ProMed Pharma's drug-eluting devices demonstrate dual expertise

Some companies make medical devices; others make drug-eluting products. ProMed Molded Products Inc., aiming to expand beyond its niche business, is doing both.

The privately held Plymouth, Minn.-based company has spent 23 years building on its reputation as a custom molder of silicone devices. It expanded during that time into related fields, such as exotic plastics and micromolding, and jumped into the pharmaceuticals sector by producing drug-eluting devices, essentially a drug molded into a silicone component.

ProMed's interest in that last area was evident when it created a sister company not long ago, ProMed Pharma L.L.C.

"There are very few companies, especially contract manufacturing companies, that can do the drug and the device sorts of components together," said Jim Arps, director of pharma services. "That's one of the unique things around ProMed."

ProMed Pharma manufactures stents, which prop open arteries and deliver a steady stream of medication over time.

Tough requirements for producers of medical devices—from the need for clean rooms and serious analytical testing, to compliance with stringent Food and Drug Administration rules and inspections—discourage many companies from entering the field, ProMed's managers said.

"There are very few contractors or suppliers involved in it," Arps said. "Many companies that are working on this, both large and small, don't have the appetite or the infrastructures to quite develop all those critical capabilities to be able to make these sorts of components."

ProMed President Pete Mangan agrees.

"We are playing in a market not many are playing in," he said.

The days of having to take a pill every day for five years are fading fast, the ProMed managers said.

"If you have a silicone device that releases it (medication) slowly and continuously for a long time you could potentially have much better effects," Arps said.

If the device doesn't do what it said it would, people could find themselves with undesirable side effects, he said.

"It can be much more strenuous," Arps said of making the drug-eluting product. "You're not just dealing with the resin; you're dealing with the drug as well."

It takes some serious research and testing, as well as special molding techniques ProMed Pharma has developed, to put the resin and the drug together, he said.

Mangan said he's read that drug-eluting devices will be the norm in the future.

"If you think of eye drops or something like that, what if I'm 80 years old, maybe I'm shaky or blind, and I'm trying to put these eye drops in," Mangan said. "My ability to hit the mark and do it consistently every day is probably not very good."

The automatic release of medication ensures a person is receiving the proper dose, delivered on time.

"In cases where patient compliance is an issue, there are things that are not in the market but in development for things like drug addiction," Arps said. "You ask drug addicts to take a pill every day, they may not. But if you have an implant that is releasing a drug, then it is more effective."

Arps said he would like to see ProMed Pharma enter the women's health area and deliver antibiotics in the future.

"We see great growth potential," Mangan said. "What we do matters to people, saves lives and helps improve people's lives."

Those characteristics of the business attracted Mangan to the company, where he has been president since January after serving as general manager for 5½ years.

"It's so easy to get people excited about this (medical products)," he said. "Your grandmother, neighbors might be getting one of these."

Mangan moved to the medical field and ProMed after a stint in his family's insurance agency in Rochester, N.Y. "I quickly realized paper and promises wasn't my thing," he said. "The medical field has been the most rewarding (for me)."

As a manager, Mangan said he has pushed the company toward automation, creating lean systems and being able to do things other companies can't.

The changes at ProMed prompted the 200-employee company into polishing, and altering, its image to reflect its capabilities.

The company's corporate motto now is "Collaboration. Integrity. Openness," with the tag line "Molding for life," which reflects the firm's desire to be around forever, according to Connie Laumeyer, ProMed director of marketing.

A company remains in business in perpetuity by catering to its customers, she said.

"Our customers have asked us to do more and more. They want us to get involved in a lot of value-added type things," Laumeyer said. This has led to ventures in thermoplastics, combination components and overmolding.

ProMed's customers encouraged the firm to get into molding thermoplastics, said Business Development Director Jim Kozlowski.

"(Customers said) if you can bring that engineering support plus the quality systems and general business commitment that we have seen in the silicones for decades, we would love to have you help us and support us in thermoplastics," he said.

ProMed also works with customers via a program it calls Design for Success. The firm brings in its customers' engineers, and teaches them about silicone, how it differs from other materials.

Eventually, according to ProMed's owner and former president, Wayne Kelly, the manufacturer hopes to expand into areas such as biocompatible plastics and add assembly of final products to its capabilities.