“In these relationships, OEMs understand that the manufactur-
ing cost of a product will likely change during development, and
that they will share in the cost improvements we are able to rec-
ognize during the development phase, as well as efficiency gains
during production. The most successful relationships are built on
honesty, integrity, trust, transparency, and appreciation of the en-
tire value proposition. In our most healthy relationships, we func-
tion as an extension of our partner’s team.”
Having a trusted partner with the same vision is also critical
for getting the most bang out of the R&D buck. Because venture
capital has declined for research, OEMs face increased compe-
tition for federal research money, which is also being cut back.
This has reduced the rate of introduction of new groundbreak-
ing products. With more researchers competing for fewer dol-
lars, focused partnerships along the supply chain are essential for
achieving cost efficiencies and staying on top of the latest science.
For example, EQS has partnered with Empirical Testing Corpora-
tion to evaluate and gain deeper knowledge about the behavior
and properties of newer materials and material combinations be-
ing introduced to the orthopedic market.
“This has helped us quantify and reliably predict product performance and stay ahead of some design and regulatory concerns
that inevitably follow any new technology,” said Trafka. “The research data has also allowed my team to create more accurate
FEA models and validate those results in the laboratory.”
Orthopedic R&D is constantly being challenged by advances in
technology and surgical techniques. OEMs are anxious to get
new products to market as quickly as possible, both to maximize
market position and help medical professionals improve patient
outcomes. Often the design inspirations come from the surgeons
who deal with the products on a daily basis, and have suggestions for improving functionality and ease of use.
“As a result, some OEMs are redesigning typically cumber-
some products to create a more streamlined and user friendly ex-
perience,” Fleming said. “Some procedures and techniques have
evolved to the point where they are now being held back in ways
by first-generation tools. Sometimes the old way of thinking
needs to be challenged, as many orthopedic devices are still not
fully advanced and user friendly.”
For example, she notes, Spectrum Laboratories recently part-
nered with a company to design a shoulder distractor and dispos-
able that allows the surgeon to control the patient’s limb from
within the sterile field, reducing the need for circulating nurses
to constantly monitor and assist the surgical team. This reduces
cross communication and puts control into the surgeon’s hands.
Despite the constant pressure to keep up with changes in
technology and design, the R&D landscape is not always over-
flowing with work. R&D companies need to be nimble to take
advantage of opportunities that arise, and have the tools and
expertise required to win the contract, as well as manage costs.
Much of the innovation is coming from surgeon entrepreneurs
or small- to medium-sized companies. OEMs (often based on
communication with end users) also seek contract manufactur-
ers with the right experience and analysis tools to determine the
cause of unsatisfactory performance in an existing product and
“design it out.” Even with these multiple needs from OEMs and
end users, there is often no predictability as to when an opportu-
nity will present itself, so R&D partners need to be ready.
“For example, you might discuss a project with a potential cli-
ent and six to nine months later the prototype opportunity pres-
ents itself,”said William Beach, medical market segment manager
for EPTAM Plastics, a Northfield, N.H.-based provider of preci-
sion-machined plastic products for the medical industry. “Or, in
contrast, a call might come in for parts that are needed within
one to two weeks or less. Regardless how much notification we
get, it is always about speed and how fast we can get parts turned
around, usually for a surgeon lab. The only predictable thing from
the manufacturing side is that it’s unpredictable.”
R&D can be highly expensive and take a toll on budgets, es-
pecially for smaller companies. The amount of engineering, tool
selection, and programming time are all major cost drivers that
make prototypes expensive. That’s why it is important for MDMs
to work closely with R&D partners up front to minimize cost and
For example, EQS recently had a client who was prepared to
spend hundreds of thousands of dollars on full working proto-
types of a complex device. The EQS team was able to simulate
and verify the function before moving forward on costly physi-
cal parts. The motion simulation and FEA studies revealed that
the design would not function as intended. The client opted for
a major redesign, rather than wasting resources on a prototype
that would fail.
“From a design standpoint, I prefer to fail early and often be-
cause it’s a quicker path to the optimum solution,” said Trafka.
“Computer simulations are critical for identifying weaknesses
early in the design process and pointing clients in the right direc-
tion for redesign. It saves time, money, and frustration.”
“Sometimes we have to remind ourselves that R&D stands for
research and development,” added Randall. “The nature of R&D
is that you are trying something new; there are no guarantees
that your idea will work.”
Companies can be too conservative with their R&D approach.
They need to be willing to fail or they will be left behind in the
innovation race—which means slow erosion of market share, re-
duced profits, loss of talent, and damaged brand.
“It is important to understand that if you don’t fail from time
to time, you’re not trying hard enough,” continued Randall. “
Failure is just another term for ‘we haven’t succeeded yet.’ The only
time you truly fail is when you stop trying.” v
Mark Crawford is a full-time freelance business and marketing/com-munications writer based in Madison, Wis. His clients range from
startups to global manufacturing leaders. He also writes a variety of
feature articles for regional and national publications and is the author
of five books. Contact him at firstname.lastname@example.org.