Playing within the lines of non-medical wellness toys is fun, but lets get serious. If you want your product to be seriously meaningful with direct impact to saving lives through diagnosis and treatment, you should expand your medical technology into the world of medical devices and undergo the submission process with FDA. Here’s why.
1. High Impact
Yes fitness and meditation apps are great. But I personally feel you will hit the glass ceiling quite quickly with these devices. If you want something meaningful, you have to have direct impact to to a serious condition. If someone has a bacterial infection, you can give vitamins in hopes of fight fighting it off, or you can prescribe antibiotics to kill it. Wellness Devices are like supplements. Medical Devices approved by FDA are like drugs.
2. Nice To Have vs Need to Have
Wellness tools are nice to have but folks don’t necessarily need them. A person suffering from diseases like cancer and diabetes need your product for their survival. There’s a direct correlation between a device’s risk profile and need.
3. Access to International Markets
When you get your product cleared by the FDA, you can get a Certificate of Foreign Government which is used to get you into other countries like Brazil and China. It essentially says that the product has been approved by FDA and can be marketed and exported from the USA. The CFG is recognized by many countries and often required for registering your product with them. Think of it like a stepping stone to getting into other countries that recognize it.
FDA has a brand. Some may argue they have a bad reputation. But when it comes to their mission, they stand for protecting the public. Safety and Efficacy is what they look for when approving a product. If your product is approved by FDA, it shows that it has undergone the rigorous quality system process and FDA review.
Your perspective will broaden on what Quality really means. The processes used to be build medical device is quite different than consumer electronics. This isn’t about a lean 6 sigma karate belt. This is about having deep experiences of building quality into the design of the product and being involved in every step. It’s about having safety and efficacy concerns embedded in your subconscious during the entire development of your product.
6. VCs & Acquisitions
Having FDA approval also gives you an edge if you are looking for funding. Having FDA clearance shows that the manufacturer is a serious medical device manufacturer. Companies like GE Healthcare and Johnson & Johnson specifically seek out these small companies to add to their repertoire of products.
7. Access to Hospital Networks
When building a medical device you are bound to work with hospitals whether it’s for feasiblity testing, pilot testing, clinical trials, or usability activities. This is a great way to build you network of potential customers and influencers in the healthcare space.
8. Rapport with FDA
Whether you need more information on how to classify your device or are getting FDA clearance for you device, you will inevitably establish a rapport with FDA to get your gadget out to the market.
9. Build Team Morale with 510k/PMA Process
The FDA submission requires everyone’s input. This is a huge milestone to reach for the team that allows employees to learn how to work together and build morale to reach a common goal of product approval.
10. Flexible Roadmap
If you have an approved medical device, the intended use allows you to later expand to wellness should your company decide to pivot. Remember that it’s much better to have a more high quality accurate device that is approved by the regulatory authorities for disease and wellness, than a less accurate device that is confined to wellness. Also, transitioning from Wellness to Medical requires is not so easy. You’ll need to instill new processes, create documentation, get certifications, audits…the whole nine yards. The most difficult thing to change will be the culture and mindset of a wellness company to a medical one. Why do you think so many Tech CEO that try their hand in Medical Startups magically disappear? Ooooo, it just got real.
Once you make the leap into medical devices, it will open a door of opportunities that would otherwise not be available to you as just another wellness toy. Make the effort, dare to make a difference, and distinguish your meaningful product.