Speed. Fast. Now. That’s all we want to hear when developing a medical device, right? Speed to market is actually a huge deal for medical device companies, and a major challenge.
Developing a medical device often feels that you are on a race, a race against competitors, against burn rate or against new technology taking over. And when talking about medical devices, we really want to speed up, Usain Bolt style. I often compare the product development process to one of my favorite shows “The Amazing Race”, the goal to be the first to cross the finish line by successfully overcoming all the challenges on the road, all those speed bumps, detours, U-turns, while enjoying the ride at the same time. Developing a new medical device, truly is an amazing race, and we definitely want to go as fast as we can without risking a “road-block” from FDA or a “U-turn” from the customers.
So how do we balance that? How can we speed up while assuring success on the market?
A quick spoiler:
You should not focus on speed, but rather on the right timing of your decisions.
Here are some tips for you if you are looking for a successful and fast product development:
Startups and founders have lots of passion and courage that often get them right into build mode, which normally the story goes something like “I had a very good idea, I have skills and friends that can help me out, I have money saved, and I could ask for a loan, so I’ll just build what I have in mind.” Jumping right into these gets a lot of U-turns along the way. First things first, listen to your customers, at least 100 of them, and ask them the right questions. You don’t want to end building the wrong product, no matter how fast you can do it.
This needs to be done right at the beginning when you have the idea, not after building a prototype, or after getting investment, right at the start. FDA classifies medical devices in Class I, Class II, or Class II based on their intended use and safety risks and has a list of product codes. If this is not done early on, or it is done poorly, expect lots of speed bumps during the way.
Don’t be afraid to just reach out if you have questions. FDA is part of your “Go-to-market” process and because of that it is strategic to talk to them early on your development. Regulations often fall behind Innovations, they are more reactive than proactive, so someone needs to be the proactive one. You can start by reaching out to them here: DICE@fda.hhs.gov
Sometimes startups get so deep into the technical aspects of the device or the technology that they leave paperwork for later, “there are more important things to deal with right now and paperwork takes too much time” is often the phrase. Missing, incomplete paperwork or disorganized documentation is one of the biggest causes of delays to market. Remember to document everything you do, and to do everything you document. We often underestimate the need for Design Controls, but it actually plays to our advantage. If it is not playing to your favor, then you are doing it wrong. When should you start with Design Controls? You don’t need to apply Design Controls if you are still in the ideation phase, developing of different prototype concepts or feasibility studies. We recommend to start once you have defined the intended use for your device and already have the final User Needs formally identified, which should be right after the ideation/research phase. As you can see this is pretty early on the development process, if you try to implement Design Controls at the end, expect a really long detour.
You maybe thinking - “What?” But my medical device is great! It is way better, is innovative, is really a game-changer, of course I’m doing disruptive.” What I mean with this is that when going to market, you should go through FDA first, and if you think that FDA is going to clear or approve your device because it is way better than anything, think again, because this raises concerns for safety. So if you want to enter the market fast, develop first the simplest version of your device, compare your device to other devices already on the market, and address all the safety concerns. Once you are on the market, you can develop your upgraded next generation.
As you know already, taking a product to market is quite challenging, and you will need help. Innovation is all about collaboration; you will need an amazing team that can help you navigate this amazing race, and that is when medical device development companies come in handy. They derisk your project, helps your team overcome challenges, and help you take the right decisions at the right time. They can become your “Fast Forward” card during the development process.
If you take the decision and implement these activities at the right time of the process will eventually speed up your successful market entry.
“Bioana team, you guys are simply amazing. Thanks so much for all your team’s hard work on this. We remain impressed beyond measure.”
"Our experience with Bioana had been outstanding. Their commitment, eye for detail, punctuality, proactivity and understanding manufacturing principles, workflow, quality and resourcefulness has been beyond our expectations."
CRO , Bolb Inc.