Starting Your Medical Device Development Journey

When starting your medical device project, it’s important to find the right development partner. But finding a partner is not easy. It’s important to be open from the start - talk about your goals, needs, and any ideas you have. Making sure you both understand what’s needed early on sets the stage for a solid, productive partnership. 

Here’s five important steps you can take to help you get started:

1.) Talk to Us Early

  • It’s never too early - even if you only have an idea or high-level need.
  • A quick discussion helps us identify opportunities, risks and next steps.
  • We’re always happy to host you at Cherry Barns - meet our multi-disciplinary team and tour our labs & facilities.

2.) Share What You Know

Provide as much background information as possible:

  • User and product requirements (if defined).
  • Prototypes and testing so far (if available)
  • Market and commercial goals (business case, competitors, stakeholders).
  • Expected outcomes (cost targets, timelines, regulatory route).
  • Supporting insights (prior studies, IP landscape, technical constraints).

Don’t worry if your inputs aren’t complete - we can help shape them.

We understand the value of IP and will take all measures to ensure your secrets are safe with us – you might even learn some of our secrets too…

From point-of-care diagnostics, to wearables, and drug delivery, we have a breadth of experience which caters to all types of devices.

3.) Choose Your Starting Point

  1. Pathway 1 - Request for proposal (RFP): If you already have a defined brief and clarity on requirements, we’ll translate it into a detailed project proposal with scope, compliance needs, cost, timescales and potential risk gaps.
  2. Pathway 2 - Innovation Workshop: Best for teams at concept or early scoping stage: If your requirements are still forming, we’ll run a structured exploration workshop to map user journeys, align stakeholders, and define early requirements.
Integrated expertise: multidisciplinary team

4.) Build a Roadmap Together

Taking the above we then work together to create a custom development proposal by:

  • Applying OPD’s proven New Product Science (NPS) framework.
  • Combine agile exploration with regulated processes (ISO 13485, ISO 14971, IEC 62366, IEC 62304).
  • Outcome: a clear, evidence-based roadmap to de-risk development.

5.) Kick Off with Confidence

You’ll start with:

  • A defined plan, costs, and timelines.
  • Clear requirements (user, technical, regulatory).
  • Agreed next design & development phases.

This gives your team and stakeholders confidence to progress, secure funding, and deliver impact.

Evidence and risk-led approach to combining agile methods with regulated processes,
Evidence and risk-led approach to combining agile methods with regulated processes,

Summary

  1. Start conversations early.
  2. Share what you know
  3. Pick the right entry point (RFP or Phase 0).
  4. Build an evidence-led roadmap with OPD.
  5. Launch your project with confidence.

Why OPD

  • Proven framework: OPD’s New Product Science (NPS) methodology takes an evidence and risk-led approach to combining agile methods with regulated processes, ensuring we efficiently generate value at every milestone.
  • Track record of medical device delivery: From point-of-care diagnostics, to wearables, and drug delivery, we have a breadth of experience which caters to all types of devices.
  • Integrated expertise: multidisciplinary team with capabilities spanning industrial design, mechanical and electronics engineering, software development, human factors, and standards/regulatory.
  • Flexible engagement: Whether you bring a detailed RFP or just an idea to explore, we adapt to fit your needs.

To start our journey together please feel free to contact us.