As more medical device manufacturers are required to conduct clinical trials on their devices, many are enlisting the help of pharmaceutical companies to leverage their expertise in navigating the complex clinical environment. At the same time, pharmaceutical companies are seeking to team up with their medical device counterparts to tap into the lucrative drug-device combination products market. I continue this series of posts on 2017 medical device trends (see the end of this article for links to the other parts) with a look at both the advantages and challenges of cross-pollinating medical devices and pharmaceuticals.
Combination Products: A New Era of Medical Product Development
Combination products merge two or more different types of regulated drugs and medical devices into a single therapy to achieve one solution. This convergence of medical device and pharmaceutical industries is fostering a new level of innovation across the medical treatment landscape.
The combined expertise of both industries establishes a new paradigm in the healthcare sector. In many cases, partnering companies can accelerate the development of sought-after therapies by repurposing existing devices and drugs that have already been developed, tested, and approved.
One example is the alliance between GlaxoSmithKline (GSK) and Verily Life Sciences LLC (formerly Google Life Sciences) to develop bioelectronics medicines. This joint effort pairs GSK’s expertise in disease biology and drug development with Verily’s technical expertise in low-power electronics, data analytics, and software development. Collaborative ventures like this indicate a growing trend that will continue to flourish as more organizations follow suit.
Advances in Personalized Medicine
Personalized medicine is the process of tailoring medical treatments based on the individual characteristics, needs, and preferences of a single patient. This approach is often necessary when patients respond differently to medical therapies, which complicates clinical decision-making and treatments.
Now, by combining the expertise of medical device and pharmaceutical manufacturers, healthcare providers are able develop personalized medicine regimens with more precision. For example, advances in genomics, medical imaging, and wireless and mobile technology contribute to more effectively align medical interventions with individual patients.
Innovation Without Growing Pains Is Rare
While the collaboration of medical device and pharmaceutical manufacturers removes many limitations with medical treatment, it does create others. Despite the level of expertise each organization contributes to the equation, many of the combination products that emerge from these symbiotic relationships are uncharted. This means the regulatory processes required for getting a new product on the market will need to begin at square one.
The Office of Combination Products (OCP) oversees the review and regulation of combination products. It assigns the premarket review responsibility to the appropriate lead center: Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), or Center for Devices and Radiological Health (CDRH). Which center receives the premarket review assignment is based on the product’s primary mode of action (PMOA). The PMOA is determined by the regulatory identification of the product as a drug, device, biologic, or combination product.
To help understand the type of information the FDA needs to determine a product’s regulatory identity, companies can request assistance from the OCP by submitting either a request for designation (RFD) or a pre-RFD.
The Usability Learning Curve
Combination products have the potential of empowering patients with managing some facet of their medical care, which can substantially reduce their healthcare costs. However, patients using self-operated medical devices don’t always have the luxury of coming up to speed on a new process or device. Groundbreaking technology is pointless if devices are too complicated to use.
Combination products have the potential to create remarkable treatment scenarios. However, both medical device and pharmaceutical organizations need to devote equal time and effort to human factors and user experience. These are critical aspects of product development that need to be integrated throughout the product’s lifecycle.
The convergence of medical device and pharmaceutical industries promises an entirely new level of value for both healthcare providers and patients. The emergence of combination products will continue to open new treatment pathways, and the collaboration of companies from both industries will continue to have a huge impact on medical product development.
Other parts of this series:
5 Medtech Trends Shaping 2017: Connected Health and Seniors
5 Medtech Trends Shaping 2017: Cybersecurity
5 Medtech Trends Shaping 2017: Trump’s Impact
5 Medtech Trends Shaping 2017: Disruption from Outsiders
As the medical device product manager, Alex Butler is focused on developing solutions that help medical device companies increase efficiencies, ensure compliance and speed time to market. Before joining MasterControl in 2014, Butler worked as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices, including the Opal Espirit Class II Corrector. With more than five years of direct medical device experience, as well as a deep understanding of the FDA’s submission process and audit procedures, Butler is a vital part of the MasterControl product management team.