Wednesday, February 17, 2016

‘been a bit busy…


The past two weeks, as faithfully logged by my tablet.  It’s a sprawl, from Poole to Nottingham, clusters in London, Sharnbrook, Reading, Cambridge, Braintree.

‘and every one a story.

The push is product: innovation  headed to market later this year.  It’s been a long time developing, organizing, fundraising, and testing: ‘wonderful to finally see it all coming to fruition.

It has meant that I am on the road and off-line most days, consequently falling behind on emails and phone messages.  I don’t know that I’ve been more than three nights in any one place since New Year’s.  I joked that my definition of ‘home’ has become ‘anywhere that I unpack a suitcase on entry’.

I’ve also left Facebook for a bit: it’s become a toxic swamp of petty cruelty that gives little happiness.  I remain active on Instagram, but have let close friends know that it’s better to look for me on email than Messenger.

The major business activity has been the establishment of manufacture at Colworth for CamStent. 

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We have our dip-coating apparatus and ovens for drying, and are in the process of wrapping a process and documentation around it.  An ‘ISO13485-compliant Quality System’, the evolving facility will be able to product around 10,000 units of Innovation is Chemistrycoated product each year: enough to prove the concept, provide commercial samples, and generate revenue before year’s end.  We have our first audit by the regulators on March 3, so it’s a race to get all 22 procedures (SOPs) and around 100 forms complete in two months with five people.

It’s ironic: I was always known for resisting the structure and strictures of formal Quality, yet here I am creating one.  It’s alternately exhilarating and soul-deadening.  We are doing something in weeks that took years in my prior experience.  But the attention to detail and consistency in the paperwork takes focus away from product and customers, my natural home.

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Arcane arguments about the difference between Documents and Records, near-religious arguments about the meaning of passages in the Standards, debates about whether a Form or Procedure is fit for purpose, scaled to fit, wear me down.

But it’s genuinely exciting to see the very polished Finished Goods coming off the line, lovely to share the pride that people have in the visible successes resulting from their work.

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