Below is an edited transcript:
Mike Keer, CEO of Product Realization Group: How does medical device development differ from other types of product development?
Howard Edelman, CEO of Advanced Resin Therapeutics: Primarily there’s a lot of formalization to the process. We’re in a regulated industry and the process for development needs to follow fairly standard guidelines set by the FDA. One of the pitfalls is that guidelines can be too cumbersome for them, and they can lose the nimbleness of rapid product development. There are ways and methods to develop products in the device industry in a concept phase for as long as possible. But you have to worry about formalizing that, considering the risk analysis that has to go along with it. Risk assessments and hazard analysis and all the things that govern device development are becoming more cumbersome and detailed as time goes on, especially with new versions of 60601 coming out.
You need to consider, and a lot of you may already been going through this, that quality has a larger seat at the table and has a presence throughout the process. It’s necessary to try and understand methods for doing things rapidly without encumbering yourself. At certain times, you really need to get them more involved and to stay closer to the process.
Walt Maclay, CEO of Voler Systems: Clearly, the difference is the regulations. If you’re selling a product in the U.S., you have to meet FDA regulations and in Europe, the CE regulations. Other countries have their own regulations. Fortunately, the difference from one country to another is not huge and is getting smaller, but you need to keep track of some of the changes. It used to be that people would introduce a product first in Europe because in Europe you only needed to have a safe product. It didn’t have to be efficacious, that wasn’t part of the requirement. That’s changing. Now it looks like people will be introducing products first in the U.S. and then Europe. That’s a big change.
Jeffrey Christian, CEO of Phoenix DeVentures: It is important to think of the regulations, as was already mentioned, as not a necessary evil,, but the way you do things in order to ensure that you’re making products that aren’t going to hurt people. That’s the intent of the regulations. Of course, we all think they go overboard sometimes, but still it’s a method of thinking and a method of organizing your work. During my first foray into medical products when I was a young buck, I took responsibility for a product that had already been launched only to find that immediately there was a complaint out of Australia because the simple product had come apart and killed a boy.
In those days we didn’t follow design controls the way we do today.The engineer on that project simply did a bad job and it killed a person. That hammered into my mind the importance of recognizing the nature of doing that work and why the regulations are critical.
Jennifer Ernst, CEO of Tivic Health: I made the transition from a tech company into medical devices and I noticed three things. One is you had to speak a really weird language made entirely of numbers. I had been sitting here, listening to two people arguing back and forth, ”Is it 60601 or .3 or are we talking about the 62344?” No English spoken. That was a noticeable point and is actually even more noticeable in medical device development.
Second is the timelines. I didn’t quite understand, coming into it, why the timelines were so long. And it wasn’t just about clinical trials. I discovered this process of sending a question to the FDA and three months later there will be a meeting scheduled to answer that question. Then they will ask you to answer something else and you will need to submit another form and three months later you can get an answer to the question. So that transition act, that process, does gate your ability to move with agility and to move as fast as I was used to moving.
The third point is that because the FDA processes are deeply embedded in a Waterfall methodology. Agile is slightly more difficult to apply crisply in the usual Agile embodiments than I’m used to, moving from tech into the medical device field. Not impossible, but more difficult.
- 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?