Ad Hoc Services

We specialize in bringing holistic, rigorous solutions to tough complex problems, especially when it comes to scoping, structuring, and executing medical technology R&D. We really want you to get off on the right foot.

That said, we empathize with your need to execute and value our partnership. If we can help you get through a milestone by taking ownership of a task for you, let us know. For example, we can tackle a variety of R&D leadership activities:

Strategic Analysis

  • Roadmapping (Technology, Clinical, Competitive)
  • First Use Case for Platform Technologies
  • System Architecture
  • Value & Positioning Insights
  • Portfolio Analysis

Operations Planning

  • Talent Acquisition Planning
  • Strategic Capabilities Development (Build vs. Buy, Insource vs. Outsource, Full-Time vs. Contractor)
  • Design for Flexibility

Development Planning

  • Integrated Development Plan
  • Design & Development Planning
  • Verification & Validation Strategy
  • Regulatory Compliance Planning
  • Quality Planning and QMS Navigation
  • Setup Design History File (DHF) & Device Master Record (DMR)

Reviews

  • Phase-end reviews
  • Design reviews
  • SOW reviews
  • Schedule and budget reviews
  • Impact assessments

Training & Mentoring

We offer training, ad hoc coworking, team-coding, and participation in innovation sessions and development meetings.

Contractor & Supplier Review

We offer supplier review to support contractor and supplier vetting and auditing, especially for leadership teams that are new to medical device development.

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All Services