Many the skills I needed about running a medical device startup I learned as a waitress. Waitressing is all about the big picture: how many tables, what is the timing of their orders, does it involve the kitchen, bar and grill or just the kitchen… you get the idea. It’s all about figuring out how to keep table 1 happy while you are serving table 4.
Being a COO of a medical device startup has surprising similarities. You have to keep a big picture “systems” view of the development/production/testing/clinical trials etc. Can you do testing while you wait for the FDA? The key is seeing where improvements can be made (in parallel) without impacting outside vendors/agencies. As COO, one of the most important questions is to be absolutely clear about “what can I control internally and for what elements do I need to rely on an external vendor/timeline”? For example, can you change the software code after FDA submission? Can you change manufacturer without permission from the 60601 tester or FDA?
The internal controllability question is how much you can push your employees to meet a deadline. Presumably, in a startup, you can push. The external deadlines are mostly out of your control, and if the vendors are overcommitted (as they may be currently with supply chain issues), all you can do is apologize to your customers and investors about missed deadlines.
For medical devices (as in restaurants), the customer-- the clinician--is king. There is no way your device will succeed (at least in the US) if the clinician won’t use it. Period. The very first touch of your device needs to be the clinician. If they don’t say “it may have promise”, ask them about it in 1000% frank terms. You do not want to produce the 6-fingered glove (shout out to Princess Bride fans).
In my experience, the delays that are out of your business’ control can be the most difficult ones. 60601 testing. Or FDA clearance. Or IRB approval. It is essential that you communicate with your investors about these elements outside your control, and to reassure these investors that you are getting done on time all the internal stuff in your control. And don’t build your business projections based on unrealistic timelines of these external vendors. The projections will come back to bite you.