Coming up with a novel idea for a medical device is easy.

In fact, coming up with an idea for anything is easy. Everyone does it.
The last time you stuck your mouth under a faucet to get a drink, because there was no cup available, you did it.

Creating a medical device company is hard.

Like it or not, unless you have someone that wants to buy your idea right out of your head (very rare), you are on the road to making a company of some sort, even if it is just a simple LLC for the activities of the project. Aside from the obvious necessities of a company that deal with things like finances, tracking, and liabilities, I would like to focus here on some lessons learned over the years that deal with issues in medical device product development that are a bit more obscure, but every bit as critical.

We all learn best by experience, but the wisest of us learn from the experience of others as well. Perhaps some of my blunders over the years can help you avoid problems in your current undertaking.

1. Don’t assume everyone knows what you know as the “idea person.”
You should be well-versed in the shortcomings of current therapies. You should know how and why your new idea is a better solution. But remember: other people don’t know. You need to show them—again and again—how you arrived at your solution and why it is superior. The apathy of others may be a dangerous weapon against the progression and product development of your medical device. The only thing to combat this time-sucking fiend is your passion, but it must be tempered with thoughtful consideration of the ideas of others, and a realistic view of time and money. Otherwise, those around you that you need for help will see you as unrealistic and demanding. This could lead to an “abandon ship” mentality that will slow things down even more.

2. Procrastination is your worst enemy
“We’ll tackle that later” is not a good mentality when it comes to quality management systems and design history files. Doing these things retrospectively (which you will have to do anyway) takes much more time and money than doing it as you go through the medical device product development process.

3. Don’t assume a reimbursement code means your device will get paid for
An insurance company’s main job is to make sure they don’t have to pay you or anyone else money. Your medical device may fall under the description for a reimbursement code, but does it bring clinical and economic value? Does in meet a large and important unmet need? Does it help with patient adherence and efficiently deal with budget restrictions? Insurance companies need to see practical value in your product to accept it. If they see value, they will reimburse. The days of a great idea taking off because it is unique are over.

4. Find out who all your real users are
Perhaps it is a surgical device, and the surgeons love it. Great. What if it takes more setup time than it does for the procedure? It would be good to know what the surgical technicians think of that. If they hate it, it could be dead in the water at the get go.

5. Ego is your second worst enemy
You can’t do everything, and you shouldn’t. In fact, your ideas about how things should be done might not be the best. Find people who are smarter than you in various disciplines, and surround yourself with them. Also, don’t fall in love with your medical device idea; it may need to change to be successful. Be open to changing the concept in the early phases of the process so you don’t have to change things later, when it becomes VERY expensive to makes changes to the product.

Pay homage to these practices and your journey may well be smoother than the average medical device startup company. And be proud of yourself: You are taking on a huge challenge, which may ultimately positively impact the lives of thousands—maybe millions—of people.

Tom KraMer portrait

Tom KraMer

The founder of Kablooe design, Tom has been involved in product design work for over 26 years. His work experience spans from toys to medical devices and everything in between: usability research, ideation, design work, and teach on the design/development process. Heck, he can even play drums in the Kablooe band as a backup to real drummers. Got a development question? Tom’s got answers.