Bootstrapping a Quality System – Advice for Medical Device Startups

Within the past few weeks, we’ve been approached by a few early stage medical device startups requesting assistance. One of the common needs of these potential clients is a FDA / ISO compliant quality system. I’ve been asked to quote a build-from-scratch quality system. I’ve also had to educate a couple others on what a quality system is and why they should even care. I suspect some quality purists would tell these startups that it is absolutely essential to implement a fully compliant quality system ASAP.

I, however, do not agree. Especially for an early stage startup. Why not?

Hiring a resource to draft and implement quality system procedures is overhead. More times than not, the capital spent establishing a FDA / ISO quality system for a very early stage startup is not the best way to spend valuable and usually limited dollars.

Don’t misunderstand me. Yes, a compliant quality system is ABSOLUTELY necessary to have in place prior to going to market. But in the world of medical device startups, this could be a very long time. In the world of medical device startups, very few quality system elements are even meaningful during the fragile product development process.

Instead, I advise my startup friends to bootstrap their quality system. In other words, build the parts and pieces as you go and as you need them. And for a startup, there are likely only a few pieces that essential during medical device product development.

In my opinion, the critical quality system components during development are:

  • Design Control / Design & Development
  • Risk Management
  • Supplier Controls (because most startups rely on a fair amount of outsourcing)
  • Document Control / Record Management

Once the startup approaches the stage of regulatory submissions, additional elements of a quality system become more pertinent. But until then, keep the quality system bare bones. Bootstrap it and build it as you go.

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