As a medical entrepreneur, I’m always interested in ways doctors can build a profitable business, and recently I’ve been intrigued with the idea of physician inventors. Is this something anyone can do with a good idea and a medical degree?

Well, yes. And, no. The more I looked into this business niche, the more I saw how doctors just like you and me are having success bringing a medical device to market that makes a real difference in people’s lives. After all, we’re well-positioned to see problems first hand every day – issues that need solutions.

But at the same time, I was overwhelmed (slightly stunned) at the Mt. Everest you would have to climb to get your great idea into the hands of your customers. This process is not a trek for the faint of heart, and you might sometimes need to stop for altitude acclimation.

One of the most encouraging journeys I followed was Dr. Amy Baxter, who is the genius behind Pain Care Labs. Dr. Baxter is a pediatric emergency physician, pain researcher, and the inventor of a suite of:

“Easy-to-use devices to address suffering and fear, giving Power over Pain.”

She has given candid interviews about her journey, and I love how transparent and relatable she is on her website and in print and interviews. She had her “great idea” in 2004, which started with a desire to help children get vaccinated without pain and fear.

Her lightbulb moment happened while driving home from work. Her car was out of alignment, which caused her steering wheel to vibrate. By the time she arrived home, her hands were numbed by the vibration.

Running inside, she grabbed a hand-held massager and her Wartenberg wheel. She asked her young son to help her with a medical experiment by letting her run the wheel on his arm at the same time as she held the massager in place. The vibration helped minimize the pain but didn’t take it away completely.

At that point, her Eagle Scout husband suggested adding a bag of frozen peas to the experiment and this, along with the vibrator, blocked any pain her son felt. Next, she expanded her test “market” to include her two other children, and the combination of ice and the vibrating action of the massager worked so well they didn’t feel a thing, even after a pinch that left a small mark.

Her advice for other physician inventors impacted me. In a recent interview with Jon Speer of Greenlight Gurus, she says,

“Don’t fall in love with your solution. Because for me, my solution was for vaccination and needle pain and needle fear. The problem was pain. Had I fallen in love with pain earlier, I would have been more open to the idea that our solution was much more appropriate for the issue of opioids, the issue of pain management, the issue of specific things that cause suffering rather than one particular utility that’s a narrow part of someone’s life.”

She is generous with sharing the steps and years it took to get her from this point to 2016 when she could quit practicing medicine to devote all her time to inventing and research.

Understanding the Journey

I will give you the best package of how the complicated and time-consuming journey to launching a medical device begins and ends. Every significant step you take has a million little steps, but I’ve found some helpful resources that I’ll be sure to include as links.

Is Your Idea a Good Idea?

The first obvious issue you need to address is whether your idea is good.

You need to have a clear concept of the current, unmet need/problem your device is trying to meet/solve.

Good Ideas

Once you’ve done that, your circle of influence plus Google can give you valuable (and accessible) feedback on your idea.

1. Do other people perk up when they hear your idea?

Talk about your idea to your colleagues, patients, and sales professionals. This step is the easiest and least expensive way of conducting a free market survey.

Don’t think you can’t talk about your idea with anyone until they sign a non-disclosure agreement. No one (unless the competitor is a spy for Johnson and Johnson or Boston Scientifics) is lurking outside your office waiting to hear a great idea they can steal from you.

Search Google to see if people are looking online for what your invention is intended to do. The Google search bar can give you hours’ worth of helpful information on where people’s pain points are and what the market is already offering.

2. Am I the first with this unique idea, and who’s my competition?

Before you go headlong into developing your idea for the market, you will want to make sure no one else had your great idea first. A quick Google search can tell you a lot, but an even more sure way is by checking for a competing provisional or utility patent.

A provisional patent is a protection granted to the first person to file. With a provisional medical device patent, you can hold your place for up to a year before you spend the money on filing a utility patent.

Can You Afford Your Good Idea?

Before we go any further, let’s have a reality check. The money it takes to bring a new invention to market is immense. Unless you are printing money in your basement, you won’t be funding this on your own.

The medical device market size in 2020 reached $442.5 billion and is expected to reach $603.5 billion by next year. That means there is money to be made, and thankfully there are more avenues to raise funds than ever before.

Afford Your Good Idea

Some of these ways include:

Read this article for an in-depth look at how medical device startups were raising money in 2021.

Getting Started

The work of bringing your invention to market can be roughly divided into four stages:

1. Business Plan 

While you can spend your week online researching who your market is and, more importantly, what kind of numbers you can anticipate, Frost & Sullivan offer 360° market research on many industries, including the trillion-dollar business of healthcare. This process will help you outline the amount of time and capital your project will take.

It would help if you had an idea of your project timeline and costs. Calculating how long you anticipate each phase to take is essential, as different stages have different capital requirements. Funding can also be dependent on achieving milestones.

Items you may need to budget for include labor, prototypes, travel, training, consulting, product testing, regulatory compliance, clinical trials, quality management system costs, and registrations in different countries.

Business Plan

The other side of the budget coin is to calculate the potential revenue; critical components of your business model include calculating reimbursements and achieving commercialization. The market value for your product varies from one country to another and even from one US state to another.

At this point, you may want to create an inexpensive prototype. A draft model can be made in CAD and then manufactured using cheaper materials than your anticipated end product. Of course, with 3D printing becoming more available, many prototypes can be printed in plastic or even, in some cases, in metal.

Once you’ve created a working prototype, you’ll be ready for some basic feasibility studies to determine if you should move forward with your product.

As soon as you have fully developed your invention, you should file your patent application. According to the USPTO, it takes 36 months for a patent to be granted after an application has been filed. Securing a patent ensures that no one else can make, use or import your invention, and, in most countries, patents last for 20 years.

2. Regulations

Developing a regulatory plan can be one of the most daunting aspects of launching a medical device. Every primary market for medical devices has its specific regulatory framework and needs to include documentation on the intended use.

Depending on how your device is classified, your route to market can change. The classification depends on “the perceived risk” of your product type and is determined by different regulators.

Regulations

The most popular classifications are for the United States and the European Union. The FDA branch CDRH oversees medical device regulations in the US, and the European Commission, known as MDR, oversees medical device regulations in Europe.

The FDA requires you to work under a Quality Management System (QMS), and while there are many medical device companies, no two quality systems are alike. You have the freedom to create one that works for your company and its needs.

There are several excellent, purpose-built digital QMS software solutions in the market, so you don’t need to build your own.

3. Product Development

You now have a good foundation in your business plan, and you’ve gone through the painful process of complying with regulations, classifications, and choosing a QMS. It’s time to take your idea and turn it into a reality.

While the natural next question is to want to know how long it will take before you launch your product, that’s not the best question at this stage. Instead, a better question is:

“How do I set up meaningful milestones to make sure I deliver a top-quality product to my customers?”

And while it involves more paperwork, documenting design controls early in the project saves yourself potential delays when your product requires remediation. That’s a waste of both time and money.

A good design control plan includes a description and timeline of all development activities, a list of who is responsible for the different actions, and an outline of clear expectations for when you will hold design reviews.

Product Development

Greenlight Guru has an excellent article on the importance of defining your medical device user needs by answering eight critical questions.

According to the FDA, design inputs refer to the physical and performance characteristics used as a basis for device design. They are transparent and objective, and written to be easily proved or disproved.

Commonly considered design inputs include:

  • The size and shape of the device
  • Material characteristics
  • Anything related to how the device functions
  • Labeling of the device

Design outputs are the drawings, specifications, or manufacturing instructions associated with your device. Your outputs will form the basis of the device master record (DMR) when you get to the production stage.

You’ll also need to provide design verification, which focuses on your design inputs, and design validation, which is done to prove your device conforms to your defined user needs and intended uses. Regulatory standards dictate that you must implement design reviews, and all design changes need to be identified, documented, and approved, both pre-launch and post-launch.

Finally, when it comes to the design portion of your process, you’ll need to organize everything into a design history file (DHF). 

And when you think you can breathe a massive sigh of relief, you’ll need to take on the beast of a risk management plan. This step involves having a well-defined risk management process along with supporting documentation.

This plan includes definitions and descriptions of your product, a description of all risk management activities, the responsible team, criteria for risk acceptability, methods to verify risk control, and a definition of how post-production information will be recorded and used.

Risk Management and Organization

This information will need to be compiled into a risk management file (RMF). The process is not for the faint of heart.

4. Go to Market

Congratulations! If you have worked through all of the above, you are ready to go to market, a project in itself.

Back to Dr. Baxter’s inspiring and encouraging story – as a physician inventor, she finds that the great thing about physicians and physician inventors is that we think very three-dimensionally. In a medical world based on two-dimensional pharmaceuticals and schematics, as doctors, we see “the whole body, we see the whole person, we see the need, and it makes it easier for us.”

It’s wanting to do something that’s the real push to move physicians into the entrepreneurial world of inventing a medical device.

That’s what I’m all about. So if you’d like help stepping into your role as an entrepreneur so you can build multiple streams of income, I’d love to chat with you.

Become an EntreMD Insider and receive emails full of tips, tricks, and tools to keep you motivated and encourage success. Sign up is simple – text the code ENTREMD to 44222 and follow the prompts.