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OCT-14 PAGE 1 OF 30 COPYRIGHT MATERIAL 2014 Pathways from Laboratory to Real World Products Dr. Erol Harvey, PhD, FTSE CEO, MiniFAB [email protected]
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OCT-14 PAGE 1 OF 30 COPYRIGHT MATERIAL 2014
Pathways from Laboratory to Real World Products
Dr. Erol Harvey, PhD, FTSE CEO, MiniFAB [email protected]
OCT-14 PAGE 2 OF 30 COPYRIGHT MATERIAL 2014
Avoiding the ���Valley of Death
OCT-14 PAGE 3 OF 30 COPYRIGHT MATERIAL 2014
R D
Valley of Death $ Investment Industrial $
Government
Grants
Public
Industrial
OCT-14 PAGE 4 OF 30 COPYRIGHT MATERIAL 2014
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
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 6 OF 30 COPYRIGHT MATERIAL 2014
WORK FLOW analysis UNDERSTANDING, SIMPLIFYING, SPECIFYING
Many names Work Flow Analysis Use Case Scenarios Voice of Customer (VoC) Human Factors Engineering User Interface
OCT-14 PAGE 7 OF 30 COPYRIGHT MATERIAL 2014
WORK FLOW analysis 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
OCT-14 PAGE 8 OF 30 COPYRIGHT MATERIAL 2014
WORK FLOW analysis 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
OCT-14 PAGE 9 OF 30 COPYRIGHT MATERIAL 2014
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)
+ + +
Physicians RNs Technicians Anesthesiologists … others
Purchasing Quality Risk management
Physical space/layout Air quality/temperature LighVng (natural v. arVficial) Color story Material selecVon Power/electricity Audio/noise polluVon
Hospital Physician office Clinics Urgent care centre Surgi center home
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
Ergono
mics +
Anthrop
ometrics clinicians context device lifecycle physical
support staff
paVents caregivers
decision-‐makers
Biomed techs Environmental services Central/sterile supply … others
condiVons
purchase
storage
in-‐use
disposal
reprocessing
maintenance
perceptual
cogniVve
Third party
PEOPLE (stakeholders/users)
PLACE ((use environments)
TASK (touch-points of use)
ABILITY (human use performance)
OCT-14 PAGE 10 OF 30 COPYRIGHT MATERIAL 2014
WORK FLOW analysis 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
OCT-14 PAGE 11 OF 30 COPYRIGHT MATERIAL 2014
Work flow analysis
Additional example
OCT-14 PAGE 12 OF 30 COPYRIGHT MATERIAL 2014
Sample introduction 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
OCT-14 PAGE 13 OF 30 COPYRIGHT MATERIAL 2014
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 14 OF 30 COPYRIGHT MATERIAL 2014
Containment and protection Caps, covers, sliders, shells
Containment of biohazard Caps Covers
Protection of surfaces Sliding Twisting Labels (including tear off) Recessed surfaces Stand offs
OCT-14 PAGE 15 OF 30 COPYRIGHT MATERIAL 2014
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 16 OF 30 COPYRIGHT MATERIAL 2014
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 17 OF 30 COPYRIGHT MATERIAL 2014
Cartridge concept example
Example Cartridge for POC
On-‐board reagent storage (wet and dry)
Microfluidic channels, mixers, valves, integrated biosensor
OpVcal detecVon chambers and interface to instrument
Product idenVficaVon
Sample input port
Waste storage
Example conceptual representation for illustration and communication purposes only.
OCT-14 PAGE 18 OF 30 COPYRIGHT MATERIAL 2014
SYSTEM requirements 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
OCT-14 PAGE 19 OF 30 COPYRIGHT MATERIAL 2014
MANUFACTURING PROCESS Design Concept
GeneraVon V&V 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)
OCT-14 PAGE 20 OF 30 COPYRIGHT MATERIAL 2014
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 21 OF 30 COPYRIGHT MATERIAL 2014
Design For Manufacture TRANSFORMING YOUR IDEAS INTO FULLY MANUFACTURED PRODUCTS
MANUFACTUREASSEMBLY ISO13485GMP QUALITY
OCT-14 PAGE 22 OF 30 COPYRIGHT MATERIAL 2014
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 23 OF 30 COPYRIGHT MATERIAL 2014
ST
AG
ED
DE
VE
LOP
ME
NT
S
TR
AT
EG
Y
Stage 0
Stage 1
Stage 2
Stage 3
Stage 4
Definition and Concepts
Proof-of-Principle
Concept Demonstrator Proto
ALPHA Prod
BETA Prod
REVIEW MANUFACTURING FOCUS DESIGN FOCUS
OCT-14 PAGE 24 OF 30 COPYRIGHT MATERIAL 2014
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 25 OF 30 COPYRIGHT MATERIAL 2014
STAGED Development ISO CERTIFIED DESIGN, DEVELOPMENT & MANUFACTURE - GMP
R D
$ Investment Industrial $
Government
Grants
Public
Industrial
Stage 0
Stage 1
Stage 2
Stage 3
Pre -‐ Stage 0
Stage 4
OCT-14 PAGE 26 OF 30 COPYRIGHT MATERIAL 2014
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 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 PAGE 27 OF 33 COMMERCIAL IN CONFIDENCE
OCT-14 PAGE 28 OF 30 COPYRIGHT MATERIAL 2014
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 29 OF 30 COPYRIGHT MATERIAL 2014
Ask for direcVons at the beginning of the journey, not at the end!
OCT-14 PAGE 30 OF 30 COPYRIGHT MATERIAL 2014
t
NEXT STEPS
MINIFAB AUSTRALIA +61 3 9764 2241
FOLLOWUS www.MINIFAB.com.au
Dr. Erol Harvey CEO [email protected]
+ 61 3 9764 2241
Dr. Micah Atkin Business Development – EU [email protected]
+44 (0)7565 968199 (direct)
Dr. Andrew Campitelli Manager, Business Development [email protected]
+ 61 3 8689 9470 (direct)
Dr. Bob Mehalso Business Development – USA [email protected]
+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.
