Key notes: 4 ways elastomers take shape in medical sector

CUYAHOGA FALLS, Ohio—Rubber in medical applications is as fascinating today for its technological advancements as it has been essential for its lifesaving capabilities.

The breadth of the topic is one reason Rubber News precedes its May 8-9 Healthcare Elastomers Conference with a Livestream on issues facing the industry, including material innovations, the changing regulatory environment and the future of medical elastomers.

And certainly, the market continues to go as the three-year-old COVID-19 pandemic goes. It is the elephant in the room that continues to drive medical demand.

Today, modern medicine depends on elastomers to advance its capabilities. Stoppers, vaccine vials, tubing, wearables, orthopedic braces and so many other devices owe their usefulness to rubber and silicone, the latter of which continues to be a game changer in the medical device arena.

Here are just 4 key points covered in the March 23 Livestream, which is still available on-demand.

Is it really over?

That is what so many along the medical device supply chain are asking in 2023 regarding the pandemic.

Three years in, and the ebbs and flows of material availability have been evident. Medical markets are shifting, that much is certain. And in some cases, demand is dropping off precipitously—consider the production of nitrile gloves—while in most other cases demand remains as strong as ever.

"We are seeing shifts in different segments," said Don Bonitati, director of Trelleborg Healthcare and Medical for the Americas segment. "Currently the (Purchasing Managers' Index) for medical manufacturing is below 50 percent, lower than it was a year ago.

"Customers have built up significant inventory to mitigate risk ... they were not going to wait for the market to replenish materials."

Erick Sharp, president and CEO of Ravenna, Ohio-based Ace Laboratories Inc., agreed the pandemic is in a different stage today.

"We have gone from response mode with depleted national reserves to replenishing those national reserves today," he said. "It became a national security issue ... we did not have the ability to make these pieces when we needed to, so we relied on our allies.

"But what is the long-term stability for getting these response projects off the ground? That is the question."

Some raw materials, like silicone rubber, continue to be in high demand for micromolders and many other manufacturers in the medical industry.

Backlogs are good for a company, but only if those backlogs can be met. And silicone has returned to some semblance of normalcy in terms of pricing and availability.

But what happens when customer requests for a certain material cannot be met, at least in a timely fashion? In many cases, it means pursuing an alternative.

"We are seeing a lot of customers attempting to mitigate risk by placing redundancies in the system," said Khaled Boqaileh, president and CEO of Kitchener, Ontario-based LabsCubed. "We are seeing a lot of research and development work, a lot of testing."

Boqaileh said customers seem to "be more flexible today as well."

"Customers seem to be more flexible in their timelines ... they seem to be thinking more about how they design products, how they can place in redundancies for what could come down the road," he said.

Businesses tend to replenish materials that are in higher demand first, Bonitati said. But other suppliers have chosen to discontinue some materials altogether.

"I would strongly recommend that now is the time to test and develop alternatives, not when you are under the gun," Sharp said.

Technology is changing at a rapid rate, especially in the medical industry.

This can be a double-edged sword, as regulatory bodies typically lag behind the development of new devices in the issuance of certifications.

Open-source hardware is available, and single-use medical devices are becoming the norm.

And patience, from a customer's standpoint, is a virtue.

"Customers who are looking for a unique material that another company can offer, something custom-to-market and not readily available, they can solve those problems," Bonitati said. "But the customer also wants a clear path to regulatory submissions.

"If we have the material set already predicated on that background ... we can offer them a sense of comfort that they already have passed some of the baseline (certification thresholds). But the customer needs to take it the rest of the way."

Interesting to watch, Boqaileh said, is how people have shed old ways. And that has affected their philosophy on the regulatory environment as well.

"Generally speaking, when you work with medical customers, everything is highly regulated—you have your standards and you have to get done exactly that," he said. "But with that flexibility that people developed, we could offer them maybe a 'standard adjacent'—and that gives them confidence.

"COVID forced this thinking."

The future of medical elastomers may already be here.

Ultra-pure silicones that can be micromolded to proportions that are nearly invisible to the naked eye; thermoplastics merging with biotechnology; and drug-eluting wearables are just a few of the innovations taking place today.

And it is important for upstream suppliers and downstream manufacturers and fabricators to know what is expected of them moving forward.

"One of the things that the pandemic did that I appreciate is it showed the importance and sexiness of polymers," Sharp said. "Rubber is innovative!

"And sometimes all people think of is a tire factory, not that tires are not enormously important themselves. Well, the pandemic changed that. It was polymers that made the vaccine happen."

From the material world, Bonitati touted the benefits of silicone rubber.

"Silicone is indeed a great carrier for slow-release and drug delivery systems," Bonitati said. "Because of this we have seen major advancements in wound care and in women's health. These are areas I expect will continue to grow."

Boqaileh noted that automation and artificial intelligence often are the only ways to improve production processes.

"Often the only way to improve the product is to have better tools to make it," he said. "And that is where AI and automation come in."