Insiders' Guide To Winning In the Drug Delivery Device Market — Part 3: Quality Systems
By Doug Roe, Chief Editor
This Q&A is the third in a five-part series that will examine industry opportunities in the drug delivery device space. Part 1 explored the overall market opportunity and some of the product design related challenges. Part 2 investigated the often conflicting guidance from CDER and CDRH. Subsequent installments will look at mHealth and the Internet of Things (IoT), and vertical integration of product development.
Whether you are an original device manufacturer, an outsourced service provider, or a component/material supplier the opportunity for growth over the next 10 years in drug delivery devices is enticing. The proliferation of biologics will lead to a large demand for new devices in an industry that lacks the needed expertise.
Companies install quality systems (QS) to lower cost and risk, and to improve outcomes over a product’s lifecycle. With proper scope and breadth, a comprehensive QS approach can have the effect of removing organizational silos: One team, one approach. But, when it comes to drug delivery devices, there usually are two independent teams due to the different quality standards for drug and device.
With the release of the FDA’s draft guidance Current Good Manufacturing Practice Requirements for Combination Products, maybe some of those walls will come down; there remain some gray areas in the guidance that will need to be clarified over time. But moving to a combined QS program is a necessary best practice for life science companies striving to capture their piece of the delivery device market.
I recently sat down with Christopher Eustace, VP of Quality Device Operations at Hospira (A Pfizer Company). He has over 27 years of quality experience in both the pharmaceutical and medical device industries, guiding such companies as Abbot Laboratories, Teleflex Medical, and GE Healthcare.
Based on your combined experience with both pharma and devices, how would you describe the state of the drug delivery device market?
Chris Eustace: It is really intriguing how different the problems are at different pharmaceutical companies. Different mindsets, cultures, and approaches to combination products. Some companies lean more into the pure-play drug side. They don’t have the device expertise in-house, and don’t want it, so they completely outsource that part. Others are leaning toward bringing drug and device under one roof, but they don’t have a combined product development strategy. The companies that are making strong progress are those that have drug and device integrated in the R&D phases.
More on the quality and regulatory side, which is my area of expertise, it is all still fairly new. This can be dangerous for both industry and regulators. Regulators do not have a full grasp yet on what they are looking for in combination products. It’s a work in progress. This leads to a lot of confusion on the industry’s part as to how we are supposed to actually bring these products to market. Once the product is commercialized, will there be changes in guidance? Will that lead to product recalls and the eventual, related lawsuits? Guarded optimism should be the approach. Right now there is still high-risk with the potential high reward.
What therapeutic areas represent the biggest opportunity for drug delivery devices in 2016-17?
Eustace: On the oncological side, dealing with cancer, one area will be targeted therapies (acting inside the cell), as opposed to more general treatment (acting on the cell or outside the cell). I think the findings are showing that new advancements in targeted therapies, like signal transduction inhibitors, are actually becoming more effective than conventional chemotherapy. I am not sure about next year. It might be a little further out in 2017. But any time you can go directly at the area that is affected, it is a much cleaner application than whole-body therapy.
Which drug delivery device platforms do you expect to have the most growth in 2016?
Eustace: A bigger part of therapy will move toward transdermal drug delivery, things like the patch and advances in microneedles. I don’t think you are going to see much on the infusion side. With the current focus on cybersecurity, the regulation evaluations and the new requirements that will be defined are putting delays on product development. The “smart pump” is probably a few years away.
What will be some of the key challenges facing companies that are expanding competencies into these delivery device platforms?
Eustace: Understanding and navigating through the regulations will be a key challenge. Regulation clarity is a big issue with the FDA, and that challenge expands as you consider your international markets and the corresponding regulatory bodies. Each is, at best, slightly different.
It may be a variation on the question, but leveraging your full company capabilities after a merger also is a challenge related to delivery via device. You have a new mix of drugs and delivery devices. Identify which offers the most effective, and potentially new, combinations. Often, this is a driver for the merger, but taking time to evaluate your combined pipelines could lead to a major opportunity.
How will drug companies drive innovation in delivery device design in 2016 and beyond?
Eustace: The reason most companies struggle with innovation is because they don’t understand the differences — and potential similarities — between the two sides of the business (drug and device). They don’t talk to each other. There is a wall that is built up. Part of that wall is the distinct quality systems. Things are too different on each side.
Installing one companywide quality system would bring the partners together early in the development cycle in order to coordinate combination-product requirements in their entirety. Then, you keep the teams together for the R&D process. Having them together will build a bridge between the differences and will lead to them discovering opportunities.
Once those teams are working together, you can focus on the customer needs. It seems like a simple thing, but it is something that a lot of companies struggle with. Who is the final customer? A hospital, a care giver, or the self-administering patient? You want to have a strong understanding and partnership with that customer so you can incorporate their desired features and usability into the design elements of your products.
What development challenges have you encountered with drug delivery devices and other combination products? Let us know in the comments, Also, for more on this topic, read Insiders' Guide To Winning In the Drug Delivery Device Market — Part 1: Design and Insiders' Guide To Winning In the Drug Delivery Device Market — Part 2: Regulatory Compliance.