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: Bryan Bobo
Suttons Creek is very happy to announce the recent addition of two new and talented combination product specialists to our team. Max Lerman, PhD and Rita Lee, PhD RAC have joined Suttons Creek as Principal Consultants, combination product regulatory affairs experts that will lead client projects for our Technical Services team overseen by Rob Schulz (President, COO) and Technical Directors, Carolyn Dorgan and Jonathan Amaya-Hodges. Both Max and Rita have extensive regulatory experience that will bring even more strength to our talented group of combination product regulatory specialists who possess in-house pharma experience, and our EU team members who are registered consultants with notified bodies.
Industry News Brief: Are You Sure You Are Ready For Launch?
Luckily, it does not happen often. But it does happen. Your drug delivery device development is underway. You have submitted protocols to the FDA and timelines to market are set with your board and shareholders. There are contracts in place and clinical studies underway. And then you get the news…
• Your manufacturer calls and advises that your planned device platform (syringe, pen injector, auto-injector, etc.) is being discontinued or will be experiencing significant development delays.
• An early study (Clinical, Human Factors, Functional Testing) indicated that device was unsuitable for the drug or patient population.
• The Commercial team determined that a change in platform is needed for competitive reasons.
You don’t need an expert to tell you that this is a big deal, but you may need some guidance about why the situation needs critical care beyond scrambling to rush a new device into its place to keep the train moving. Right now, your team is dealing with a likely unprecedented process that will require device selection and integration with the project timeline at a hyper-speed pace.
New Hires: Max Lerman and Rita Lee
Suttons Creek is very happy to announce the recent addition of two new and talented combination product specialists to our team. Max Lerman, PhD and Rita Lee, PhD RAC have joined Suttons Creek as Principal Consultants, combination product regulatory affairs experts that will lead client projects for our Technical Services team overseen by Rob Schulz (President, COO) and Technical Directors, Carolyn Dorgan and Jonathan Amaya-Hodges. Both Max and Rita have extensive regulatory experience that will bring even more strength to our talented group of combination product regulatory specialists who possess in-house pharma experience, and our EU team members who are registered consultants with notified bodies.
Industry News Brief: New Draft Guidance on Human Factors Information in Medical Device Marketing Submissions
Luckily, it does not happen often. But it does happen. Your drug delivery device development is underway. You have submitted protocols to the FDA and timelines to market are set with your board and shareholders. There are contracts in place and clinical studies underway. And then you get the news…
• Your manufacturer calls and advises that your planned device platform (syringe, pen injector, auto-injector, etc.) is being discontinued or will be experiencing significant development delays.
• An early study (Clinical, Human Factors, Functional Testing) indicated that device was unsuitable for the drug or patient population.
• The Commercial team determined that a change in platform is needed for competitive reasons.
You don’t need an expert to tell you that this is a big deal, but you may need some guidance about why the situation needs critical care beyond scrambling to rush a new device into its place to keep the train moving. Right now, your team is dealing with a likely unprecedented process that will require device selection and integration with the project timeline at a hyper-speed pace.
What Happens When You Need To Switch Your Drug Delivery Device Mid-Development?
Luckily, it does not happen often. But it does happen. Your drug delivery device development is underway. You have submitted protocols to the FDA and timelines to market are set with your board and shareholders. There are contracts in place and clinical studies underway. And then you get the news…
• Your manufacturer calls and advises that your planned device platform (syringe, pen injector, auto-injector, etc.) is being discontinued or will be experiencing significant development delays.
• An early study (Clinical, Human Factors, Functional Testing) indicated that device was unsuitable for the drug or patient population.
• The Commercial team determined that a change in platform is needed for competitive reasons.
You don’t need an expert to tell you that this is a big deal, but you may need some guidance about why the situation needs critical care beyond scrambling to rush a new device into its place to keep the train moving. Right now, your team is dealing with a likely unprecedented process that will require device selection and integration with the project timeline at a hyper-speed pace.
De-risking Biosimilar Development
Suttons Creek is excited to share a new whitepaper from BD that references work by Suttons Creek to improve execution of partner programs in the combination product space. This qualitative commercial market research study is highlighted in an article written by BD’s Victoria Meyer, Senior Global Strategic Marketing Manager. Her article, first featured on the Drug Development & Delivery website, highlights ways to de-risk the autoinjector launch process, including research-based best practices and considerations around selection of your device partner. Learn more about de-risking and speeding up your combination product launch for a competitive advantage by reading this informative article.
Quick Changes Needed: Applying cGMPs for Combination Products to Ophthalmic Devices
Carolyn Dorgan is bringing her 10+ years of experience in the Medical Device and Combination Product industries, including 6 years leading the FDA’s Infusion Devices team, to Suttons Creek. Known in the international regulatory community from her active speaking engagement schedule, Carolyn has literally “set the standard” by participating in over a dozen international standards ranging from infusion devices to needle-based injection systems, on-body delivery systems, and infant incubators. Her knowledge of international Combination Product standards and, more critically, their interpretation and application to various drug delivery devices will play a crucial role in SCI’s regulatory services team, led by Rob Schulz, VP of Regulatory Affairs & Technical Consulting.
Combination Product Expert Carolyn Dorgan Has Joined Suttons Creek, Inc. As Principal Systems Engineer, Regulatory Affairs
Carolyn Dorgan is bringing her 10+ years of experience in the Medical Device and Combination Product industries, including 6 years leading the FDA’s Infusion Devices team, to Suttons Creek. Known in the international regulatory community from her active speaking engagement schedule, Carolyn has literally “set the standard” by participating in over a dozen international standards ranging from infusion devices to needle-based injection systems, on-body delivery systems, and infant incubators. Her knowledge of international Combination Product standards and, more critically, their interpretation and application to various drug delivery devices will play a crucial role in SCI’s regulatory services team, led by Rob Schulz, VP of Regulatory Affairs & Technical Consulting.
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.
Previous Speaking Engagements Have Included:
“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” – Pre-filled Syringes & Auto-injectors Forum / PharmaEd Resources, 2022
“Best Practices for Cross-Functional Engagement Throughout the Combination Product Lifecycle” – PharmaEd Resources Combination Products Summit, 2022
“Software as a Medical Device in the Pharmaceutical Industry” – Combination Produce Lifecycle Management Summit, 2018
“Integration SaMD and Connectivity into Your Company” – Xavier University, 2018
“Design Manufacturing: Accelerating the New Product Commercialization Process” – MD&M West 2017
“Trends in Shaping MedTech Strategy and Innovation” – MD&M West, 2016
“Systems Engineering in Healthcare” – Presented to LMU, 2016
“A Few Technical Insights on Combination Products, and How to Help” – Keck Graduate Institute, 2016
“Systems Engineering in Healthcare” – INCOSE Healthcare Working Group, 2015
“Verification & Validation Best Practices” – CMC Strategy, 2015
“Autoinjector Process Improvement Opportunities” – Presented to Client, 2015
“A Systems Engineering Approach to Risk Management” – AAMI Summit, 2015
“Pharma and Vendor Co-Development Models: Strategy, Execution, and Implications” – PDA, 2015
“Fast Tracking your Scale-Up Strategy with Limited Time and Money Resources” – BioMedTech San Jose, 2014
“Combination Products as a Systems Approach” – PDA, 2014
We’ve Also Delivered the Following Keynotes:
“Device Teams – To Build or Buy?”
“Digital Health Integration”
“Tech Evaluation Process”
“Best Practices for Pharma”
“I want to build a Combination Product, now what?”
“How to set up your Small Pharma Company for Combination Product success”
“How to integrate SaMD into your Pharma Company”
“Digital Health – To Build or Buy?”