How to avoid mistakes and problems when developing a Medical Device
Developing and launching a new medical device to the market requires a long and tedious process, and if not executed correctly, can lead to a series of mistakes and problems that will set you back in the process.
If you want to have a successful product, I’ve made a list, that in my opinion, are the major key factors to focus on when developing and launching a medical device.
key factors to focus on when developing a medical device
- Listen to your customers – most of the medical/ biomed startups are initiated by a technological person, a physician, an engineer or someone that is from the medical / biomed industry and found an unmet need. You often see R&D teams working on a great technological solution but not really answering what the customer needs. Most of the time the customer doesn’t know what they need so you need to go out and talk—and more important still, listen—to what your users tell you they want.
- Less is more – focus on the core functions the device needs to have – get 5 core functions and once you finish these, add more features – KISS – keep it simple stupid. The more features you have, you will end up with a more complex product.
- Handling regulations – a medical device needs to be safe and effective. You need to have proof to show it, prepare for all scenarios and test them before submitting your device to the regulatory authorities, you really don’t want them to find the problems for you. Make sure you know exactly what is needed for your device before submitting it to the regulatory authorities.
- Plan ahead – Don’t try to find shortcuts. Follow the process step by step and show evidence by verification and validation of what you are trying to claim. Planning is the key! Make sure you understand the process of launching a medical device and follow it from the beginning, early as possible.
- Prepare for a rainy day – plan your budget and time and know that it will take longer and cost more than you think. Add buffers to your timelines and budgets, but reasonable ones. Being too early or not using all your budget can also affect how the investors will fund you in the future and shows your ability to plan ahead.
- Time to market – there is an interesting TED talk – The single biggest reason why start-ups succeed by Bill Gross – that shows that although execution is important and matters a lot, it could be that timing is even more important and matters more. Make sure the market is ready for your product – that it is not too early or too late. If it is too early, you have to educate the world, if it is too late you might have too many competitors to deal with. Study the market well, know what your customers need, understand the environment and know your competitors.
- Leave it to the experts – work with experts who have experience with medical devices that you don’t have. Work with people who can get it through the FDA/ CE/ CFDA etc. and launch it to the market properly. Although you came up with the idea or the start-up doesn’t mean you know everything that needs to be done in order to launch a product.