DTx helps medical device companies manage the life cycle of their products from design through maintenance. It works with customers to define performance and life cycle goals upfront. DTx provides component roadmaps and change management to minimize revalidation costs from shorter-lived electronic parts. Its Planned Technology Control Program allows medical devices to have long stable lives despite changing components.

1. White Paper:
Design and Development
with Product Life-Cycle
Management (PLM) in Mind
1800 Penn Street Melbourne, FL 32901 321.728.0172 www.DTx.com
EN ISO 13485:2003
ISO 9001:2008

2. Successful product life-cycle management for medical devices begins with an interactive
development process between DTx and its customers but also continues throughout the
complete life of the medical device.
In vitro diagnostics, imaging and other medical instruments integrate embedded computing for
instrument control and user interface. The embedded computing sub-systems manage
electro-mechanical, fluid mechanics along with motor and temperature controls to drive the
actions of the medical device. Additional computing modules may be included to run the data
acquisition and user interface applications. In all instrument designs, the embedded computing
modules are a critical consideration for overall instrument product life-cycle.
While electromechanical components such as motors, valves, pumps and may have longer
life-cycles, computing components often do not. The design complexity inherent in medical
instrumentation combines a variety of industrial and commercial off the shelf (COTS) computing
components with varying life-cycles. The nature of FDA regulated devices requires stability of the
overall instrument design regardless of its design complexity or life-cycles of its individual
components.
To insure the long term stability of a computing platform, the design and life-cycle goals must be
clearly defined during the development cycle. DTx works closely with customer design teams to
outline the performance specifications as well as the expected overall life of the medical device.
In addition to the design specifications, validation and change control requirements are defined
so that a plan can be developed to support the computing platform for the medical device over
the long term.
Medical OEMs may have specific validation schedules tied to a new product release or may
provide for planned re-validation efforts as component changes occur to maintain a released
product in the field. DTx understands the OEM design, verification and validation processes and
works in concert with the OEM during the development process. In a new product release, it is
critical to launch the product built around the longest component lives possible to minimize any
revalidation efforts early in the medical device life cycle. This is often difficult as components are
selected early in the product development schedule and configurations are fixed during the
validation process. DTx provides component level roadmaps, manufacturer product plans and
integrates new technology trends to insure the embedded computing modules meet the overall
medical device design and life cycle requirements.
Some component level change is inevitable. In order to manage overall design costs, COTS
computing components are an integral part of most medical instruments. While COTS
components lower costs, they typically maintain shorter life cycles. This requires the OEM to
revalidate new components as changes occur to maintain FDA, safety and emissions regulatory
compliance. DTx works with the OEM design and sustaining engineering teams to provide
visibility into the changes and develop re-validation strategies that minimize risk and cost while
maintaining design reliability.
By providing component level roadmaps and manufacturer product plans, DTx and the OEM can
plan end-of-life driven engineering changes so that multiple changes can be validated at the
same time. Consolidating changes may require extending availability of some components
through inventory management and planning changes against OEM production and validation
schedules.
1800 Penn Street Melbourne, FL 32901 321.728.0172 www.DTx.com

3. In addition, DTx can conduct component level testing and validation to minimize the required
resources to support these activities by the OEM. DTx works with the OEM to develop a test and
validation plan complete with the required reports, content and format required to support the
OEM validation process. This allows the OEM to focus its critical engineering resources on core
product development activities instead of product change management.
Computing platform life-cycle issues are often thought of in terms of the component life-cycles
that comprise the computing device. While embedded computing technologies are available and
manufacturers have developed components such as single board computers and CPUs with
extended lives, storage and graphics components often present a greater design challenge. The
exploding demand for data storage in the consumer markets and the chase to continually lower
the cost per gigabyte presents a very fluid situation for storage products such as hard drives and
optical drives. The propagation of high definition video, computer gaming and GPU technologies
has driven graphics product life-cycles to ever shorter durations.
The impact on medical OEMs of these diverging life-cycle factors is that medical computing
platforms require comprehensive life-cycle planning to support the initial design goals and the
long term goals for field service and repair. Medical OEM devices must be maintained in the field
for longer periods than many industrial systems and the added constraints of FDA regulation
require that complete device history be maintained over the life of the product. DTx has focused
its Planned Technology Control ProgramTM to deliver long term platform life-cycle stability even
when the individual computing technologies remain dynamic in nature.
Product revalidation and unplanned change management drive excessive costs for medical OEMs.
Differing types of medical instrumentation, applications and supporting computing platforms
result in a wide range required life-cycle and change control demands. DTx’s long experience
with medical OEMs and its Planned Technology Control Program™ provide the foundation and
structure to manage medical computing platforms life-cycles while lowering their total cost to
deploy and maintain.
This type of interactive approach is key to the successful support of a medical computing
platform for a typical 5-7 year or often longer product life. The approach integrates customer
design, validation, and life-cycle goals with the PLM tools DTx has developed to support the
extended life-cycles of medical devices.
DTx provides planned product life-cycle and medical device stability as an integral part of its
value proposition to medical OEM customers. Medical device market pressures require that the
risks of product change caused by shorter computing technology life-cycles and the costs
associated with those changes be reduced. Medical OEMs must reduce design and development
costs, time to market and increase reliability while providing their customers with long-life
products and maintaining those products for longer periods. Since 1991, DTx has focused on the
unique life-cycle challenges faced by medical device manufacturers and continues to deliver
long-life computing solutions to meet the full range of medical instrumentation needs.
Dan Butler has been with DTx for 19
years, and is currently Director of
Engineering. Dan holds an MBA and
a BS in Mechanical Engineering
1800 Penn Street Melbourne, FL 32901 321.728.0172 www.DTx.com

4. About DTx
DTx is an Original Design Manufacturer
(ODM) providing value engineering services,
integrated systems and supply chain
management. We deliver value through
product design and innovation, lean
manufacturing, life cycle management and
post warranty support for intelligent
electromechanical systems. Our end-to-end
solutions enable you to focus on your core
Contact DTx
DTx Inc.
1800 Penn Street
Melbourne, FL 32901
Phone: 321-728-0172
Fax: 321-722-2216
www.DTx.com
1800 Penn Street Melbourne, FL 32901 321.728.0172 www.DTx.com