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.
Navigating the Combination Episode 1 Jeff Gensler
Welcome to the first episode of the Navigating the Combination podcast!
When Jeff Gensler walked into Pfizer Meridian on day one, FDA had left the building just a week earlier. What followed — a warning letter response, 15 FDA meetings in four months, a CDRH site audit, and an agency directive to redesign the entire product — was a challenge, but also an opportunity for in-depth examination of the company’s quality systems. In this episode, Jeff joins Parth and Jonathan to unpack those early days, the gaps he found between pharma and device quality thinking, and how that experience shaped his entire approach to process capability, CAPA, and compliance.
Jeff breaks down why the transition from attribute to variable data is so much more than a methodology switch — and shares a real example of how catching a single worn mould cavity early saved millions of dollars in scrapped components. He also makes the case for why quality professionals need to stop speaking compliance-only and start building business cases that leadership can actually act on. Now VP of Quality at Kindeva Drug Delivery, Jeff reflects on what the shift to the CDMO space looks like, where the industry is heading, and why he believes quality is becoming a competitive advantage rather than a cost center.
VENDOR SELECTION AND BRIDGING STRATEGY
In combination product development, the selection of a device constituent vendor is among the most consequential upstream decisions a sponsor will make. We examine how regulatory authorities expect to review combination product data when the device constituent is vendor supplied and the downstream impact this procurement decision has across the entire program. Vendor alliances become regulatory and development architecture decisions that determine clinical strategy, evidentiary burden, lifecycle flexibility, and ultimately, asset valuation. Unfortunately, vendor decisions are routinely made too early, too narrowly informed, and with too little appreciation for the downstream regulatory and clinical consequences. The result is predictable: sponsors discover at Phase 3 that their device vendor selection has constrained their bridging options, inflated their clinical burden, or created development and inspection vulnerabilities that threaten the program timeline.
The central thesis is straightforward: the device vendor you select today is the co-author of your regulatory and commercial future. Choose poorly, and you will spend years and significant capital correcting the decision.
Changing EDDO GUIDANCE
Consider a combination product program that has navigated early development successfully. Design inputs established, verification testing underway, and a regulatory submission on the horizon. Then FDA issues a revised version of a foundational guidance document that redefines baseline expectations for how drug delivery performance is defined, verified, and maintained. What was considered a complete data package may now require meaningful rework. The submission timeline shifts. The conversation with leadership is difficult. For teams working on combination products today, one such signal deserves close attention, the pending update to the FDAs Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products, also commonly referred to as the EDDO Guidance.
Design Input Requirements
Design input requirements (DIRs) are rarely where leadership attention naturally goes. They sit deep within the development process, owned by engineering, reviewed by quality, and often treated as a technical exercise rather than a strategic one. But in combination product development, DIRs are not just documentation. They are where key program decisions become embedded. When DIRs are well constructed, teams move with clarity. Verification is straightforward. Regulatory conversations are grounded in objective evidence. Programs progress with fewer surprises. This article outlines the characteristics of high-quality DIRs, not as a writing guide, but as a lens for evaluating whether your program is set up to execute cleanly downstream.
A Preventable Pattern: Where Early Integration Pays Off
In practice, this misalignment can reflect a broader disconnect between the core elements of product innovation and development, and nonclinical strategy for demonstration of safety and performance (efficacy). Within combination products, the nonclinical workstream is inherently interconnected, spanning material selection and characterization (including extractables and leachables), toxicology and biocompatibility, in vivo models for safety and function, and the unique interactions between device and drug.
Often, the heart of this slowdown pattern can be a specific kind of misalignment: Toxicology and device strategy are both present but they are not advancing together.
BD and Suttons Creek Partner
BD and Suttons Creek Partner to Help Pharma and Biotech Companies Deliver Combination Products to Market with Confidence
The collaboration brings together consulting, device agnostic testing, and drug delivery expertise to help pharmaceutical and biotech companies reduce risk and navigate complexity for combination products, including biologics and GLP1 therapies.
A Leadership Update from Suttons Creek
Founder Steve Badelt is moving from his role as Divisional Head into an executive consulting position. He will remain actively involved and advising on client engagements.
Steve built Suttons Creek from the ground up and shaped how the company approaches combination product development. Over his tenure, that has translated into real outcomes for clients: helping teams navigate complexity, make better decisions earlier, and move therapies forward with more confidence. In many cases, that work has played a role in getting important treatments to patients sooner. The company is grateful for what he has built and for the role he will continue to play.
Stat Woman Part 1
Pharma and biotech teams often feel prepared when they begin thinking about integrating an auto-injector (AI) into their program.
They have a QMS.
They have SOPs.
They understand their clinical milestones.
But readiness for an auto-injector development program is much more than internal infrastructure. It requires the right timing, the right strategy, and the right cross-functional alignment — and this is where most teams fall short.
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