Lessons Learned in Medical Device Product Development

 In News

In 2016, I was the CEO of a small, private-equity-owned medical device company in West Lebanon, NH. After nurturing our third product line — a clinical data registries platform with strong revenue growth — the chair of our board and I decided that it was time to test the market.

It had been 15 years since I’d thought about joining a new company, but after a successful sale to a company in Seattle, I was interested in pursuing a new challenge. I knew Simbex’s CTO, Jeff Chu, and sent him a note. This led to a meeting with Jeff and Simbex’s CEO: Rick Greenwald.

In that first meeting, Rick and Jeff shared with me the Simbex story. 

Founded to develop medical device and consumer health products of their own, they began to document the common regulatory requirements, healthcare reimbursement options, and clinical considerations which carried over from project to project. Consequently, they began honing the Simbex approach to the product development process in their search for the most efficient commercialization pathway.

By repeatedly facing the challenges associated with developing new products, Rick and Jeff also began to better understand the holistic approach needed to commercialize a new technology. They explained to me how Simbex now employs those same principles to nurture product ideas and provide clients with broad support to achieve commercial success.

I was impressed by the breadth of Simbex’ development experience and the emphasis on more complex products, wearables, real-world data and electro-mechanical systems. Furthermore, I was struck by how Simbex worked with each customer as a partner, and how they helped clients navigate every nuanced step of the commercialization process.

They asked me to help them grow. I jumped at the opportunity!

My first job was to find the right partners. I learned the markets, familiarized myself with the technologies, learned the language, and started working with potential clients.

Along the way, I’ve learned many lessons about medical device product development:

  1. There are so many people with great ideas and passion to solve problems in healthcare.
  2. A majority of innovators don’t appreciate all the steps required to get a product to market.
  3. Even established companies have a hard time communicating what they want to develop.
  4. The product development process is much harder than most people think.
  5. Product development, without process, represents significant risk.
  6. There are a lot of Accelerators, Innovation Hubs, Entrepreneurship Boot Camps, etc. and few really give you the tools to get to market.
  7. When someone says they have “complete product requirements” or “understand their customer’s needs”, be skeptical.
  8. The product development process is, by nature, exploration. Therefore, knowing what it is going to cost to create the product with less than optimal product requirements is unrealistic.
  9. For all the conversations we have, and de-risking we do, there is always uncertainty and unexpected challenges. For that reason, product development should be done, not as a customer and a client, but as a partnership. Create partnerships, not clients.
  10. At the end of the day: process rules, solid teams succeed, and innovation in the medical device and consumer health space flourishes.

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