The drug delivery and combination products market is made up of a number of markets, all based on the means by which the drug is delivered. Some are administered through injection, some through infusion, some orally, some transdermally, and the list continues. Nanomedicine and nano delivery systems are emerging as a method of targeted drug delivery, in which particles attracted to diseases cells directly treat those cells. Implant technology can also deliver targeted medication, providing longer-lasting, localized therapy.
 
In order to gain more insights about the trends and challenges affecting the diverse drug delivery and combination products markets, I spoke to Ted Mosler, CEO of Gilero, a Morrisville, N.C.-based single-source partner for design, development, and manufacturing in the medical and drug delivery markets. A portion of his input was included in the November/December issue feature article “Delivering the Goods: The Evolving World of Combination Products.” The entirety of our interview is featured here.
 
Sam Brusco: What were the trends that drove the biopharma and drug delivery/combination product markets in 2019?
 
Ted Mosler: Over the past year we’ve noticed trends in smart devices, non-clinical use of medical devices and an increased need for safety and overall ease of use. Smart devices are being used to drive medication compliance and share patient data with healthcare providers. In addition to smart devices being put into the hands of patients and caregivers, there are also growing numbers of non-clinician device users such as patients self-administering injectable medications at home. These trends call for drug delivery devices and combination products to be intuitive, easy to use and safe to operate for individuals without medical training.
 
Brusco: Which latest developments and/or innovations in drug delivery technology/combination products have captured your attention?

Mosler: Mobile apps becoming medical devices is something that has really piqued our interest. Gilero has had the opportunity to work on some of these projects, and it is inspiring to see the ways in which technology can put more tools into the hands of users to help them manage their health. One of the biggest challenges with apps as medical devices is how to regulate them, and it will be interesting to see how this technology evolves in the medical device and drug delivery markets over the next few years.
 
Brusco: What effect is the convergence of pharma and medtech having on the medical device industry?
 
Mosler: More unique drug formulations are being developed and we are seeing a rise in unique devices used to access and deliver these drugs. Customers working on chemotherapy drug delivery, inhaled medications and ophthalmic solutions have asked us to design and develop entire medical devices around a specific drug. As drugs become more potent and we learn more about the risks of addiction, there is an even greater need for increased safety. Innovative device solutions can play a huge role in ensuring successful drug delivery while keeping patients and caregivers safe.
 
Brusco: How does the approach to designing, manufacturing, and/or testing a drug delivery device/combination product (or components that go into these devices) differ from other medtech products?
 
Mosler: Other medtech products do not have the same complexities of FDA regulations that pharmaceutical products do. The pathways of demonstrating safety and effectiveness of drug delivery devices and combination products vary a great deal.  Depending how the drug is prescribed and delivered, non-clinical users of the device often come into play. This is when human factors becomes an even more important step in the development process. Gilero has seen an increase in customers inquiring about human factors services like user research, formative studies and summative studies. Our in-house human factors group has been increasingly busy with studies for prefilled syringes, needle safety devices and other drug delivery products.
 
Brusco: What are the challenges and opportunities for drug delivery and combination products in the next few years?
 
Mosler: We are finding that the regulatory changes in Europe are making the launch of new devices in the European market extremely challenging. In the US, there is a real possibility of the transition to a single-payer healthcare system. This means we need to reduce the cost of drug delivery and combination products without compromising product effectiveness or safety. Finding opportunities to reduce cost while improving the overall health and wellbeing of patient populations is a challenging dichotomy. The projects we work on with the best market outlook appear to do both.
 
Brusco: Is there anything else you’d like to say regarding the manufacturing of drug delivery/combination products or components?
 
Mosler: At Gilero, we have seen an overall increase in the demand for self-administered medications, combination products and advanced safety solutions that make drug delivery safer and easier for everyone involved. We believe this demand is only going to grow and we are expanding our offerings to keep up with it.