Saturday, March 4, 2017

Poole, into London

DSC01298 (867x1300)A close friend called, asked if I could meet him in London today on a personal matter.  Of course, anything, let me get the train in.  I pick up a flower and a some fizzy water before heading out.

I’d planned a day along the beach, long overdue.  A storm surf would have been wonderful, white foam and booming breaks, but the early morning was placid along the harbor and the beachfront.  Still, lovely to walk the sands and share the morning with the couples and dog-walkers.

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Right.  9 am: hit the roads north.  On arriving in Basingstoke, though, there were a few adjustments.  There is no more cruel word in Dutch than snelbus. The British equivalent is Replacement Bus, evident only after I’d paid for parking.  When track works are on, the transit times double.

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In this case, the delays start with waiting for an onwards bus, and end with further 45 minute waits for a train in Woking.  Still, it’s a chance to see the place, and, in my case, to find the landing spots for Wells' Martians.  They are well remembered in the city: a landing spot near the mall, the mechanical tripod striding along the thoroughfares.

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All in all, five hours to London, car, bus, and train.  And there will be an equal measure back for the evening.  Still, the visit with the family in St. Thomas meant a lot for all of us.  Between conversations, there were moments free for walks along Southbank.  A small food fair, a burst of rain, a lot of tourists to study.

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‘not a terrible trade for the day on the beach.

Thursday, March 2, 2017

Making the Milestone

imageOur Technical File was submitted to our Notified Body today.

I know, it’s one of those ‘What did he just say?’ statements.  A bit of background, then:

Medical Devices in Europe do not enter the market until they conform to the European Medical Device Directive.  Each country has a standards group, the Competent Authority, which sets the rules for approving devices, and those rules are applied to individual products by the Notified Body. 

The Notified Bodies are commercial organisations who audit the paperwork systems that companies must set up to create and produce product (the Quality System), inspect manufacturing facilities (granting ISO 13485Approval), and judge the evidence portfolio (the Technical File) that documents a product’s safety and effectiveness.  In the latter case, the review leads to granting of a CE mark, which allows the product to be sold to physicians and to hospitals.

The Technical File is a large and detailed document: ours runs nearly 100 pages and references over fifty standards and nearly 200 supporting documents.  imageWe had a half-dozen people and a handful of supporting test facilities in the US, UK, and France engaged for six months to perform the final testing and write the submission.

We kept an aggressive schedule and produced a very high-quality report.  It will be some time before it is fully reviewed and we get approval, but this is the milestone that bridges R&D to marketing and sales, transforming a project into a business.  ‘Many thanks and a lot of credit to our employees and contractors, our investors and our partners who have have worked together to achieve this inflection point.

Wednesday, March 1, 2017

Chilling with the snowdrops

DSC01151 (1300x867)Today was the day for submitting our Technical File to our regulator, but a couple of key bits were still missing.  The Notified Body was gracious about accepting a 12-hour slip, but it was difficult for me to step back and accept that we needed to accept a delay.

DSC01155 (867x1300)In research, always a first time for a new technology or product category, we only have best guesses of when things will be done. A board layout takes a month instead of a week; a clinical finding requires an investigation; a failed test necessitates a redesign.

It’s always something, and thus rare to hit a milestone on time (although we always hit them in sequence).

DSC01166 (1300x867)Nonetheless, when I push myself to meet a committed deadline, I hate to give it up.  When my Body Pump instructor says to give it my all for another eight presses, I don’t have an extra four in me at the end.  If I say I’ll stop at the next turn-off, I know its irritating to ask to go one more stop.   Similarly, if co-workers put in extra effort to finish on-time, I not right for me to slip the deadline.

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This time, though, the job was huge, the delay small, and I’d had my say abut the situation.  It was time to step back and take a walk in the woodlands.

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It’s snowdrop season in the UK, the first certain breath of spring.  The white flowers bloom in forests in February, and it’s been a couple of years since our last visit to Welford Park to see the display.

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It was chilly, wet, fairly deserted at mid-week.  Admission still seems steep at £6 per head.  ‘But the forests and grounds are lovely, and it’s a nice fugue to lose myself in the fresh air and flowers for a few hours.

Tomorrow, we finish.

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Sunday, February 26, 2017

Saturday errands and walks

DSC01246 (1300x864) - CopyIt’s a day for catching up, sorting through small jobs and picking up parts.  I’d promised to fix a lock for the house, screws, oil, and  fat screwdriver to get the cover off.  Whereas, in the US, I’d be off to Home Depot or (back in the day) Ernst, here in the UK it’s a trip to B&Q (DIY Store, as the Brits say, rather than an American Hardware Store, but the same idea).

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With a bit of help, I found the little machine screws at one end of the warehouse, a can of light oil at the other, and the tools somewhere in between.  It’s been a long time since I did minor carpentry, and I’m sort of looking forward to working with my hands and getting a bit dirty again.

DSC01105 (1300x860) - CopyI’m also trying to sort out my phone: its been three years since my last purchase, and O2 has consistently downgraded me with each insurance claim until I have something that barely works now.  With the business still largely virtual, I rely heavily on my connectivity: I need pure Android, good reception and battery life, decent Bluetooth, a serviceable camera, and pocketable size.  The alternatives seem to be an HTC-10, Pixel C, Sony XZ, or OneTouch 3T (Sorry, I’m not going near a Samsung). 

I’ve inquired about upgrade through O2 but they only carry one of the phones.  Their full replacement insurance has also degraded over the years, from ‘Instant swap‘ to ‘Send it in and we’ll let you know in a week or so what we want to do’.  I’m talking with Carphone Warehouse and others now, and like the phones and insurance better.

The two choices remaining are whether to wait a month for O2’s upgrade charge to disappear, and whether to wait for April to see what the spring HTC-11 and OneTouch 4 look like.

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Otherwise, my w.wezen and I took the car to Farnborough for repairs and looked for a nice evening out for dinner.  Farnborough turns out to be a culinary desert: a pedestrian mall lined with budget shops, a couple of low=end pubs, and a few fast-food chains.  ‘Better to go to Reading and try something new.

DSC01100 (1300x836) (2)The Bluegrass BBQ was a good choice, reminiscent of Blue’s Smokehouse, a personal favorite in Bracknell.  Not the portion size or intense bar-b-q flavour that good Southern smokehouses would have, its nonetheless a credible local substitute.  The burnt ends were better than the brisket, the burger better than the fries, the craft beers better than the US.

DSC01120 (1300x866)Although a bit of a rainy night, we decided a walk home would beat a bus or taxi.  It settled the dinner appropriately, and afforded some good opportunities to photograph light and reflections.

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