Below is an edited transcript:
Mike Keer, CEO of Product Realization Group: What are the most common causes of failure, or delay, when developing a medical device that you’ve encountered?
Howard Edelman, CEO of Advanced Resin Therapeutics: There are many reasons for things to fail which run the gamut from the team not being synergistic, to problems with the technology, to not being able to sell the device. By the way, there are incubators and accelerators that can help. I’m part of the UCSF Lean Launchpad, and SkyDeck and my co-chair runs the SkyDeck at Berkeley. California Life Science Association also has a great accelerator. There are many of them.
Howard Edelman: One of the things they do at UCSF is to encourage people to go out and do customer interviews and this is true in any market. It is necessary to understand what customers want to define the customer. It could be a clinician, a patient or could be many different people. It is necessary to understand your customers and their needs. However, another common cause for product failure is a lack of close collaboration with development partners.
Howard Edelman: Even though you are relying on them, the partners don’t care as much about developing the product. It’s necessary to monitor the development of the product closely, to make sure it is working properly, to get prototypes into the field, to get customer feedback, and to really understand what the customer wants.
Walt Maclay, CEO of Voler Systems: Yeah, I will underscore the importance of understanding the customer, whether it’s medical or not. That’s a common failure. In medical devices, the failures are usually from a lack of understanding of how long development is s going to take. Extra time is needed because of the regulations, for obtaining FDA approval, and for obtaining reimbursement codes. People who haven’t been through the process before might not allow enough time, and that often means running out of money as well.
Jeffrey Christian, CEO of Phoenix DeVentures: I agree with what’s been said. I’d add to that, in my opinion and observation, perhaps the most common source of these failures is bad decisions. If you make a bad decision, you can pivot and you can backtrack if you recognize it quickly enough. But if you spent two years based on a bad decision, you’ll never get those two years back, and those two years may have just cost an investor millions of dollars. So, what’s the trick? How do you identify a bad decision? There’s the magic.
Jennifer Ernst, CEO of Tivic Health: How do you know a bad decision and find the courage to tell the investor? So, if we are knee-deep in the development, how do we explain that cycle times take longer and it will take a lot longer than expected, even with back timing. I would strongly encourage product development teams to think about the end goal and factor timelines out from that, as a best practice, rather than saying, “I’m just going to do the next incremental thing.” Because your CEO has to have a plan, and has to know how long it’s really going to take, and how much money it will take to get to that milestone.
Jennifer Ernst: Then I’ll add one more thing on the investment side. When you’re building a company, you’re developing two products at the same time. One of them is the product you’re going to put in the customer’s hands and the other is your shares. Your equity is a product that you are building as you’re building the product and the team. In terms of the overall strategy development, you’re building value in the shares of your company along with building a product.
- What are the most common causes of failure, or delay, when developing a medical device that you’ve encountered?
- What advice would you give for newbies making the transition from non-medical to medical device development?
- How does medical device development differ from other types of product development?