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Innovation and Commercialization Part 4 of 4

Posted on December 17 2013 | Author: Admin

Regulations - a Trajectory
Addressing a Life Sciences Ontario audience recently, Cameron Piron, CEO, Synaptive Medical (2nd start-up venture for this 30-something Canadian, having sold his first company for $85M+) summed up the regulatory barriers which impact on his solution-focused medical devices (used by 18/20 of the top US Cancer Centers):

  • Bar constantly changing as technology and market changes
  • No world-wide synchronization
  • Regulatory environment moves opposite to innovation - understandable

He gets it – understandably. All life science legislation must be scientifically sound.  Regulations lag behind the laboratory, leveling the playing field.

The Anomaly of Organic Food
UK organic food regulations became law in 1987, a decade before the dormant sector erupted.  The basis of all organic food trade today, the UK organic food regs stem from guidelines and standards set in 1967 by an NGO, the UK Soil Association.  Two major forces in the 1990’s dramatically reduced UK consumer confidence in conventional farming:  the launch of genetically-modified food, closely followed by an unrelated outbreak of BSE disease in UK cattle. The organic food sector thrived due to pre-existent regs.  Two supply factors curtailed growth: inadequate volume, due to a mandatory 3-5 year washout period of conventionally-fertilized soil, and, no federal organic food regs in other nations – required to claim imported food as organic in UK/EU markets.  The current Cda and USA organic regs pleaded for by North American stakeholders has facilitated exports and spurred domestic demand. 

The Canadian Organic Food Sector totaled $3.5B in 2012, triple the 2006 value. The American Organic Food Sector grew 11% Y/Y in 2012 to US$28B.  A life science? Innovation? A life science sector kept unto itself, organic food lacks the distinctive mark – industry turmoil without new market creation – of disruptive innovation.  It is part radical innovation in that only a portion of conventional food has been displaced.  However, worth watching, one study claims organic agriculture can indeed feed the world.

Water Quality, Fracking, Due Diligence
Some methods of extracting gas from the earth’s crust significantly contribute to the carbon footprint.  Separately, farmers are concerned about water supply, quality and cost. An innovation, hydraulic fracturing (fracking), accesses subterranean gas with much less carbon generation but may contaminate the water table. Accordingly, at least two fracking proposals in Canada’s eastern provinces have been stalled, due to citizen resistance and East Coast wit.

Younger concedes that the US approach has been one of trial and error. It remains to be seen if fracking can meet his description, and if regulatory control can render fracking economically feasible and environmentally safe, inclusive of water quality.

Motor Power Enters the Streets of London - Call for Regulations  23 August 1913, The Tablet
The application of motor power to vehicles has revolutionized the traffic of London, and with the growth of it the danger to life and limb has also shown a proportionate increase. […] a Select Committee was appointed to inquire into the problem and recommend means for ensuring the safety, especially, of foot passengers in the streets. […]  in 1907 there were 3, 866 horse cabs and 5, 952 hansoms licensed.  There are now only 2, 385 of the two together.  In 1907 there were 2, 961 horse omnibuses and tramcars and 2, 973 electric trams and motor omnibuses.  The last horse bus has now run its last journey through the City.  

In 1912, there were 5, 767 electric trams and motor omnibuses, and the smaller powered vehicles included 8,000 motor cabs…Among the minor recommendations or suggestions are the following:  Tramcars and omnibuses alike should have speed registers; all driving offences should be endorsed on the license; motor horns should be of a standard type; dazzling head-lamps in lighted streets should be prohibited; all slow vehicles should keep to the kerb; unsound vehicles should be prohibited in the streets.  Upon one point the recommendations have been keenly criticized, that which gives the control of traffic, routes, time-tables, and the number of stage carriages to be used, to the County Councils.

Carol T. Culhane, PHEc, MBA
President, International Food Focus Ltd.
Bioenterprise Regulatory Advisor

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