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5 Tips for Commercialising Lab-on-a-Chip

San Diego 24 Sept 2012
by

Erol Harvey

on 18 October 2012

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Transcript of 5 Tips for Commercialising Lab-on-a-Chip

Internal Technology Base Current Market Dr. Erol Harvey
CEO
www.minifab.com.au 5 Tips
for Commercialising
Lab-on-a-Chip 1. The Team 2. The Goal 3. Feel Factor 4. The Design 5. The Cost Multidisciplinary Common Language Biochemists
Engineers
Software specialists
Regulatory specialists
Investors
Clinicians
End users Use Networks, Alliances, Partnerships, Experienced Contractors ... to extend your capacity Biochemists
Engineers
Software specialists
Regulatory specialists
Investors
Clinicians
End users All specialists have their own jargon and prejudices.

Make sure you know what your project is inheriting Microfluidic Toolbox Thank you for your attention ... Define what success looks like ISO 13485:2003 + AC:2009
ISO 9001 User needs
Performance targets
Price targets
Use case(s)
Investor needs
Regulatory needs
Rebate strategy Use a staged development strategy

Start with high level concepts and a
Product Requirements Document (PRD)

Use the PRD to drive subsequent R&D User Needs R&D Input R&D R&D
Output Product /
Service Review V erification V alidation Sample to answer ... easy to say, hard to define Specimen collection method
Specimen tracking
Sample transfer
Sample preparation

Reagents - onboard / offboard
Biohazard containment
Disposal method

Power, Optics, Data Temperature
Humidity
Dirt, dust, debris
Users
Competitors Think outside the box (i) Design to match manufacturing techniques (ii) Make each part serve many functions (iii) Reduce the number of materials (iv) Understand calibration and control methods How far will your funding get you? Manufacturing cost model ... and does everybody understand this? Inventors
Investors
Engineers
Marketing
.... and you Use a Staged Development Plan to grow value and reduce risk Intelligent scaling Making more reduces unit costs
How to meet $ targets at product launch? Manual manufacturing
Semi-automatic manufacturing
Fully automatic manufacturing GMP Regulatory compliance Impact of design decisions Cost modeling early in R&D 1. The Team 2. The Goal 3. The Feel Factor 4. The Design 5. The Cost Licensing Technology Spin-offs Technology Insourcing External Technology Base New Market Source: Chesborough (2006)
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