Annex B: ASEAN Dx Initiative
Project Evaluation Criteria
i. Strategic Fit to ASEAN Member States
- Health impact to ASEAN member state
(e.g. Does the product reduce cost to healthcare delivery?)
ii. Value Proposition
a. Medical Value
- Addresses unmet medical needs
- Clear and viable intended use
- Clinical utility (effectiveness, practicability, accessibility, acceptability)
- Provides early window for therapeutic intervention
- Aligns with local clinical KOLs, clinical strengths & interests
b. Workflow Efficiency
- Labour saving and cost reduction
- Minimal packaging and waste
- Minimal to no training required
- Enhances productivity in healthcare sector
- Fits into existing clinical diagnostics and patient management workflows
c. Performance Characteristics
- Accuracy, safety and reliability
- Analytical performance: eg. detection limit, accuracy & precision, QC
- Clinical performance: eg. false positives & negatives, correlations, actionable results
iii. Competition, Partnerships, Regulatory Pathway
a. Competitive Landscape
- Comparison of proposed solution against the existing solutions (What is the unique selling point?)
- Competing emerging technologies and start-ups (ie. can it easily be copied?)
- Freedom to operate / execute (IP)
- Cost & speed of in-licensing
b. Development Roadmap
- Regulatory hurdle, commercial deployment pathway
- Workplan, deliverables & budget
c. Development Bandwidth
- Can the industry partner execute development & commercialization
- Access to clinical specimens and patients
- Involvement of local development partner
iv. Market and Operationalization
a. Commercial Attractiveness
- Size of addressable market
- Niche market segmentation
- New market creation
b. Product Commercial Viability
- Clear go-to-market roadmap (eg. user, payor, government buy-in, health economics etc.)
- Product manufacturability and/or outsourcing plans
- Product cost and scalability
- Market adoption and access
- Viable and sustainable supply chain
c. Commercialization Party Profile
- Co-development commitment
- Potential licensee credibility or track record
- Further funding downstream
- Commitment to co-funding (through host country or enterprise)