Suttons Creek

Last month we published Part 1 of?Kelly Wedig's article?"Risk Management for Drug Delivery Systems", giving a birds eye view?of what a combination product risk management process looks like. We have recently followed up with Part 2, which provides tips for executing that risk management process.?Read it here: https://lnkd.in/e7MiUat5

What deliverables should your combination product risk management process generate? And who is responsible? https://lnkd.in/g2RguZJm #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice #riskmanagement

What should risk management look like for a combination product? https://lnkd.in/gDGT5q_5 #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice #riskmanagement

The FDA released a number of guidance documents in early January 2025 as the change of federal administration approached, and we have insights on the first important documents of note?related to use of Artificial Intelligence. We will be sharing them with our email subscribers this Thursday at noon (Pacific). To receive the information, simply sign up here: https://lnkd.in/gA4ngeWi #combinationproduct #artificialintelligence #ai #biotech #pharma #medtech #devicedevelopment #fda #regulatoryaffairs #deliverydevice #drugdelivery

An everyday life example of applying risk management to help you better understand how to apply it to combination products: https://lnkd.in/grW7NpvH #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice #riskmanagement

Launching a drug-device combination product brings added complexities in post-market support and surveillance activities. For a few specific examples and considerations (such as scaling issues, commercial and marketiing challenges, and pricing and reimbursement challenges) to keep in mind, visit: https://lnkd.in/g6Z2E2Xn #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice?

As we have mentioned recently in a LinkedIn post, it can't be "business as usual" when you add a delivery device constituent to your drug. Drug and combination product processes differ, including risk management. If you want to make sure you don't miss any crucial steps in your submission process, check out?Kelly Wedig's article?"Risk Management for Drug Delivery Systems [Part One]"?to get a birds eye view?of what a combination product risk management process looks like. https://lnkd.in/gpUC4aZ2

Device development requires the expertise of engineers and adds new external partners to the mix. For the why, the who, and the how of this change in development approach, visit https://lnkd.in/g6Dj7Bc7 #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice?

At Suttons Creek, we have observed significant shifts in Human Factors (HF) review expectations, particularly around device-led combination products, by the FDA. These changes are critical for companies preparing for regulatory submissions such as 510(k) or PMA. To receive an email exploring these trends in detail, including the distinct differences in HF review processes for device-led and drug-led combination products, sign up here: https://lnkd.in/gA4ngeWi. The email will go out to our subscribers this Thursday morning. #combinationproducts #drugdelivery #devicedevelopment #humanfactors

Often when we are hired by a Pharma or Biotech company to support their drug delivery device development, even in the most sophisticated of companies that have been to the combination product rodeo before, we find that they do not have a culture that fosters combination product development success. There are a few main reasons for this:? 1. Drugs/biologics and devices are developed very differently, and drug companies tend to try to fit a device’s square peg into the drug’s round hole.? 2. Drugs/biologics and devices are regulated similarly, in some cases by the same regulatory body (the FDA), however regulatory schemes are different and the divisions responsible for the review may be different.? 3. Management does not provide sufficient resources and weight to the importance of, and unique processes of, device development. When embarking on a combination product development program, it’s essential to recognize that each initiative is unique. The complexity and development phase will shape your company’s strategies and understanding certain key factors will play a critical role in building a robust combination product organization. For a breakdown of these factors, visit: https://lnkd.in/g-GXbHe7 #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice?