business plan of a medical device

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Medical Device Business Plan

Published Nov.06, 2023

Updated Sep.14, 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:

Projected use of funds of medix - Medical Device Business Plan Sample

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-rated document, 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.

Any questions? Get in Touch!

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Medical Device Development Business Plan [Sample Template]

By: Author Tony Martins Ajaero

Home » Business Plans » Medical and Healthcare

Are you about starting a medical device development company? If YES, here is a complete sample medical device development business plan template & feasibility report you can use for FREE .

Okay, so we have considered all the requirements for starting a medical device development company. We also took it further by analyzing and drafting a sample medical device development marketing plan template backed up by actionable guerrilla marketing ideas for medical device development companies. So let’s proceed to the business planning section .

In order to become a business player in the healthcare industry, you don’t necessarily need to become a medical doctor, a pharmacist or a nurse. If you are interested in the healthcare industry, one of the many businesses that you can successfully start is a medical device development business ; it is a business that is promising and profitable in the united states of America.

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The Medical device development business basically develops and manufactures various devices that are used in the healthcare industry. Just like most businesses, the medical device development business is open to as many people that are interested in the industry as long as they have the required experience and qualifications.

If you are sure this type of business is what you truly want to do after you must have conducted your feasibility studies and market research, then the next step to follow is to write a good business plan.

The truth is that it is one thing to have a fantastic idea cum business plan, and another thing for the business plan to translate to money (profits), and that is why it is important to assemble a team of dedicated staff to work with you if you want to be successful in your business.

Below is a sample medical device development business plan template that will help you successfully write yours with little effort.

A Sample Medical Device Development Business Plan Template

1. industry overview.

Medical device development business is under the Medical Device manufacturing industry and players in this industry include manufacturers of electromedical and electrotherapeutic apparatuses such as magnetic resonance imaging equipment, medical ultrasound equipment, pacemakers, hearing aids, electrocardiographs and electromedical endoscopic equipment.

The industry also engages in the manufacturing irradiation apparatus and tubes for applications such as medical diagnostic, medical therapeutic, industrial, research, and scientific evaluation among others. The Medical Device manufacturing industry revenue has increased steadily due to demand for effective and efficient devices. Rising product prices have also supported industry growth.

Revenue is projected to rise over the five years to 2022 as healthcare providers continue to invest in new equipment to keep up with growing demand for healthcare services. New product development by medical device manufacturers will also contribute to industry growth by offering new solutions to health issues.

The Medical Device Manufacturing industry is indeed a thriving line of business in most countries of the world. In the United States of America, the industry generates over $43 billion annually from more than 993 medical device development and manufacturing companies scattered all around the United States of America.

The industry is responsible for the employment of over 94,106 people. Experts project that the industry will grow at a 1.0 percent annual rate between 2012 and 2017. The establishments in this industry that has dominant market shares in the United States of America are Abbott Laboratories, General Electric Company, Johnson & Johnson and Medtronic.

A recent report published by IBISWORLD shows that the Medical Device Manufacturing industry has a moderately low level of capital intensity; for every $1.00 an average industry company spends on labor, they invest $0.06 into capital improvements.

Although the cost of assets can be high for industry operators, not all products can be manufactured on an automated production line.

The report further stated that medical device manufacturers produce a range of products for highly specialized applications, and the production of many of these devices requires hands-on work, which keeps industry labor costs high.

Skilled specialists are needed to research and develop medical devices, and these employees command salaries well above the manufacturing sector’s average wage.

Over and above, medical device development and manufacturing business is a profitable business and it is open for any aspiring entrepreneur to come in and establish his or her business; you can choose to start on a small scale manufacturing limited devices or you can choose to start on a large scale manufacturing various medical devices not just for the US market, but for international market.

2. Executive Summary

Eden® Medical Device Development Company, Inc. is a registered medical device development and manufacturing business that will be located in one of the industrial estates in Dover – Delaware, United States of America. We have been able to lease a facility that is big enough to fit into the design of the kind of standard medical device Development Company that we intend launching.

Eden® Medical Device Development Company, Inc. will design, develop and manufacture medical devices; we will engage in fabricating medical diagnostic and therapeutic apparatus, marketing and distribution. We are set to sell our products to a wide range of clientele not just in the United States of America, but also all across the world.

We are aware that there are several large and small medical device development companies, which is why we spent time and resources to conduct a thorough feasibility studies and market survey so as to be well positioned to favorably compete with all our competitors.

We will ensure that we engage in continuous improvement of our products so as to suite the ever – changing trends in the healthcare industry .

Eden® Medical Device Development Company, Inc. will ensure that all our customers are given first class treatment whenever they purchase any of our products. We have a CRM software that will enable us manage a one on one relationship with our customers no matter how large the number of our customer base may grow to.

We will ensure that we get our customers involved in the design and manufacturing of medical devices and also when making some business decisions.

Eden® Medical Device Development Company, Inc. will at all times demonstrate her commitment to sustainability, both individually and as a firm, by actively participating in our communities and integrating sustainable business practices wherever possible.

We will ensure that we hold ourselves accountable to the highest standards by meeting our customers’ needs precisely and completely whenever they patronize our products.

Eden® Medical Device Development Company, Inc. is a family business that is owned by Engr. David Eden and his immediate family members. Engr. David Eden has a B.Engr. in Electronic Electrical Engineering, with well over 5 years of experience in the medical devices development industry, working for some of the leading brands in the United States.

Although the business is launching out with just one outlet in Dover – Delaware, but we will ensure that we market and distribute our products all across the United States of America and other countries of the world.

3. Our Products and Services

Eden® Medical Device Development Company, Inc. is in the medical devices development industry to sell our products to a wide range of clients and of course to make profits, which is why we will ensure we go all the way to design, develop and manufacture various medical equipment.

We will ensure that we do all that is permitted by the law of the United States to achieve our aim and ambition of starting the business. Our product offerings are listed below;

Neuromodulation and spinal devices
Cardiovascular devices
Diabetes devices
Irradiation devices
Patient recovery and noninvasive devices
Surgical instruments
Dental instruments
Hospital beds and other specialized hospital furniture
Personal safety equipment

4. Our Mission and Vision Statement

Our vision is to become one of the leading brands in the medical device development industry in the United States of America and Canada.
Our mission is to establish a world – class medical device development company that will manufacture a wide range of medical devices and build a brand that will become a household name not just in the United States of America, but also other parts of the world.

Our Business Structure

Eden® Medical Device Development Company, Inc. knows the standards expected from companies that are into the manufacturing of medical devices hence the need for us to conform to industrial best practices. We will ensure that we hire people that are qualified, honest, customer centric and are ready to work to help us build a prosperous business that will benefit all our stake holders.

As a matter of fact, profit-sharing arrangement will be made available to all our senior management staff and it will be based on their performance for a period of ten years or more. In view of that, we have decided to hire qualified and competent hands to occupy the following positions;

Chief Executive Officer (Owner)
Production Manager
Human Resources and Amin Manager
Engineers (Production Engineers)

Sales and Marketing Manager

Accountants/Cashiers
Customer Services Executive

5. Job Roles and Responsibilities

Chief Executive Officer – CEO:

Increases management’s effectiveness by recruiting, selecting, orienting, training, coaching, counseling, and disciplining managers; communicating values, strategies, and objectives; assigning accountabilities; planning, monitoring, and appraising job results; developing incentives; developing a climate for offering information and opinions; providing educational opportunities.
Responsible for fixing prices and signing business deals
Responsible for signing checks and documents on behalf of the company
Evaluates the success of the organization
Responsible for providing direction for the business
Reports to the board

Admin and HR Manager

Responsible for overseeing the smooth running of HR and administrative tasks for the organization
Sustains office supplies by checking stocks; placing and expediting orders; evaluating new products
Ensures operation of equipment by completing preventive maintenance requirements; calling for repairs
Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
Improves department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
Outlines job positions for recruitment and managing interviewing process
Carries out staff induction for new team members
Responsible for training, evaluation and assessment of employees
Responsible for arranging travel, meetings and appointments
Oversee the smooth running of the daily office activities

Production Manager:

In charge of approving designs for the organization
Responsible for managing the daily activities in the production facility
Ensure that the production facility is in top shape and goods are properly arranged and easy to locate
Interfaces with third-party suppliers (vendors)
Controls medical equipment and instrument manufacturing, distribution and supply chain inventory
Supervises the workforce in the production facility
Manages external research and coordinate all the internal sources of information to retain the organizations’ best customers and attract new ones
Models demographic information and analyze the volumes of transactional data generated by customer purchases
Identifies, prioritizes, and reaches out to new partners, and business opportunities et al
Identifies development opportunities; follows up on development leads and contacts; participates in the structuring and financing of projects; assures the completion of development projects
Responsible for supervising implementation, advocate for the customer’s needs, and communicate with clients
Develops, executes and evaluates new plans for expanding increase sales
Documents all customer contact and information
Represent the company in strategic meetings
Aids the increase sales and growth for the company

Accountant/Cashier:

Responsible for preparing financial reports, budgets, and financial statements for the organization
Provides managements with financial analyses, development budgets, and accounting reports; analyzes financial feasibility for the most complex proposed projects; conducts market research to forecast trends and business conditions
Responsible for financial forecasting and risks analysis
Performs cash management, general ledger accounting, and financial reporting
Responsible for developing and managing financial systems and policies
Responsible for administering payrolls
Ensuring compliance with taxation legislation
Handles all financial transactions for the organization
Serves as internal auditor for the organization

Medical Devices Production Engineers

Responsible for designing, fabricating, developing and manufacturing medical devices such as Neuromodulation and spinal devices, Cardiovascular devices, Diabetes devices, Irradiation devices, noninvasive devices, Surgical appliances, Surgical instruments, Dental instruments, Hospital beds and other specialized hospital furniture, and Personal safety equipment
Responsible for the manufacturing electromedical and electrotherapeutic apparatuses such as magnetic resonance imaging equipment, medical ultrasound equipment, pacemakers, hearing aids, electrocardiographs and electromedical endoscopic equipment

Client Service Executive

Ensures that all contacts with clients (e-mail, walk-In center, SMS or phone) provides the client with a personalized customer service experience of the highest level
Through interaction with customers on the phone, uses every opportunity to build client’s interest in the company’s products and services
Manages administrative duties assigned by the human resources and admin manager in an effective and timely manner
Consistently stays abreast of any new information on the organizations’ products, promotional campaigns etc. to ensure accurate and helpful information is supplied to customers when they make enquiries
Enquires about customers’ needs, recommend, select and help locate the right merchandise, describe a product’s features and benefits.
make suggestions and encourage purchase of products
Provides information about warranties, manufacturing specifications, care and maintenance of merchandise and delivery options

6. SWOT Analysis

Eden® Medical Device Development Company, Inc. is in business to become one of the leading medical devices development companies in the United States of America and we are fully aware that it will take the right business concept, management and organization structure to achieve our goal.

We are quite aware that there are several medical device development companies all over the United States of America and even in the same location where we intend locating ours, which is why we are following the due process of establishing a business. We know that if a proper SWOT analysis is conducted for our business, we will be able to position our business to maximize our strength, leverage on the opportunities that will be available to us, mitigate our risks and be welled equipped to confront our threats.

Eden® Medical Device Development Company, Inc. employed the services of an expert HR and Business Analyst with bias in manufacturing to help us conduct a thorough SWOT analysis and to help us create a Business model that will help us achieve our business goals and objectives.

This is the summary of the SWOT analysis that was conducted for Eden® Medical Device Development Company, Inc.

Our strength lies in the quality of our finished medical devices, the power of our team and the state of the art medical device production plant that we own. We have a team of highly trained and experienced engineers and support staff that can go all the way to design and produce top notch medical devices. We are well positioned in the heart of Dover – Delaware and we know we will attract loads of clients from the first day we open our medical device development company for business.

Our major weakness is that we are a new medical devices development and manufacturing company and we don’t have the financial capacity to compete with multi – billion dollars medical device development companies such as Abbott Laboratories, General Electric Company, Johnson & Johnson and Medtronic et al when it comes to manufacturing and selling medical devices at a rock bottom prices. So also, we may not have enough cash reserve to promote our brand the way we would want to do.

Opportunities:

Our well-equipped medical device development company provides us with unlimited opportunities to sell our products to a large number of hospitals and health facilities. We have been able to conduct thorough feasibility studies and market survey and we know what our potential clients will be looking for when they visit our show room and production plant; we are well positioned to take on the opportunities that will come our way.

Just like any other business, one of the major threats that we are likely going to face is economic downturn. It is a fact that economic downturn affects purchasing/spending power. Another threat that may likely confront us is the arrival of a new medical device development company in same location where ours is located. So also, unfavorable government policies may also pose a threat for businesses such as ours.

7. MARKET ANALYSIS

Market Trends

If you keep tabs with happening in the medical devices manufacturing industry, you will agree that technological advances, the legislative expansion of healthcare access and the improving economy have stimulated demand for medical devices over the last five years, and the aging US population has further contributed to revenue growth due to the high incidence of health issues requiring medical devices among the elderly.

A report published by IBISWorld shows that industry revenue will grow going forward. Over the five years to 2022, this growth is expected to continue, with revenue increasing at a slightly faster rate. The aging baby-boomer population and technological developments will continue to bolster industry growth, but the changing regulatory environment will likely hamper profitability.

So also, technological advances, expansion of healthcare and the improving economy have stimulated demand. Industry operators often have the weak hand in price negotiations and recent healthcare legislation has created a degree of uncertainty for medical device companies.

Lastly, as part of marketing strategies, medical device development companies now ensure that they have showrooms at different locations where they display their products. As a matter of fact, it is even cheaper to purchase directly from these showrooms established by medical devices development companies as against purchasing from medical device retail stores. It is a strategy that helps them increase sales and income for their business.

8. Our Target Market

We have positioned our medical device development and manufacturing company to service businesses in the healthcare industry in and around Dover – Delaware and every other location where our show rooms will be located all over key cities in the United States of America and other countries of the world.

We have conducted our market research and feasibility studies and we have ideas of what our target market would be expecting from us. We are in business to design, develop and manufacture a wide range of medical equipment and instruments for the following customers;

Medical laboratories
Medical colleges
Dental clinics
Optical centers

Our competitive advantage

Eden® Medical Device Development Company, Inc. is launching a standard medical device development and manufacturing company that will become the preferred choice for hospitals and other healthcare facilities in the United States of America and other countries of the world. Our production plant is located in very good locations.

One thing is certain; we will ensure that we design, develop and manufacture a wide range of medical equipment and instruments that are in high demand in the healthcare industry. We will also go all the way to ensure that we work with some of our high – profile clients in designing, developing and manufacturing of customized medical devices that suits their business.

Lastly, our employees will be well taken care of, and their welfare package will be among the best within our category in the industry meaning that they will be more than willing to build the business with us and help deliver our set goals and achieve all our aims and objectives. We will also give good working conditions and commissions to freelance sales agents that we will recruit from time to time.

9. SALES AND MARKETING STRATEGY

Sources of Income

Eden® Medical Device Development Company, Inc. is in business to design, develop and manufacture a wide range of medical equipment and instruments. We are in the medical device development industry to maximize profits and we are going to go all the way out to ensure that we achieve our business goals and objectives.

In essence, our source of income will be the supplying and selling of a wide range of medical equipment and instruments at affordable prices . Eden® Medical Device Development Company, Inc. will generate income by selling the following products;

10. Sales Forecast

We are set to go into the designing, developing and manufacturing of various types of medical equipment and instruments and we have put plans in in place that will help us always attract customers cum sales and that will sure translate to increase in revenue generation for the business.

We are well positioned to take on the available market in the United States of America and we are quite optimistic that we will meet our set target of generating enough income/profits from the first six months of operation and grow the business and our clientele base.

We have been able to critically examine the medical device development industry and we have analyzed our chances in the industry and we have been able to come up with the following sales forecast. The sales projection is based on information gathered on the field and some assumptions that are peculiar to startups in Dover – Delaware.

First Fiscal Year: $750,000
Second Fiscal Year: $1.2 million
Third Fiscal Year: $3 Million

N.B : This projection is done based on what is obtainable in the industry and with the assumption that there won’t be any major economic meltdown and there won’t be any major competitor manufacturing same medical equipment and instruments as we do within the same location. Please note that the above projection might be lower and at the same time it might be higher.

Marketing Strategy and Sales Strategy

Before choosing a location for Eden® Medical Device Development Company, Inc. we conducted a thorough market survey and feasibility studies in order for us to be able to penetrate the available market and become the preferred choice for hospitals and healthcare facilities in and around Dover – Delaware. We have detailed information and data that we were able to utilize to structure our business to attract the number of customer we want to attract per time and the number of products to be sold monthly.

We hired experts who have good understanding of the medical device development and manufacturing industry to help us develop marketing strategies that will help us achieve our business goal of winning a larger percentage of the available market in the United States of America.

In other to continue to be in business and grow, we must continue to sell the medical equipment and instruments that we developed and manufacture which is why we will go all out to empower or sales and marketing team to deliver.

In summary, Eden® Medical Device Development Company, Inc. will adopt the following sales and marketing approach to win customers over;

Open our medical device development plant in a grand style with a party
Introduce our business by sending introductory letters alongside our brochure to hospitals, dental clinics, optical centers , medical laboratories and key stake holders in the United States of America
Ensure that we design, develop and manufacture a wide range of medical equipment and instruments needed in the healthcare sector
Make use of attractive hand bills to create awareness and also to give direction to our show rooms
Position our signage/flexi banners at strategic places around Dover – Delaware
Position our greeters to welcome and direct potential customers
Create a loyalty plan that will enable us reward our regular customers
List our business and products on yellow pages ad (local directories)
Leverage on the internet to promote our business
Engage in direct marketing and sales
Encourage the use of Word of mouth marketing (referrals)
Join local chambers of commerce and industries to network and market our products

11. Publicity and Advertising Strategy

Despite the fact that our medical device development plant is well located, we will still go ahead to intensify publicity for the business. We are going to explore all available means to promote our medical devices development company.

Eden® Medical Device Development Company, Inc. has a long-term plan of exporting our medical devices to other countries of the world and to become a household name in the healthcare industry which is why we will deliberately build our brand to be well accepted in Dover – Delaware before venturing out. As a matter of fact, our publicity and advertising strategy is not solely for winning customers over but to effectively communicate our brand.

Here are the platforms we intend leveraging on to promote and advertise Eden® Medical Device Development Company, Inc.;

Place adverts on community based newspapers, radio stations and TV stations
Encourage the use of word of mouth publicity from our loyal customers
Leverage on the internet and social media platforms like YouTube, Instagram, Facebook, Twitter, LinkedIn, Snapchat, Google+ and other platforms to promote our business.
Ensure that our we position our banners and billboards in strategic positions all around Dover – Delaware
Distribute our fliers and handbills in target areas in and around our neighborhood
Contact hospitals, dental clinics, optical center, medical laboratories and other health facilities by calling them up and informing them of Eden® Medical Device Development Company, Inc. and the products we sell
Advertise our medical equipment and instruments in our official website and employ strategies that will help us pull traffic to the site
Brand all our official cars and vans and ensure that all our staff members and management staff wear our branded shirt or cap at regular intervals

12. Our Pricing Strategy

Aside from quality, pricing is one of the key factors that gives leverage to players in the medical device development and manufacturing industry, it is normal for customers to go to places where they can get quality medical equipment and instruments at cheaper price which is why big players in the medical device development and manufacturing industry like Abbott Laboratories, General Electric Company, Johnson & Johnson and Medtronic et al will attract loads of corporate and individual clients.

We know we don’t have the capacity to compete with the market leaders in the industry, but we will ensure that the prices and quality of all the medical equipment and instruments that we develop are competitive with what is obtainable amongst medical device development companies within our level.

Payment Options

The payment policy adopted by Eden® Medical Device Development Company, Inc. is all inclusive because we are aware that different customers prefer different payment options as it suits them but at the same time, we will ensure that we abide by the financial rules and regulation of the United States of America.

Here are the payment options that Eden® Medical Device Development Company, Inc. will make available to her clients;

Payment via bank transfer
Payment with cash
Payment via credit cards/Point of Sale Machines (POS Machines)
Payment via online bank transfer
Payment via check
Payment via mobile money transfer
Payment via bank draft

In view of the above, we have chosen banking platforms that will enable our client make payment for all purchases without any stress on their part. Our bank account numbers will be made available on our website and promotional materials.

13. Startup Expenditure (Budget)

In setting up any business, the amount or cost will depend on the approach and scale you want to undertake. If you intend to go big by renting/leasing a big facility, then you would need a good amount of capital as you would need to ensure that your employees are well taken care of, and that your facility is conducive enough for workers to be creative and productive.

The tools and equipment that will be used are nearly the same cost everywhere, and any difference in prices would be minimal and can be overlooked. As for the detailed cost analysis for starting a medical device development and manufacturing business; it might differ in other countries due to the value of their money.

These are the key areas where we will spend our startup capital on;

The total fee for registering the business in the United States of America – $750
Legal expenses for obtaining licenses and permits as well as the accounting services (software, P.O.S machines and other software) – $3,300
Marketing promotion expenses for the grand opening of Eden® Medical Device Development Company, Inc. in the amount of $3,500 and as well as flyer printing (2,000 flyers at $0.04 per copy) for the total amount of $3,580
The total cost for hiring Business Consultant – $2,500
The total cost for payment of insurance policy covers (general liability, workers’ compensation and property casualty) coverage at a total premium – $9,400
The total cost for long – term leasing of a standard warehouse and showroom – $250,000
The total cost for remodeling the production facility and showroom – $20,000
Other start-up expenses including stationery ( $500 ) and phone and utility deposits – ( $2,500 )
Operational cost for the first 3 months (salaries of employees, payments of bills et al) – $60,000
The total cost for Start-up inventory (purchase of medical device making tools and equipment and the purchase of raw materials inclusive) – $250,000
The total cost for store equipment (cash register, security, ventilation, signage) – $13,750
The total cost for the purchase and installation of CCTVs – $10,000
The cost for the purchase of office furniture and gadgets (Computers, Printers, Telephone, TVs, Sound System, tables and chairs et al) – $4,000
The total cost of launching a Website – $600
The total cost for our opening party – $7,000
Miscellaneous – $10,000

We would need an estimate of $950,000 to successfully set up our medical devices development plant in Dover – Delaware.

Generating Startup Capital for Eden® Medical Device Development Company, Inc.

Eden® Medical Device Development Company, Inc. is a private registered business that is solely owned and financed by Engr. David Eden and his immediate family members. They do not intend to welcome any external business partner which is why he has decided to restrict the sourcing of the startup capital to 3 major sources.

Generate part of the startup capital from personal savings
Source for soft loans from family members and friends
Apply for loan from my Bank

N.B: We have been able to generate about $350,000 ( Personal savings $200,000 and soft loan from family members $150,000 ) and we are at the final stages of obtaining a loan facility of $600,000 from our bank. All the papers and documents have been signed and submitted, the loan has been approved and any moment from now our account will be credited with the amount.

14. Sustainability and Expansion Strategy

The future of a business lies in the number of loyal customers that they have, the capacity and competence of the employees, their investment strategy and the business structure. If all of these factors are missing from a business, then it won’t be too long before the business close shop.

One of our major goals of starting Eden® Medical Device Development Company, Inc. is to build a business that will survive off its own cash flow without the need for injecting finance from external sources once the business is officially running.

We know that one of the ways of gaining approval and winning customers over is to retail our wide range of quality medical equipment and instrument a little bit cheaper than what is obtainable in the market and we are well prepared to survive on lower profit margin for a while.

Eden® Medical Device Development Company, Inc. will make sure that the right foundation, structures and processes are put in place to ensure that our staff welfare are well taken of. Our company’s corporate culture is designed to drive our business to greater heights and training and re – training of our workforce is at the top burner.

We know that if that is put in place, we will be able to successfully hire and retain the best hands we can get in the industry; they will be more committed to help us build the business of our dreams.

Check List/Milestone

Business Name Availability Check: Completed
Business Registration: Completed
Opening of Corporate Bank Accounts: Completed
Securing Point of Sales (POS) Machines: Completed
Opening Mobile Money Accounts: Completed
Opening Online Payment Platforms: Completed
Application and Obtaining Tax Payer’s ID: In Progress
Application for business license and permit: Completed
Purchase of Insurance for the Business: Completed
Leasing of facility and remodeling the factory: In Progress
Conducting Feasibility Studies: Completed
Generating capital from family members: Completed
Applications for Loan from the bank: In Progress
Writing of Business Plan: Completed
Drafting of Employee’s Handbook: Completed
Drafting of Contract Documents and other relevant Legal Documents: In Progress
Design of The Company’s Logo: Completed
Graphic Designs and Printing of Promotional Materials: In Progress
Recruitment of employees: In Progress
Purchase of the needed machines, tools, furniture, racks, shelves, computers, electronic appliances, office appliances and CCTV: In progress
Creating Official Website for the Company: In Progress
Creating Awareness for the business both online and around the community: In Progress
Health and Safety and Fire Safety Arrangement (License): Secured
Opening party/launching party planning: In Progress
Compilation of our list of products that will be available in our store: Completed
Establishing business relationship with vendors: In Progress

Sample Business Plans
Medical & Health Care

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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Download a sample medical equipment business plan

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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