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Case Study.

Design transfer for combination products.

A company from the medical technology sector that develops combination products was faced with the challenge of efficiently organizing the design transfer from development to production and overcoming regulatory hurdles.

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The Challenge.

The transfer of combination products, which integrate both medicinal products and medical devices, into production presented the company with several challenges:

  • Regulatory uncertainties (EU MDR): The requirements of the EU directives for combination products led to delays in compliance, as unclear regulations made compliance more difficult.
  • Complexity of FDA regulations (21 CFR Part 4): The simultaneous fulfillment of the requirements for drugs and medical devices in accordance with the strict FDA regulations slowed down the transfer process considerably.
  • Limited internal resources: There was a lack of internal expertise to cover the complex requirements of both areas - medicinal products and medical devices - which led to delays.
  • Operational gaps: The transition from development to production was inefficient, which delayed market entry and caused additional costs.
  • Delayed market entry: Lengthy regulatory approval processes and operational challenges significantly delayed market entry.

The Benefits.

  • Conducting a gap analysis to identify regulatory and operational gaps in design transfer.
  • Provision of regulatory support for compliance with EU MDR and FDA 21 CFR Part 4 requirements.
  • Optimization of the design transfer process to make the transition from development to production efficient.
  • Provision of interdisciplinary expertise that meets the requirements for both medicinal products and medical devices.
  • Implementation of modern processes and systems to ensure efficient and compliant transfers.

The Outcome.

25% faster regulatory approval

through targeted support in complying with regulations.

15% reduction in transfer costs

through process optimization and the implementation of efficient systems.

Accelerated market entry,

as operational gaps were closed and regulatory requirements were met more quickly.

The Result.

Thanks to the targeted support and optimization of the design transfer, the company was able to bring its combination products to market successfully and more quickly. The reduction in transfer costs and the acceleration of market entry led to an overall more efficient production process and greater competitiveness.

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