Being a part of a startup company is exciting. The newness of it all –the product, the facility, the knowledge of your peers – is enough to make anyone want to jump in head first. But, as with any startup, it’s important to formulate business strategies and goals before diving in. Doug Carr, the Founder and CEO of Thermedx, LLC, spoke to this topic at AD&M in March 2017.
When it comes to a medical device startup company specifically, factors like staffing, resources, development and – most importantly – compliance, come into play. Ideally, each of these elements will be fulfilled before product launch.
Key word: Ideally
In a perfect world, your startup will be equipped with the following:
- A full staff
- Ample resources
- A seamless product development process
Realistically, this won’t happen. So, what’s a startup to do?
Chances are, at some point, your startup is going to experience one, if not all, of the following:
- Low staffing
- Limited resources
- A delay in product development
From a staffing perspective, the realities of hiring Quality & Regulatory (Q&R) personnel is much more difficult than expected. And when it comes to having the necessary resources for seamless product development to ensure full compliance, it can be challenging. It also takes roughly 177 days from submittal for FDA clearance. The early adaptation process can be difficult, and it should not be overlooked.
Despite any obstacles, a medical device startup company’s goal from day one should always be full compliance. It’s imperative to be sure your quality system supports full compliance and can be appropriately structured for the stage and size of your company.
So, what’s the takeaway here? If you’re beginning a startup or in the midst of growing one, be sure to plan for unforeseen challenges. Do this, and you’ll save yourself – and your team – a lot of unnecessary wasted time and stress.