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.
“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.
(Network with ProMed experts at DeviceTalks West, Dec. 11–12 in Orange County, Calif.)
It’s not easy, so leave it up to the specialists
“Once the device company is ready to commercialize, then custom laser equipment can be seamlessly developed if the laser micro-manufacturer offers the unique product offering of both being a high-volume contract manufacturer and having an in-house custom laser system design team. This powerful combination accelerates the development of complex, 3-D ablation processes while simultaneously engineering automated equipment,” Ogura said.
Even decisions that seem simple – like choosing a product’s material – can require an expert’s input.
ProMed Pharma’s Arps noted that his company helps clients pick the appropriate material for a drug-device product by considering the drug’s physical and chemical characteristics, such as solubility and thermal decomposition properties.
“We have a lot of experience in being able to work with our customers to try to identify the right types of materials that would be best for their application,” he said.
Product size can also affect where a device company will go in search of manufacturing help. When it comes to creating something that’s really small, companies should rely on manufacturers with expertise on that scale, according to Tully.
“In many instances, micro part features that can be seen with the naked eye require more specialized tools and techniques than what’s required for a microscopic part with simple geometry,” he said.
The case for taking on a drug-device product
Although the development process can be precarious, combining a drug with a device can be a beneficial move for companies looking to improve patient outcomes and boost sales.
“Pharmaceutical companies can opt for a business strategy to develop novel drug delivery platforms to reinvigorate drug sales by re-introducing drugs coming off patent protection,” Ogura said.
Companies use Resonetic’s laser micro-manufacturing capabilities to build a wide array of drug delivery devices, including implants and drug-eluting infusion devices.
“There are multiple market drivers to use laser micro-manufacturing to fabricate drug delivery devices,” he said. “Novel pulmonary, ophthalmic and nebulizer delivery devices incorporate laser-drilled micro-hole arrays (typically 10µ to 100µ in diameter) in thin polymer membranes to improve the efficacy of drug delivery such as targeted localized delivery with smaller dosage.”
MTD Micro Molding has manufactured internal components like micro-molded, ultra-thin-wall cannulas in wearable bolus injectors and drug infusion sets. The company has also used its micro molding expertise to manufacture bioabsorbable implants, permanent implants and microneedles.
“Micromolding enables solutions for various drug delivery applications, making drug delivery devices more convenient, painless and effective for patients,” Tully said. “Many of the drug delivery micromolding projects we take on are rescue projects – those that failed with other molders or methods and may have been thought to be ‘impossible.’”
Don’t let manufacturing be an afterthought in design
Whether the contractor specializes in laser ablation, silicone or micro molding, they all seem to agree on one thing: Don’t wait until the last minute to involve a manufacturer.
“If possible, it is beneficial to the client to not be completely locked into their part design by the time they enter into a new supplier relationship with a micro molder,” Tully said.
Early on, companies should consider whether the design of a product is scalable and remain open to change in case it isn’t, the manufacturers agreed.
“We want to think very early on about how manufacturable it could be, because we don’t want to get too far down the road in development and find out that we’re miles apart in terms of what the end product might need to cost,” Arps said.
“In the very early stage of development, device companies must understand the business roadmap to production to ensure that the chosen fabrication method can meet quality, cost and volumes requirements. There is no point going down a development pathway that has no means to scale into production,” Ogura added.
But whether clients come to them with the very beginnings of an idea or a product that is ready for full-scale production, the expertise of a contract manufacturer can help turn a drug-device combo from a vision into a reality.
“Some people come right at the ground floor where they may have a medical device company that has a current device that doesn’t have a drug incorporated with it but has an idea for it and how can they get there,” Arps said. “They may not have either the facilities, the knowhow, the scalability to do that, and then they can take advantage of the fact that we’re a [good manufacturing practices] facility and have done this before. Then we’ll take it from there.”
