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

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

Process for Global Product Development Overview Process for Global Product Development

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

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

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

Key phase objectives and considerations Product Development Key phase objectives and considerations

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

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

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

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

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

Peripheral IV Catheters Needle stick & blood exposure safety

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

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

Questions?