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.
New Hire Paul Chao
Suttons Creek is pleased to announce that Paul Chao has joined the firm as Vice President, Solutions Engineering, reporting to Senior Vice President, Rob Schulz. In this role, Paul will help lead the development of integrated technical solutions for pharmaceutical and biotechnology companies developing combination products, working closely with client teams to navigate the complex intersection of device engineering, regulatory strategy, and product development execution.
Strategic Readiness
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.
Swissmedic Review of NBOps
In a recent review exercise, Swissmedic, the Swiss national health authority examined a small set of Notified Body Opinions (NBOps) submitted in support of medicinal products with integral medical device components. What they found should make any combination product sponsor uncomfortable: despite these opinions being formally issued by designated Notified Bodies, many were incomplete, ambiguous, or of limited value for regulatory decision-making.
Post-Market Change
For combination products, launch isn’t the finish line—it’s the point where the lifecycle becomes commercially real and operationally exposed. Post-market change is inevitable, driven by forces that rarely align to commercial timelines:
Component or material obsolescence
Quality signals and corrective actions
Scale-up, automation changes, and site transfers
Supply chain resilience initiatives
New indications or expanded patient populations
New features and product improvements
Expanding Business Development to meet Industry Demand
Sharing device-related information and wisdom that will help you succeedSuttons Creek Expands Business Development Leadership to Meet Growing Industry Demand Pharmaceutical and biologics companies continue to accelerate investment in device combination products, and...
QSMR 2026 Broken Down
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.
New technical experts 2025
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.
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.
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