ISO 11608: Best Practices to De-Risk & Shorten Time to Market for Wearable Injectors

As the regulatory guidance and expectations around drug device combination products continues to develop, the agreed upon approaches to demonstrate safety and effectiveness likewise develops. One long awaited significant change involves the 2022 revision of ISO 11608, Needle-based injection systems for medical use — Requirements and test methods: Parts 1-5, along with the addition of Part 6, which is specific to On-Body Delivery Systems.

This new standard is a result of collaboration between industry and global regulatory authorities via the ISO Technical Committee 84 working groups. The 2022 versions of ISO 11608 Parts 1-6 were recognized by the US Food and Drug Administration (FDA) as consensus standards for on-body injectors (Product Code QLF) on May 30, 2022. The 2022 revisions were created in part to satisfy the increase in wearable injection devices, where no existing standard directly applied.

Although the prior versions of the ISO 11608 series of standards (Parts 1-5) have been in place, the expectation from the FDA is that compliance to the 2022 revisions should occur prior to July 9, 2023, and compliance with Part 6 is in effect as of May 30, 2022. Therefore, medicinal product manufacturers should work with their device counterparts on a plan for implementation to ensure timely global regulatory compliance. Understanding the impact of these new revisions on development timelines is vital as wearable injectors become more desirable by patients.

The featured speakers will cover highlights of the major updates, including the impact to both device and pharmaceutical manufacturers, and how holistic implementation strategies can decrease risk and shorten time to market. In addition, the speakers will showcase interactive best practices examples that provide real-world methods for aligning drug and device development pathways for a combination product-centric approach.

Register to learn how the new revisions and additions to the 2022 ISO 11608 series impacts the wearable injectors market.

Speakers

Carolyn Dorgan, Director, Technical Services, Suttons Creek, Inc.

Carolyn Dorgan has over 10 years’ experience in the medical device and combination product industries, including six years at the US Food and Drug Administration (FDA) leading the Infusion Devices team. Carolyn is active in the international regulatory community through speaking engagements and has participated in over a dozen international standards ranging from infusion devices to needle-based injection systems, on-body delivery systems and infant incubators. In addition, her unique approach to product development and risk management has been instrumental in working with products for which there are no established performance or regulatory standards which includes pediatric medical devices, infusion pumps and rare disease combination products. Carolyn has a demonstrated ability for working through complex problems at a system level. She implements practical solutions using her multi-disciplinary background of engineering, software, cybersecurity, human factors and business.

Carolyn has a BS in biomedical engineering from the University of Minnesota and an MS in technology commercialization from the University of Texas. She also has an ASQ Six Sigma Green Belt certification and is qualified in Medical Device Quality Systems through AAMI. She is also trained in Total Product Lifecycle Management Regulatory, Regulatory Affairs/Strategy, Quality and Reliability Engineering, ISO 13485, ISO 14971, 21 CFR 820 and 21 CFR Part 4.

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Lauren Orme, Director, Regulatory Policy and Intelligence West Pharmaceutical Services, Inc.

Lauren Orme has over 15 years of experience in pharmaceutical packaging, medical device and analytical services industries. Currently, Lauren leads the Regulatory Affairs Intelligence and Policy group, which oversees monitoring of global regulatory requirements, changes in regulatory landscapes and strategies related to implementation of those strategies. Prior to her current role, Lauren held commercial roles to support customers with education and adoption of West’s products and services.

Lauren earned a Bachelor of Science in Biology from West Chester University. She is certified as a Project Management Professional (PMP).

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