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TECHNOLOGY CHANGING HEALTHCARE, 19TH MAY 2010




            WORKSHOP: “FROM CONCEPT TO COMMERCIALISATION”




© Wideblue Ltd, 2010
WIDEBLUE DESIGN PROCESS ‐ OVERVIEW



                                                                                                                                          SUPPLY CHAIN MANAGEMENT
                                                                                           PROJECT MANAGEMENT
                                                               DESIGN RISK MANAGEMENT AND PRODUCT ROBUSTNESS
                  REQUIREMENTS AND SPECIFICATION




                                                                                                                                                   APPROVAL FOR SALE
                       CONCEPT REVIEW




                                                                           DESIGN REVIEW




                                                                                                                  DESIGN FREEZE
                                                  GO / NO‐GO




            CONCEPTS                                                                                                                              MANUFACTURE / 
           CONCEPT FEASIBILITY                                                                 DESIGN
                                        FEASIBILITY                                                                                             COMMERCIALISATION
                                                               SYSTEM DESIGN
                                                                                           DETAIL DESIGN FOR MANUFACTURE
                                                                                                                                  MANUFACTURE START‐UP
                                                                                                                                             STEADY STATE MANUFACTURE




                SKETCHES                        RIGS            TECHNOLOGY DEMONSTRATOR                  WORKING PROTOTYPES                 PRODUCT FOR SALE




© Wideblue Ltd, 2010
WIDEBLUE DESIGN PROCESS ‐ OVERVIEW



                                                                                                                                          SUPPLY CHAIN MANAGEMENT
                                                                                           PROJECT MANAGEMENT
                                                               DESIGN RISK MANAGEMENT AND PRODUCT ROBUSTNESS
                  REQUIREMENTS AND SPECIFICATION




                                                                                                                                                   APPROVAL FOR SALE
                       CONCEPT REVIEW




                                                                           DESIGN REVIEW




                                                                                                                  DESIGN FREEZE
                                                  GO / NO‐GO




            CONCEPTS
                                        FEASIBILITY
                                                               SYSTEM DESIGN
                                                                                           DETAIL DESIGN FOR MANUFACTURE
                                                                                                                                  MANUFACTURE START‐UP
                                                                                                                                             STEADY STATE MANUFACTURE




                SKETCHES                        RIGS            TECHNOLOGY DEMONSTRATOR                  WORKING PROTOTYPES                 PRODUCT FOR SALE




© Wideblue Ltd, 2010
BREASTLIGHT : ENLIGHTENED BREAST AWARENESS


 Breastlight is a new health and wellbeing product for 
 women. It helps women notice changes in their breasts 
 over time.
 The product works by shining a bright red light through 
 the breast tissue. The light passes through the breast 
 tissue and reveals dark areas where blood is present. It 
 is therefore quite normal to see a pattern of veins, but 
 if there is a dark cluster this is a potential abnormality 
 that should be checked out. 
                                                               In the 1990’s Dr David J Watmough highlighted the 
                                                               specific mechanism by which a tumour could be 
                                                               illuminated to best effect.  His company, Highland 
                                                               Innovation, created a technology demonstrator to carry 
                                                               out clinical testing.
                                                               In 2007 Highland Innovation approached Wideblue and 
                                                               asked us to help take the product concept forward.  
                                                               Today the Breastlight product is being sold in high street 
                                                               retail pharmacies in Canada, Finland and the UK.  It is 
                                                               also being sold through distribution in four other 
                                                               European countries plus the Middle East and Singapore.
                                                               20 thousand units have been sold to date

© Wideblue Ltd, 2010
STAGE 1: CONCEPT



 WHAT DOES THE PRODUCT LOOK LIKE                  WHO INFLUENCES THE DESIGN?
 AT THIS STAGE?
                                                  Inventors
                                                  End users
                                                  Sales / marketing
                                                  Product design team



 MAIN ACTIVITIES                                  PROJECT MANAGEMENT TOOL

 Explore and develop the product concept          Concept selection matrix
 Refine the business concept                           Shortlist promising concepts

 Define the business model                             Define selection criteria
                                                       Rank each concept against each criteria
 Plan the organisation – in‐house vs outsourced




© Wideblue Ltd, 2010
STAGE 2: FEASIBILITY



 WHAT DOES THE PRODUCT LOOK LIKE                   WHO INFLUENCES THE DESIGN?
 AT THIS STAGE?
                                                   Market research team
                                                   End users
                                                   Product design team
                                                   Regulatory advice



 MAIN ACTIVITIES                                   PROJECT MANAGEMENT TOOL

 Stress‐test the business model                    Functional review 
 Market and user research                               Assess the product in “functional blocks”

 Risk assessments – product, safety and market          Structured risk assessment of failure modes
                                                        Focus on interfaces between functions
 Proof of principle demonstrations
 Engineering models and prototypes


© Wideblue Ltd, 2010
STAGE 3: DESIGN



 WHAT DOES THE PRODUCT LOOK LIKE                               WHO INFLUENCES THE DESIGN?
 AT THIS STAGE?
                                                               Product design team
                                                               End users
                                                               Marketing
                                                               Regulatory
                                                               Key suppliers

 MAIN ACTIVITIES                                               PROJECT MANAGEMENT TOOL

 Design and development engineering:                           Bill of materials database
         Electronic, mechanical, aesthetic, user‐interface,         Components, materials, suppliers, manufacturers, 
         software, optical, thermal analysis, etc.                  costs, price breaks, minimum orders, equivalents, 
                                                                    issue levels, etc.
 Make or buy decisions
                                                                    A special‐purpose database is more flexible than 
 Design verification testing                                        Excel spreadsheets
 Engineering pilot

© Wideblue Ltd, 2010
STAGE 4: MANUFACTURING / COMMERCIALISATION



 WHAT DOES THE PRODUCT LOOK LIKE                 WHO INFLUENCES THE DESIGN?
 AT THIS STAGE?
                                                 Supply chain
                                                 Product design team
                                                 Packaging and instructions design team
                                                 Manufacturing team
                                                 Sales / marketing

 MAIN ACTIVITIES                                 PROJECT MANAGEMENT TOOL

 In‐house or sub‐contract decisions              Supply chain risk assessment
 Manufacturing pilot                                  Always have a plan B

 Manufacturing inception and scalability              Include RoHS compliance checks

 Web sales, distribution, high street retail




© Wideblue Ltd, 2010
BREASTLIGHT DESIGN PROCESS, ACTUAL TIMESCALE




                                                                            




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                             Ju                                                                                                                                         SUPPLY CHAIN MANAGEMENT

                                                                                                              PROJECT MANAGEMENT

                                                                            DESIGN RISK MANAGEMENT AND PRODUCT ROBUSTNESS

                            REQUIREMENTS AND SPECIFICATION




                                                                                                                                                                                    APPROVAL FOR SALE
                                CONCEPT REVIEW




                                                                                             DESIGN REVIEW




                                                                                                                                             DESIGN FREEZE
                                                               GO / NO‐GO




                  CONCEPTS

                                                 FEASIBILITY

                                                                            SYSTEM DESIGN

                                                                                                                  DETAIL DESIGN FOR MANUFACTURE

                                                                                                                                                             MANUFACTURE START‐UP

                                                                                                                                                                          STEADY STATE MANUFACTURE



                            SKETCHES                       EYE SAFETY                                                                      BETA PROTOTYPES                          DVT
                                                                                            PROOF OF PRINCIPLE RIGS
                            OBSERVATIONAL                  ESTIMATED COSTS                                                                 BETA DVT                                 PRODUCT FOR SALE
                                                                                            SCHEMATICS
                            RESEARCH                       OBSERVATIONAL 
                                                                                            ARCHITECTURE
                                                           RESEARCH – FORM
                                                                                            COMPONENT SELECTION
                                                           ID LANGUAGE

© Wideblue Ltd, 2010
TECHNOLOGY CHANGING HEALTHCARE, 19TH MAY 2010




                                         GRANT KING
                                         DIRECTOR

              POLAROID BUILDING   TEL 44 (0)1389 714432 FAX 44 (0)1389 714153
              VALE OF LEVEN IE    GRANT.KING@WIDE-BLUE.COM
              DUMBARTON G82 3PW   WWW.WIDE-BLUE.COM




                                       MAKING TECHNOLOGY HAPPEN

                                                                                                           STUART KELLY
                                                                                                           SENIOR MANAGER

                                                                                POLAROID BUILDING   TEL 44 (0)1389 714355 FAX 44 (0)1389 714153
                                                                                VALE OF LEVEN IE    STUART.KELLY@WIDE-BLUE.COM
                                                                                DUMBARTON G82 3PW   WWW.WIDE-BLUE.COM




                                                                                                         MAKING TECHNOLOGY HAPPEN




© Wideblue Ltd, 2010

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Concept To Commercialisation Breastlight Case Study

  • 1. TECHNOLOGY CHANGING HEALTHCARE, 19TH MAY 2010 WORKSHOP: “FROM CONCEPT TO COMMERCIALISATION” © Wideblue Ltd, 2010
  • 2. WIDEBLUE DESIGN PROCESS ‐ OVERVIEW SUPPLY CHAIN MANAGEMENT PROJECT MANAGEMENT DESIGN RISK MANAGEMENT AND PRODUCT ROBUSTNESS REQUIREMENTS AND SPECIFICATION APPROVAL FOR SALE CONCEPT REVIEW DESIGN REVIEW DESIGN FREEZE GO / NO‐GO CONCEPTS MANUFACTURE /  CONCEPT FEASIBILITY DESIGN FEASIBILITY COMMERCIALISATION SYSTEM DESIGN DETAIL DESIGN FOR MANUFACTURE MANUFACTURE START‐UP STEADY STATE MANUFACTURE SKETCHES RIGS TECHNOLOGY DEMONSTRATOR WORKING PROTOTYPES PRODUCT FOR SALE © Wideblue Ltd, 2010
  • 3. WIDEBLUE DESIGN PROCESS ‐ OVERVIEW SUPPLY CHAIN MANAGEMENT PROJECT MANAGEMENT DESIGN RISK MANAGEMENT AND PRODUCT ROBUSTNESS REQUIREMENTS AND SPECIFICATION APPROVAL FOR SALE CONCEPT REVIEW DESIGN REVIEW DESIGN FREEZE GO / NO‐GO CONCEPTS FEASIBILITY SYSTEM DESIGN DETAIL DESIGN FOR MANUFACTURE MANUFACTURE START‐UP STEADY STATE MANUFACTURE SKETCHES RIGS TECHNOLOGY DEMONSTRATOR WORKING PROTOTYPES PRODUCT FOR SALE © Wideblue Ltd, 2010
  • 4. BREASTLIGHT : ENLIGHTENED BREAST AWARENESS Breastlight is a new health and wellbeing product for  women. It helps women notice changes in their breasts  over time. The product works by shining a bright red light through  the breast tissue. The light passes through the breast  tissue and reveals dark areas where blood is present. It  is therefore quite normal to see a pattern of veins, but  if there is a dark cluster this is a potential abnormality  that should be checked out.  In the 1990’s Dr David J Watmough highlighted the  specific mechanism by which a tumour could be  illuminated to best effect.  His company, Highland  Innovation, created a technology demonstrator to carry  out clinical testing. In 2007 Highland Innovation approached Wideblue and  asked us to help take the product concept forward.   Today the Breastlight product is being sold in high street  retail pharmacies in Canada, Finland and the UK.  It is  also being sold through distribution in four other  European countries plus the Middle East and Singapore. 20 thousand units have been sold to date © Wideblue Ltd, 2010
  • 5. STAGE 1: CONCEPT WHAT DOES THE PRODUCT LOOK LIKE  WHO INFLUENCES THE DESIGN? AT THIS STAGE? Inventors End users Sales / marketing Product design team MAIN ACTIVITIES PROJECT MANAGEMENT TOOL Explore and develop the product concept Concept selection matrix Refine the business concept Shortlist promising concepts Define the business model Define selection criteria Rank each concept against each criteria Plan the organisation – in‐house vs outsourced © Wideblue Ltd, 2010
  • 6. STAGE 2: FEASIBILITY WHAT DOES THE PRODUCT LOOK LIKE  WHO INFLUENCES THE DESIGN? AT THIS STAGE? Market research team End users Product design team Regulatory advice MAIN ACTIVITIES PROJECT MANAGEMENT TOOL Stress‐test the business model Functional review  Market and user research Assess the product in “functional blocks” Risk assessments – product, safety and market Structured risk assessment of failure modes Focus on interfaces between functions Proof of principle demonstrations Engineering models and prototypes © Wideblue Ltd, 2010
  • 7. STAGE 3: DESIGN WHAT DOES THE PRODUCT LOOK LIKE  WHO INFLUENCES THE DESIGN? AT THIS STAGE? Product design team End users Marketing Regulatory Key suppliers MAIN ACTIVITIES PROJECT MANAGEMENT TOOL Design and development engineering: Bill of materials database Electronic, mechanical, aesthetic, user‐interface,  Components, materials, suppliers, manufacturers,  software, optical, thermal analysis, etc. costs, price breaks, minimum orders, equivalents,  issue levels, etc. Make or buy decisions A special‐purpose database is more flexible than  Design verification testing Excel spreadsheets Engineering pilot © Wideblue Ltd, 2010
  • 8. STAGE 4: MANUFACTURING / COMMERCIALISATION WHAT DOES THE PRODUCT LOOK LIKE  WHO INFLUENCES THE DESIGN? AT THIS STAGE? Supply chain Product design team Packaging and instructions design team Manufacturing team Sales / marketing MAIN ACTIVITIES PROJECT MANAGEMENT TOOL In‐house or sub‐contract decisions Supply chain risk assessment Manufacturing pilot  Always have a plan B Manufacturing inception and scalability Include RoHS compliance checks Web sales, distribution, high street retail © Wideblue Ltd, 2010
  • 9. BREASTLIGHT DESIGN PROCESS, ACTUAL TIMESCALE   8 ly 00 nd am 7 7 ul 7 7 fu ogr 00 00 00 7  2 00 ed  f 00 Pr ly 2 ly v 2  2  2  2 Ju ril g No ne Ju Au Ap Ju SUPPLY CHAIN MANAGEMENT PROJECT MANAGEMENT DESIGN RISK MANAGEMENT AND PRODUCT ROBUSTNESS REQUIREMENTS AND SPECIFICATION APPROVAL FOR SALE CONCEPT REVIEW DESIGN REVIEW DESIGN FREEZE GO / NO‐GO CONCEPTS FEASIBILITY SYSTEM DESIGN DETAIL DESIGN FOR MANUFACTURE MANUFACTURE START‐UP STEADY STATE MANUFACTURE SKETCHES EYE SAFETY BETA PROTOTYPES DVT PROOF OF PRINCIPLE RIGS OBSERVATIONAL  ESTIMATED COSTS BETA DVT PRODUCT FOR SALE SCHEMATICS RESEARCH OBSERVATIONAL  ARCHITECTURE RESEARCH – FORM COMPONENT SELECTION ID LANGUAGE © Wideblue Ltd, 2010
  • 10. TECHNOLOGY CHANGING HEALTHCARE, 19TH MAY 2010 GRANT KING DIRECTOR POLAROID BUILDING TEL 44 (0)1389 714432 FAX 44 (0)1389 714153 VALE OF LEVEN IE GRANT.KING@WIDE-BLUE.COM DUMBARTON G82 3PW WWW.WIDE-BLUE.COM MAKING TECHNOLOGY HAPPEN STUART KELLY SENIOR MANAGER POLAROID BUILDING TEL 44 (0)1389 714355 FAX 44 (0)1389 714153 VALE OF LEVEN IE STUART.KELLY@WIDE-BLUE.COM DUMBARTON G82 3PW WWW.WIDE-BLUE.COM MAKING TECHNOLOGY HAPPEN © Wideblue Ltd, 2010