A
Regulatory Primer (Part 1): Consider
Regulatory Early On
Regulatory hold-ups can delay time to market
for early-phase companies.
This is the first in a series of articles concerning
the critical regulatory hurdles that have to be overcome
before medical device products can be sold in the major
world markets.
It is easily understood that new companies developing innovative
technologies to solve clinical problems concentrate their thoughts
on optimizing the technology for the intended use, and keeping the
company afloat financially.
Unfortunately, however, unless issues relating to
regulatory compliance are also considered early on,
this can lead to problems closer to the time when
the product is ready for marketing.
This may result in delays, sometime substantial, in having
the product available for sale, with knock-on effects in
meeting critical investment milestones, and even to the
survival of the company itself.
The company's initial business plan should include an outline
regulatory strategy that is closely aligned to
the marketing strategy (indeed, the regulatory strategy
may often drive the marketing strategy).
Having experienced, professional regulatory advice available
to the company, even from its early days, is therefore
essential in ensuring that the technological and clinical
advances made are not wasted because the regulatory requirements
are not understood by senior management. Such advice may
be provided either by employed staff or by consultants,
but the advice they can provide can mean the difference
between success and failure.
Two Major Markets, Two Different Systems
Most early-phase companies
aim to market their devices in the United States
and Europe and, often depending on the location of the
clinical experts with whom they are collaborating, one
market is selected over the other as the place for market
entry.
Unfortunately, the regulatory regimes
in these two major markets are significantly different, so an understanding
of both systems is important. Indeed, some devices may
be more easily cleared for sale under one regime than
the other, and this may have a significant effect on
how the company moves forward.
Both regimes classify devices on
the basis of perceived risk to patients, but
this doesn’t always result
in similar classifications. Once the classification
is established under each regime, the requirements
and options for "route to market" become
clearer, allowing the company to firm up its regulatory
and marketing strategies, giving much needed confidence
to its investors.
For example, the majority of lower-risk
(Class I) devices in Europe may be placed on the
market without any pre-market oversight -- in simple
terms, the company "self-certifies" the
product as being in compliance with a set of "essential
requirements" listed in the relevant medical
devices Directive, places a CE mark on the device,
and makes it available for purchase.
In the United States, most
lower-risk devices (again Class I) are exempt
from pre-market review, while others will require
successful completion of a 90-day pre-market notification
process. In addition, compliance with
certain quality system requirements will be required,
unless specific exemptions apply, although third-party
certification is not required.
Subsequent articles in this series
will explore in greater detail both European and U.S.
requirements and their differences, allowing
managers and entrepreneurs of start-up companies to
understand basic, but extremely important, regulatory
issues, and plan for their incorporation into business
plans.
About the author:Roger
Gray holds a B.Sc. in mechanical engineering and
is Director, Global Regulatory Affairs at Donawa
Consulting (Rome, Italy), where he is responsible for assisting
medical technology clients obtain marketing clearance
for both Europe and the USA, in addition to managing
the company’s
European Authorized Representative portfolio. He has
over 25 years' experience in the device industry and
was involved with the development of the Medical Devices
Directive during its formative stages.
