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.
What are the uses of TRL?
TRLs are a technology management communication tool
- Used to improve understanding of the status of technology, among all sectors involved in development, deployment and use.
Explain why at some point it becomes inappropriate for a technology to be subsidised
As current technology matures and performance improves, it is no longer breakthrough tech.
- Technically advanced for industry to take over
- Questions over using public money to take products to market
- Gov’t against funding products to market & wants to avoid “crowding out”
- If public sector invests too heavily, no incentive for private sector to enter market
Explain why private-sector investment in the transition to emerging technologies is inhibited
- They prefer to capitalise on significant previous investments from high performance/low cost products
- Small emerging technology markets require significant process technology investment
- This results in higher unit costs
However, the prospect of initial performance-price gap leads private sector to assign substantial technical and market risk in new technology development.
Explain the differences between technology readiness and manufacturing readiness
- Technology readiness develops the ability to deliver its function
- Manufacturing readiness develops the ability to produce the final product
What are MRL’s
MRL’s are a common language for assessing manufacturing maturity of a technology or product.
- Complement the existing TRL’s
- Used to assess maturity and risk of a technology’s underlying manufacturing processes
- Designed to address manufacturing risk mitigation
Emerging technology R&D and associated manufacturing R&D need to go ‘hand in hand’
Describe what is in every sub-thread and MRL level
Each MRL contains 9 threads and 22 sub-threads
With every sub-thread and MRL level, there is:
- A brief description of the element to be assessed
- A more detailed description of the purpose for assessing this element
- Details about suggested sources of information about this element
- Any specific questions that need to be assessed at this MRL
- Any additional considerations that are recommended to include at this stage
- A summary of the lessons learned from previous projects and reviews, that can be translated to general manufacturing assessment
List and explain the different MRL milestones
Milestone A: MRL 4-5
- A focused effort to mature, prototype and demonstrate relevant technologies
- A successful MA initiates the Technology Development phase
Milestone B: MRL 6-7
- Engineering and Manufacturing Development (EMD) phase
- Goal is to develop an affordable and executable manufacturing process
Milestone C: MRL 8-9
- The Production and Deployment phase
- The system should achieve operational capability that satisfies mission needs
FRP: MRL 9-10
- Full-Rate production of system
USA’s Materials Genome Initiative for Global Competitiveness
What’s their goals? What is their innovation structure? What do they aim to improve?
Goals to double rate at which advanced materials are discovered, developed and scaled-up to manufacturing
Through a development of an innovation infrastructure:
- Computational tools
- Experimental tools
- Digital data
- Collaborative networks
These combine to produce an infrastructure that aims to improve:
- Human welfare
- Clean energy
- The next generation workforce
- National security
Why is the valley of death widening (for manufacturing technologies)?
Reduction in private-sector investments:
- Complexity of new application technologies – risks across multiple component technologies
- Accelerating technology lifestyles – ROI constrained within narrowing windows of opportunity
- Firm “specialisation” in a limited set of technology applications
Risk associated with necessary, but non-core competency technologies and tools
