Pathways from the Laboratory to Real World Products
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After 20 years of incubation, Lab-on-a-chip technologies are ready to realize their potential. Critical to achieving this goal is their ability to attract investment. Traditionally there has been a disproportionate emphasis on prototypes in the quest for investment. On too many occasions this disparate focus has created a vicious cycle of expensive and lengthy failures, leaving exciting technologies and ideas in the 'valley of death'. Understanding user requirements, adopting a design-for-manufacture approach and having a clear idea of what your end-goal looks like can eliminate the dangers of the 'valley of death'. Another crucial strategy is implementing a staged development strategy that segments the project into manageable, investible and technically achievable stages, concentrating on risk-based developments as opposed to agile ones. For the investment community, processes such as these represent a mature and disciplined approach to translating lab-on-a-chip technologies from the bench top, into real-world products that address new commercial opportunities. MiniFAB CEO Dr Erol Harvey presented this talk at Lab-on-a-Chip Asia in Singapore, November 2014.
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Pathways from the Laboratory to Real World Products
- 1. Pathways from Laboratory to Real World Products Dr. Erol Harvey, PhD, FTSE CEO, MiniFAB erolharvey@minifab.com.au OCT-14 PAGE 1 OF 30 COPYRIGHT MATERIAL 2014
- 2. Avoiding the Valley of Death OCT-14 PAGE 2 OF 30 COPYRIGHT MATERIAL 2014
- 3. R D OCT-14 PAGE 3 OF 30 COPYRIGHT MATERIAL 2014 Valley of Death $ Investment $ Industrial Government Grants Public Industrial
- 4. PATHWAYS to CONSIDER : • Funding channels • Market opportunity • Technical approach • IP landscape • Product offering • Regulatory compliance • Manufacturing strategy … and a whole lot more OCT-14 PAGE 4 OF 30 COPYRIGHT MATERIAL 2014
- 5. PATHWAYS to CONSIDER : • Funding channels • Market opportunity • Technical approach • IP landscape • Product offering • Regulatory compliance • Manufacturing strategy … and a whole lot more OCT-14 PAGE 5 OF 30 COPYRIGHT MATERIAL 2014
- 6. WORK FLOW analysis OCT-14 PAGE 6 OF 30 COPYRIGHT MATERIAL 2014 UNDERSTANDING, SIMPLIFYING, SPECIFYING Many names Work Flow Analysis Use Case Scenarios Voice of Customer (VoC) Human Factors Engineering User Interface
- 7. WORK FLOW analysis OCT-14 PAGE 7 OF 30 COPYRIGHT MATERIAL 2014 UNDERSTANDING, SIMPLIFYING, SPECIFYING FDA Medical Device DATA 100,000 reported incidents p.a. More than 1/3 involve “user error” 44% of FDA product recalls related to design problems – often resulting in use errors
- 8. WORK FLOW analysis OCT-14 PAGE 8 OF 30 COPYRIGHT MATERIAL 2014 UNDERSTANDING, SIMPLIFYING, SPECIFYING FDA Medical Device DATA 100,000 reported incidents p.a. More than 1/3 involve “user error” 44% of FDA product recalls related to design problems – often resulting in use errors
- 9. USE CASE analysis Exploring potential for optimisation Patient Sample container Sample direct to cartridge Practitioner Packaging Labeling Potential error Assay Removing reagents / steps Combining reagents / steps Sample preparation + + + Source : Copeland/Willing-‐Pichs (Ximedica) OCT-14 PAGE 9 OF 30 COPYRIGHT MATERIAL 2014 PEOPLE (stakeholders/users) Physicians RNs Technicians Anesthesiologists … others Biomed techs Environmental services Central/sterile supply … others Purchasing Quality Risk management Hospital Physician office Clinics Urgent care centre Surgi center home Physical space/layout Air quality/temperature LighVng (natural v. arVficial) Color story Material selecVon Power/electricity Audio/noise polluVon Deconstructed “moments” Who uses what, when, how? Gross motor Fine motor Reach range Vision Audio TacVle Olfactory HeurisVcs GUI interface SituaVonal awareness Mental models Decision making Ergonomics + Anthropometrics clinicians context device lifecycle physical support staff paVents caregivers decision-‐makers condiVons purchase storage in-‐use disposal reprocessing maintenance perceptual cogniVve Third party PLACE ((use environments) TASK (touch-points of use) ABILITY (human use performance)
- 10. WORK FLOW analysis OCT-14 PAGE 10 OF 30 COPYRIGHT MATERIAL 2014 EVALUATION OF WORK FLOW OPTIONS Exploring potential for optimisation Patient Sample container Sample direct to cartridge Practitioner Packaging Labeling Potential error Assay Removing reagents / steps Combining reagents / steps Sample preparation
- 11. Work flow analysis Additional example OCT-14 PAGE 11 OF 30 COPYRIGHT MATERIAL 2014
- 12. Sample introduction OCT-14 PAGE 12 OF 30 COPYRIGHT MATERIAL 2014 Whole blood from finger stick or pipette Experience working with whole blood + components Includes specimen acquisition Sample prep Add reagents Aliquot Mixing Lysing Filtration Experience with other specimens Sputum Saliva Turbid water samples
- 13. Sample introduction Separate Sample Containers Sample containers Cartridge interfaces Integrated swabs + caps Drop-in swabs Biohazard containment Dried reagents Liquid reagents Slip fit connections Locking connections OCT-14 PAGE 13 OF 30 COPYRIGHT MATERIAL 2014
- 14. Containment and protection OCT-14 PAGE 14 OF 30 COPYRIGHT MATERIAL 2014 Caps, covers, sliders, shells Containment of biohazard Caps Covers Protection of surfaces Sliding Twisting Labels (including tear off) Recessed surfaces Stand offs
- 15. FAILURE to CONSIDER : • Product nobody can use • Product nobody wants • Product nobody buys • Product nobody will fund… and a whole lot more OCT-14 PAGE 15 OF 30 COPYRIGHT MATERIAL 2014
- 16. PATHWAYS to CONSIDER : • Funding channels • Market opportunity • Technical approach • IP landscape • Product offering • Regulatory compliance • Manufacturing strategy … and a whole lot more OCT-14 PAGE 16 OF 30 COPYRIGHT MATERIAL 2014
- 17. Example Cartridge for POC OCT-14 PAGE 17 OF 30 COPYRIGHT MATERIAL 2014 Cartridge concept example On-‐board reagent storage (wet and dry) Microfluidic channels, mixers, valves, integrated biosensor Product idenVficaVon OpVcal detecVon chambers and interface to instrument Sample input port Waste storage Example conceptual representation for illustration and communication purposes only.
- 18. SYSTEM requirements OCT-14 PAGE 18 OF 30 COPYRIGHT MATERIAL 2014 MICROFLUIDIC TOOLBOX Break down system into components Identify system interfaces Define system architecture On cartridge functions Instrument functions Challenge assumptions Flow sequence Number of reagents Volumes of reagents Temperature and pressure Developed in parallel with Product Requirements Design Requirements Risk Watch List
- 19. MANUFACTURING PROCESS OCT-14 PAGE 19 OF 30 COPYRIGHT MATERIAL 2014 Design Concept GeneraVon VV Plan 3D CAD Technical Risk Analysis FMEA Design for Manufacture Concept GeneraVon Workflow analysis Component SoluVons Valves Mixers Filters Metering Lysis Bubble Handling Bead Handling Integrated Electrodes ReplicaVon Electroform Tooling Hot Embossing Nano Imprint CasVng InjecVon moulding Die Cufng Punching Pad PrinVng Pagerning Photolith Excimer Laser CO2 Laser Fibre Laser 3w Nd:YAG DRIE (partner) Micro Milling FIB (partner) Assembly LaminaVon Thermal Diffusion Solvent Assist Adhesive Bonding Wire Bonding Flip Bump Bonding Laser Welding Ultrasonic Welding Packaging Polymer Packages Ceramic Packages Fluidic Connectors Reagent Blisters OpVcal Windows Air VenVng Bio-‐Hazard Containment Flow Wrap Test InspecVon OpVcal Microscopy SEM Laser Scanning Confocal Mini-‐ ChemLab Bio FuncVonal XRD (partner) Fluorescent Microscopy Confocal IR (partner)
- 20. Design For Manufacture DESIGN SIMPLIFICATION MANUFACTURE INTEGRATEDDESIGN CRITICALTASK Multi-purpose Platform: Automation of the fluidics for a bead-array based platform diagnostic p-BNC KEYOUTCOMES System integration and simplification Work-flow analysis and packaging On-board reagents, metering, filtering, venting CURRENTSTAGE Pre-clinical trials OCT-14 PAGE 20 OF 30 COPYRIGHT MATERIAL 2014
- 21. Design For Manufacture TRANSFORMING YOUR IDEAS INTO FULLY MANUFACTURED PRODUCTS MANUFACTUREASSEMBLY ISO13485GMP QUALITY OCT-14 PAGE 21 OF 30 COPYRIGHT MATERIAL 2014
- 22. PATHWAYS to CONSIDER : • Funding channels • Market opportunity • Technical approach • IP landscape • Product offering • Regulatory compliance • Manufacturing strategy … and a whole lot more OCT-14 PAGE 22 OF 30 COPYRIGHT MATERIAL 2014
- 23. OCT-14 PAGE 23 OF 30 COPYRIGHT MATERIAL 2014 STAGED DEVELOPMENT STRATEGY Stage 0 Stage 1 REVIEW DESIGN FOCUS MANUFACTURING FOCUS Stage 2 Stage 3 Stage 4 Definition and Concepts Proof-of-Principle Concept Demonstrator Proto ALPHA Prod BETA Prod
- 24. INSTRUMENT test bench MiniChemLab: DESIGN INPUT TO INSTRUMENT DEVELOPMENT Initial test bed with minimal development PoP development Early CDP development Determine and demonstrate Flow rates Pressures Temperatures Fluidic control strategy Mixing Metering Hydraulic and pneumatic control In-house built platform for assay and instrument development Customisable to Client requirements Co-location of instrument(s) at MiniFAB and Client sites OCT-14 PAGE 24 OF 30 COPYRIGHT MATERIAL 2014
- 25. STAGED Development ISO CERTIFIED DESIGN, DEVELOPMENT MANUFACTURE - GMP R D $ Investment OCT-14 PAGE 25 OF 30 COPYRIGHT MATERIAL 2014 $ Industrial Government Grants Public Industrial Stage 0 Stage 1 Stage 2 Stage 3 Pre -‐ Stage 0 Stage 4
- 26. MiniFAB Quality System ISO CERTIFIED DESIGN, DEVELOPMENT MANUFACTURE - GMP Documented procedures compliant to 21 CFR 820.30, ISO 13485 ISO 9001 are used to ensure control over the design and development process. Ensures systematic assessment of the design throughout the development process to guarantee the final design meets the design requirements and is appropriate for its intended use. Stages are planned, design inputs and design outputs are documented, risk assessments and stage reviews are conducted at appropriate intervals, verification and validation is conducted, and a Design History File is developed. GLP GMP OCT-14 PAGE 26 OF 30 COPYRIGHT MATERIAL 2014
- 27. OCT-14 PAGE 27 OF 30 COPYRIGHT MATERIAL 2014 WHO WE ARE 12 years, hundreds of projects worldwide QUICKSTATS Private company established in 2002 Headquarters in Melbourne, Australia Satellite offices in Europe, USA Team of 120+ highly experienced people Over 900 projects completed, Over 200 clients UNIQUEQUALIFICATIONS ISO13485 and ISO9001 certified Custom contract development from product design and prototype development to full-scale manufacturing services Specialist in polymer micro-engineering solutions SEP-13 33 COMMERCIAL IN CONFIDENCE
- 28. GLOBAL PRODUCT DEVELOPMENT MELBOURNEAUSTRALIA Phone: +61 3 9764 224 Skype: andrew.campitelli.minifab ROCHESTERUSA Phone: +1 (585) 370-8368 Skype: bobmehalso.minifab BRISTOLUK Phone: +44 (0)7565 968199 Skype: micah.atkin.minifab OCT-14 PAGE 28 OF 30 COPYRIGHT MATERIAL 2014
- 29. Ask for direcVons at the beginning of the journey, not at the end! OCT-14 PAGE 29 OF 30 COPYRIGHT MATERIAL 2014
- 30. t OCT-14 PAGE 30 OF 30 COPYRIGHT MATERIAL 2014 NEXT STEPS MINIFAB AUSTRALIA +61 3 9764 2241 FOLLOWUS www.MINIFAB.com.au Dr. Erol Harvey CEO erolharvey@minifab.com.au + 61 3 9764 2241 Dr. Micah Atkin Business Development – EU micahatkin@minifab.com.au +44 (0)7565 968199 (direct) Dr. Andrew Campitelli Manager, Business Development andrewcampitelli@minifab.com.au + 61 3 8689 9470 (direct) Dr. Bob Mehalso Business Development – USA bobmehalso@minifab.com.au +1 (585) 370-8368 (direct) Selecting MiniFAB as your Disposable Cartridge development and manufacturing partner, gives you commitment and dedication to the business success of this initial product and other products in your pipeline.