Simon Collings is the founder of Collings Medical, a medical device consultancy built on twenty-five years in product design and development and a lifetime on the receiving end of the medical device industry.
I was born four weeks premature in Dublin. A Gregory Head Box kept me breathing, and two blood exchange transfusions followed in my first weeks of life.
At seven, my bone age was four years behind where it should have been based on x-rays taken. The blood bags that had kept me alive as a premature baby, used PVC softened with chemicals that, years later, were found to have affected neonatal growth, and that included me. I fortunately joined one of the first biosynthetic human growth hormone trials.
Five years of daily injections, cold storage, travel letters for customs, and an Owen Mumford auto-injector that taught me what user-centred design feels like from the inside long before I had a name for it. The click and thud of the auto injector were reliable. The pain that followed, not always.
In my late thirties, chronic ear disease took me through a series of operations and eventually to the bone-anchored Cochlear BAHA Attract system I wear today. During one of those operations, an alert anaesthetist spotted Wolff-Parkinson-White syndrome on my ECG, now managed with flecainide. I am still, in other words, a user of the kinds of device I work on.
A product design career spanning twenty-five years has involved furniture, consumer goods and a huge range of manufacturing processes, leading eventually to medical devices, where my professional story and my personal one finally lined up. Drug delivery systems, a breath training device, cancer therapy devices, CAR-T cell manufacturing for novel therapies, IVDR diagnostics and connected health to list a few.
Ten years at IDC, going from Senior Design Engineer to Director, leading medical device projects and holding the role of ISO 13485 and ISO 9001 Management Representative, being accountable for on going certification and hours spent sat in audits. Sitting concurrently on the board of Naiad Plastics, an ISO 13485 certified injection moulding company. Most recently Head of Medical at Oxford Product Design, leading the medical sector strategy and project delivery.
Collings Medical is the combination of all of that: the design experience, the regulatory knowledge applied to medical device development, the manufacturing reality, and a perspective that can only come from having been the patient and ongoing user of medical devices.
CORE COPETENCIES: Medical Device Design & Development | ISO 13485 & ISO 9001 | MDR / MDD / IVD / IVDR | FDA Awareness (510k / PMA) | Human Factors Engineering | Business Development & Strategy | Proposal & Commercial Management | Cross-functional Team Leadership | Regulatory Quality Systems
