Manufacturing drug device products: challenges and best practices

Integrating a drug with a mechanical device can, in some cases, improve patient outcomes and boost sales. But manufacturing these products is no simple feat: It often requires a specialized contract manufacturer with extensive experience in the field to make a drug-device combo buildable and scalable.

There’s a lot to consider when manufacturing a medical device. Add to that the challenge of incorporating a pharmaceutical component, and things can quickly go awry. MTD Micro Molding, a micro injection molding manufacturer that develops such products as atomizing nozzles and bioabsorbable polymers, points to this challenge as just one reason companies should rely on the experts.

“Active drugs compounded with bioabsorbable materials present a myriad of challenges,” said Dennis Tully, MTD’s president. “The handling of material from storage through prep, molding, packaging, shipping in order to preserve the drug – each step is an opportunity for failure.”

For companies that haven’t worked in the drug-device combination space, the increased development timeline can be shocking, noted Glenn Ogura, market development SVP at laser micro manufacturer Resonetics.

“Drug-delivery devices can follow lengthy development cycles before commercialization,” Ogura said.

That means companies need to be ready to approach contract manufacturers with a target product profile, according to contract R&D and manufacturing company ProMed Pharma, which specializes in manufacturing drug-releasing dosage forms and drug-eluting combination products.

There’s a plethora of factors companies must work through with clients, including the material of the device, drug formulations and the size of the end product, said Jim Arps, director of pharma services at ProMed.

Get the full story on our sister site, Drug Delivery Business.