually log a visit, call, email, or text data again.

Even better, reps can communicate with prospects via the SPOTIO platform as well. Make calls and automate sales emails and texts from a single interface.

Build and nurture relationships

Your reps won’t make sales if their prospects don’t know and trust them. That’s why the best medical device sales strategies focus on relationship-building .

How do you build solid relationships in this industry? Make sure your reps tell the truth about the products they sell, always keep their promises, and communicate with leads on a regular basis. (Just not  too  regular. Doctors don’t want daily emails.)

As your reps’ relationships with their prospects grow, they can personalize their outreach efforts more, too. For example, they’ll know which doctors like to shoot the breeze and which like to get right down to business. They can then use this knowledge to craft better experiences for each prospect, leading to more sales.

Set minimum daily sales activities

It doesn’t matter how well-trained your medtech sales reps are. They can’t control who buys from them and who doesn’t. They can  control their effort levels, though.

For this reason, set minimum daily sales activities for your sales team.

Reps should be required to make a certain amount of visits/calls and send a certain amount of emails/texts per day. This will hold them accountable.

It will also give you the information to know if poor performance is due to effort or training. You can then adjust your medical device sales process to match.

Automate the sales process

Automation will supercharge your sales team.

Seriously, once you invest in the right tool, you’ll be able to streamline admin work, build automatic outreach campaigns, and a whole lot more. Take advantage!

The question is, which automation platform is best for you? Since you’re in medtech sales and likely manage a field sales team , SPOTIO is a good bet.

With our platform, reps can automate their email and text campaigns . They can automate calls and visit reminders, too, which will prevent leads from falling through the cracks. Oh, and forget about tedious administrative tasks. SPOTIO handles many of them, boosting rep productivity by a whopping 46%.

Track activity and performance metrics

Finally, track individual and  team performance. Doing so will help you learn what you’re doing right and where you need to improve. You can then adjust your medical device sales strategies to ensure greater success in the future.

Once again, SPOTIO is an ideal tool for this .

Sales managers can easily see where their field reps are in real-time, view activity metrics, and understand how specific actions lead to certain results. Important KPIs can then be reported on using the My Reports  feature.

Enable medical device sales reps for success

Medical sales is changing. Your sales team needs to change with it by adopting a hybrid communication strategy and implementing the tips above. Once you do, your reps will experience more success and your company will beat its competitors.

To help you accomplish these things, consider investing in SPOTIO. Our platform was specifically made for field sales teams. As such, it has the tools your team needs to succeed. Sign up for a free demo of SPOTIO today  to see it in action!

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7 steps to building a winning medtech sales strategy

Apr 5th, 2024

The world of medical device sales is a complex one. You have a life-changing product, but reaching the right people and guiding them through the buying journey can be daunting. This blog, adapted from our comprehensive e-book, summarizes the seven crucial steps to medical device sales success. For a deeper dive into these concepts and a comprehensive roadmap to medtech sales, download the e-book .

Step 1: Define your ideal customer

In medtech sales , success hinges on knowing exactly who you’re selling to. Not all providers and facilities have the same challenges or needs, so pinpointing the specific organizations that can unlock the greatest value from your medtech solutions is key. Here's where your ideal customer profile comes in. Think of it as a blueprint for your perfect partner. This profile should go beyond demographics. Define your goals, timeframe, and capabilities. Then figure out the value you provide and the value an ideal customer brings to you. By understanding your ideal customer, you can target these providers and facilities with laser precision.

Step 2: Segment the market

Once you've identified your ideal customer, the next step is to segment the market . The medical device market is vast and complex. Targeting every facility or provider is an inefficient and costly approach. Grouping together organizations with similar characteristics allows you to streamline your sales strategies and tailor your approach to each segment's specific needs. A few segmentation approaches include:

• Hospitals/IDNs : Segmentation can consider factors like GPO affiliation, IDN affiliation, hospital type, and account size.
• Physicians : You can segment based on physician specialty, affiliation type, referral volumes, and annual procedure/diagnosis volumes.
• Alternate sites: Consider facility type (e.g., imaging center, outpatient clinic), network affiliation, and procedure volume.

By segmenting the market, you can develop targeted marketing campaigns, allocate resources more effectively, and prioritize your sales efforts based on the potential of each segment. Ultimately, focusing on the most promising segments allows you to optimize your efforts for the best return on investment.

Step 3: Map your territory

With market segmentation in place, it's time to map out your territories to ensure efficient coverage. Divide your segmented market into manageable geographic areas, considering factors such as technology adoption rates, demographic and firmographic data, and competition. Mapping territories allows you to strategically allocate sales resources, prioritize accounts, and plan efficient travel routes for sales representatives. By mapping out territories, you can streamline your sales efforts and ensure comprehensive coverage across your target market.

Step 4: Target the right accounts

Within each territory, focus on identifying high-potential accounts that are most likely to benefit from your medical device. Conduct in-depth research to understand the specific needs, challenges, and priorities of each account. Pinpoint key decision-makers and influencers within the organization and tailor your sales approach to resonate with their objectives. For instance, when targeting IDNs , messaging should go beyond HCP-centric value propositions. It should also align with the quality measures and cost drivers specific to the IDN. By zeroing in on the right accounts with the right message, you can prioritize your sales efforts and improve your chances of success.

Step 5: Pre-call planning is key

Before every call or meeting, become an expert on the account. Research their challenges, budget constraints, and existing solutions. Use this intel to craft a laser-focused message. Here's the magic: by highlighting how your device addresses their specific needs, you demonstrate that you understand their world. This positions your medical device not just as a product, but as the ideal solution to their problems. Pre-call planning is an investment that pays off in spades. It boosts your credibility, fosters trust, and increases your chances of closing the deal.

Step 6: The art of the sales call

Your sales call is your opportunity to showcase the benefits of your medical device and persuade the customer to make a purchase. Turn your sales call into a problem-solving session. Master the art of active listening to understand the customer's needs and pain points fully. Then, craft your presentation to directly address their specific challenges and priorities.

Don't just talk features – demonstrate how your device directly improves patient outcomes, streamlines workflows, or reduces costs. Quantify the benefits with data and case studies whenever possible. Be ready to answer questions with confidence and overcome objections with persuasive arguments. A successful sales call hinges on effective communication, credibility, and the ability to articulate the value proposition of your device convincingly. By focusing on your prospect’s needs, you can turn features into solutions and conversations into conversions.

Step 7: Build long-term relationships

The medtech sales process doesn't end once the deal closes. A sale marks the beginning of a long-term relationship with the customer. Deliver exceptional post-sales support to ensure smooth implementation of your device and promptly address any questions or concerns. Become a trusted advisor by nurturing ongoing relationships with regular communication, product updates, and personalized support. This commitment to their success fosters customer loyalty and advocacy, turning them into champions for your brand. Remember, building long-term relationships is key to sustainable business growth and maximizing the value you bring to your customers throughout their journey.

By following these seven steps, you'll be well on your way to mastering medical device sales. Remember, success hinges on truly understanding your customers, crafting targeted strategies that resonate with their needs, and building long-lasting, trust-based relationships. For a deeper dive into these concepts and a roadmap to medical device sales success, download our comprehensive e-book . Want to put these insights into action even faster? Book a demo of our newest medtech solution Carevoyance and gain access to the intelligence you need to streamline your sales process and maximize your impact.

About the Author

Nicole witowski.

Nicole Witowski is a Senior Content Writer at Definitive Healthcare. She brings more than 10 years of experience writing about the healthcare industry. Her work has been…

Top 3 Medical Device Sales Strategies to Grow Sales in 2024

Let’s face it: the pandemic changed things for a lot of business. Sales teams that relied on meeting face to face with clients and prospects were suddenly forced to reimagine the way they did their job. Entire sales processes were upended, and while some companies faced setbacks, others simply didn’t survive. Medical device sales teams were no exception.

In this article, we give you the strategies you need to be using to grow your sales in 2024 and beyond. Keep reading to learn more!

A Well-Developed Sales Process in Use

For many companies, COVID not only forced them to reimagine their sales experience, but it also showed sales managers the weaknesses in their overall sales process. In the spirit of keeping first things first, you need to have a well-developed foundational sales process before incorporating the strategies discussed below.

If you haven’t already, it’s worth taking a step back and analyzing your sales process, start to finish. Doing the hard work now will pay dividends for years to come by allowing your sales team to operate at higher levels for a longer period of time.

You’ll want to make sure you take the time to thoroughly analyze your sales process to address the weaknesses and make improvements. While you’re doing this, talk to your sales team to get their feedback, and the feedback they hear on a daily basis from prospects and clients. This information can make the difference between having a mediocre sales process and having a great sales process. After all, as HubSpot notes, the most important component of choosing and implementing your sales strategy is your customer.

As you invest in building a well-developed sales process, you can work in the appropriate strategies into your sales process and put them to use.

3 Medical Device Sales Strategies for Growth

A sales strategy is defined as a documented plan for selling your product or service to potential clients in a way that differentiates your offering from your competitors.

Within your sales organization, a sales strategy is meant to provide clear guidance to your sales representatives. This helps them communicate clearly both internally and externally and keeps the sales team on the same page.

In its simplest form, a sales strategy exists to make sure your salespeople hit their goals, and that your business as a whole grows.

There’s plenty of information on the internet about sales strategies, but they all start to sound the same after a while. For example, if you search for “sales strategy” on Inc.com, you will get over 12,770 results! Unfortunately, a lot of good information gets drowned out by all the noise. That’s why we’ve provided the top three medical device sales strategies that you probably haven’t heard of below.

1. Study Your Competition That is Crushing It

Whether you are the leader in your industry, or just getting started, there is a lot that can be learned by studying your competition. Industry “leaders” being replaced by new startups happens more now than ever. They don’t simply get unseated as the leader. The new startup has to be doing something remarkable to accomplish that.

And at the same time, in other industries, the leaders have created such a competitive advantage, new ventures have no chance at unseating them.

The point here is that you can always learn something by studying your competition, both big and small.

The reality is that 2020 shook up a lot of things. Some companies adjusted better than others, and some sales teams adapted better than others. If you feel your sales team is still missing something, or that your sales process is weak, start by studying your competitors that are gaining market share. One of the easiest ways is to simply shop their product or offer.

2. Ask Your Customers & Prospects How COVID Affected Business

By now, it’s no surprise that the pandemic brought many challenges for just about every business. Everyone is already thinking about it, and honestly, it’s probably one of the easiest things to talk about right now. But it’s not just about small talk and breaking the ice.

It’s likely that your customers and prospects will actually reveal to you their biggest challenges right now.

As any great salesperson knows, this provides you the opportunity to uniquely position your product or service to solve those challenges for their business. Do not overlook this!

For example, here at Infuse , we help medical device sales organizations by providing them with the technology and resources to increase sales. We offer solutions such as app development, including sales enablement apps, video production and animation. As we’ve had these conversations with our customers and found out what their current challenges are, it has provided us the opportunity to introduce additional services that solve their needs. We get to serve our customers at a higher level and still grow our revenue.

3. Use 3D Animation to Show, Not Tell

With more sales meetings happening remotely, it’s never been more important to make sure your sales teams are equipped to be able to show customers and prospects what your products and services offer. It helps that more and more organizations and people are getting comfortable with video conferencing solutions like Zoom, Google Hangouts and Microsoft Teams.

This means that you can shift what would traditionally be a sales call over the phone to a video conference. You then have the opportunity to use technology to your advantage and actually show your customers your solutions, rather than simply having to tell them about them.

We all know the old saying, “a picture is worth a thousand words.” So how much would a 3D animation that shows your medical device in detail and clearly explains what’s in it for your prospects, including the end result, be worth to your business?

How many more deals do you think your sales team could close in the current environment if they had a powerful 3D animation as part of their sales strategy?

We recently shared how 3D medical animation helps sell medical devices and we invite you to read that article to learn more.

Find the Right Partners

We hope you found the three strategies above helpful and identified ways to grow your sales.

Unfortunately, it’s not always possible to implement every strategy or great idea right away. Often times, businesses find themselves and their employees already stretched thin as they try to maximize the output of every employee. A common solution to this problem is to identify the right partners to help develop and implement strategies to take your business to the next level.

If you find yourself in this situation and are looking for a strategic partner to help you grow your medical device sales in 2021 and beyond, please simply reach out to us. We look forward to helping your business grow!

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Developing Your Business Plan

A Business Opportunity Assessment takes a studied view of the factors that influence a project in given markets and identify risks that might derail a project from achieving commercialization. These often include intellectual property, ownership of the idea, market size and trends, outside influences, regulatory issues, revenue limitations, and current and alternative solutions being used by customers.

Understanding the project in the context of identified threats and opportunities, reveals insight that informs a decision to move forward with the next step towards a commercialization effort. Competitors and prospective customers enlighten the innovator as to where and how they currently buy their products and how they obtain after-the-sale service.

A structured review of these competitive solutions is accomplished by conducting a SWOT (Strength, Weakness, Opportunity, and Threat) analysis. SWOT analyses are used in business strategic planning when decisions about direction, policy or operations need to be made. By performing this analysis on competitors and including the customer’s point of view, insight and direction on how to develop, differentiate and promote the new technology will be gained.

“What doesn’t kill you, makes you stronger” is fine for an exercise routine, but in medical device commercialization, wasted resources, wrong product features, assumptions about adoption, buying, using or any reason at all, has the potential to end your commercialization attempt.

We mitigate errors like those described by embarking on a path to discover what is not known. This uncovers risks that are not known and permits an opportunity to overcome those risks when they are easy and relatively inexpensive to fix and therefor avoid altogether. 

Much as is thought to be known as to who the customer is, every project has twists and turns that result in a shifting landscape. To overcome this undulating hurdle, it is imperative to identify the problem or need from the perspective of each stakeholder who influences the buying decision. Medical device selection, approval and adoption likely have additional stakeholders who have some level of influence, these could include internal clinical review groups, hospital administration, hospital or clinic quality committees, department heads, safety committees, and those involved with distribution or reimbursement. Bring all these opinions to light in order to learn from them what is required for a product/process to be successful in their eyes, which leads to their support.

How a project transforms from an idea into a revenue generating business requires careful consideration because it doesn’t happen by accident. Existing problems have existing solutions. People don’t like change. To overcome inertia (and get someone to pay for the device) the new business needs to understand what outcome would be better than the existing solution. What innovators often do not take into consideration is that their stakeholders fit into an existing business model for some other business that is also vying for the same customer dollars. At a minimum, that business model needs to be understood. Then, devising a replacement business model (which includes the transformed idea into a product needs to consider all the elements necessary to create and deliver that product. The greater this is understood prior to prototyping the less resources will be needed to create a market ready product. 

Without funding, none of the above or aforementioned activities will be accomplished in a timely manner or at all. The need for translational funding varies based on the how far along the development pathway the project is. As a starting point, understand that funding which originates from beyond your own bank account falls into two categories. It is either dilutive or non-dilutive .

When a potential investor wants to give you cash, they want something in return. If what they want is a percentage of ownership, this is described as dilutive funding. Dilutive funding results from investments made by Angel investors, Angel groups, Venture funds, partnerships and possibly family/friends. Dilutive funding refers to a watering down of your ownership percentage. If you are the sole owner, you start off with 100% of the equity of the newly formed company. If there are two owners, you will need to come to an agreement as to who owns what percentage of the company and this agreement may take the form of a partnership agreement (not covered in this guide). Dilutive funding will reduce your equity from 100% to something less. How much less is based on a number of factors; company valuation, amount of investment (equity) which is being infused to the company and risk of failure. Cash or investment for which an investor does not want a percentage of ownership in return for is called non-dilutive funding. Examples of non-dilutive funding includes grants, debt, and gifts. Non-dilutive funding doesn’t affect your ownership percentage.

Product Market document (PMD) is repository of all the business model and customer interviewing information described into concise statements of customer needs. The PMD ensures that all future product development activity is based on customer desires, to create a technology they see value in. The PMD outlines the goal of the product or enhancement, who makes up the target and addressable markets, how the innovation fits into the workflow of users, and potential risks to successful implementation and adoption of the product.

The PMD articulates what the customer wants in the areas of key product capabilities, performance metrics, distribution, documentation and geographic requirements. PMD reduces risk toward the project in two significant ways; 1) it focuses product development on features and benefits that the customers find value in, 2) it ensures that capital and resources are focused on developing features and benefits that are directly related to identified customer value instead of features and benefits that customers will not appreciate or value. With development focused in this way, the end product should be something customers are willing to buy.

Simbex is an experienced medical device and consumer health product design and development partner that excels in transforming your most complex ideas into game-changing commercial solutions.

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Blueprint Launched To Help Medical Device Companies Overcome GPO Barriers

Zane Myers Company introduces the Stakeholder Engagement Blueprint to help medical device companies navigate the complexities of group purchasing organizations (GPOs) and hospital adoption resistance, accelerating market access for cutting-edge medical technologies.

Bellevue, United States - August 22, 2024 —

Zane Myers Company has developed the Stakeholder Engagement Blueprint, a proprietary system designed to assist medical device companies in increasing their sales by helping them navigate the complexities of the healthcare industry and connect with key decision-makers.

Further details are available at https://zanemyers.com/

“GPOs play a significant role in the procurement process, often focusing on contract compliance,” explained Zane Myers, founder of Zane Myers Company. “This can sometimes present challenges for introducing new technologies that fall outside of established agreements.”

Recognizing this challenge, Zane Myers Company has introduced its new Stakeholder Engagement Blueprint, a systematic approach designed to navigate the healthcare system and expedite the adoption of innovative medical devices within healthcare systems across the country. The Blueprint provides a pathway for medical device companies to directly connect with key decision-makers and clinicians, ensuring that groundbreaking technologies do not get lost in the shuffle of bureaucratic resistance.

“While GPOs influence many purchasing decisions, there is also a need to ensure that innovative technologies are given due consideration,” said Mr. Myers. “The Stakeholder Engagement Blueprint helps companies showcase their innovations directly to those who can benefit most—the clinicians.”

Zane Myers Company’s Stakeholder Engagement Blueprint is particularly effective in addressing the problem of innovation adoption in healthcare, where the process of building trust and gaining consensus among stakeholders can be slow and resource-intensive. By leveraging targeted outreach, video testimonials from respected clinicians, and a dedicated follow-up team, the Blueprint accelerates the sales cycle, reduces the cost per sale, and drives faster, more profitable growth for medical device companies.

With the Stakeholder Engagement Blueprint, sales professionals will learn how to gain direct access to clinicians. By helping medical companies navigate administrative roadblocks, the Blueprint makes it easy for innovations to reach the clinicians who are most likely to champion them.

Additionally, the Blueprint aids clients in expediting trust-building. Through peer-to-peer video endorsements, it rapidly establishes credibility and trust—a process that traditionally takes months or even years for medical device companies to achieve.

Zane Myers Company also provides comprehensive support for medical device companies. From initial outreach to securing appointments, the Blueprint offers a complete system for engaging healthcare stakeholders and driving adoption.

Zane Myers Company is committed to helping medical device companies overcome the traditional barriers to market entry, enabling them to bring their innovative technologies to the forefront of healthcare. "With the Stakeholder Engagement Blueprint, companies can navigate the complexities of the healthcare system more effectively and ensure that their products have the impact they were designed to achieve," Mr. Myers added.

For more information about how the Stakeholder Engagement Blueprint can help medical device companies, contact Mr. Myers directly at [email protected] or visit https://zanemyers.com/

Contact Info: Name: Zane Myers Email: Send Email Organization: Zane Myers Company Address: 15600 NE 8th St., Bellevue, WA 98008, United States Website: https://zanemyers.com

Release ID: 89138930

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5 Questions About the Medical Device Tax, and Its Potential for Repeal

Subscribe to the economic studies bulletin, gregory w. daniel gwd gregory w. daniel former brookings expert, healthcore.

November 12, 2014

Quickly following on the heels of the November 4th elections, a select few policy issues made it to the top of Congress’ priority list. Mitch McConnell (R-KY), Senate Minority Leader and presumed majority leader for the 114th Congress, has indicated that the medical device tax is a key target, inspiring confidence within the medical device industry that a repeal is, in fact, possible. Below is a basic primer about the tax, its contentious history and how it may fare in the 114th Congress.

1. What is the medical device tax?

Included in the Affordable Care Act (ACA) and launched in 2013, the medical device tax imposes a 2.3 percent sales tax on medical device supplies. The tax applies broadly to a range of products, including pacemakers, artificial joints, surgical gloves, and dental instruments. It does not apply to eyeglasses, contact lenses, hearing aids, wheelchairs, or any other device that the public generally buys for individual use. Further, the tax is applied equally to imported and domestically produced devices, and devices produced in the U.S. for export are tax-exempt.

2. Why was it included in the Affordable Care Act?

According to the Joint Committee on Taxation, the tax is estimated to bring in $29 billion over the next decade. The tax was one of many revenue-raising provisions designed to offset the cost of providing coverage to more than 25 million Americans through the ACA, and these newly insured individuals would likewise increase demand for medical device manufacturers’ products and services. Other industries were subject to levies as well, including health plans (an estimated $101 billion), and employers (an estimated $130 billion). It has been noted that then-Senator John Kerry from Massachusetts helped negotiate the tax from 4.6 percent to 2.3 percent.

3. How has the medical device industry responded?

The U.S. is home to more than 7,000 medical device companies with estimated annual sales of $106 to $116 billion per year. The largest concentrations of companies are located in California, Massachusetts, New York and Minnesota. Since 2010, the medical device industry has led a full court press effort to repeal the tax. Companies and trade groups argue that the tax would cost over 40,000 U.S. jobs, and undermine innovation by moving manufacturing offshore – conclusions that are heavily contested by the tax’s supporters.

By some accounts this tax is coming at a particularly challenging time for medical device innovation. A recent analysis by Ernst & Young reported that venture capital investment in medical devices in 2013 fell 17% from the previous year, a downward trend that has been observed for the past seven years. In addition, investment funding is also shifting towards less risky later-stage medical device companies instead of smaller earlier stage ventures. These trends are worrisome since early-stage investment companies can promote innovative and disruptive medical device technologies that introduce new therapeutic benefits or quantum improvements in patient care.

It is unclear what impact the medical device tax will have on investment in early stage innovation. Key factors that have reduced the availability of venture capital for early-stage medical device companies pursuing pre-market approval include U.S. regulatory unpredictability and delays in approval, and an uncertain reimbursement environment. Additionally, efforts outside the U.S to attract medical device investment, such as offering tax havens and other incentives for device developers in Ireland and the Netherlands add to the attractiveness for device companies to move out of the U.S. Moving to a country that has lower tax rates and less stringent corporate governance requirements may save large device companies billions of dollars.

Recognizing that the “country of first choice by medical device developers is a key contributor to early patient access to high-quality, safe and effective devices,” the Center for Devices and Radiological Health’s (CDRH) at the U.S. Food and Drug Administration issued its 2014-2015 Strategic Priorities, which describe their efforts to improve regulatory predictability and device development efficiency in order to “help medical device developers choose the U.S. as the country of first choice for their technologies.” While the FDA’s efforts seem to focus on encouraging medical device innovation in the U.S., the medical device tax seems to be contradictory to this effort.

Some also argue that while expanding insurance coverage will help drug companies sell more products and bring in new patients for providers and hospitals, it will not help sell more devices because the majority of potential beneficiaries are much older and already covered by Medicare.

Hundreds of companies and trade groups have signed on to letters opposing the tax from industry associations, like the Medical Device Manufacturers Association (MDMA) and AdvaMed. Others have launched significant lobbying efforts to support the tax’s repeal, an industry that accounts for $30 million in lobbying expenditures annually since the ACA was passed in 2010. The Center for Responsible Politics has also identified $5.7 million in political contributions on behalf of medical device companies to specific candidates during the 2013-2014 campaign cycle.

4. How are lawmakers responding?

The tax’s repeal has been supported by Democrats and Republicans alike. Many opponents cite the Senate’s fiscal 2014 budget resolution as an indicator of support – drumming up 79 supporters for repeal, including 33 Democrats. However, the resolution “was non-binding and viewed as a free vote to show displeasure with an unpopular aspect of the health law.” The tax’s repeal has garnered outspoken support from Orrin Hatch (R-UT) and Mitch McConnell (R-KY), as well as Elizabeth Warren (D-MA), Al Franken (D-MN), Amy Klobuchar (D-MN) – Democrats with notably high concentrations of medical device companies in their states. The House has approved the repeal of the device tax three separate times in the past two years, including as recently as September 2014. The White House has historically opposed these efforts, but President Obama recently indicated he would entertain the idea (see Question 5).

A report from the nonpartisan Congressional Research Service, released last week, concluded that the tax is unlikely to hurt the profits of device companies, estimating that it will reduce industry output and employment by no more than .2 percent. CRS states, “The effect on the price of health care, however, will most likely be negligible because of the small size of the tax and small share of health care spending attributable to medical devices.” A separate report from Ernst & Young last month finds that domestic revenues for medical technology firms grew 4 percent to $336 billion in 2013, the first year the tax went into effect – about the same rate from 2012, indicating that the industry seems financially stable for now.

5. What are the tax’s implications under the 114th Congress?

The tax’s fate will be determined by a couple of key questions: Will enough Democrats turn up in support of a repeal? And will President Obama support the repeal? White House officials said the administration would be willing to review the tax in a broader discussion of the ACA, provided that opponents find a way to replace the $30 billion in funding the tax was projected to raise over the next decade. It’s not yet clear how the budget shortfall will be replaced. Alternatively, if the President does not support the repeal, and instead indicates that it will be vetoed, Republicans will need to have enough Democratic support for a veto-proof majority. The decision is also further complicated by the fact that a repeal could also encourage a domino effect from other industries, particularly hospitals that have voiced discontent over steep federal cuts. A “me too” response could put about $370 billion at risk over the next decade.

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August 23, 2024

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Upcoming Events and Exhibitions in the Medical Device Industry

The medical device industry is an innovative and constantly evolving industry. The global market for medical devices is enormous, and it will continue to grow in the future. The industry is predicted to grow by nearly US $800 billion by 2030. There is an increasing demand for innovative new devices as lifestyle diseases become more prevalent.

A medical device exhibition is a great platform for manufacturers to showcase their medical devices, and meet prospective customers and people who might help enhance their business.

We have compiled the list for you. Go through the list of upcoming events happening all over the globe. Following are some of the national and international level events in the medical device industry.

2024 Medical Device Trends and Global Market Outlook

Events happening in india.

Medicall Chennai 2024

Medicall Chennai stands as India’s premier B2B Medical Equipment Exhibition, facilitating connections among dealers, distributors, importers, exporters, sales professionals, business developers, and entrepreneurs aiming to broaden their product portfolios.

02 - 04 Aug 2024

Chennai trade centre, chennai, india.

UP Dental Show 2024

The UP Dental Show is dedicated to embracing the future of dentistry and nurturing the next generation of dental specialists. It features engaging scientific sessions on topics such as lasers, digital dentistry, implants, and microscopic surgeries.

03 - 04 Aug 2024

Hotel pride plaza, new delhi, india.

Medical Device Regulatory and Quality Summit 2024

The Annual Medical Device Regulatory and Quality Summit will bring together regulators and industry leaders to discuss and share ideas that benefit their organizations and the entire industry. This conference will review evolving regulations, and their impact on the industry, and provide an in-depth look into quality control and assurance.

23 - 24 Aug 2024

Medicall delhi 2024.

Medicall Expo, the biggest B2B Medical Equipment Exhibition in India, provides a comprehensive range of hospital necessities like a super-market. It is highly regarded among healthcare professionals, hospital owners, and decision-makers as a convenient one-stop-shop for equipment selection.

05 - 07 Oct 2024

Pragati maidan, new delhi, india.

India Med Expo Hyderabad 2024

The India Med Expo is a specialized show for Medical, Surgical, Hospitals, Diagnostics, and other Healthcare Industries. It brings together healthcare leaders to collaborate and learn, providing opportunities to cover the enormous Indian healthcare market and consider the potential of big metropolitan areas.

06 - 08 Dec 2024

Hitex exhibition centre - hyderabad - india.

Medical Expo Lucknow 2024

Medical Expo is India’s leading B2B medical equipment, diagnostic equipment & lab device trade show, followed by Medicon Healthcare Conference.

13 - 15 Dec 2024

Indira gandhi pratishthan, lucknow, india, events happening in worldwide.

Medic East Africa

Medic East Africa co-located with Medlab East Africa stands as the premier healthcare and medical laboratory event platform in the East Africa region. This event unites regional and international professionals who value the power of learning, networking, and business.

04 - 06 Sep 2024

Kenyatta international convention centre, nairobi, kenya..

American Medical Device Summit 2024

The American Medical Device Summit is a premier event for senior-level medical device professionals. It focuses on development, quality management, manufacturing, and life-cycle management. With a limited number of sponsors, the summit ensures high-quality interactions and offers personalized speaking opportunities.

30 Sep - 01 Oct 2024

The westin lombard, rosemont, usa.

Indonesia Hospital Expo 2024

The International Hospital Expo in Indonesia highlights medical, pharmaceutical, clinical, and laboratory equipment, as well as medicines. This event offers industry professionals an excellent opportunity to showcase products and innovations while networking for profitable investments.

16 - 19 Oct 2024

Jakarta convention center, jakarta, indonesia.

Global Health 2024

Global Health Exhibition serves as a gateway to Saudi Arabia’s evolving market, offering a platform for international and local companies to connect, network, seek investment, acquire education and CME points, and stay updated on the latest market developments.

22 - 24 Oct 2024

Riyadh convention & exhibition centre, malham, saudi arabia.

Africa Health 2024

Fueling innovation and collaboration, Africa Health 2024 is setting the stage for groundbreaking advancements in healthcare across the African region.

Cape Town International Convention Centre, South Africa

Medica 2024

With over 5,300 exhibitors from almost 70 countries and 83,000 visitors  MEDICA  in Düsseldorf is one of the largest medical B2B trade fairs in the world.

11 - 14 Nov 2024

Messe dusseldorf, düsseldorf, germany.

BIOMEDevice

BIOMEDevice is a meeting place for engineers and business leaders from MedTech, biotech, and pharma, to inspire and collaborate on the next life-changing medical device. In just two days, you will discover new suppliers showcasing the latest technologies transforming medical devices, engage in expert led education discussing topics from regulations to design, and connect with industry pioneers on the latest market trends. 

20 - 21 Nov 2024

Santa clara convention center.

Operon Strategist stands as a global medical device regulatory consulting firm , offering its expertise and services to clients across the world. With our extensive knowledge and experience in the medical device industry, we provide comprehensive regulatory guidance and support to ensure compliance and facilitate market access. We strive to stay ahead of the changing medical device industry. Our goal is to help our clients succeed in this competitive field by providing them with the right information and expertise. We make sure to stay updated and connected, which enables us to offer comprehensive and strategic consulting services. Our aim is to support our clients in achieving success in the medical device sector. Contact us for further information.

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• Meet Delrus

Key figures

Our customers.

• Licenses and certificates
• Manufacturing in Eurasian Customs Union
• Get the presentation
• Apply for parthership
• Get in touch

We offer medical equipment and consumables to almost all groups of customers in the healthcare system. Delrus has a large customer base, deliveries to more than 1000 localities and thousands of loyal customers.

We have the largest regional distribution network in Europe. It includes 75 sales offices. Our company's regional network comprises the territory with a population of 225 million people. The offices are open daily from 9am to 6pm, and our customers' website is available on  www.delrus.ru 24 hours.

We hold a well-developed infrastructure: by having office space, technical centers, warehousing, including facilities with special storage conditions and vehicles fleet. We provide personal medical advisors, the warehouse staff, and contract support work every day to ensure that customers all over Russia receive the best service. The company's customers are advised by more than 500 medical representatives in the regions. A personal manager is assigned to every customer. The representative of the company knows everything about the customer needs and follows a package approach in dealing with issues related to the selection, purchase, supply, and service of medical devices.

Full equipment

Delrus has a wide range of competencies and choice of experts. Our success is determined by the package approach that we demonstrate by working with each client. We do not only sell the equipment but offer multiplex solutions. We design medical facilities, completing them with first-class equipment. Delrus guarantees quality and conformity with accepted standards.

Delrus uses its experience and numerous technical solutions for the complex equipping of hospitals, blood banks, and perinatal centers. Due to its financial stability, the company acts as an investor in private-public partnerships. 

Technical service

Service centers of the company operate in large cities of Russia and the CIS. Engineers of the Delrus service network are high-end professionals, constantly trained at the premises of manufacturing companies in Russia and abroad. 310 service engineers support the operation of the sophisticated equipment in hospitals, laboratories, and private clinics so that the medical devices remain a reliable tool for saving lives in the hands of doctors.

Historical 30 years with Delrus

Broad competence, these are some of the world famous manufacturers.

You have a solution, we already have a buyer

Commitment to new technologies and our desire to develop the most advanced health practices have allowed the company to become a reliable partner for the world's leading manufacturers of medical equipment and materials. Over 290 leading manufacturers of medical equipment and supplies trust Delrus with promotion and sales in the territory of Russia and the CIS.

We offer flexible cooperation conditions to the manufacturers of medical equipment and consumables because Delrus takes on issues related to the registration process and delivery of products to the customer. Delrus points the way to the Russian market of medical equipment for its partners.

Certified activities

Manufacturing facilities in Eurasian Economic Union

• Moscow region
• Ural region
• North-West region

Dubna medical plant

The production site was founded in 2004 in the city of Dubna, Moscow region. The enterprise produces disposable medical products made of polymer materials. Products we use in various fields of medicine meet modern requirements for quality and safety.The products are manufactured in clean rooms of class "C" - class 7 and "D" - class 8. Technological procedures are organized in strict accordance with the requirements of the GMP standard. The main goal of the enterprise is to manufacture reliable, high-quality competitive products. Currently itproduces more than 30 items constantly increasing the range. All products are registered and have the necessary permits.

Yekaterinburg production site

In Yekaterinburg Delrus holds the production site of medical supplies for blood services, sterilization, and hospital equipment. The equipment is known under the brand "Leadcore". Leadcore offers high quality medical technologies that meet modern standards and safety requirements at a reasonable price to medical and preventive treatment facilities. Leadcore's policy of the trademark is customer care, flexibility in work, optimized delivery terms, timely proficient warranty and maintenance service.

Biotechnological company "Biopalitra"

"Biopalitra" was founded in 2011 by a group of scientists and entrepreneurs from Novosibirsk. The company develops and produces the promising and innovative test systems. "Biopalitra" focuses on a small group of products, which allows to maintain high quality and minimize production costs. The team of developers has many years of experience in the development and modernization of molecular diagnostics based on ELISA and PCR. Since 2013, Biopalitra has been producing and supplying reagent kits for in vitro diagnostics of HIV infection, hepatitis B, hepatitis C, and syphilis to the Russian market. The head office and the main production of the company are located in Saint Petersburg.

For 32 years our company has kept up a reputation of a reliable partner, supplier and innovator in the field of healthcare. Start partnership with Delrus today.

Apply for partnership.

Personal Data Processing Agreement

I give consent to DELRUS CJSC to my personal data processing, namely to performance of the following operations: collection, recording, systematization, accumulation, storage, updating (correction, alteration), retrieval, use, transmission (dissemination or otherwise making available), depersonalization, blocking, erasure, destruction in the cases stated by the legislation of the Russian Federation or other legal acts.

Personal data processing is conducted to provide compliance with the laws and other legal acts of the Russian Federation; intended for individual reporting; information systems of monitoring; research, organizational, financial and economic and other activities of the company.

The rush to Russia's booming med-tech market

For medical technology giants such as ge, philips, siemens and toshiba, russia has become a highly promising market, with the potential further increasing in its growing private hospital sector. during the russian radiology congress (26-29 may, moscow) meike lerner of european hospital met with company representatives to discuss their presence in russia and any problems relating to financing in a market that has no great experience of capitalistic structures, as one of the biggest foreign companies, ge healthcare has about 200 employees in cities across russia and, up to now, has supplied around 5,100 units to over 2,900 medical institutions..

In 2007, GE´s revenues in Russia/CIS reached US$ 207 million, which is expected to more than double in 2012. According to Richard di Benedetto, President and CEO of GE Healthcare’s Eastern & Africa Growth Markets (EAGM), which includes Russia, this success is based on strong regional partnerships that introduce GE´s technologies and solutions, as well as its focus on training local medical staff. ‘Providing a superb service is one of the most important aspects, if you follow our aim to provide all parts of Russia with medical equipment,’ explained Slava Grischenko, who heads GE Healthcare in Russia. ‘Although our products cover all necessary hospital areas, users need very good training to benefit from the technology. To provide this service we need to establish strong partnerships in manpower within the company itself; this wasn’t easy when we began here 20 years ago. Today, GE is very well prepared for that task.’ For the near future the priority is to focus more on the private patients sector, he pointed out. ‘The middle class is growing exceptionally fast; in just a few years that population will be higher than in China. Consequently, demand for healthcare beyond the basic system will rise. Additionally, compared to the West, Russian health levels are bad: Stroke rates are 20 times higher and the average life expectancy for men is about 56 years. Russia’s healthcare market faces a backlog, which is a great opportunity for us.’ Richard di Benedetto believes the Russian situation fits neatly in GE Healthcare’s global vision that the future is about early health. ‘This means moving healthcare delivery to pre-symptomatic and earlier disease detection. The idea of investing today to avoid ever-increasing costs in the future is a powerful and inspiring opportunity. Given the social shift in Russia, we now have the perfect basis for this strategy because people are becoming aware of prevention.’ The biggest challenge: knowledge distribution For Joost Leeflang, Philips CEO for Russia, Belarus, Ukraine & Central Asia, the reasons why investing in Russia has been so interesting in the past five years are clear: ‘Russia is an unbelievably large country, with oil producing a very good income and, in general, it has a highly educated workforce and population. In addition, the government structure is stable and it aims to provide high-quality medicine across the country, as well as make it accessible to the entire population. So the government is investing huge sums in the national project for public health services. That’s basically why money is not much of an issue for our customers. So, we don’t face the same problems as in the UK or Germany, for example, which have huge private sectors and where every cent must be turned twice before spending. Of course, that’s something developing in Russia as well, and we expect a strong increase of private hospitals over the next few years. But, as a provider of medical technology equipment, this trend is another opportunity.’ His colleague Ilya Gipp, who is responsible for Philip’s CT and MR business added: ‘In previous years we have seen the market become more developed and it’s growing. But, for us, development of the infrastructure is also important. If we install a MR or CT system in a more rural hospital an infrastructure must be developed for it to be utilised and to allow a sensible patient throughput for the system. Considering this infrastructure, one big issue in Russia is education. Although the doctors’ knowledge is incredible, the country has missed the step to the latest diagnostic technologies. Besides technical know-how of the systems, another point is that Russia has very specialised hospitals, based on clinical fields such as oncology or pulmonology. What’s important to think about in the near future is that equipment must be used for various treatment areas, which is only possible if there is an infrastructure to support that. In a nutshell: The challenge is to ensure there is the right infrastructure to maximise the benefit of our technology. In geographical terms, getting the knowledge distributed is the biggest challenge.’ For Philips, equipment installation only begins collaboration with customers, training and education programmes are integral. The firm has piloted a CT training programme with Moscow State Medical University, for which certification courses were established. CT and MR scanner sales are up At Toshiba’s Satellite Symposium on CT and MR, which was held at the congress, Dr Jörg Blobel, of Toshiba Medical Systems Corporation, Japan, and Dr Lucia Kroft, from the University Medical Centre, Leiden, the Netherlands, described first experiences with the Aquilon ONE 320-slice CT. Audience interest was keen: Toshiba has already sold some of these scanners to customers around the globe and according to Mikhail Smirnov, Product Manger for Toshiba Medical Systems in Moscow, there is more than one potential customer thinking of a purchase in the near future. ‘We’ve had good beginnings with Aquilon ONE in Russia. Along with features such as 4-D dynamic image acquisition, the option for low-dose scanning is of particular interest. In Russia dose regulations are far stricter than in Western Europe,’ he explained. ‘In the last years, Toshiba has increased its market share, especially in CT (we hope to number one, now). In previous years, a lot of ultrasound systems were installed because they were affordable. Now it is CTs turn, because its clinical value is much appreciated. With Russia’s growing economy, the number of CT scanners and MR systems being installed is increasing tremendously.’ However, he emphasised that entering the private hospital sector is a huge challenge: ‘Private institutions and hospital networks are created by big Russian corporations, such as oil and gas firms, which are eager to equip them with the ultra-modern technology. Our next task is to participate successfully in that sector.’

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Reporting by Sriparna Roy and Puyaan Singh in Bengaluru; Editing by Sriraj Kalluvila, Devika Syamnath and Alan Barona

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Sriparna reports on pharmaceutical companies and healthcare in the United States. She has a master's degree in English literature and post graduate diploma in broadcast journalism.

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