Recap of the 2025 Combination Products Summit
by Teresita Pileggi
The energy was infectious at this year's Combination Products Summit hosted by PharmaED Resources Inc., where industry and vendor attendees came together in the Philadelphia Historic District to discuss regulatory guidance insights, risk management considerations, and new product and technology innovations. With global attendance from teams within product development, quality, regulatory, manufacturing, and more; this summit was the place to be to hear about the conversations and activities at the forefront of the industry. In this blog post I will recap some takeaways from the summit, as well as briefly highlight the presentation Sara Waxberg McNew and I introduced on unlocking the full potential of Human Factors Engineering for combination products.
Regulatory Guidance Insights
One of the most talked about areas at the summit was navigating regulatory submissions, which is a significant trend in the industry. Those of us in the combination product space want to make sure that after all of our hard work in development, we're able to take our products across the finish line for approval by regulatory bodies to be used out in the real world.
What I think was a particular benefit of this summit for participants was the discussions on navigating the multitude of regulatory guidance documents to outline the various pathways and key areas for consideration. There were presentations that jumped into discussions about the Essential Drug Delivery Outputs (EDDOs) and Essential Performance Requirements (EPR) for products, as well as provided advice for global submissions, which highlighted how some of the regulatory requirements are distinctly different.
Risk Management Considerations
Looking through my human factors engineering lens, I was also excited to hear some of the risk management cases that were presented. Most notably, we heard recommendations for foundational risk management architecture, and keeping risk management at the heart of product development. Since risk documents are living documents that require constant upkeep throughout development, I thought the presentations included great reminders for attendees to implement effective strategies early, and update often, to optimize risk management while working towards safe and effective products.
New Innovations
One of the hot topics at the summit that has been popping up across almost all industries and fields lately, was the varying roles and opportunities of Artificial Intelligence (AI). AI provides opportunities within product development as a research tool to identify key insights with regulatory submissions as discussed at the summit, but also in ways that have yet to be explored. I am particularly partial to further research on ways in which AI may be used to source data across multiple regulatory body platforms before the submission process to help find and sort applicable product pitfalls.
And in terms of physical product innovations, we also heard about some novel devices in the combination product world such as a new prefilled syringe with a tapered needle (Terumo) and a new large volume high viscosity autoinjector (Gerresheimer). I continue to be excited by the advances made in the field to continue to meet the ever-evolving needs of product users, so it was great to be a part of some of these conversations to learn more about the development and considerations of these new products.
Presentation Recap
Lastly, I wanted to highlight the opportunity that Sara and I had to present to the attendees on Human Factors Engineering. Our presentation, "Beyond Validation: Unlocking the Full Potential of Human Factors Engineering" aimed to provide real-world examples of applying HFE throughout the product development process. It is well known that many medical devices and combination products require HF summative validation testing to submit to the FDA and other regulatory bodies, however there are additional HF activities that can be performed before validation that will serve not only to further advocate for the end users but also create a stronger case for a product's safe and effective use. We talked through various examples ranging from early-stage contextual inquiry field research to injection force studies, expert reviews, and iterative IFU testing all of which are HF activities that we perform at Design Science to help our clients improve their product's usability, safety, and appeal.
Overall, the Combination Products Summit was a great opportunity to connect with industry partners both new and old and hear about some of the latest and greatest issues and innovations attendees are facing for their products. I personally enjoyed the variety in the discussions I had with other attendees, the specific cases shared to leverage new learnings, and I am always happy to talk about human factors opportunities for others to utilize as well. Looking forward to next year already!
Stay tuned for my next blog post where I will give a more detailed overview of the presentation Sara and I gave at the summit to highlight the opportunities available for manufacturers to supplement their HF requirements (e.g., validation summative studies) with additional HF activities throughout product development to strengthen their overall HF submissions.
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