3P10: Chronicles 3 Flashcards Preview

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Flashcards in 3P10: Chronicles 3 Deck (33):

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


  • 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


  • 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)



  • 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



  • 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



  • 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



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


What are Generic technologies?

Generic technologies are a platform for product or process innovation

  • These have the potential to be applied to a variety of applications
  • Proof of concept of a set of technical principles – demonstrates basic functionality upon which applications could be developed
  • Require lots of subsequent R&D by private sector to be commercial available
  • E.g. additive manufacturing


What are Infra technologies?

Quasi-public goods, acting as technical tools which are underpinning, translational and highly appropriable

  • E.g. Scientific and test methods
  • Standard reference materials
  • E.g. Handbooks containing detailed collations of mechanical properties
  • Scientific and engineering databases
  • Process materials
  • Analysis techniques



What are production technologies?

Production technologies are public goods


What are the key messages of L11?

  • Emerging technology making the transition from the applied science domain to an engineering industrial domain may need to innovate a novel set of engineering tools and manufacturing technologies.
  • The firms developing the new product technology may not have core competencies in the technical areas relevant for the new tools.
  • Reducing private sector investor risk (“Valley of Death”) may require de-risking a broad range of technologies
  • A range of government agencies may need to be involved to address associated ‘market failures’
  • Firms may need to access a complex system of public research & innovation programs/institutions when the crossing the ‘Valley of Death’


USA: National Network for Manufacturing Innovation (NNMI)

Combines applied research + education/workforce skills to develop future manufacturing hubs

  • A “private-public partnership”
  • Provides a manufacturing research infrastructure for industry & academia to solve industry related problems

Composed of linked Institutes for Manufacturing Innovation with common goals

  • Academia & government partners leverage existing resources to collaborate and accelerate commercialization of manufacturing innovation

They build workforce skills at all levels and enhance manufacturing capabilities in companies of all sizes


What do Manufacturing Institutes do and what are their goals?

  • Interface with academia
    • Universities and National Labs, community college
  • Mission:

Promote sustainable domestic innovation ecosystems, and the training of a skilled workforce to accelerate the development, scale-up and deployment of promising advanced manufacturing technologies


The Engine (MIT)

A start-up accelerator based on:

  • Early proof of concept stage, scale-up to the commercial production stage

Different support for different stage of scale-up

  • Facilities – labs, computers, facilities, office space
  • Expertise – capital raising, team building, marketing, product development
  • The engine accelerator fund – targets investments in hard-technology firms (e.g. biotech, MD’s)
    • Focuses on firms at the translation stage between science and start-up



HVM Catapult’s network has 7 centres

  • Established by Innovate UK £200m government investment
  • Mission to invest in TRL 4-6 technologies
  • Centres where engineers work on late-stage R&D to transform “high potential” ideas to products


Areas of interest: high value manufacturing, cell therapy, satellite applications



  1. Emerging technology scale-up is challenging due to the technological risk associated with a potential wide range of technologies
  2. To cross the VoD requires aligning technology de-risking efforts with other activities (e.g. HR, skills)
  3. Firm may not have technical/operational competencies needed to address these risk
    1. But may be found in private/public sector organisations