The startup pivot: How to rethink your medical device company

In the medtech market, startups have to be flexible; the startup pivot is crucial. “Companies have to morph as they go,” said Maria Palasis, CEO of bioresorbable drug delivery system company 480 Biomedical.

Palasis explained that startups, and even mature companies should expect to shift their technology in one way or another through the course of getting a product to market. It might mean changing focus to address an unmet need in a different disease state or alter the technology to more effectively impact the disease. The process is expected and built into lean startup models.

(Palasis will be speaking in the CEO Sessions panel at DeviceTalks Boston on Oct. 2,  about technologies that are changing the paradigm of care.)

480 Biomedical has gone through such shifts.

“As we set out to define our strategic vision for the company, we were simultaneously pushing forward our technology development while evaluating two important factors: (1) clinical needs where we could improve outcomes and/or safety; and (2) market opportunities in which we could develop a viable business based on the regulatory path, competitive environment, payor receptivity and clinician adoption drivers,” Palasis said.

“We were originally developing bioresorbable stents for superficial femoral artery disease, which is a vastly underserved segment of the large peripheral vascular market. After evaluating the iterative development efforts and investment which would be required to ensure successful commercialization and positioning, we started to more seriously consider other options for our technology. We soon landed on a more compelling market opportunity in which we believe we will be successful in addressing an unmet clinical need with a clear path to commercialization.”

Many successful companies end up doing something different from what they originally intended, but that doesn’t mean it’s an easy process.

“This is a really challenging part of the business,” Palasis said. She noted that if a company does decide that it needs to pivot, the process can be enormously complicated, but there are steps that can help organize the tasks to make the transition.

1. Don’t rush. Recognize that this process cannot happen abruptly. The goal is to make the transition as smooth and well-thought out as possible.
2. Figure out if there is a better problem to solve or a better market opportunity for your technology. Again, when evaluating the new opportunity: 1) assess product development risk, the regulatory path, and clinical risk; 2) understand the market size and growth drivers, including the payor environment; and 3) determine if there are investors and strategics committed to the problem you’re trying to solve. Pivoting to a new opportunity with lower development risk, a large, validated market, and potential interest from the investment community makes it easier to get stakeholders on board.
3. Do the feasibility work. You have to feel confident that you can make the case to all your stakeholders. Engage with thought leaders in the medical field, conduct independent market research, and develop and test the product concept before moving forward.
4. Bring your board and employees along. It takes time to make everyone comfortable with a decision to pivot. Once you have determined which direction to go, and the skunkworks have been done, be upfront about your decision.

(Palasis will be speaking in the CEO Sessions panel at DeviceTalks Boston on Oct. 2,  about technologies that are changing the paradigm of care.)

From the Hospital Bed to the Finish Line Heidi Dohse was diagnosed with a rare arrhythmia in 1982 and has been 100% pacemaker dependent for over 30 years. With the help of wearable devices, she has been able to pursue her dream to become a competitive cyclist. You can hear her story and more when you register for DeviceTalks Boston, October 8-10. REGISTER NOW Use code FINISHLINE to save an additional 10%.