The new European Medical Device Regulation: Friend or foe for hospitals and patients?

Nüssler, Andreas K.

doi:10.1016/j.injury.2023.110907

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2024

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Cited by 2 publications

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Design and Manufacturing Requirements for Medical Devices

Hasirci,

Hasirci

2024

Fundamentals of Biomaterials

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Design and Manufacturing Requirements for Medical Devices

Hasirci,

Hasirci

2024

Fundamentals of Biomaterials

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Mitigation of supply chain challenges in cell therapy manufacturing: perspectives from the cord blood alliance

Killela,

Herrity,

Frontier

et al. 2024

Stem Cells Translational Medicine

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Cellular therapies rely on highly specialized supply chains that often depend on single source providers. Public cord blood banks (CBB) manufacturing the first cell therapy to be highly regulated by the FDA and related international agencies are a prime example of being subject to this phenomenon. In addition to banking unrelated donor cord blood units for transplantation, CBBs also source and characterize starting materials for supply to allogeneic cell therapy developers that often employ customized technologies offered by just a small number of manufacturers. As such, these supply chains are especially sensitive to even minor changes which often result in potential major impacts. Regulations can shape supply chain efficiencies, both directly via the definition of restricted technology and process requirements and indirectly by steering strategic business decisions of critical supply or service providers. We present 3 current supply chain issues with different root causes that are swaying efficiencies in cord blood banking and beyond. Specifically, the shortage of Hespan, a common supplement used in cord blood processing, the decision by the provider to stop supporting medical device marking of the Sepax system broadly used in cord blood banking, and a new European ruling on phasing out plasticizers that are critical for providing flexibility to cord blood collection bags, are all threatening downstream supply chain issues for the biologics field. We discuss overcoming these hurdles through the prism of unified mitigation strategies, defined, and implemented by multi-factorial teams and stakeholders, to negotiate resolutions with providers and regulators alike.

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The new European Medical Device Regulation: Friend or foe for hospitals and patients?

Cited by 2 publications

References 10 publications

Design and Manufacturing Requirements for Medical Devices

Design and Manufacturing Requirements for Medical Devices

Mitigation of supply chain challenges in cell therapy manufacturing: perspectives from the cord blood alliance

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