Medical device expertise.
Collings Medical offers independent advisory and review services for medical device development, from someone who can look at where a project actually is, not where the programme plan says it should be.
The perspective behind it comes from twenty-five years in design and development, and a lifetime using medical devices.
Sound Familiar?
Your team cannot independently review its own design, and the regulations expect it.
Your engineers are excellent. Your design history file is another matter.
Your first ISO 13485 audit is booked and nobody in the building has been through one.
Your programme is behind schedule and the explanations keep changing.
None of these are expertise problems. They are perspective problems and perspective is hard to generate from inside.
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ABOUT
The person behind Collings Medical
Simon Collings is the founder of Collings Medical, a medical device consultancy built on a career in product design and development and a lifetime on the receiving end of the medical device industry.
I have spent twenty-five years designing and developing products, the last eleven leading medical device programmes - drug delivery, diagnostics, connected health, CAR-T manufacturing. I have also spent my whole life on the receiving end of the industry: kept alive as a premature baby by devices, five years of daily growth hormone injections as a child, and a bone-anchored hearing system today.
When I ask whether a design works for the person depending on it, the question comes from real experiences.
SERVICES
How I can help
Some teams need a specific review at a specific moment. Others need a senior voice available on a regular basis.
Collings Medical works both ways.
Programme reviews
If your programme has missed a milestone more than once and the explanation has been different each time, the problem is rarely the one everyone is focused on. A programme review establishes where the project actually is - in days, not months.
Independent design reviews
The people closest to a design are the wrong people to review it independently, and the regulations know it. I have been the engineer under scrutiny and the director doing the scrutinising. I know what a thorough review looks like and what gets missed when it is done as a formality.
Design and requirements reviews
Requirements everyone agreed on but nobody interrogated are the most common cause of expensive rework. I challenge the groundwork before you build too much on top of it.
Usability and human factors reviews
I am trained in human factors and I have spent a lifetime as a device user. When I ask whether a design works for the person depending on it, I am asking from experience.
Process reviews
Strong teams rarely fail on engineering. They fail on design controls, because nobody has had to live with ISO 13485 before. I help you build controls proportionate to the business you actually are - a system people understand is a system that survives an audit.
DFM & DFA reviews
Most of a product’s final cost is locked in before it reaches a factory floor. I review designs through a manufacturing lens shaped by years alongside toolmakers, machine setters and assembly teams. The earlier the questions are asked, the cheaper the answers.
Project-based
A focused engagement for a specific need. You know what you want looked at and when.
SaMD design controls
ISO 13485 does not care whether the output is a moulded housing or an algorithm. Most SaMD programmes come unstuck where iteration speed meets design control. I map agile development onto ISO 13485 so the two stop fighting each other, and act as independent reviewer for the design history. Framework, risk and usability - not the software implementation.
Manufacture readiness
The design-to-manufacture handover is where underestimation gets expensive: work instructions, supplier selection, PFMEA, quality agreements, production controls. If you are approaching that stage, I can tell you whether you are actually ready.
New product development
Some companies need more than a review, they need a device built. I assemble a proven team of specialists around your project and act as the single point of accountability, with the design control framework in place from day one. An experienced team without the overhead of building one.
Fractional advisory
Some teams do not need a project; they need a senior voice available regularly - sitting in on design reviews, sense-checking regulatory questions, reviewing documentation before it goes to a notified body, asking the questions that do not otherwise get asked. A defined number of hours each month: director-level judgement without the director-level overhead.
Training
Practical training for teams working in a regulated environment for the first time - design controls, requirements, document management, introductory ISO 13485. It comes from having run these systems for years as management representative, internal auditor and director, not from a bought-in course. It pairs naturally with a process review: the review finds where understanding is thin, the training closes the gap.
Not sure where to start? Book a consultation to talk through scopes and timelines.
Not sure where to start? Book a consultation to talk through scopes and timelines.
Established programmes that have lost their way
A development programme behind schedule, explanations compounding, and nobody inside able to see it freshly.
Who I work with
Four situations come up again and again - If you recognise yours we should probably talk.
Small in-house teams without an independent reviewer
Capable engineers who have all touched the design, which is exactly why none of them can review it independently.
Startups approaching their first ISO 13485 audit
A quality system built from templates, an audit date getting closer, and nobody in the building who has been through one.
Strong engineering teams new to medical devices
Excellent engineers - hardware or software - meeting design controls for the first time.
The gap is real but it closes quickly with the right senior input, and it does not need a full-time hire.
PROCESS
How we work together
Every project runs through a clear, structured process so you always know what's happening next.
STEP 1
Discovery call
A no-commitment conversation to understand your situation and whether I can help.
STEP 2
NDA
In place before for a detailed discussion. Yours or mine.
STEP 3
The brief
A clear picture of what the engagement would involve, what I would be looking at.
STEP 4
Proposal and agreement
Scope, timeline and commercial terms. Nothing complicated, just something clear on both sides before we start.
STEP 5
Getting to work
Focused project-based engagement or as a regular fractional advisory arrangement with you kept informed as we go.
"We want to sincerely thank you for the time we spent working together. During a project that challenged all of us, you remained a reliable colleague-always calm, committed, and a true team player.
Your dedication and attitude, especially during the more demanding phases, not only helped move the project forward but also strengthened our team spirit. For that, we are truly grateful."
Marina Cuzzupe
COO, Anel AG
TESTIMONIALS
Real feedback from people I've worked with
400+
Projects designed or managed
25+
Years of experience
"We worked with Simon and the team at IDC while developing our Class 2 three-wheeled mobility scooter. Simon was our main point of contact throughout from initial meetings to a successful working prototype.
What made the difference was that Simon didn't just deliver the work, but helped train us in how to develop product requirements properly ourselves, covering everything from user needs to safety, so we came away with skills we could keep using and apply to other areas of the project that we kept ownership of. On top of that, Simon was really easy to work with and kept the project on track throughout, with clear communication from start to finish."
Tom Morgan
Founder Supersmith
"Simon has introduced and hosted many sessions at BioUK events by giving a patient perspective from his personal experiences as a user of medical devices and how this relates to his own medical device development journey.
He has a very valuable perspective informed by his own experiences, which illustrates in a personal and moving way the impact of medical devices on patient’s lives.
Simon is also always a real joy to work with."
Liz Pattison
Events Project Manager, BioUK
FAQs
Common questions, clear answers
My team can read the ISO 13485 standard. Why do we need external input?
Reading the standard and knowing what an auditor will actually ask are different things. Ten years of BSI audits teaches you the difference. A system that reads correctly on paper and a system that holds up in a stage 2 audit are not always the same thing
A consultant will not understand our specific device.
Review discipline transfers across device types. Having worked across drug delivery, diagnostics, surgical, connected health and IVDR diagnostics means the questions are well practiced. A fresh pair of eyes is precisely part of the value, and most review work does not require deep product-specific knowledge, it requires knowing what good design controls look like for any device.
Can you work alongside an existing team or consultancy?
Yes. I am not there to replace an existing team. I can come in as an independent reviewer, a pre-audit checker, or a standing fractional advisor alongside whatever is already in place.
What about confidentiality?
An NDA in place before any meaningful conversation, as standard. I am happy to sign yours or to provide my own. Confidentiality is not an afterthought, it is step one of the process.
What types of clients do you work with?
I collaborate with early-stage startups or spinouts and established teams of any size who value external input from someone who has been through the medical device development process as a designer to project manager and need clear communication.
What is your pricing structure?
Projects are priced per scope, not per hour. After our initial conversation, I'll outline options so you can choose the level that fits your needs and budget.
Can you help with software as a medical device (SaMD)?
Yes. I can help with the design control, risk and usability framework that SaMD programmes live inside. Where I sit is on the framework side rather than hands-on software implementation, which in my experience is the side that costs the most to get wrong.
We are not sure what we need yet. Is a discovery call still worth having?
Yes. Most of the most useful engagements started with exactly that. A no-commitment conversation usually clarifies the situation quickly, and there is no obligation to take it any further.
How much of our time will this take?
For fractional advisory, the hours are agreed upfront and shaped around what you need. For project-based work, the scope and timeline are set out in the proposal before anything starts. I aim to minimise the demand on your time while maximising the value of mine.
Do you work with companies outside the UK?
Yes. Most review and advisory work can be done remotely. Where an in-person visit would genuinely add value, that is something we can discuss.
CONTACT
Lets talk
If something on this page has resonated, the best next step is a short conversation. Fill in the form and I will come back to you within one working day.
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simon@collingsmedical.co.uk
Collings Medical
Independent Medical Device Development Consultant
