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published on March 01, 2017 by
Earlier this month, I attended the Drug Delivery Partnerships (DDP) Conference in Florida. The conference covered a wide range of topics impacting the combination product sector including digital health, mixed reality, risk management, new technologies in manufacturing and molecular development.
The benefit of attending these conferences is that you not only hear industry thought leaders’ views and opinions on key topics and issues, but it gives you an opportunity to press pause on the express train that governs our daily activities to reflect on changes and trends that may impact our daily activities in the very near future. Following are some of the key takeaways that made me pause and reflect on what may be a sign of things to come.
The concept of Open Innovation has been ongoing for over 15 years, however, traditionally companies within the biotech industry have worked with their partners to establish exclusivity for use of a proprietary design and/or technology. Panelists raised questions about the benefit of exclusivity in an industry that is increasingly leveraging technologies from non-traditional industry partners, like the consumer electronics industry. These non-traditional industry partners have a very different view of IP and believe as much as possible should be shared to improve and advance technology faster.
In addition, working with these non-traditional partners makes negotiation a very different ballgame, and one panelist specifically highlighted the opportunity this creates to shift the focus away from the technology and back to the patient. The patient is not concerned with the “engine” inside of the device, they simply want it to work.
One of the more surprising revelations from the conference was the payer’s perspective on the impact of device on patient compliance. Specifically, the presenter indicated that patient compliance behaviors don’t necessarily change with better delivery devices. The analysis seemed to suggest that the device does not drive use of the product, rather, compliance is driven by the inherent behavior of the patient. Meaning, if the patient doesn’t want to take care of their own condition an easier to use delivery device may not necessarily motivate them to care and treat their illness. However, it was stated that significant improvements and changes in a therapy may help improve patient compliance, i.e., injections that move from 7 times per week to 3 times per week can help improve patient compliance.
Despite the views and opinions shared from the payer perspective, various industry panelists and conference participants strongly reinforced that industry is heavily invested in understanding and enhancing the patient experience. The emphasis by the FDA on understanding the user needs and demonstrating through human factors analysis requires biotech companies to listen and design devices that meet the needs of the target patient population.
One of the rapidly moving trends within the consumer good industry is the use of virtual reality and 3D glasses used in gamification and user experiences (e.g., travel, etc). A thought provoking presentation highlighted the impact of virtual reality is starting to have on the biotech industry in both development and commercialization stages of drug delivery devices.
Examples included the use of virtual reality by engineers in designing 3D models, and specifically using virtual reality tools to revolve model frame/figures from all angles in order to visualize potential issues before design was released for tooling build. The more impressive example was the use of virtual reality training kits that were being developed to help patients learn how to use the product in a proactive hands-on approach rather than just reading the fine print on an IFU (Instruction for Use).
The impact of the use of this technology on the biotech space is only starting to scratch the surface and it will be interesting to see how these tools impact development, and training and ultimately patient compliance.
It goes without saying that almost everyone in the biotech industry is seeking to understand the impact of the new administration, however, it appears that wait and see is really the only answer that could be offered up. The presenter indicated that a lot of factors are at play that may provide an indication as to the impact to the industry. Some key factors to monitor includes, but are not limited to: national budget for 2018, Device Tax and Sunshine Act, User Fees at the FDA, and practical application of executive orders (specifically around de-regulation).
In summary, the Drug Delivery Partnerships 2017 program provided many interesting Points of View on what are the key trends and issues to consider when contemplating your Combination Product Development strategies and execution.
Lilli Zakarija is President & CEO of EdgeOne Medical Inc.
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 Programs for the past fifteen years. Services include Strategic Product Development, Project Management, Regulatory Strategy & Submission, Quality Systems, Remediation, Risk Management, and Device Product Testing.