However, as Angel Domingo, director of quality and regula-
tory services for Irvine, Calif.-based Pro-Dex Inc., maker of pow-
ered solutions for medical and other markets, told Medical Product
Outsourcing, “Anticipating regulatory requirements for specific in-
tended uses and regulatory markets can feed into the prototype
design, so determining a regulatory strategy early on is important.
tant for in-human use devices. Though sometimes, early stage,
small-run devices made for clinical trials are called“prototype” devices, this term is misleading. Such devices are better called“pilot”
devices, and often are created so that OEMs can move quickly into
clinical trials to speed the regulatory approval or clearance process.
Microspec_MPO_140226 2/26/14 1:52 PM Page 1
“Some prototypes may be representative of units to be used in
verification and validation (V&V) activities,” she continued. “To ensure regulatory/compliance needs are considered, adequate pro-
limits of extrusion
totype quantities should be considered to
represent statistically valid quantities in those
studies. Further, prototype materials for V&V
activities may need to be compliant to RoHS
(Restriction of Hazardous Substances Directive), WEEE (Waste Electrical and Electronic
Equipment Directive), REACH (Registration,
Evaluation, Authorisation and Restriction of
Chemicals) and Conflict Minerals regulations.”
FOR OVER 20 YEARS, medical device
companies the world over have turned to
Microspec for medical tubing that challenges
the limits of extrusion technology.
The Microspec team combines time proven
extrusion science with the extrusion artistry
our clients rely on time after time.
Contact Microspec with your extrusion
challenge – we’ll create a solution.
• BUMP TUBING
Every year, manufacturing and prototyping methods get better and faster, pushed by
OEMs wanting devices on the market faster
and faster in order to be more competitive
and profitable. But as Jared Sunday, director
of engineering for Ci Medical Technologies
Inc. (formerly Classic Industries, a Latrobe,
Pa.-based injection-molded components
manufacturer for medical, pharmaceutical
and healthcare applications), told MPO, “The
old saying of‘quality, speed or cost: you get to
pick two of three’ is not applicable anymore.
Trends and demand to remain competitive,
continue to push the envelope to deliver all
three of these goals.”
• MULTI-LUMEN TUBING
• PROFILE EXTRUSIONS
• COATED WIRE
• NEW CONCEPTS
001.603.924.4300 • email@example.com
327 JAFFREY RD • PETERBOROUGH, NH 03458 • USA
PLEASE CONTACT US directly at
we will be happy to speak with you
in detail about your extrusion project.
Western & Gulf Coast States:
Ari Kettunen • Diablo Sales
Especially now, 3-D printing is increasingly becoming the process more often associated with “quick and easy.” With more
patents on 3-D printing technologies expiring, many last year and this year, 3-D printing machines and printers are easily acquired
and cheap. Any CMO can have one in house,
and unlike a mold, for instance, one printer
can suffice to make any shape and design.
However, as Sunday suggests, CMOs and
OEMs need not be beholden to speed and
convenience alone when it is eminently possible now to achieve low cost and speed, as
well as quality.
You may also speak directly to our
regional outside Manufacturers’
U.S. East Coast:
Sales Representatives in your area:
Mike Rudziensky • Symphony Sales
Europe: Dr. Thomas Heinrich • IS Sommer
e-mail: T.Heinrich@is-sommer.com •
Tel: + 49 (0) 171 8643478
“Three-D printing offers a quick product
for a reasonable cost without the need for
capital tooling expense,” Sunday explained.
“Three-D printing is often used for components of quantities under 50. These components offer rapid delivery of parts for form
examination and marketing evaluation. This
can be done without the added cost and lead