In all my years working with start-up CEOs who have an innovative medical device sketched out on a napkin, I watch certain issues show up again and again. I’ve never met a successful medical device start-up CEO who feels they have the luxury of unlimited time and funds. Time and money are usually your enemies when you’re operating in competitive markets. Yet, if you’re built to go fast from Day 1, time becomes your ally, which often means less funding is required. Having run an extraordinary number of medical device product development teams, I can tell you three barriers-to-speed show up most frequently as you work to bring your innovation to market rapidly. I’m betting one…perhaps all…apply to you:
- Unclear product design goals and a hazy product development plan. When requirements for your product feel a bit fuzzy, development gets fuzzy… and then stops. Maybe the development path mapped out seems unrealistically ambitious… or not ambitious enough.
- Too much of one type of resource and not enough of another. You’ve hired lots of great design engineers, but not enough quality engineers. You’ve got talented project managers, but no one in-house can manage the machine shop. Getting a new medical device off the napkin and into manufacturing requires a wide range of talent. This is probably the most common problem I watch start-ups face as you can only hire a shoestring staff. You may have a couple of the very best engineers in the world, yet it’s unlikely they are experts in the myriad skills your product requires: program management, materials engineering, design engineering, technician work, machine shop, injection molding, rapid proto-typing, quality engineering, pre-clinical engineering and regulatory specialists. Got all that?
- Managing it all yourself. Ouch. As the CEO, you’ve got hundreds of “first” priorities on your plate… determining corporate structure, managing SEC filings, securing and protecting intellectual property, creating business plans, getting funding and more. If you’re also attempting to manage the technical aspects of your product development, well, something’s got to give. Are you going to put off talking to that potential investor, or put off your prototype date? Spreading yourself too thin challenges many CEOs… and it inevitably slows you down.
Time will either be your enemy or friend. Beating the barriers-to-speed will enable you to not only bring your innovation to market, you just might be able to get it there ahead of schedule! -Eric Johnson & Phil Burke