key to successful design to manufacturing - siddharth desai, i-flow corporation

Strategies to Accomplish Successful Design Transfer to ManufacturingTransfer to Manufacturing

Siddharth Desai, Vice President, R&DDate: 06/27/2012

‘A classic picture of Innovation!’

Objectives

• What is the anatomy of innovation?H i i ti ti d ith M f t i d R&D• How is innovation tied with Manufacturing and R&D in the innovation process?

• What are critical elements of a successful designWhat are critical elements of a successful design transfer to manufacturing?

• Are there examples of great design transfer to manufacturing?

• How do we accomplish successful design transfers?transfers?

I-Flow: Leader in infusion therapy

I-Flow commences sales of medical devices in 1991• Loyal customer base• Trusted products in the field, pioneer• Pain Management leadership – ON-Q brand Key Product Lines• Homepump• ON-Q• EasypumpProduct used in different therapies• Pain Management• Antibiotics• Chemotherapy• Chemotherapy

I-Flow has a long history of delivering innovative therapeutic solutions over last 21 years!

R&D/Engineering Mission

“Science Passion and Pursuit of Excellence ”Science, Passion and Pursuit of Excellence.

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ON-Q® Painbuster®

• A simple, disposable pain relief system that automatically deliverssystem that automatically delivers a local anesthetic to or near a surgery site over multiple days.

• Portable and easy to wear.

• Smallest device on the market.

• Unique, patented catheter

Innovation:

“Technically, "innovation" is defined merely as"i t d i thi " th lifi f"introducing something new;" there are no qualifiers ofhow ground-breaking or world-shattering that somethingneeds to be—only that it needs to be better than what wasthere before. And that's where the trouble starts when anorganization requests "innovation services" from aorganization requests innovation services from aconsulting firm. Exactly what are they really requesting?The fact is, innovation means different things to differentpeople.”

B i k J 31 2006- Businessweek, January 31, 2006

Innovation has nothing to do with how many R&D dollarsh It' t b t It' b t th lyou have... It's not about money. It's about the people you

have, how you're led, and how much you get it. -Steve Jobs

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What is innovation?“Innovation is dreams realized!’

• Innovation is Invention + Execution + Renewal!

• Innovation is Creating something new!

• Innovation is the journey that commences from Ideato Execution and to Renovation.

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Examples of Manufacturing and R&D alignment leading to success:g g

• Medical Devices– Conversion of glass bottles to flexible containers

R&D I ti i t i d i• R&D: Innovation in container design• Manufacturing: Innovation due to film manufacturing

processes• (Source: ‘Innovating for Change, The story of Baxter

International Thomas G Cody’)International, Thomas G. Cody )

– Angioplasty catheters to address arthrosclerosis blockages• R&D: Innovative idea to enable a balloon to increase hoop

stress on the artery.M f t i M lti l t i i ti d• Manufacturing: Multi-lumen extrusion innovation andballoon molding capabilities

– Flexible Silicone Intra Ocular Lenses• R&D: Foldable lens enables smaller incision for IOL

i tiinsertion• Manufacturing: Liquid Injection Molding with Platinum

Cured Silicone process enables high volume manufacturing

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Examples of Manufacturing and R&D alignment leading to success:g g

• Medical Devices– Elastomeric Pumps– Elastomeric Pumps

• Unique IP related to elastomeric pump based on Hagen-Poiseuilleequation

• R&D: Material properties enable power source and container in one device coupled with flow restrictor t h ltechnology.

• Manufacturing: Flow restrictor and Bladder manufacturing processes enable evolution of the product.enable evolution of the product.

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Objectives


• What are critical elements of a successful designWhat are critical elements of a successful design transfer to manufacturing?



Innovation Funnel: Basic Framework

ReferencesWh l i h S C d Cl k K B 1992 R l i i i P d• Wheelwright. S. C. and Clark. K. B., 1992, Revolutionizing Product Development, The Free Press, New York.

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Commence Development

• Understanding unmet needs initiates planning process.

P tf li l ti th it f i ti• Portfolio selection commences the pursuit of innovation.

• Strategic decision making and prioritization through ranking or programsranking or programs.

• Initiation of programs.

• Key stakeholders include Business R&D Marketing• Key stakeholders include Business, R&D, Marketing, Manufacturing, Quality, and Finance.

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The Journey: Development Process!

Review unmet needs

Renovation

Improve/Enhance/Recreate

• Ideation• Brainstorming • Convert to

Concept • Design• Proof of

concept • Manufacture

Development• Launch• Customer g

• Unmet needs

Invention

concepts

Design

• Validations interface

Commercialization

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Is innovation about revolution?

"Since we moved away from serendipity led R&D nobodySince we moved away from serendipity-led R&D nobody yells 'Eureka!' anymore."

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Innovation Process: Stage Gates

Concept Feasibility Design and V&V Plan LaunchConcept• Develop an

outline• Define ideas• VOC

Feasibility• Develop

alternative prototypes

• Define initial

Design and Development• Select a

concept• Develop

V&V Plan• Process

capability• Process

Validation

Launch• Build and

capacity plan meet requirements

• Develop specification

• Review options in manufacturing

process design

• Review financials

• Selection

manufacturing processes and equipment

• Customer needs tested

• Design output• Trace Matrix• Manufacturing

process finalization

• Product performance meeting requirements

• Customer ti f tig

criteria for • KOL opinion

• Financial metrics

feedback

and Capacity Plan

• Customer focused feedback

satisfaction• Financial

metrics

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• Where are the requirements?

– FDA requirement: 820 30 CFR for Design Controls and ISOFDA requirement: 820.30 CFR for Design Controls and ISO• Design Input• Design Output

D i V ifi ti d V lid ti• Design Verification and Validation• Design Reviews• Design Transfer

– Business requirement• Speed to market• Revenue plans• Revenue plans• Quality metrics• Manufacturing metrics

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Design Control

ISO Requirements: ISO13485:2003Product Realization Process Flow DiagramUser ReviewUser

NeedsDesign

Design Process

gInput

Design Output

Process

M di lVerification

Medical Device

Validation

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Objectives


• Why is successful design transfer to manufacturingWhy is successful design transfer to manufacturing critical?



Risk Mitigation through Integrationg g gRisk Review

Business Risks

Manufacturing

World class manufacturing

R&D

World class new products

Speed to Market

Supply

L h

Manufacturing core competence

Predictable mfg. metrics,

S l d it ti

Differentiated product designs

Well designed processes

D i f Mf A l Launch

Schedule

Regulatory Approval

Supply and capacity on time

Integrated at all phases

Compliance of the site, V&V

Design for Mfg., Assly.

Integrated at all phases

Design dossier and History File egu ato y pp o a

Financial Risks

Process Development

Co p a ce o t e s te, &

COGS, Capital Costs

Financial Risks

Design dossier and History File

Product and Program Costs

Process focus for ease of mfg

Differentiated Product Design

Unique products and processes provide core competence

Unique product and processes build knowledge link

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Critical Elements of A Design Transfer Plang• Develop a plan• Process Flow Diagram: From material to finished device• Selection of SuppliersSelection of Suppliers

– Supplier quality

• Complete process, assembly assessmentBOM Drawings Critical components and processes– BOM, Drawings, Critical components and processes

– Tooling, Fixtures, CpK of processes

– Launch plans and capacity plans

D t ti M t• Documentation Management– Error free transfer to manufacturing

• Quality plan– Process FMEA, Inspection, V&V plans, Test plans

• Financial Elements– Cost of components, Manufacturing process financials

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Objectives





Two Case Studies; Case 1

Case 1: Multilayer Bladder Construction to a Single Layer Bladder Construction with Material Change

Fundamental Business ObjectiveDevelop a Latex free and DEHP free product

Manufacturing and R&D ObjectivesManufacturing and R&D ObjectivesImproved consistency

Improved flow rate accuracyp y

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Case 1: Latex to Silicone conversionConcept Phase

Evaluated several material options.Operations described manufacturing and supplier p g pp

requirements.Designers developed alternative suppliers.Marketing described customer requirements

throughout the world.g

Feasibility PhaseR&D developed prototypes from different material options.A single layer bladder vs. a three layer bladder was chosen.Operations assessed alternative materials and related financial

impact

3 Layers vs. 1impact.

Precise Extrusion process defined.Regulatory affairs prepared global registration plans.

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Case 1: Latex to Silicone conversionDesign and Development Phase

R&D optimized design. Bladder design was optimized for stable modulus of elasticity.

Operations led validation efforts in the plant.Complete assessment was carried out with regards to

process capability, cost of goods and ROI. Marketing prepared launch plans.g p p pComplete trace matrix was developed.

LaunchFull launch occurred with marketing launch plans.Sales dashboard metrics measured.Sales dashboard metrics measured.Follow up on post launch monitoring for fixes.

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Case 1: A new Phacoemulsification equipment that is compact in size and more reliable in performance.

Fundamental Business ObjectiveDevelop a compact electromechanical system that is more reliableDevelop a compact electromechanical system that is more reliable.

Manufacturing and R&D Objectives Prevent too many DOAs.

Prevent several failures of modules during use.

Ensure consistency in performance.y p

Develop critical success metrics.

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Suppliers• Power SupplyPower Supply• FootswitchComponents# of Boards: 22 vs 5# of Boards: 22 vs. 5Testing• Reliability studies

B i t t• Burn-in tests• ICT, AOIDesign Transfer PlanLimited Launch

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Case 2: Compact Phaco EquipmentConcept Phase

Evaluated fundamental requirements regarding existing product for reliability and functionality.

Developed a core list of non-negotiable items for design, manufacturing and service.

Developed initial concepts.

Feasibility PhaseR&D developed non-functioning industrial design prototypes to

reflect size and number of components.Operations developed critical development requirements

Size of the machine (Refrigerator vs Desktop)Size of the machine (Refrigerator vs. Desktop)# of PCBReliability metricsOperations prepared manufacturing plans.

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p p p g pRegulatory affairs prepared global registration plans.

Case 2: Compact Phaco EquipmentDesign and Development Phase

R&D optimized design. Design with 6 total PCB vs. 21 current.Power Supply chosen was from a qualified supplier.pp y q ppComponent tests added to ensure reliabilityFinished device tests such as burn-in tests were added. Operations led validation efforts in the plant.Service strategy was included in the assessment metrics.Pilot launch with few units was carried out.Marketing prepared launch plans.

LaunchFull launch occurred with marketing launch plans.Sales dashboard metrics measured..

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Overall Summary• Innovation through R&D and Manufacturing integration.• Design transfer to manufacturing ingrained with overall

project plan.Q alit is designed in the prod ct and processes• Quality is designed in the product and processes.

• Thorough validations.• Limited launch plans.

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Objectives





10 Commandments of Successful Design Transfer

1. Thou shalt not start a project without a project leader and a core team.

2. Thou shalt not publish schedule without 80% confidence.

3 Th h lt t t t D i T f d t il ith t d t il d l3. Thou shalt not start Design Transfer details without a detailed plan.

4. Thou shalt not miss Design For Manufacturing assessment.

5. Thou shalt not work without a supply and capacity plan.

6. Thou shalt not work with unproven suppliers.

7. Thou shalt not proceed without complete validations.

8 Thou shalt not launch a product without a launch plan including limited8. Thou shalt not launch a product without a launch plan including limited launch, capacity plans and robust forecasts.

9. Remember, on a signoff day, R&D and Operations, shall be fully integrated for phase gate closures.for phase gate closures.

10. Thou shalt not ignore learning from prior launches and post launch monitoring.

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Five Blind Men and an Elephant - - -• What did each one say?

A Tree A Rope

A WallA WallA Snake

A Spear

Conclusion

A true Design Transfer to Manufacturing success comes from execution excellence in all phases of Innovation Processes including:

Project ManagementCustomer IntimacyCustomer IntimacyDesignManufacturing ProcessesSupply ChainLaunch PlanningRisk Assessment

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