OUTSOURCING OUTLOOK
Product Design
Medical device product development is
driven by several trends such as the increased
use of telemedicine, which has been made
possible by advanced biosensors and smart
handheld devices. Another contributing factor
is the aging of the baby boomer population,
which requires increased care in the areas of
cardiovascular medicine, orthopedics, and
neurology. In addition, nanotechnology is
contributing to the development of medical devices, promoting
improved drug delivery as well as better networking and data
management capabilities. These trends are making new products
more efficient, less costly, and more capable.
A successful medical device design firm provides concept-to-consumer services that go beyond following specifications provided
by OEMs. New products need to be designed for manufacturability,
serviceability, maintainability, efficiency, and cost-effectiveness,
while adhering strictly to quality and regulatory standards.
Finished-product engineering is more robust when designs are
completed using state-of-the art CAD tools, rapid prototyping,
and finite-element programming. Human-factors engineering can
reduce the likelihood of errors when consumers use new devices.
Design firms can best interface with their OEM customers
by providing all of these capabilities. The use of outsourced
design services allows OEMs to build more-flexible and more-agile organizations that can respond quickly to an ever-changing marketplace. By relying on external engineering and
organizational resources that can focus on a single project and
produce the documents required for 510(k) approval, OEMs can
expect to achieve faster development timelines for new projects
and bring improved devices to the market.
—Daniel A. Miller, vice president of engineering, Inteprod LLC,
Eagleville, PA.
Service Provider
Offers Medical
Device Design
A medical device service provider combines product
design and manufacturing capabilities to ensure effective product
development. In addition to having expertise in the fields of plastics and
manufacturing technologies, the company designs products for drug-delivery,
medical, and diagnostic devices in accordance with ISO 13485 guidelines. Offering
rapid prototype development, new product testing, and approval support, the
supplier uses Solid Works CAD design modeling as well as failure modes and effects
analysis techniques to minimize risks at the early phase of the development process.
■ Medisize
VANTAA, FINLAND
www.medisize.com
Manufacturer Designs Optical Systems
Specializing in the development of integrated optical systems, a designer offers a
range of services, including optical design, engineering, and analysis; mechanical
design and engineering; thermal and structural analysis; manufacturing
engineering; and assembly and integration. The company also provides consulting
services at the project requirements definition phase; conceptual and detailed
design services at the engineering phase; and manufacturing, engineering, and
fabrication expertise at the
prototype and production phase.
Among its services, the company
has redesigned an optical
subsystem for a medical start-up
that has a pulsed laser, custom
beam-shaping optics, an optical
splitter, imaging optics, and
cameras aligned to a microscope.
■ Light Works Optics Inc.
TUSTIN, CA
www.lightworksoptics.com
Designer Develops Electronic
Medical Devices
Using biomedical, electrical, mechanical, software, and mechatronic
engineering tools, a service provider develops a range of electronic medical
devices, such as a laser-based stroke treatment system, a catheter-based
intravascular hypothermia system, and a radio-frequency ablation system
for atrial fibrillation and renal denervation.
The ISO 9001– and ISO 13485–certified and
FDA-registered company for Class I, II,
and III medical devices employs CAD tools
for design and simulation, a proprietary set
of project management tools, and pretested
functional building blocks called MedBlox. It
has also designed and manufactured an ultrasonic
soft-tissue repair system, blood processors, DNA
sequencing instruments, a nanofluidics processor, a
plasma-based electrosurgery system, an RFID drug-tracking system, an ophthalmic measurement device,
automated reagent processors, a urinary incontinence
treatment device, and liposuction instruments.
■ California Med Tech
MENLO PARK, CA
www.calmedtech.com
Contract Manufacturer
Specializes in Medical Device Design
Specializing in medical device design, a contract manufacturer offers concept
generation, design input, design planning, analytical study, design refinement,
prototyping, cost estimating, and design review. The company maintains cross-
functional design teams with specialists
in product and tool design, injection mold
processing, and program management.
Its engineering capabilities include
product design using Pro E and CADKey
platforms; the creation of 3-D models;
prototype tooling; mold-filling analysis;
production tooling; and installation,
operational, and performance
qualification process validation. The
company also offers plastic injection molding, mold design, mold manufacturing,
prototyping for both short and long product runs, and contract assembly and
value-added services.
■ Precision Tool & Die
DERRY, NH
www.precisiontoolanddie.net
Contractor Designs for
Manufacturability
A service provider offers design, development, and contract manufacturing
services to medical device OEMs and emerging life science companies. The
company’s engineering team designs products for manufacturability, serviceability,
maintainability, efficiency, and cost-effectiveness. The company has experience in
designing and manufacturing medical products such as handheld devices, point-of-care and bedside diagnostic devices, lab-on-a-chip technology, patient monitoring
equipment, analytical tools, and minimally invasive surgical instruments. Adhering
strictly to quality and
regulatory standards and
supply-chain controls, the
company also provides full
documentation and 510(k)
submission assistance.
■ Inteprod LLC
EAGLEVILLE, PA
www.inteprod.com
To find more product design
companies, go to the Buyers
Guide tab at devicelink.com/mpmn and click on the R&D, Design,
and Business Services category
