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.

De-risking Biosimilar Development

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.

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Quick Changes Needed: Applying cGMPs for Combination Products to Ophthalmic Devices

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.

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Combination Product Expert Carolyn Dorgan Has Joined Suttons Creek, Inc. As Principal Systems Engineer, Regulatory Affairs

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.

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Interpreting Drug & Device Regulations In A Changing Landscape: The Impact of Innovation and COVID-19

Interpreting Drug & Device Regulations In A Changing Landscape: The Impact of Innovation and COVID-19

Technology and innovation is challenging the regulatory landscape and presenting stakeholders (Drug Companies, Device Companies, Regulating Bodies) with new boundaries for interpretation. With consistent new technology development, there is going to be a learning curve with regard to how regulations apply, both on the manufacturing side and even within the regulatory bodies that created the regulations.

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Planning Usability Testing During Covid-19

Planning Usability Testing During Covid-19

Despite this pandemic, the medical industry strives to continue designing medical devices that are capable of supporting the clinicians serving Covid-19 and other patients around the globe. Whether standalone devices such as ventilators or combination devices such as autoinjectors and pre-filled syringes, human factors specialists work to gather information from the user that can inform the usability of these devices. If you find yourself in need of conducting a human factors usability formative or summative study during this pandemic, here are 5 important considerations.

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SCI Is Building Its Talent Pool

SCI Is Building Its Talent Pool

During 2020, a year of many pivots, new priorities and business assessments in the pharmaceutical industry particularly, Suttons Creek, a combination product device consultancy based on the Los Angeles area, spent its time building up its executive team and consultant roster to ensure its clients’ needs would be covered from initial strategic planning, through all elements of device development and regulatory approval, all the way to commercialization and post-launch activities. Four of the biggest areas of growth were in Commercial, Human Factors, EU MDR Preparedness and In Vitro Diagnostic / Companion Diagnostic specialties.

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3 Tips: Writing Effective Requests for Feedback

3 Tips: Writing Effective Requests for Feedback

If you are one of the many organizations that struggle with crafting regulatory body responses, there are ways to improve your maneuvering through the intimidating regulatory submission process. The FDA (Food and Drug Administration) strives to provide plenty of pathways for sponsors to receive feedback, guidance, and assistance in order to maximize a sponsor’s chances to be successful. Representatives from the organization regularly participate in conferences such as the International Symposium on Human Factors in Health Care, provides content on the FDA Learning Portal, publishes numerous guidance documents to their website, and has established opportunities to have direct engagement with FDA staff via written responses, teleconferences and in person meetings. Suttons Creek’s combination product specialists track all of these resources, and we have curated a clear-cut path to getting what you need to improve your regulatory submission processes.

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3 Considerations for Designing Medical Devices to Optimize the User Experience

3 Considerations for Designing Medical Devices to Optimize the User Experience

While technology innovation for medical devices is more visible to the public eye, improving and refining patient care and user experience along with technology is an often-overlooked critical innovation focus. It is essential because, despite the advancement in technology, the innate characteristics of humans stay the same. These innate characteristics of human users present physical, perceptual, and cognitive limitations that make them error prone, and these limitations need to be accounted for; not only device design, but extending into the design of ancillary items like instructions, packaging, and labeling. Incorporating a human-centered design approach with all aspects of their product innovation presents manufacturers additional opportunities to produce user friendly devices.

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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:

“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?”