LMITransactions&Report2014-15

LMI Transactions and Report 2014 - 2015
current looped to an indifferent electrode.
FES has a role in the rehabilitation of patients with
Dropped Foot due to upper motor neurone lesions due
to stroke, MS, head injury, cerebral palsy, HSP,
Parkinson’s disease and spinal cord injury (but only
above T12). FES has no role in the rehabilitation in
patients with lower motor neurone damage due to
polio, motor neurone disease, peripheral nerve
damage, Guillain-Barre syndrome or spinal cord injury
below T12.
It was in the 1970s that Nightingale and Glanville set
up FES research in Southampton and, in 1984, the
Spinal Unit at Salisbury began work with FES using a
modified Slendertone machine. The service developed
and an in-house design for FES was introduced
culminating in 37 patients with a variety of
neurological conditions causing a Dropped Foot being
treated between 1988 & 1992. The FES clinical service
started in 1992 coinciding with an article in the
Independent newspaper.
Initially, all the equipment was made in-house for
research work. In 1996, the clinical success of FES was
evident and other centres were asking for the
equipment so the Salisbury unit started manufacturing
to a view to commercial development. In 1998, the
Medical Devices Directive came into force and the
Salisbury unit applied for ISO 9000 accreditation which
was granted in October of that year. Patents were
granted in the UK, US and Canada during the period
2002 – 2004.
(ii) The setting up of a commercial company
It became clear that trying to manufacture and sell
products from within an NHS Department would be
fraught with problems. The sales income distorted the
financial position of the NHS department with issues
such as income not being ring fenced, money not
rolling over from one financial year to the next, lack
of funding for long term investment, not being able
to advertise and difficulties with overseas accounts
being just some of the problems.
However, in 2004, the regulations within the NHS were
changed to allow NHS 3 Star Trusts to set up spin-off
companies to capitalise on R&D work carried out
within these NHS Trusts. A business plan was
submitted in 2005 and Odstock Medical Limited started
trading in April, 2006.
Setting up a spin-off company had its initial problems
(such as separating the company and NHS budgets,
seconding staff between the two entities, appointing
an MD with commercial experience and shareholder
agreements.) The company was set up successfully
with 68% owned by the NHS Trust, 18% by Trustees,
12% by staff and 2% by Bournemouth University. The
company appointed its first directly appointed
employee in December 2006 by taking on its Managing
Director. The company turnover in 2006/07 was £820k.
OML went from strength to strength such that in 2015,
3.5 wte NHS staff were seconded to OML, 16.6 staff
were directly employed by OML, there was a separate
accounts system established and the company was
profitable with a projected turnover in 2014/15 of ~
£1.8m.
(iii) Clinical results for the application of FES
Professor Swain described several clinical cases where
patients experienced significant improvements in
walking following the onset of Dropped Foot. Patients
measured their improvement either in increased
walking speed or increased walking confidence, often
accompanied with a significant decrease in fear of
falling and a consequent increase in stability. Patients
frequently reported a reduced (self-rated) effort in
walking.
As an example, he cited results from a group (n = 144)
of patients with Dropped Foot following Multiple
Sclerosis during the period 2008 - 2013. From that set
of results, 91% of patients were still using FES after 18
weeks, there was a significant increase in walking
speed (p