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PA OPINION

Compliance assurance during medical product development: safeguarding commercial success

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Medical device companies face more exacting requirements to obtain approval for medical products and increasing scrutiny to ensure their products remain compliant. At the same time teams developing medical devices and diagnostics are being tasked to deliver more with less due to increased competition and shorter product lifecycles.

PA Consulting Group works closely with the leaders of medical device companies and medical diagnostics companies and their project teams throughout the development process and particularly at critical decision points. We help them overcome these challenges and reduce time-to-market, without making compromises that could jeopardize commercial success.

We provide independent and objective technical and compliance assurance experts, cross-sector experience and change management excellence to reduce uncertainty and increase confidence across medical device companies and medical diagnostics companies.

Guidance and coaching for medical product development

  • Embed effective project and risk management practices and tools

  • Guide the project team to avoid design, manufacturing and testing pitfalls

  • Challenge the product development team to find pragmatic and unique means to enhance performance

  • Interpret regulatory standards and implement appropriate quality measures

Independent project and technical review

  • Provide impartial assessment of the current project state and identify improvements

  • Expose hidden risks, unrealistic assumptions and propose mitigating actions

  • Identify quality and compliance issues that may affect regulatory submissions

  • Ensure all viewpoints are considered and recommendations are appropriate

  • Prioritize mitigations to minimize risk and address the gaps in a timely manner

Critical problem resolution for medical product development

  • Quickly understand the issues, agree desired outcomes, execute structured data driven root cause assessment and develop optimum compliant solutions

  • Rapidly provide subject matter expertise when it is not available in the team

  • Provide the catalyst and tools to increase team alignment on the way forward.

Manufacturing readiness planning

  • Ensure critical product quality attributes and process parameters are defined and quality management practices are embedded to assure appropriate monitoring

  • Develop compliant manufacturing scale-up and supply chain strategies

  • Identify and implement cost reduction opportunities during development

  • Prepare for and execute efficient and successful transfer to manufacture.

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