1. 9/9/2013
Best Practices in Fostering Innovation
while Retaining Quality and Compliance
Geoff Hutchins
Chief Operating Officer

2. 2
W E L L N E S S F O R B U S I N E S S
®
Understand the business value and objective
Keep the business objective at the forefront to define priorities
• Define and communicate the business value
– Why are we undertaking this project and what is the business goal
• Product development type
– New to market product or platform
– Next generation or enhancement of existing product or platform
• Market entry strategy
– Staged approach to understand user perception and value
– First to market or fast follower
– Geographic market entry
– Maximize initial sales due to imminent competitive threat

3. 3
W E L L N E S S F O R B U S I N E S S
®
What Design Quality Management
System?
Document
Control
Roles and
Responsibility
Change
Control
Inspection
Measurement
and test
Purchasing
Controls
(Suppliers)
Training
Design
Controls
•Define the supporting QMS elements
•Plan Design QMS activities
•Partition responsibility
•Document in Quality Plan
•Monitor QMS performance
• Plan Manufacturing transfer QMS
When did I start to design?
•Be very clear when you start the design
•Try not to do technology development and product
design at the same time
Concept Design
Design
Controls
Begin Kimberly A. Trautman

4. 4
W E L L N E S S F O R B U S I N E S S
®
Analysis of Premarket Review
The real review time
Average Time To 510(k) Decision Percent with AI Request on First Cycle

5. 5
W E L L N E S S F O R B U S I N E S S
®
Medical Mobile Applications (MMA)
Regulated
MMA
Mobile Apps subject to
Enforcement Discretion
Unregulated Mobile Apps

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