1. Global Product Development
2014 BioUtah Summit
Salt Lake City, Utah
November 5th, 2014
Jon Burkholz, Fidelin Willybiro

2. Any unmet needs? Although not typical, all too common experience…..
Are there other possibilities to this experience?
Is there a way to re-define safety?
I’d like to start with an example of the possibilities that can come from critically examining an excepted and common procedure or clinical experience for unmet needs.
patient experience
user experience
worried; satisfaction; unease
best care; fear; satisfaction
confidence; mastery; convenience
empathy; safe; best care

3. Process for Global Product Development
Overview
Process for Global Product Development

4. business, commercial, technical, & design reviews
Product Realization
There is a patient at the end of everything we do…
strategy, needs, outcomes, objectives
People
Purpose
Process
Possibility
patient, customer, team, leadership
people centric
purpose aligned
process discipline
possibility driven
product, outcomes, performance
product development & business processes
concept
definition
development
qualification
global launch
lifecycle management
business, commercial, technical, & design reviews

5. Global Team Organization
Cross functional core team
core & extended team
Functional organization support
functional excellence & resources
Cross site collaboration
design & manufacturing centers
Regional business integration
marketing, sales, distribution
Finance
Marketing
R&D
Core Team Leader
Medical
PAD RA
Operations
Quality
core team
extended team

6. Global Product Development Process
Iterative process with review points
Increasing confidence
Retiring risk
Increasing investment
Transition from dev team to business
confidence
accuracy
concept
definition
investment
development
qualification
global launch
lifecycle management
risk
functional, design, commercial & business reviews B D C F B D C F B D C F B D C F B D C F

7. Key phase objectives and considerations
Product Development
Key phase objectives and considerations

8. Concept Phase market need solution feasibility business viability
Concept ideation & prototyping
Preliminary technology & IP assessment
Process, molding & automation technology assessment
Operations assessment
Prelim quantitative & qualitative research
Needs identification, screening & prioritization
Market assessment
Market Need
Business Viability
Technical Feasibility
market need
solution feasibility
business viability
Is there a compelling business potential?
Preliminary business case
Preliminary opportunity assessment and business case development
Strategic innovation, market research,
Key Phase Highlight: focus on needs, not solution’s; is there a business potential?
concept
definition
development
qualification
global launch
lifecycle management
functional, design, commercial & business reviews

9. functional, design, commercial & business reviews
Validate prioritized customer requirements
Determine needs for additional market research
Assess commercial readiness
Definition Phase
Define product requirements
Refine concepts
Preference & usability
Down select concepts
Technical assessment
Business Viability?
Market Assessment
Operations Strategy
Design Definition
Process & molding technology assessment
Ops, supply chain & sourcing strategy
Refined cost model
Scale-ability assessment
customer & product requirements
concept refinement & down selection
operational strategy
market & commercial readiness
Is the business case still attractive?
Key Phase Highlight: validate global and regionally needs; leverage common platform technologies; strengthen business case
Refined business case
concept
definition
development
qualification
global launch
lifecycle management
functional, design, commercial & business reviews

10. Development Phase Business Viability?
Re-assess market conditions
Product design vs claims alignment
Branding considerations
Global Marketing Plan preparations
Commercial readiness
Development Phase
Final concept selection
Human factors
Concept certification
Product design & opt
Pre-clinical testing
DV strategy & testing
Business Viability?
Market Strategy
Operations Plan Execution
Design & Dev
design for performance robustness & use-ability
concurrent product & process design for sustainability
operational strategy execution
commercialization excellence strategy
Is the business case still attractive?
Concurrent product, process & mold design
Mfg process dev & optimization
Pilot equip & mold dev
Sourcing, distribution & capacity plans
Key Phase Highlight: concurrent design, process, molding and automation development; design for scale-ability; use-ability & human factors; commercialization excellence
Validated business case
concept
definition
development
qualification
global launch
lifecycle management
functional, design, commercial & business reviews

11. Qualification Phase Business Implementation
Communication plan readiness
Refine distribution strategy
Finalize regional launch Plans
Clearly define metrics
Sales training planning & execution
Refine targeting, forecast, inventory levels
Business Implementation
Market Tactical Planning
Operations Qual
Design Qual
Design validation
Summative human factors study
Packaging & labeling
Regional registrations
Manufacturing & supply qualification & validation
Execute supply chain & procurement plans
Refine cost of estimates
Production scale-up plan
design verification & validation
manufacturing & supply qualification
regional registration
regional commercialization plan
Is the business case still attractive?
Key Phase Highlight: product and process qualification; regional registrations, market dev, HEOR, KOLS, publication, etc
Budgeted business case
concept
definition
development
qualification
global launch
lifecycle management
functional, design, commercial & business reviews

12. Launch Phase Business Sustenance go to market execution
Monitor performance to metrics
Post market surveillance
Business Sustenance
Marketing Plan Execution
Operations Scale-up & CI
Design Support
Lifecycle management
Quality monitoring
Regional registration approvals
Continuous improvement
Supplier evaluation & contingency plans
Scale-up capacity assessment & execution
go to market execution
post market surveillance
regional registration
operations scale-up & CI
life-cycle management
Has the product met expectation?
Business performance & metrics
concept
definition
development
qualification
global launch
lifecycle management
functional, design, commercial & business reviews

13. Peripheral IV Catheters
Needle stick & blood exposure safety

14. PIVC safety redefined…
needle stick
blood exposure
patient experience
user experience
more at ease; satisfaction
confident in care; less fear
confidence; mastery; safe
convenience; providing best care

15. Turning purpose into possibility…
People
Purpose
Process
Possibility
…to elevate the standard of care for patients and health care workers around the world
Fostering a product realization eco-system (environment) and using a people centric, iterative and concurrent product development process, is an effective way to turn “purpose into possibility” to elevate patient care around the world.
concept
definition
development
qualification
global launch
lifecycle management
business, commercial, technical, & design reviews

16. Questions?