When it comes to today’s injectable and inhalable therapies, drug administration won’t necessarily be kept under the control of a professional, observes Bill Welch, chief technology officer for Phillips-Medisize Corp. “Drug administration will increasingly be placed in the hands of a patient,” he says.

Thankfully, the pharmaceutical industry is changing to become more patient focused, Welch notes. The real challenge, however, is developing a design that is useful, usable, desirable, and manufacturable and that meets quality and cost expectations, he says. “I’ve seen so many great ideas that couldn’t get to market because they couldn’t be cost competitive with existing therapies,” he adds.

Welch will be speaking about achieving a “successful design” June 10 at Pharmapack North America in the session, “Packaging Technologies for Driving Patient Adherence, Convenience, and Safety.”

To arrive at a useful and usable drug-delivery device design, pharmaceutical manufacturers should employ human factors engineering methods and research. “The role of a drug-delivery device is to be so intuitive to use that its use cannot be misinterpreted,” Welch explains.

Welch has examined a number of field failures pertaining to drug delivery devices, and many of them relate to patient handling, he says. “You cannot plan for all abuse, but you can work to ensure that the device won’t be misused,” he says.

The solution often lies in making devices “smaller and smarter,” Welch says. “Smaller devices allow portability, which is important because the device cannot dominate a patient’s life—it must be discreet. And smarter means that the device is intuitive, almost natural to use, and in some cases integrate electronics and wireless communication in a connected ecosystem that includes the patient and caregivers.”

Inspiration for such “smaller and smarter” devices is being found in consumer electronics and other markets, Welch says, almost leading to a convergence of healthcare products and consumer electronics. There’s a “blending of technology and intuitiveness in smart phones, and the drug-delivery market is taking these cues,” he says. It makes sense, because “these same consumers are also likely patients self-administering their prescribed drug regimens.”

Innovation is expected in autoinjectors, pens, pumps, inhalers, and transdermals, Welch notes. “We’re seeing tremendous innovations aimed at easing use, reducing pain, and monitoring doses for compliance and feedback,” he says. “Some of the first electronics were used in insulin pumps, but now we are seeing them emerge for inhalers, transdermals, and pens. Next-generation inhalers will sense patient breathing and deliver drug doses automatically during inhalation, for instance. But these devices cannot be exactly like a consumer electronic, because they cannot be vulnerable to any interference from other electronics.”

Such “human-centered design has become a cultural mindset within the Phillips-Medisize Design Development Center,” says Welch. “Smaller and smarter devices is where Phillips-Medisize is differentiating ourselves—we develop such ideas at our design centers and manufacturing facilities across the globe,” he adds, mentioning locations in North America, Europe, Mexico, and China.

To learn more about human factors, usability, and manufacturability, plan to attend Pharmapack North America June 10.

Other speakers in the “Packaging Technologies for Driving Patient Adherence, Convenience, and Safety” session include Dave Manera, R&D Manager, Comar LLC
; and Guenter Nadler, Director, Business Development Consumer Health Care Division, Aptar Pharma
.