Making the Milestone

Our 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.  We 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.

‘Not the year for Carnival

i had set time and travel aside to be in Maastricht for Carnival this year – the four-day  pre-Lent celebration filled with food, drink, and costumes (did I mention drink?).  The parade is Sunday, official kick-off in the Vrijthof square with the raising of ‘t Mooswief, and the ‘skade filled with color until the wee hours of Tuesday.

Unfortunately, work and milestones overwrote good intentions this year.  We are literally days from regulatory submission on the project, everyone hard at work testing, writing, and collating. 

The amount of detail in these Technical Files is really daunting, and every cross reference and report has to be checked, verified, and files into a particular slot. 

The product descriptions, the Design History file, is a constant work-in-progress, requirements and specifications revised each time a test falls sort, the failure mitigations being revisited each time someone imagines a new risk.

We’ll get there, but it isn’t the time for travel.  We’ve spent years getting to this point, and we need to cross the finish line successfully.

TEFAF comes in a few weeks, birthday and spring beyond: ‘time enough to celebrate when the work is complete and submitted.  Still, I don’t like subverting scarce free time to ever-expanding work-time (I’ve been working through the past four weekends).  It violates the spirit of balans en grenzen that I committed to years ago, and reminds me to see that everyone gets a reward and a break when our work is done.

Improbable wins

As one who grew up in Chicago, it would be impossible to overemphasize the significance of the Cubs winning the World Series this week.  Coming back from a three-game, must-win deficit after Game 4, I thought that the series was headed to another disappointment for the 100+ dry years for their true fans.  I have always been a White Sox person, truth be told, but this is the season that I could get behind my brother’s North Side team.

The win is one of a series of improbable victories lately, many fortunately, in my ballpark.

The photo to the left is one example.  It may not look like much, but there are several million pounds and years of work hidden beneath the bubble wraps.
‘back in the day, I said this would be easy.  By turns arrogant and overconfident, I was sure that I’d be in and out in three years, product approved and on market, a 30x exit at hand and a three-day work week of Board work and mentoring ahead.

‘time later, and product is ready.  One is entering clinic this week, patients being enrolled in validation work at a hospital near Chicago.  The other is headed to Ohio, France, and the UK for exhaustive safety testing that will last until Christmas.

‘'Entrepreneurship is passion,” goes the conventional wisdom.  What is my passion in entrepreneurship?

I am proud of the products, grateful for the efforts of employees and the support of investors, who all made this possible.  I believe that they will help patients to have fewer complications during their hospitalization, and ensure that staff can deliver better, more cost-effective health care.

But my passion, on reflection, is for the success of competing the process.  There has been so much to do, to overcome, to learn, and to motivate.  I get satisfaction from seeing this through successfully, for being honest with employees commitment and investors money, and for persevering when things looked their darkest.

I don’t know what lessons to draw from the experience.  One of my companies, well-planned and deliberately started, never got rolling, and became a consultancy.  Another was always the underachiever, needing a push and encouragement every step along the way.  The third was the wild child, always in trouble with the banks and the law.  But that was the one that, most improbably, performed the best.

In the sports bars and hotel lobbies around Chicago, I followed the Cubs from loss to loss to win.  When I left, they needed three games.  One loss would be the end.

 

In a season of improbably wins, the Cubs took three in a row to clinch the Series.  And I pressed on through good times and lean, to introduce our products to hospital customers. 

On camera

The company website has been in sad shape for some time.  Out of date, incomplete, it marks the space for the company rather than excites people about the great things we are attempting and accomplishing.  As our product moves towards market, there’s no question that it deserves a better home (frame).

Our COO brought in an inbound marketing team, unusual for the medtech space, but a different approach might be the right one.  We spent time recounting what we do, describing our characteristics and aspirations, and gathered the assorted sticky notes into a brand definition.

A new logo was one of the first outputs, then a redesigned website.  The graphics were livelier, the messaging sharper, and the company instantly became more professional.  We were telling our story more clearly and completely.  Curated content will be added soon using Passle, then a blog, newsletter, and an inbound program through Hubspot.  It will be exciting to see it all come alive.

Early on, we storyboarded a five-minute video that we could create around the campus and production facility at Colworth.  We set a date: I got a new dark shirt to stand out against the light backgrounds (get advice from a woman who’s taste you respect) and made sure that teeth, hair, and chin were sparkling.  We started at 8 am, meeting the cameraman, director, producer, illustrator, and getting  the campus shots done in low morning light.   The script arrived the night-before, but I was pretty relaxed about being on camera.  (I’d done Radio, back in the day, after all…).

Of course, that is nothing like actually *being* on camera.

  

We did most of my filming in the atrium, repeated takes in front of the crew and company, curious tenants and visitors wandering past.  Don’t close your eyes when you start talking, the director admonshed.  Don’t look to the side when you stop talking.  Keep your eyes here.  Obey punctuation: it’s there for a reason.  Use your hands to stimulate your voice.  Crank your emotions up a notch.

All very natural.

We did five story segments, and then a full voiceover (mostly cut in favour of a professional who could get more  excitement (and the right accent) into the intro).  I closeted with the illustrator, an Oxford-trained artist who tried to render the narrative of biofilm formation and disruption into a single graphic.  Our lead chemist peered into microscopes and donned his clean suit on cue.

We finished (wrapped) at six, they really put in a lot of effort on our behalf.  I’m looking forward to seeing how it all comes out in a week…

En dank je, wezen, voor mijn mooie overhemd.

Supplement: Here’s the link to the finished site: the finished video is at the bottom of the home page.

Building professionalism

One of my objectives for the coming months is to hand off executive authority for running the in-market businesses to folks who have the experience and connections to do it well.  I have never run a sales force or a marketing campaign, and, while I’’;m sure that i could learn, the inevitable mistakes would cost time and confidence.  It’s better to focus on what I do best, bridging innovative product to clinical customers.

I’ve been fortunate to bring good operations people on-board, and I’m trying to support their working style.  We need to become a more professional company, and successful funding rounds finally give us the resources.  So, we’re implementing core offices, IT services with electronic calendars and shared addresses, improved purchasing systems, inbound marketing in web site upgrades, and employee contracts with pensions and share schemes.

It’s more to coordinate, so communication tools beyond emails and skype are being considered.  I traditionally work from paper notes, consolidated into to-do lists, and cocktail-napkin sketches of project plans.  They are idiosyncratic notes to myself, and there are calls to be more standard and transparent in making time and budget commitments, and more accountable for slippages .

I bristle a bit at the implied judgement of ‘overrun’ or ‘slippage’: we work hard and take good decisions.  The wise choice can be to invest in people, time, or tooling that ensures better outcomes.  I’m not going to pad schedules and budgets to give myself  cover,  But am learning how to talk positively about deviations while biting my lip over the language used.

One executive requests plans in the form of to-do lists, with dates and names next to each item.  I think it’s an awful way to communicate process and progress.  At a daily level, items are too numerous and dynamic to spend time updating, reporting, and defending.  At a monthly level, they amount to a disconnected wish list of idealized targets.  There are milestones, but they are few and fit within project narratives.

I prefer simple Gantt charts, laying a half-dozen streams of activity in parallel with dependencies defining the milestones.  If work stops when raw material runs out, then getting replenishment budgeted and shipped is a key event to monitor.  If submission of a regulatory file starts a clock to market introduction, it focuses people on bringing together the component tasks and parts.

Moving all of this from Excel into a formal tool like Project has been difficult. The structure falls apart as we move bits, and the output doesn’t fit neatly onto A4 paper.  Another executive has advocated a ‘Slippage chart’ showing deviations instead of plans: it proved counter-intuitive and folks have requested a simple project chart.

It’s all growing pains as we adopt professional standards and tools.   We’ll settle into methods that work for us.  A simple Gantt chart, clearly communicated in meetings and updates, with dependencies driving milestones and to-do lists, seems to work best at present.

Now if I could just make peace with my electronic calendar over my paper diary.

Highways and windows

Google maps chirped in my lap, another suggestion for a route around congestion ahead.  I took the suggestions: my tablet has evolved into a capable guide, even on familiar roads.

There have been many during the past couple of weeks, captured on my tracking map.  Poole is the bottom extension, working and walking Dorsett.  The leftward branch is the Gloucestershire weekend, the excursions north are to work at Colworth, while the branch right leads to Cambridge.  There’s a tangle around Reading, but no visits to London (although I am fidgeting to see the new Tate extension).

‘Not an atypical period.  But,with three hour journeys Poole to Cambridge as a yardstick, it’s also indicative of the amount of road time and my need to consolidate locations.

  

Last night’s drive to Cambridge took nearly six hours, slow traffic punctuated by accidents everywhere because of torrential rains.  The occasion was my class’s graduation, held on a spring-like evening at Clare College.  Congratulatory speeches and celebratory drinks flowed throughout.  I caught up with colleagues and friends about their travels and companies, shared my recent experiences and traded leads and contacts.  It would be nice for you to get one more zero…, suggested the department chair, pointing out a fellow who recently exited for $40 million and has made a big endowment to the University.  It’s an old joke:  Accomplishments are valued differently by the company’s parents than by its mentors.

The ceremony closed around nine and I walked back to the car, quiet streets and light drizzle, building a small portfolio of Hopper-esque window scenes along the way.

   

The evening’s speakers had pressed the importance of purpose and passion in creating a business.  It echoed discussion of what it means to create a body of work, and a lecture on how labour defines or alienates people.

Too often, perhaps, my passion has been to succeed at what I do, independent of the content that I create.  The result is an impressive list that lacks cohesion: the threads really do need gathering  into a better narrative and as a whole.

What picture, really, have I painted in the brushstrokes of my travels during the past two weeks?

Navigating our S1 audit

This starts out geeky, but leads to a happy ending.

Medical Devices require regulatory approval before they can be sold to doctors and patients.   In the US, this review is performed by the Food and Drug Administration, while Europe uses private companies under government oversight.  In either case, the goal is to check that the products are safe and effective for their intended use, and to ensure that manufacture produces product of consistently high quality. 

Europe operates under an EU Medical Devices Directive, which requires countries to set up panels of experts to establish rules and test procedures for every type of medical device.  These Competent Authorities, the MHRA in the UK, approve companies, the Notified Bodies, who apply the rules and approve devices for use.  The approval itself is a registered CE mark, which is applied to conforming product.

Thus, passing through the approvals process is the major gate standing between development and revenue.

 

The gate is opened by passing three audits: one for organizing and documenting manufacture appropriately, one for operating manufacture appropriately, and one for providing evidence that the product is safe and effective.  We have been configuring and documenting our manufacture during the past two months, ‘Establishing an ISO –Compliant 13485 Quality System’ in the industry jargon.

It is a very detailed and tedious process: we have 22 central Standard Procedures that have to be written and reviewed, nearly 100 Forms, and lots of supplemental pieces like meeting minutes, IT support, job descriptions, problem reports, training records, and company policies. 

 

Four of us have worked all day, every day for the past two months to get this all set up in anticipation of our first audit by our Notified Body today.

Establishing a Quality System normal takes 6 months to a year, but we are trying to do it much more quickly: funds, licenses, and rule changes would be deadly for the startup if things lingered on that long. 

A scientist / entrepreneur / free-thinker, I have long struggled with documentation, compliance, and audit conformance in corporate environments: it is too many limits and too much pedantic detail.  Thus, it’s both ironic and frightening that I have to set up my own system and be tested on it.

 

So, the audit was today and….We Passed!  (‘actual photo of audit in process, above) 

We had a couple of minor non-conformances (goals need to be measureable; auditors need to be impartial) and three majors (two for meetings that need to be held and one for selecting a sterilization vendor), all easily fixed.

Our Clean room will be installed on Monday, and we will begin producing product samples for testing in the following weeks.  But this is a big deal and a huge step forward towards creating a revenue-generating and profitable company.