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Why would a company want to outsource the
development of their new product to a product developer when they have a
design and engineering team in-house? The number of businesses using
outside product developers to design and engineer their medical devices is
growing at the rate of 20% per year. According to the Advanced Medical
Technology Association, the medical device industry itself is growing
at a 7 percent annual rate. It will be a $310+ billion dollar industry
by 2010. 
"Many managers
believe the only reason to hire and outside product developer is if their
company doesn't have the talent in-house." says Rex Bare,
president of Omnica Corporation. "That rationale may make sense if the home
team isn't busy or there aren't any new projects on the horizon. But in
this
economic climate there is no such thing as a secure status quo.
Smart competition and tighter operating budgets are two reasons for
businesses to seek our help when they are faced with technical
challenges. We know that many of our
clients are businesses who could do the project at-hand, if they only had the
time" continues Rex.
Rex Bare, president of
Omnica Corporation has been
in the product development business for more than 30 years.
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What to look for
when hiring a product developer
- Hire
a design and engineering firm who's primary business is product
development, not manufacturing.
- You should expect more from a
well-staffed service provider than just a collection of technical
people to develop your project.
- Seasoned contractors are familiar with
the latest technologies.
- Over time they have cultivated
reliable vendor contacts.
- The team should have the resources to
supply a fresh point of view.
- They should have the
depth of resources to bring
significant specialized experience to any project.
- Ideally, they should have the required
resources at their location, and don't need to hire any outside help
to do your project.
One of Rex's favorite
quotes is, "If the only tool you have is a hammer, you will see
every problem as a nail." That particular state-of-mind compounds
the challenge of identifying a "full service product developer"
who will fit your needs. It is especially applicable today since injection
molders, rapid prototypers (SLA service bureaus), board houses, and even
plastics suppliers are now describing themselves as product developers.
Even if you are an experienced project manager it's a good practice to
make sure that the contractor you hire is not limited to solutions based
on their core business.
- Omnica
personnel are "on staff" for several large companies who
have too much on their plate.
For startups and medium-sized
organizations who want to compete with larger businesses, we are
frequently the only design and engineering team they have. In general, the
profile of the type of businesses we work for are those who want to
maintain their most productive course and, at the same time, complete
challenging projects with a minimum of concern. Using Omnica team as a
product developer also allows companies to take advantage of opportunities
which are not part of their core business and develop
products that are not simply extensions of their existing product lines.
- There are
other factors to be aware
of.
Some companies choose to expand by adding
staff, but identifying and hiring the right people, especially in
high-demand areas of the country, can be time consuming. At best it takes
weeks for new personnel to assimilate and come up-to-speed with new
project requirements. And there is always the burden
of employee benefits and vacation time. It is also necessary to
consider the significant front office, regulatory, and documentation
support needed when developing a product.
For most projects the
skills of many disciplines will be necessary, and with the demands of
today's budgets and schedules, managers have to know before work begins,
that the consultant they've hired can supply the required resources to
complete the project. As an example, many "product
developers" fall short in the area of documentation. In addition
to the FDA's regulations, the European market has made proper reporting a
critical part of their requirements.
Omnica
personnel are part of a complete package that includes all the
resources and manpower needed for an accepted project. We can perform all
of the design and engineering, source vendors, complete the
technical and FDA documentation, and hand-off to manufacturing. Our
personnel have the experience and resources to provide inclusive design
histories, 510-K submissions, and the correct materials for UL,
CE, TUV, and QSR design control requirements.
We're not a
manufacturer, a molding shop, or a circuit board house. If you need the
services of a bona fide product developer, we have the people, the tools,
and the experience to bring your ideas into reality. Upon
completion, the organization that hired us can take over and continue with
business as usual.
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