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Do you know what the biggest surprise about this industry was for me when I got into regulatory years ago?
The incredible talent, and entrepreneurial spirit of the small manufacturer.
My father worked for Medline for years. And these brands (BD, Medtronic etc.) were really all I was aware of growing up. They’re the big boys, distributors on the biggest scales, and their logos are plastered all over hospitals worldwide.
But as many of you know (because you work for them), the medical device industry has an entire sub-culture of ‘get-it-done’ innovators and engineers. Striving to raise money, operate on shoestring budgets and bring a cool new procedure/device to market that solves a hyper-specific clinical problem.
Some of these ‘small’ manufacturers have been in the game for decades. They built a great product, treat their customers like human beings (shocking strategy, I know), and have thrived since before I could even read an IFU.
But it’s not all sunshine, innovation and piles of profits in the small manufacturer world. There are inflating costs, supply chain/production challenges, and ever-increasing competition from bigger fish that slashes profit margins.
And now it’s gotten even worse. Because the costs of compliance in Europe have boarded an Elon Musk rocket ship, and blasted themselves to the moon and beyond.
MDR and IVDR take time, and know-how. For Most smaller-ish companies that boast a Quality/Regulatory team of 1 (who also does the billing from time to time), that translates directly into having to hire more people or consultants to get the job done.