plot. The shape of this curve is distinctive for each material and
dependent on the material, as well as the temperature of the
material and speed of loading. The final curve reveals the critical properties of the material and is a final test to see if it delivers the properties the designer or engineer is looking for.
In the area of metal fabrication, tool manufacturers continue
to develop creative solutions to small part machining challenges.
For example, Pulse Systems has done work in producing parts that
combine the capabilities of turning by conventional machining
with very fine features cut on a laser, according to Bellucci.
“We’re able to run tubing in our Swiss screw machines and
then process on a laser workstation as a secondary operation,”
In response to trends in customer supply chain consolidation,
Pulse Systems is moving toward a“value-added”approach to precision metal manufacturing. Rather than focusing on individual
components, they are seeking projects that are combinations of
parts, requiring multiple capabilities.
“Minimally invasive devices and implants are demanding
smaller and smaller parts, with tighter tolerances,” said Bellucci.
“We have added CNC machining capabilities for small parts,
which opens new business opportunities for us in value-added
assembly of welded sub-assemblies. Our new CNC machine tools
are specifically configured for small parts, with very fine features.
We’re making machined parts .030 inches in diameter or smaller,
with features of .001 inch or less and tolerances of a few ten-thou-
sandths of an inch.”
One thing that can slow down prototyping and production is
the lead time for raw materials and components. In recent years
many suppliers have changed their model from stock to made-
to-order. In product development and prototyping, changes fre-
quently take place; delays caused by suppliers also make speed to
“ASI is able to manage these challenges through our specialized enterprise resource planning systems,”said Pavlik.“The systems manage and track every raw material and every component
necessary for production. Everything is integrated, from our pro-totype/design phase to production, sterilization and delivery, allowing us to anticipate raw materials in the early stages.”
One of the biggest challenges with prototyping and production is
a non-technical one—maintaining clear lines of communication
between all parties involved to ensure no small details are missed.
Informed, quick decisions have become an absolute necessity for
success in the medical device market. Project managers must communicate clearly with OEM engineers, buyers and management,
all of whom may have a variety of input; they also must confirm
all information is relayed accurately to sub-vendors and that all
production issues/solutions are relayed back to the OEM.
This becomes especially complex when there are many sub-assemblies and components, coming from different vendors,
FEATURE: Prototyping & Production
which may be scattered around the world in today’s global sourcing market.
“The best way to overcome these communication challenges is
to ensure detailed change control is clearly defined and implemented, along with specific team member role and responsibility
delineations, in the standard operating procedures (SOPs) for all
suppliers and vendors,”said Bhugra.
Although this may seem straightforward, he noted, it is often
untested until unusual circumstances arise and an appropriate response becomes dependent on someone’s interpretation, which
may be error prone, rather than on detailed SOPs.
“Also, compliance with GMP (good manufacturing practices)
and ISO 13485 standards is required to support the framework of
effective information transfer,” said Bhugra.“Additionally, ongo-
ing training of staff and new hires must not be overlooked and is
an area in which we continually invest.”
Bhugra also indicated that customers are requesting greater
visibility into process measurements and assessment of any met-
ric variances. The company has responded by providing customers
with specific statistical process control measures such as biobur-
den testing for work-in-process and clean-room environments,
ongoing sterile packaging validations and batch-based qualifica-
tions of trays and thermoseals, including peel-strength measure-
ments to ensure low variance.
Bellucci stressed there is nothing“magical” about the current
generation of 3-D printing/modeling tools. Despite the impressive ability to produce“good-looking”parts, they are rarely representative of the actual physical characteristics of the part, such as
strength of materials, functionality, reliability, etc.
“The high-tech prototyping methodologies can certainly ac-
celerate the process of getting to a workable design, but there is
ultimately no substitute for actually making the part by conven-
tional methods,” he said.“It all starts with the CAD tools, which
provide the means to develop the models and to communicate
them forward to the manufacturing process. The 3-D printers, the
CNC machines and mold tool-makers all use those CAD files to
do their work.”
Ruffner is excited to see the new materials and advance-
ments in software that allow easier use of additive manufactur-
“To me, the most exciting part is the potential AM has for
bringing jobs back to the U.S.,”he said.“OEMs and contract manufacturers that embrace the need for additive manufacturing will
need to hire new staff to run the equipment, etc. The coolest part
about prototyping is seeing a part go from design to production—
if companies are prototyping then they are innovating, which
means they are making new products that will create more jobs
and boost the U.S. economy.”;
Mark Crawford is a full-time freelance business and marketing/com-munications writer based in Madison, Wis. He can be reached at