Biomedical Engineering Reference
In-Depth Information
FDA approval typically requires certification to RESNA standards [
5
]. Some
jurisdictions make this more cumbersome by using their own rules and pro-
cesses to certify a new device. A small market AT company needs to prior-
itize these jurisdictions to focus on the ones in which they have established
strength (e.g., through sales channels and relationships with clinicians). Nav-
igating the regulatory process requires money, people, and product samples,
all of which can be scarce commodities in small market companies.
Devices considered AT are usually more complex than mainstream prod-
ucts. Consider, for example, a powered wheelchair with custom seating as
opposed to a mountain bike. AT products require ongoing support and ser-
vicing that often only specialists can perform. Funding agencies often insist
on long term support contracts with retailers, an additional burden for small
manufacturers with unique products.
Finally, demographics may play a transformative role in the AT industry
in the coming years. Similar to many small businesses, the founders of many
AT companies are nearing retirement. If in-house heirs are not forthcoming,
will the pool of outside investors commit to make significant acquisitions
and continue supplying much needed products to these niche markets? The
nature of these poorly understood businesses, often with marginal growth
prospects, may force many products out of the market. Hopefully, these ob-
stacles will create opportunities elsewhere for other small innovative compa-
nies to prosper.
11.2 Small Market Opportunities
The above obstacles notwithstanding, small markets in the AT industry also
offer opportunities to small, nimble, and innovative enterprises.
Necessity often drives the development of new innovations, and there are
certainly examples of this in AT. Even the founder of the early monopo-
listic Everest and Jennings wheelchair company used a wheelchair. Highly
motivated people who clearly understand the problem will hopefully develop
better products. User-driven design is often paramount in small market inno-
vations, and seen not only in companies (e.g., Marilyn Hamilton of Quickie
Wheelchairs), but also in academia and in non-profit organizations. For in-
stance, The Tetra Society and CanAssist are staffed by engineers and techni-
cians able to create solutions to many problems. However, the effort is only
undertaken once an end-user has identified a problem and initiated a solution.
Sophisticated customers thus contribute to the innovation process. Resulting
solutions are then made available to others when possible and contribute to
the overall technology pool of available AT solutions. There are rarely issues
surrounding intellectual property or proprietary technology that prevent dis-
semination of new AT solutions developed in this manner. Big businesses are
simply unable to easily contribute to the overall community innovation effort
in this way.
