Combination Product Industry News & Guidance
Sharing device-related information and wisdom
that will help you succeed
Stay Current and Informed.
As a global leader in combination product and medical device development and regulatory approval, Suttons Creek has the experience and the industry connections to be a vital source of information for companies like yours, who work with medical devices and combination products. We produce extensively researched articles that share our know-how and keep you up to date on important business, regulatory & technology issues.
Case Study IND Rescue
A clinical-stage biopharma company developing an injectable therapy in a standard prefilled syringe engaged Suttons Creek for support with two priorities:
1. Developing a bridging strategy to an eventual auto-injector configuration
2. Light review support for an upcoming IND amendment
However, at project kickoff the sponsor revealed that the IND amendment was only two weeks away from submission, and they required full review of all combination-product–related content.
Combination Product Business Case Template
When Pharma and Biotech leaders begin considering a delivery device for their therapeutic, one of the first challenges is not just deciding what device strategy makes sense—but justifying that decision to boards, investors, or other decision-makers who control funding. The natural question we hear from project leads considering a delivery device for the first time: is there a standard template or a set of best practices for building a convincing business case?
Cross-Center Master Files
FDA recently issued a new draft guidance titled Cross-Center Master Files: Where to Submit that provides some basic information on master files across all medicinal product centers at FDA.
EUDAMED is mandatory
For those who have been following the almost decade-long Medical Device Regulation (MDR) transition in the EU – the day has finally come, EUDAMED will become mandatory for selected modules as of May 28, 2026: Actor registration, UDI/Devices registration, Notified Bodies & Certificates, Market Surveillance.
Downstream Cost of Uncoordinated Use Risk Analysis
Avoiding rework and regulatory headaches through early planning and smarter design alignment
A sponsor approaches Phase 3 with urgency. Their investigational product has been delivered through vials and disposable syringes in earlier studies. Now, they want to switch to a prefilled syringe partway through Phase 3 and eventually commercialize using an autoinjector. The delivery systems have not been standardized, the study syringes vary in configuration, and the needle sizes used at sites are undocumented. Can they bridge to the final presentation? Maybe. But the cost and risk just became very real.
At Suttons Creek, we have seen this story unfold many times. Compressed development timelines, decentralized sourcing, and incomplete clinical oversight can leave sponsors scrambling to justify bridging between early clinical formats and their commercial-ready delivery systems.
This challenge is especially acute in combination product programs, where device performance, usability, and patient handling all impact regulatory expectations. Yet with better planning in Phase 1 or 2, much of the downstream burden can be avoided.
Webcast: Regulatory Shifts Redefining Combination Product Success
Navigating the Next Wave of FDA Shifts for Combination Products: What You Need to Know (and Why You Should Join Our Upcoming Webcast)
Combination product teams are entering a new era of regulatory clarity—and complexity.
The FDA is issuing multiple guidances that collectively redefine how combination product developers demonstrate safety, quality, and lifecycle control. For executives and technical leads, the challenge is no longer whether to integrate drug and device development—but how to operationalize that integration in real time.
From Vial to Prefilled Syringe to Autoinjector: How Early-Phase Delivery Decisions Can Make or Break Your Regulatory Timeline
Avoiding rework and regulatory headaches through early planning and smarter design alignment
A sponsor approaches Phase 3 with urgency. Their investigational product has been delivered through vials and disposable syringes in earlier studies. Now, they want to switch to a prefilled syringe partway through Phase 3 and eventually commercialize using an autoinjector. The delivery systems have not been standardized, the study syringes vary in configuration, and the needle sizes used at sites are undocumented. Can they bridge to the final presentation? Maybe. But the cost and risk just became very real.
At Suttons Creek, we have seen this story unfold many times. Compressed development timelines, decentralized sourcing, and incomplete clinical oversight can leave sponsors scrambling to justify bridging between early clinical formats and their commercial-ready delivery systems.
This challenge is especially acute in combination product programs, where device performance, usability, and patient handling all impact regulatory expectations. Yet with better planning in Phase 1 or 2, much of the downstream burden can be avoided.
Navigating the Regulatory Landscape for CGTs
Cell and gene therapies (CGTs) are redefining what is possible in modern medicine, but they are also redefining how we approach delivery system selection. Across the pharmaceutical industry, CGT development teams are finding themselves at a frustrating intersection. The science backing the therapy is advanced, the regulatory team is ready to engage, and the clinical development timeline is set. Yet one detail delays progress: the delivery system.
Looking for more information? Our founder Steve Badelt, PhD and our Suttons Creek consultants have hit the speaking circuit and given addresses on a wide variety of combination product-related topics
Click here if you would like more information on any of these topics, or to discuss the possibility of Suttons Creek consultants speaking to your team or at your next event.
Recent Speaking Engagements Have Included:
“Simplifying the Complexities of Combination Product Development: Lessons Learned Across the Industry” – RESCON Summit, 2024
“Critical Challenges and Proven Strategies: From Vial to Combination Product” – PDA Universe, 2024
“Innovative Combination Products for the Next Generation of Medicine” – Healthcare Products Collaborative Combination Product Summit Workshop, 2024
“Aligning Risk Management Approaches Between Sponsors, Suppliers, and CDMOs” – Healthcare Products Collaborative Combination Product Summit Panel, 2024
“Dose Overlap with Autoinjectors: The Critical Importance of Device Selection” – PODD Conference, 2024
“Achieving Regulatory Success in Targeted Delivery of Cell and Gene Therapies” – PharmaEd Resources Combination Product Summit
“Connected Health Opportunities & Complexities for Injection and Infusion Devices” – SAE Media PFS East Coast, 2024
“Combination Product Development: Commercial Roles + Responsibilities” – Biopharma New Product Planning Network, 2023
“A Technique for Integrating Risk Management Processes for Combination Product Development” – PharmaEd Resources Pre-filled Syringes & Auto-injectors Forum, 2023
“Partnering for Success: Higher level collaboration (within and btw organizations) that delivers Program Success and ROI” – PharmaEd PFS/AI Forum, 2023
“Parallel Development: How multiple development pathways for Combination Products can reduce risk and potentially address more unmet medical needs” – PharmaEd Resources Combination Products Summit, 2023
“Connected Health Opportunities and Complexities of Inhalation Devices to Consider Prior to Starting Development” – RESCON Summit, 2023
“Investigational Combined Use: Industry Perspective & Proposal” – Healthcare Products Collaborative Combination Product Summit Panel, 2023
“Building Clarity to Address Regulatory Challenges of On-Body Delivery Systems” – Healthcare Products Collaborative Combination Product Summit Panel, 2023
“Lessons from Integrating the Pharmaceutical Industry” – Pre-filled Syringes & Auto-injectors Forum / PharmaEd Resources, 2022
“The Intersection of Risk Management & Human Factors in Platform Injection Devices” – PharmaEd Resources Pre-filled Syringes & Auto-injectors Forum, 2022
“Best Practices for Cross-Functional Engagement Throughout the Combination Product Lifecycle” – PharmaEd Resources Combination Products Summit, 2022