CUYAHOGA FALLS, Ohio—Health care product manufacturing is becoming more democratized as smaller companies are increasingly jumping into the business.
There was a time when the biggest companies—think Johnson & Johnson, Becton, Dickinson and Philips, for example—had a grip on the health care device market. But the business is seeing an influx of upstart companies looking to quickly make their mark and turn a profit. And even be flipped.
"At the moment health care has seen a lot of evolution and shifts in technology," said Bobby Boyer, director of product development at HS Design Inc., that is allowing a pathway for startup companies to find success.
"These startups are still using the same kind of methodology as in other industries, using the tech-minded lean methodology. That's really where their mind is going to try to incorporate that," he said during the virtual Healthcare Elastomers Conference organized by Rubber & Plastics News.
So smaller more nimbler companies, powered by a different mindset, are seeking ways to gain entry and make a breakthrough product while minimizing the amount of time it takes for regulatory approval. And it's not uncommon for these smaller firms to seek a buyout from one of the larger players once they have established success.
Instead of seeking traditional clearance through the Federal Drug Administration for their products, some of these newer companies see pathways to success through Emergency Use Authorizations, for example, Boyer said. Another approach to cut approval time is to seek a so-called 510K clearance from the FDA that shows a new product is substantially equivalent to an already-approved device.
These approaches can shave time needed to reach the market. And saving time means saving money.
"Medical devices are now seen as this big investment opportunity, which means there is a lot of money pouring in from investors into novel devices, creating a lot of different niches in the market and also changing the way typical companies are structured," Boyer said.