[MEET THE EXPERT] - Medical Cluster

Design excellence tools used to optimise New Medical Product Development:
illustration on the new “Viper F2” system
Henri Défossez, PhD; DePuy Spine Sàrl, Johnson & Johnson; Le Locle, Switzerland
Introduction:
Design Excellence (DEX) tools have been widely
used in the industry; and as such are integrally part
of the New Product Development (NPD) process at
DePuy Johnson & Johnson. The appropriate
selection and use of DEX tools significantly
facilitate the development (design, manufacture,
marketing ...) of new medical products. This is illustrated
with the recent development of the new
Viper F2 system; an orthopaedic
spinal implant system
dedicated to transfacet pedicular
fusion treatment, as shown in
figure 1).
Fig. 1: Viper F2.
DEX Overview:
A plethora of DEX tools are available at various
stages of the new product development; as
illustrated in figure 2 representing the linkage
between Design Excellence and New product
Development process of Medical Devices and
Diagnostics. Since every project is different and
often tends to evolve in scope throughout time; it is
appropriate to regularly review and assess which
tools are most relevant to support the project
throughout its lifecycle. For the Viper F2 project,
figure 3 presents those most important tools
selected during the project phases.
Fig. 2: Linkage between DEX and NPD.
Define Phase: Measure Phase:
Business Case Definition,
Market Research & Value
Proposition, Multi Generational
Plan, Gant Chart Definition
Benchmarking with Pugh
Matrix, Focus groups with
Small & large internal/external
VOC groups, Top-level Risk
Assessment
Analyze Phase: Design / VV phases:
Detailed Risk Management Plan
and Report (DFMEA+), Product
Map (“technical” usage map),
Preliminary Surgical Technique
and training plan
Design of Experiments coupled
with Manufacturing Process
validation, Brainstorming K,
Biomechanical testing with
ANOVA, CTQs “Plus”
Fig. 3: Main DEX tools employed as part of the
Viper F2 development.
Main outcomes:
The following tools were found to be most
successful at developing the correct product for
market penetration while reducing the number of
design iterations and manufacturing validations:
• Cost analysis & Pugh Matrix & Multi
Generation Plan: this enabled to develop early
on a robust rationale to develop the right
project; with a specified scope with associated
in roll-out phases, so to avoid project scope
creep and incorrect product portfolio allocation.
• Risk Management Plan & Product Map: the
new levels of details within the tools employed
allowed to establish an unprecedented technical
verification/validation program.
• Design of Experiments & Process Quantification:
it was possible to start even at the
concept phase to focus on critical mechanical
features of the system to be designed and
validated for manufacture.
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