Archives for June 2016

Picking up the Pen

June 16, 2016 by Dave Hampton

“If I waited till I felt like writing, I’d never write at all.” — Anne Tyler

It’s been a couple of months since I last wrote a note or posted a picture. Thank you to the friends and followers who wrote asking if everything was okay: It is.

There has been a lot going on since April 22, milestones and changes, good times and difficult intervals. And the further I fell behind in sharing it all, the more difficult it became to start again.

Still, I made notes to myself, collected pictures and bookmarked articles, banking content for the future.

So, pen to paper and back to it.

I’ll likely backfill a bit, certainly look forward, and update on the many changes in life as time allows. Some of the constants are still there: I can be found in the same haunts in Poole and Maastricht, for now. My w.wezen and my medtech /entrepreneurial dreams remain my passions. I remain somewhat FOMO’d on weekends and occasionally tortuous under questioning.

But life is generally good, even if transitioning yet again.

ISO 13485 et. al.

June 14, 2016 by Dave Hampton

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.

Along the Wye Valley

June 13, 2016 by Dave Hampton

The River Wye flows through a rugged cleft heavily forested, in southeastern Wales. Literally inhabited for millennia, with cave artifacts dating back 12,000 years to Paleolithic times, the valley was also a medieval religious centre and a modern industrial complex. Abundant timber for charcoal and cascading rivers for power supported iron kilns, copper and paperworks, along the length of the navigable river. Industrial development went into decline a century ago, and the area is re-forested today to become an Area of Outstanding Natural Beauty.

The main road leads up from the south along the River, winding beneath steep cliffs and through small villages. The best of these is Tintern, once site of a shallow ford and later the host of a vast abbey raised along the banks. Established in 1131 as a Cistercian retreat, the monks emphasized manual labour and self-sufficiency, agriculture and ales. Their abbeys similarly embodied utilitarian order and gothic simplicity, unadorned arches and pillars.

Today, Tintern Abbey is a shell, only the walls and pillars remaining. But the remains tower over the brassy meadows within, arches and windows largely intact, catching the light and framing the forests. it’s amazing to walk through, the stone arches intersecting far overhead, the monk’s stairs leading up the walls.

I found the minutia of the place most interesting. The stone segments of the walls and pillars are mortared together, stone glue holding for 700 years. The shorter walls have a matrix of pebbles and clay, almost a coarse concrete, several inches thick. The main supports for the vaults have much thinner seams, as might be expected for the great weight that they bear.

The surprise is the shale-like stone embedded in the mortar. It cant be very sturdy, yet it’s everywhere in the main nave. I wonder if it isn’t a shim, intended to level the stones, rather than a structural element. Amazing, though, that it still remains: I always think of shale as brittle and crumbling.

The northern reaches of the valley, where the walls open and there are larger towns and farms, isn’t as interesting generally as the southern part. The exception is Ross-on-Wye, if only for the ubiquitous presence of the Man of Ross-on-Wye throughout the town.

John Kyrle, a bachelor of modest living and charitable deeds, arrived in the mid-18800s. He committed himself to settling disputes, supporting the schools, tending the sick, helping the poor, beautifying the town, and preserving its landscapes.

‘rare philanthropy then, moreso today.