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Are you
sure you're contracting with a company who has your best interests in
mind?
The
practice of contracting the design, engineering, and manufacturing of new
products to third parties is common among medical device companies,
especially start-ups. But sourcing and qualifying vendors is a daunting
task. The search is further complicated by firms who optimistically offer
everything medtech companies are looking for at one location. All too
often, further investigation reveals possible conflicts between what is
best for the client and the needs of the contractor. How does one
identify candidates who offer a balanced and unbiased approach to product
development and manufacturing?
There
are many interpretations of “full service” design and engineering.
 Traditional
product development firms perform design and
engineering as distinct services, not including manufacturing.
Companies who combine product development (meaning design and engineering)
with manufacturing services are sometimes known as “full-service
manufacturers.” A significant percentage these firms also market
themselves as “product developers.” It is sometimes unclear if the
company in question is a conventional manufacturing firm or a product
developer who also supplies manufacturing
services. The “one stop” approach (design and manufacturing combined)
suggests an attractive option, but the corporate cultures and
motivations are so different, one questions whether the two services can
effectively coexist in a single company.
At
right is a breast cancer screening device we developed for NeoMatrix,
LLC.
Structural foam and RIM molding were considered for the case.
Generally, both processes are not available from a single manufacturer.
Full-service
manufacturers face unique challenges.
In
the manufacturing paradigm there are two motivating issues. One is that
designs created by a manufacturer are generally driven by the company
model. Secondly, engineering resources in these firms tend to be utilized
for support of the revenue-generating manufacturing branch.
Manufacturers
have preferences and comfort levels that fit what they have done in the
past. They perform services that are extensions of their primary
business and have a tendency to design what they can build. Paul
Gleason, Director of Laboratory Instrumentation for Omnica Corporation
(previously, Paul was the international marketing and sales representative
for an OEM instrumentation manufacturer) notes, “With a full-service
manufacturer, whether its processes, materials,
molding or assembly, the whole design of the
product is driven by their manufacturing paradigm and the
experience base of those people. What they envision or are willing to try
has to fit their process. It is in their best interest to design something
they are set-up to manufacture.”
Sustaining
a full-time manufacturing engine is demanding. Few firms operating at
capacity have “extra” engineering resources for the development of
non-manufacturing endeavors. In these multi-disciplined firms, when an engineering problem needs to be solved before manufacturing
can continue, any available engineers are assigned to the task. Paul
comments, “There is always a focus on the primary income source. Any
action that could move resources from that source encounters great
resistance. If there are problems on the floor, the necessary engineering
resources are always on call to resolve them.”
 As
a result of familiar challenges in a limited number of areas, manufacturing
support engineers usually don’t have the experience to do principal
engineering. The types of projects they see are directly related to
whatever the company manufactures. Paul notes, “An example is an optical
component that becomes obsolete and needs to be redesigned. If the
component is not part of their general manufacturing technical expertise
they will either need outside help to fix the problem, or lose production
time while the necessary experience is developed in-house.”
Design
and Engineering Firms - The Product Developer Model
The
business model for a product development firm is based on time and
materials. They sell technical expertise and resources, not
manufactured goods. The goal of a successful product developer is to
supply their clients with the best possible manufacturable designs and
ideas in a relatively short period of time.
At
left is Paul Gleason. Before coming to Omnica, Paul worked with an OEM
instrumentation manufacturer for 15 years.
Specialties
are more diverse with this group compared to others. The engineers see a
much wider range of projects than those in manufacturing companies. As a
resource, experience in many areas makes them an especially good fit for
technical products or those in feasibility studies. “You want your
product design to be accomplished by engineers who are broadly versed in
the possibilities of the art,” adds Paul.
Finally,
product developers are not constrained to a specific manufacturing
technique. Their job is to design for manufacture (DFM), then find a
company that is a good fit for production. When the decision has been made
to employ a product developer who will ultimately hand-off the design to a
manufacturer, Paul illustrates the advantages of working with firms who
employ personnel familiar with the needs of a manufacturing environment.
“They are in a better position to understand what it takes to get the
labor content out of a device, how to iron-out potential liability and
cost issues, and identify which manufacturing processes are most
appropriate.”
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