Respect the game.
Medtech, healthtech, and healthcare, continue to be one of the highest growth industries and continues to move closer to the consumer.
Existing and successful multi-billion dollar technology companies are entering the game.
As these high-tech non-medtech companies enter into the medtech / healthtech industry, I have watched a number of shared errors either through ignorance, lack of experience or the liability of ego.
– Do not disrespect the FDA or under-club the regulatory process. They are the gatekeeper. Remaining collaborative, communicative, flexible, and patient are critical qualities. Expect the FDA to be rightfully hyper-vigilant to new entrants who plan on coming into contact with patients and clinicians.
– Get your development people, especially your engineers and program / project managers in front of all of the customers. Patients, clinicians, payers, and providers. And when you think you have been in front of them enough, double that time and send out new engineers and program / project managers. Remove as much bias as possible.
– Bringing a medtech / healthtech device to market has a lot less in common than bringing your current technology to market. The “while it is in play” iterative process culture that you can administer to a commercial product is not applicable to the FDA regulated industry.
– Regardless of your current quality system, the quality system that is required in medtech is likely going to be a major issue.
To all leaders.
We are much more of what we do not know than what we do know