Medical device & healthcare consultancy

From promising technology to clinically credible, regulatory-ready, commercially viable products.

Karandash Consulting provides senior, practical support across product strategy, R&D, clinical development, regulatory pathways and commercialisation.

Medical Devices Advanced Wound Care Biomaterials Clinical Development Commercial Strategy

What I do

Focused expertise where product, evidence and market meet.

Karandash works with founders, leadership teams, manufacturers and investors who need experienced, commercially minded support to move a medical technology forward.

R&D & Product Strategy

Define the product, claims, development priorities and evidence needs before time and budget are committed.

  • Portfolio and pipeline strategy
  • Product development planning
  • Technical and design review

Clinical Development

Build clinical programmes that answer the right questions and generate evidence that supports adoption.

  • Clinical strategy and study design
  • Protocol and evidence review
  • Clinical development oversight

Regulatory Strategy

Bring regulatory requirements into product strategy early, so claims, evidence and development stay aligned.

  • US FDA, UKCA and EU CE marking strategy
  • Regulatory pathway, classification and claims planning
  • Technical documentation and evidence gap review
  • Submission readiness and regulatory risk

Commercialisation

Translate technical and clinical value into a proposition customers, distributors and partners can understand.

  • Go-to-market planning
  • Positioning and value proposition
  • Distributor and partner strategy

Due Diligence & Advisory

Independent assessment of technology, evidence, development plans and commercial potential.

  • Technology and pipeline review
  • Investment / partner diligence
  • Board and leadership advisory

Fractional Leadership

Senior R&D and innovation leadership for businesses that need capability now without a full-time appointment.

  • Interim / fractional R&D leadership
  • Team and programme direction
  • Cross-functional decision support

How I work

Start with the decision, not the deliverable.

Clarify the objective

What decision needs to be made, what does success look like, and what are the real constraints?

Identify the critical gaps

Focus effort on the technical, clinical, regulatory or commercial issues that could genuinely change the outcome.

Build a practical route forward

Clear recommendations, sensible priorities and an executable plan — not consultancy for consultancy's sake.

About

Christian Stephenson

Founder, Karandash Consulting

Christian Stephenson is a medical device executive and consultant with senior experience spanning R&D, clinical development, regulatory strategy and commercialisation, with particular depth in advanced wound care and biomaterials.

His experience covers global medtech organisations, growth-stage businesses and early-stage technologies, helping leadership teams make the product, evidence and market decisions that determine whether a technology progresses successfully.

Karandash gives companies direct access to that senior experience for defined projects, due diligence, interim leadership and specific development challenges — without the overhead of building a permanent team around the problem.

R&D Leadership Clinical Strategy Regulatory Commercialisation Advanced Wound Care

Get in touch

Have a product, programme or decision that needs experienced input?

Send a short note about what you are working on and where you need help.

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