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Eberhard Mayer
Using QFD to support FDA Requirements along the development process of medical equipment.
Track: K1
Abstract:
The purpose of this paper is to describe how QFD can be used in a generic manner
to assure that FDA regulatory requirements are considered throughout all relevant
product development processes of medical equipment. The primary goal is to
incorporate a set of pre-production design controls in order to prevent errors in
medical devices which could be attributable to problems of product quality. This
should increase the likelihood that the design output, when transferred to
production will translate into devices which are appropriate for their intended
use. The incorporation of design controls will greatly reduce the risks involved
in the use of medical devices and will save lives by identifying in advance
significant problems in these devices. Both the FDA and QFD have to meet
identical requirements. These requirements are closely tied to customer
satisfaction, which is well known as the primary concern of QFD methodology. It is
the common goal of QFD and FDA to focus their efforts on improving productivity,
product quality, customer satisfaction and company competitiveness through the use
of a properly documented design control system. The application of QFD within the
guidelines of FDA regulatory requirements for design control will combine customer
orientation and regulatory concerns to achieve the common goal of developing safe
and innovative medical devices for the medical profession and for the benefit of
the patient. This complex process includes the design of the device through the
entire development phase and through the subsequent manufacturing planning process
of the product. The effective use of design control tools will play a decisive
role. This is justified since it has been found that 44 % of the problems which
affect the quality and performance of medical devices are caused by errors in the
design which did not foresee either potential use-related hazards or the
unpredictable effects of unknown interaction between users, devices and use
environment.
Author:
Eberhard Mayer has a degree in Mechanical Engineering (Dipl. Ing. FH
Esslingen Germany) He worked for HP for now more than 30 years and has 15 years
experiences in designing medical equipment. His main focus was to hear and
understand the voice of customers and translate those into technical solutions.
With this engineering background he had the challenge joining HP´s procurement
group as Material Engineer responsible for electromechanical components and OEM
Assemblies. In this function he was the link between internal R&D groups and
outside partners. It was needed to develop a vendor selection process to
synchronize external and internal project requirements to take into account the
increasing importance of outsourcing. Eberhard Mayer is convinced that a rigorous
customer orientation is the key of success. QFD methodology is supporting this.
To share "best practice" within HP´s organisation he had the opportunity
presenting his idea on HP´s Corporate Procurement Panel (1997). The benefits
of QFD along the complete Supply Chain Management Process have reached strategic
importance. Gathering experiences by applying QFD, the generic 4 phase approach
has been enhanced and enriched fitting better into the environment of Product
Generation Process. Since November 2000 Eberhard Mayer is doing his own business
(MECS GmbH). The focus is Quality Engineering Consulting, to help firms doing
things better by means of QFD applications. Additional Eberhard Mayer is
cooperating with a "Newcomer Company" developing Human Interface Technologies
for medical applications (Allied Panels Austria). This expresses that teaching
theories and applying them to own projects is not conflicting.
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