DR STUART GRANT PhD CEng

PRODUCT DEVELOPMENT LEADERSHIP

FOR MEDICAL DEVICES & SURGICAL INSTRUMENTS

I work with founders when decisions start to carry real downstream consequence - and getting it wrong becomes expensive.
Medical device development reaches a point where progress continues, but earlier decisions begin to constrain what happens next.
Moving forward without experienced product development leadership is no longer a risk worth taking.
That’s typically when I get involved.

Three ways to work with me:

DECISION-READY PRODUCT DEVELOPMENT ROADMAP

When teams need clarity before committing to major next steps or board decisions.

CRITICAL ISSUE RESOLUTION

When a specific issue has already emerged and needs to be resolved without destabilising the wider development programme.

FRACTIONAL PRODUCT DEVELOPMENT LEAD

When decisions are no longer isolated and experienced ongoing leadership is required.

WHAT I DO

TAKING RESPONSIBILITY AS COMPLEXITY INCREASES

I PROVIDE PRODUCT DEVELOPMENT LEADERSHIP ACROSS THE FULL MEDICAL DEVICE PRODUCT DEVELOPMENT PROCESS — FROM EARLY PRODUCT DEFINITION THROUGH MANUFACTURING TRANSFER, REGULATORY READINESS, AND LAUNCH.

I TAKE RESPONSIBILITY FOR IDENTIFYING WHERE COMPLEXITY IS BUILDING, WHAT REQUIRES FOCUS, AND ENSURING DECISIONS NOW DON’T CREATE PROBLEMS LATER.

WHEN THIS BECOMES NECESSARY

Founders usually involve me when progress is still being made, but decisions no longer feel straightforward.

The product is moving and milestones are being hit - yet decisions carry more consequence than they used to. Different parts of the product development process begin to overlap, and choices in one area start to constrain others. When this isn’t handled expertly, the cost is paid later through rework, lost time, and avoidable expense.

Without strong product development leadership, this can quickly become fragmented. With teams in place, it often shows up as work falling between roles, with no one clearly responsible for resolving how decisions interact.

This is where experienced product development leadership changes the shape of the work - by seeing across overlaps, anticipating downstream effects, and resolving issues early.

WHERE I FOCUS

I WORK END-TO-END ACROSS PRODUCT DEVELOPMENT, WITH PARTICULAR ATTENTION ON THE STAGES WHERE DECISIONS BECOME DIFFICULT — AND EXPENSIVE — TO UNWIND LATER.

CLINICAL INSIGHT → PRODUCT DEFINITION

Translating clinical need into a clear, defensible product definition. Surfacing assumptions early and shaping requirements that will hold up downstream.

DEVELOPMENT PLANNING & DESIGN CONTROLS

Establishing a coherent development plan and proportionate design controls. Aligning engineering & design, testing, regulatory, and quality so progress remains meaningful rather than cosmetic.

DESIGN FREEZE → REGULATORY READINESS

Pressure-testing designs and evidence before they become costly to change. Reducing late-stage surprises and protecting regulatory and investor credibility.

MANUFACTURING TRANSFER & SCALE-UP

Guiding decision-making as designs meet manufacturing reality. Resolving issues without destabilising the product or undermining earlier work.

WHO I WORK WITH

I work with founders who:
  • are developing physical medical devices or surgical instruments
  • are beyond concept stage, with real development underway
  • are funded, either through bootstrapping or external investment
  • are approaching inflection points where decisions will soon be locked-in
  • are concerned about the cost of rework, delay, or regulatory surprises
This work is best suited to founder-led MedTech companies operating in or targeting the UK, US, and Australia, particularly teams navigating complex regulatory pathways and export-led markets.
I BRING MORE THAN 25 YEARS OF END-TO-END MEDICAL DEVICE AND SURGICAL INSTRUMENT DEVELOPMENT EXPERIENCE TO FOUNDERS WHO KNOW THINGS ARE GETTING MORE COMPLEX, BUT AREN’T SURE WHAT MUST BE DEALT WITH NEXT.
My experience spans the full product development process - from engineering & design, project management, and regulatory readiness through manufacturing transfer and scale-up - which is why I can see what will matter later, not just what’s busy now.

I’ve been directly accountable for product development decisions under regulatory, manufacturing, revenue, and investor pressure, including EU MDR and FDA market approval for commercially critical device portfolios.

My work has been shaped across UK, US, European, and Asia-Pacific markets, including export-led development contexts, giving me direct exposure to how decisions play out under different regulatory, manufacturing, and commercial conditions.

WHO I AM

DR. STUART GRANT PhD, CEng

Read MORE

“Stuart brings significant real-world experience and a thorough and systematic approach to problem solving to the table.”

Engineering Fellow
DePuy Synthes

“Stuart has a wealth of experience in the orthopaedics industry that couples well with his process-oriented mindset.”

Director
Johnson & Johnson MedTech

“Stuart not only provides clients with his engineering talent, expertise in Product Realization and NPD, but they also benefit from his drive and can-do attitude.”

Fellow (FIMECHE)
Institute of Mechanical Engineers

HOW I WORK

HOW WORK TYPICALLY BEGINS

WHEN YOU REACH OUT, MOVING FORWARD MATTERS — BUT MOVING FORWARD WITHOUT A CLEAR PLAN NO LONGER FEELS ACCEPTABLE.

MY JOB AT THE START OF ANY ENGAGEMENT IS TO BRING CLARITY QUICKLY, ESTABLISH A CREDIBLE PATH FORWARD, AND GET YOUR PRODUCT LAUNCHED ON TIME AND ON BUDGET. I TAILOR MY INVOLVEMENT TO WHAT THE PRODUCT ACTUALLY NEEDS TO MOVE FORWARD WELL.
DECISION-READY PRODUCT DEVELOPMENT ROADMAP
When teams need clarity before committing to major next steps.
This engagement is designed to surface where existing product development decisions introduce risk, constraint, or downstream cost - and to define a credible, decision-ready path forward before those risks become expensive to unwind.

I review the product end to end - product definition, development strategy, evidence approach, design controls, and manufacturing assumptions - to identify where decisions are already interacting, where optionality is closing, and which choices will most strongly influence timeline, cost, and regulatory outcome if left unaddressed.

The output is a single, coherent product development roadmap that aligns scope, sequencing, timeline, and budget, and makes explicit which decisions matter most now and why. It provides a defensible basis for moving forward and can be shared confidently with investors or the board.

Typical delivery is around two weeks at a fixed fee of $20,000.

This work delivers substantial value in its own right. Some teams take the roadmap forward independently; others use it as the foundation for engaging ongoing product development leadership as decisions continue to interact and carry consequence.
CRITICAL ISSUE RESOLUTION
When a specific issue has already emerged and needs to be resolved without destabilising the wider programme.
Founders often reach out when a particular problem - technical, regulatory, evidentiary, or organisational - is starting to hold progress back.

I work directly on the issue, get clear on what’s driving it, and determine the action needed to resolve it while maintaining alignment with the broader product development pathway.

The scope, timeframe, and fixed fee are defined up front.

This type of engagement is often used where an issue has already been identified, or where clarity from earlier work has highlighted a specific constraint that must be addressed before progress can continue.
FRACTIONAL PRODUCT DEVELOPMENT LEAD
When decisions stop being isolated and experienced leadership is needed to carry them through.
At this stage, progress is still being made - but choices in one area are beginning to constrain others. Without clear decision ownership, work can fragment, rework increases, and confidence erodes.

When engaged as Fractional Product Development Lead, I take responsibility for leading product development end to end, staying close to the work and applying ongoing decision-making to keep it aligned as it progresses toward launch.

I intervene early where decisions interact, resolve issues before they propagate, and ensure progress remains meaningful rather than cosmetic - protecting timeline, budget, and regulatory credibility.

This work is structured as a monthly retainer, reflecting the ongoing nature of the role. Engagements typically begin with a minimum commitment of six months.

LET’S TALK

If you’re ready to move your product forward and want to discuss what I can do for your product development, find me on LinkedIn and send me a message. I typically respond within 24 hours.

If you want to review my background, experience, and current thinking in more detail before reaching out, you’ll find that on LinkedIn as well. Follow me

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