ISO 13485 et. al.

Medical device development is governed by Standards.  If you want to bring a product to market, then there’s only one way to do it: Compliance with the rules.  

And it’s not enough to say that you do.  You have to prove it.

The relevant Standard under the European Medical Device Directive is ISO 13485: 2012 – Quality Management Systems for Medical Devices.  It sets out best practices for building a medical product, including design process, control of manufacture, human resources, and business organization.  In each EU Member Country, the Competent Authority of experts sets the rules for each type of product in accord with these guiding principles.  Then private companies, the Notified Body, assesses businesses and grant permission to market product by affixing a CE mark.

Gaining ISO 13485 Certification and a CE mark is not easy. The rules are detailed and inflexible.  For years, in corporate life, i resisted the whole idea: writing down the detailed methodology and assessing risks assumed that you understood the solution.  It blocked truly creative thinking that led to innovative breakthroughs. 

I preferred  ‘agile’ approaches, in which projects step, learn, and iterate.  i was well known for the ‘Research Exemption’, setting my department apart as an exceptional case that didn’t have to follow the rules.

‘all the more ironic that I was required to build a fully compliant system in less than six months.

As previously noted, we passed our Stage 1 Audit by the Notified Body (NB) back in March.  We had three major non-conformances (gaps in our system that must be addressed), and two minor ones (deficiencies to be remedied).  Our NB gave us an extra two months to come into compliance, with our Stage 2 Audit scheduled for June 13-14.

It was an enormous amount of work.  There were endless debates about terminology ('What is a lot, and how does it differ from a batch?), procedures (How often do we deploy settle plates to assess our clean room?), design requirements (Does the static resistance of the coating matter more than the dynamic resistance?), and process validation (Do we define the operating limits of temperature or the best operating point?).  I suppose that it forces you to really understand the business, how to assure a safe product.

If you watch a professional cooking show like Chef’s Table, the key to a good restaurant is only 10% innovation and presentation.  90% is consistency: Can staff deliver a great experience to everyone, repeatedly, day after day.  Arguably, if you order the same dish twice, it should be the same dish.  Professionals strive obsessively towards that goal.

Similarly, every medical product unit that we produce should be as safe and effective as every other one.  Numbing consistency is the Standard.

So, for the past two days, two auditors assessed how numb we have become.  They combed through details of every aspect of the Colworth facility, following paper trails from purchase to product, design documentation from concept to production.  The pre-rumor was that NBs had walked out on unprepared facilities.  Everyone was involved in making sure that the apocryphal tale didn’t become our story.  Our advisors orchestrated the inspections and evaluations flawlessly, we corrected, printed and signed dozens of final documents.  We were able to discuss every procedure, produce (almost) every piece of paper, that was required.

And, at the closing review, we had only one minor non-conformance and were recommended for certification.

It’s really an amazing outcome.  A first-time startup, a half a dozen people and six months to build it from nothing.  The odds are heavily against passing on the first try in any case, much less with so little to apply to the task. 

Yet we did.  It stands testament to the quality and effort of the people, and their attitude and experience in meeting the challenge.

I think that folks in my corporate life would never believe that one of my groups could achieve this.

And most colleagues don’t understand it today, either.  The dominant theme today was ‘That’s nice: Why hasn’t my task gotten done yet?”

‘One thing at a time; we’ll all get there in the end.