3P10: Chronicles 3 Flashcards
Microfluidic coupon
- Designed to perform bio sensing test in 10 minutes
- Based on ELISA technology
- When placed under a machine, the coupon changes colour if certain enzymes are present
Applications:
- Detect antibodies against Toxoplasma in serum
- Detect tuberculosis both in GP office and hospital laboratory
- Detect tuberculosis
Define Scale-up
Scale-up can be defined as the translation of an innovation into a market
Scale-ups are enterprises with average annualised growth in employees (or in turnover) greater than 20 per cent a year over a three-year period, and with 10 more employees at the beginning of the observation period.
What are the challenges face during scale up?
- Technologies function well at large scale
- Markets develop to accept products produced at scale
- Supply chains must be developed, demand created and capital employed
- Go through different requirements for capital, management, skills and organisational structure
- People working within these scale-up companies can experience ‘growing pains’ due to shifting demand
What are the dimensions of scale-up?
- Value chain scale-up
- Business scale-up
- Process/Production Scale-up
- Technology development Scale-up (TRL2-TRL9)
® Emerging programmes addressing scale-up are aiming to:
- Integrate support, and
- Facilitate linkages and alignment between different innovation activities
D1:Technology development scale-up
Novel products face technical uncertainties and risks
- Transforming lab prototype to product for potential of full scale production
- Challenging for devices based on integrated technologies
- Process appropriate for one technology may not be appropriate for another
D2:Process/Production scale-up
Research need for:
- Novel production technologies (e.g. additive manufacturing)
- Adapting known processes for novel technology
Many novel production processes/technologies require:
- Demonstration of functionality/cost effectiveness at greater production volumes
Crucial to: create routes to examine pilot-scale production, demonstrate and test infrastructure
D3:Business Scale-up
From niche to large markets – technical and operational capabilities and organisational structures need to expand.
Challenges include:
- Finding right employees, building leadership capability, accessing customers in other markets, accessing right combination of finance, navigating infrastructure in each region.
D4:Value Chain Scale-Up
Needed to support new products, business models and markets with new manufacturing capabilities, technical services and supply of materials.
Example 1: Carbon nanotube devices:
- Ensuring quality
- Coordinating with suppliers
- Format
- Transportation
Manufacturing scale-up will increasingly require co-operation across the industrial value chain.
What are the different frameworks for managing dimensions of scale-up
- Critical Path Dimensions: Regulation-focused
- Looks at safety, medical utility and industrialization
- From basic research to FDA Filing approval
- Innovation “4 journeys”: Focus on investment and markets
- Technology journey
- Company journey
- Market journey
- Regulation journey
- Aligned innovations: Role of government (e.g. partnerships)
- Looks at public/private & government incentives
- Industrial Emergence Mapping – Looks at:
- Market
- Policy: regulation, standards, etc
- Application
- Technology
- Enablers: Science, enabling technologies
CASE STUDY: Appligraf
- Talk about the 4 dimensions applied to Appligraf
Appligraf is a tissue engineering product
- A unique, advanced treatment for healing
- Created from cells found in health human skin
- Looks like a thin, real piece of skin
Market
- Overestimated market for artificially engineered skin
- Based returns on current money being spent to treat chronic wounds
- Difficult to get physicians to use a novel therapy
® Marketing problem needed understanding of customer and the business model of a clinic (and how to fit into it)
Policy
- Patents & regulations couldn’t keep up due to long review/approval times
- No harmonisation in regulations between US, EU, Australia
- Restrictions on reimbursement for the products
- Takes 1+ years after approval to decide reimbursement
Application
- A case of technology looking for an application
- Appligraf only appropriate for specific types of chronic wounds (so a small market)
- Was not for small nor really bad wounds – somewhere inbertween
Technology
- High cost to produce, maintain and transport these products
- Short shelf life reduced availability to patients
- Had to ship cells warm
- Invested heavily in manufacturing capital at an early stage left them vulnerable
- Not investing in manufacturing research to consider scale-up challenges also problematic
Future
Appligraf was re-launched with new business models and supply chains ® successful
Describe what the phase-gate is
A standard risk management framework used in industry – focus of this process is on product development
The project has 4 phases – they outline a structured idea-to-launch process
Used to execute the 4 principle elements of innovation:
- Idea generation
- Project selection
- Product development
- Commercialisation
Explain the stage in the phase-gate
- Each stage is designed to collect specific information to help move the project to the next stage
- Activities in each stage are designed to gather information and progressively reduce uncertainty and risk
- Stages are increasingly costlier
- The results of this integrated analysis become a set of deliverables that provide the input to decision meetings (i.e. the gates)
Explain the gates in the phase-gate framework
Preceding each stage, a project passes through a gate
- Here a go/kill decision is made – determines whether or not to continue investing in the project
- These serve as quality control checkpoints with three goals:
- Ensure quality of execution
- Evaluate business rationale
- Approve the project plan and resources
- Four outcomes at the phase-gate evaluation
- Go, kill, hold (suspend project till market returns), recycle (more work needed at current stage)
List out the phase gate metrics:
- Strategic fit & Importance – degree of alignment and/or innovation strategies
- Product & Competitive Advantage – competitive advantage
- Market attractiveness – size & growth of the market
- Technical feasibility – degree of technical complexity
- Synergies & core competencies – ability to leverage core competencies & availability of resources
- Financial risk vs rewards – Length of PP, financial risk
Define a TRL
A measurement system that supports assessments of the maturity of a particular technology and the constant comparison of maturity between different types of technology.
A TRL scale is a sequence of defined categories of development activity – used to categorise the maturity of a novel technology.