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published on April 30, 2015 by
Today's Therapeutic-focused Combination Product (Drug/Biologic & Device) Companies: The Good, The Bad, and The Ugly. Which one are you?
The landscape of new medical products is being transformed from “pure biologics and pharmaceuticals” to products of complexity that require an understanding and application of multiple development disciplines from each product type--drug and device or biologic and device. Inherently, innovators of combination products (CP) who have developed novel products over the last 10-15 years have evolved and learned from their successes and failures. Contrast these mature companies with those that are now entering the Combination Product landscape and are just becoming aware of newly implemented regulations. The coupling of different development methodologies along with new regulations is a recipe for development stagnation and continual rework. With this backdrop, let’s now look at three different categories that CP firms may fall into: Good, Bad, and Ugly.
First, let’s look at the Good companies. There are relatively few companies in this category. These companies are best characterized as “proactive”. They realized that the regulations were changing several years ago, and were proactive in their approach by adapting their processes and organization accordingly. They networked with third party consultants and the FDA to better understand how the landscape was changing. They also have a dedicated device development organization to complement their drug or biologic development team. Even today these companies would say that they struggle with implementing an interfacing device and drug process due to complexities with device design freeze and the beginning of phase 3 clinical trials. Despite their proactive approach, they are still unsure if they are doing things well. Typically, they have been in the Combination Product business for 7-10 plus years.
Now, let’s review The Bad: These firms have a few people aware of the regulatory changes, however the organization has large gaps of understanding for implementing new procedures in the context of the device design control regulations (820.30).
There is a lack of organizational infrastructure to implement needed changes in the quality system, as well as individuals to create compliant design documentation, particularly around the device regulations. They have started to reach out to potential combination product experts but have not fully pulled the trigger to grant the appropriate authority to run their Combination Product development project. A trademark of these Bad organizations is that they realize what they don’t know and have begun reaching out to experts who understand developing device constituents in the context of the entire combination product. Typically, these companies have been in this space for 3-6 years.
Then the Ugly: These firms are not fully aware that the landscape is changing. Because of this, they have not budgeted or discussed the strategic ramifications of the changing Combination Product environment. These firms need to urgently find outside experts to right-size the organization and help steer the boat out of the rough “unknown” FDA waters. On average, these companies have worked in this space from 1-2 years.
Pharmaceutical and Biologic license holders have encountered an evolution in devices that deliver therapeutic molecules, both large and small. These delivery systems have become a competitive, differentiating factor in the crowded pharmaceutical industry. In order to achieve market advantage, one must not forget that the newly implemented combination product regulations (21 CFR Part 4) dictate requirements for development, submission, and post-market compliance.
How does a pure therapeutic-based company create a competitive advantage in its therapeutic area? Companies that define a unique delivery device strategy during the combination product’s concept/feasibility stage provide opportunities for the business to explore and set requirements that supports an already targeted drug/biologic. This strategy helps separate the good from the bad.
The underpinning competitive advantage for Good Combination Product (CP) companies can almost always be traced back to two differentiating strategies: 1) implementation of a robust Combination Product development process that accounts for each combination product constituent, and 2) utilization of a device organization that understands how to develop the differentiated delivery system under the pretense of FDA’s Combination Product regulations. If you don’t have the expertise in this area, it may be time to enlist the support of a third party combination product expert.
EdgeOne Medical and the leaders of their Combination Product Development Services Team have been supporting the device development component of Drug/Biologic and Device Combination Product Program for the past fifteen years. Services include Strategic Product Development, Project Management, Regulatory Strategy & Submission, Quality Systems, Remediation, Risk Management, and Device Product Testing.
