New players are entering medical device manufacturing

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.

"In the past, medical devices were primarily made at large corporations," he said.

With larger medical device companies now looking to buy these smaller players as a way to capture new business, the startups seek to build devices more quickly to enable a profitable sale, Boyer said.

HS Design, based in Morristown, N.J., is a product development and medical design firm, so Boyer and his colleagues have a front-row seat to the changing landscape in the medical device business.

As the landscape for medical device manufacturers widens, so too does the marketplace, he said.

"In the past, medical devices were relegated to hospitals," he said, and other professional settings. But they are now become more and more like consumer products that people can access and use at home.

Smart watches and phones that can monitor the body are examples of how the health care device business is evolving, Boyer said.

HS Design, itself, recently was part of the change taking place in the medical device field. The company was acquired by SteriPack Group, a contract manufacturer in the medical device, pharmaceutical, diagnostic and allied health care industries.