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Medical Device Remediation Expertise: Build or Buy?

Regulatory changes are accelerating globally. Today, it’s the European Union’s Medical Device Regulations (EU MDR) and phasing out ethylene oxide (EtO) sterilization. Tomorrow, it will be strict cybersecurity and artificial intelligence requirements.

Medical device companies that excel in proactive compliance and remediation will have a competitive advantage.

They can choose to build an in-house competency and/or establish strong partnerships with expert advisors. Each approach brings advantages and challenges. The choice will depend on a company’s long-term strategic priorities, expertise, size, budget, and more. Here, several considerations for making an informed decision.

 

Build an in-house competency Partner with consultant(s)
Control
  • Full strategic control
  • Shared
Cost
  • High initial investment
  • Recurring cost
  • Cost effective long term
  • Fixed cost
  • Immediate value
  • Short-term nonrecurring expense
  • Variable cost
Timing
  • Takes time to build
  • Quick to start
Knowledge base
  • Institutional knowledge
  • Product knowledge
  • Deep specialized knowledge
  • Industry best practices
  • Specific remediation experience, expertise
Training
  • Steep learning curve
  • Ongoing investment
  • Short learning curve
  • May serve as trainer or mentor
Resources
  • Shared with NPD, other initiatives
  • Overworked at peak times
  • Scalable
  • Dedicated
  • Focused
Tools
  • Custom
  • Take time, experience to build
  • Advanced
  • Proven tools tailored to fit
Culture
  • Existing relationships
  • Potential politics, silos
  • Objectivity
  • Fresh perspective
  • Bridges silos
Sustainability
  • Long-term adaptability
  • Agility
  • Institutional knowledge
  • Organizational capability built and knowledge transferred before program completion

Take the Next Step

If your company doesn’t have the experience and expertise to manage the next big regulatory program, or if you’re working to build an in-house remediation competency, download Apply Lessons from EU MDR to Upcoming Regulatory Changes.

 

Author

  • Director and Medical Technology Industry Lead
    Integrated Project Management Company, Inc.
    LinkedIn Profile

    See more content from this author

    Carl Manthe is a Director in IPM’s Los Angeles office and the company’s Medical Technology industry lead. Carl has been managing complex projects for more than 30 years and has extensive experience leading teams in product development, business process optimization, change management, capital expansion, quality, portfolio management, and business integration projects.

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Author

  • Director and Medical Technology Industry Lead
    Integrated Project Management Company, Inc.
    LinkedIn Profile

    See more content from this author

    Carl Manthe is a Director in IPM’s Los Angeles office and the company’s Medical Technology industry lead. Carl has been managing complex projects for more than 30 years and has extensive experience leading teams in product development, business process optimization, change management, capital expansion, quality, portfolio management, and business integration projects.

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