IntroductiontoProofofConceptIntroduction to Proof of Concept...• ISO 80601-2-70Medical electrical...
Transcript of IntroductiontoProofofConceptIntroduction to Proof of Concept...• ISO 80601-2-70Medical electrical...
PoC
Western Balkans Proof of Concept Scheme
Introduction to Proof of ConceptIntroduction to Proof of Concept
Project funded by the European Union Implemented by
www.eu4tech.eu
Project funded by the European Union PoC
Introduction and over-view of the podcastPoC WB6
• Defining ‘PoC’
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g• Technology Readiness Levels (TRL)• PoC as a stage in the process of transforming
an idea to an innovation.• Activities to build value for technology
adoptersadopters.• Activities to identify a route to market and
important stakeholders/ early adopters.
Project funded by the European Union PoC
What is ‘PoC’?PoC WB6WB6
“Proof of concept (PoC) is the realization of a method or idea in
order to demonstrate its feasibility, or to y,verify that a concept or theory has practical potential.
evidence, typically deriving from an experiment or pilot project, which p p p j ,demonstrates that a design concept, business proposal, etc. is feasible.
a small exercise to test a design idea or assumption.
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PoC as a stage in a journeyPoC WB6
• PoC is one stage in the development journey that
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g p j ytakes us from an idea to an innovation.
• PoC is level ‘3’ of the Technology Readiness Scale.Project funded by the European Union PoC
gy
What is the TRL Scale?PoC WB6
The Technology Readiness Level (TRL) scale was originally defined by NASA in the 1990’s as a means for measuring or indicating the maturity of a given
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the 1990 s as a means for measuring or indicating the maturity of a given technology.
The TRL spans over nine levels as follows:TRL 1 – Basic principles observedTRL 1 Basic principles observedTRL 2 – Technology concept formulatedTRL 3 – Experimental proof of conceptTRL 4 Technology validated in labTRL 4 – Technology validated in labTRL 5 – Technology validated in relevant environment (industrially relevant
environment in the case of key enabling technologies)TRL 6 – Technology demonstrated in relevant environment (industriallyTRL 6 – Technology demonstrated in relevant environment (industrially
relevant environment in the case of key enabling technologies)TRL 7 – System prototype demonstration in operational environmentTRL 8 – System complete and qualifiedTRL 8 – System complete and qualifiedTRL 9 – Actual system proven in operational environment (competitive
manufacturing in the case of key enabling technologies; or in space)
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PoC WB6
TRL3: PoCPoC WB6WB6WB6
• PoC sits at Level 3 on the Technology Readiness Scale (TRL)(TRL)
• above basic and applied research activity (TRL 1-2)research activity (TRL 1-2)
• below TRL4: Technology validated in the lab.validated in the lab.
• Most government fundedMost government funded research projects end at TRL2.
Project funded by the European Union PoC
Typical outputs at the PoC levelPoC WB6WB6
Prototype• an early sample, model, or
Minimum Viable Product (MVP)• A minimum viable
release of a product built to test a concept or process.
product (MVP) is a version of a product with
• just enough features to satisfy• a new type of machine or device which is not yet ready to be made in
• just enough features to satisfy early customers and provide feedback for future product yet ready to be made in
large numbers and sold.development.
• allows a team to collect the i t f lid t dmaximum amount of validated
learning about customers with the least effort.
Project funded by the European Union PoC
From Prototype to ‘MVP’ towards a commercial productPoC WB6WB6
Project funded by the European Union
Western Balkans Proof of Concept SchemeEuropeAid/140158/DH/SER/MULTI
Example PoC: Can a bike fly?PoC WB6WB6
Project funded by the European Union PoC
Example PoC: Flying bike prototypePoC WB6WB6
Project funded by the European Union PoChttps://www.youtube.com/watch?v=8Ovsgui4YWs
‘Hoverbike’PoC WB6WB6
Project funded by the European Union PoC
PoC: Next stepsPoC WB6
• Milan Duchek, technical director of Duratec, a
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, ,bicycle frames maker, says more powerful batteries will be needed before a human takesbatteries will be needed before a human takes a two-wheeled flight.
• (But the concept of a flying bike has been proven!)p )
Project funded by the European Union PoC
Adding ‘value’ 1: Monopoly rightsPoC WB6WB6
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Capturing PoCPoC WB6
• What is the concept?
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– flying bike• What is the main question you will be answering?
can a bike be built that will fly?– can a bike be built that will fly?• What are the more detailed technical questions you
hope to answer to move this towards this a commercialhope to answer to move this towards this a commercial product?– How stable is the bike? (Design)– What load can it carry? (max load/ minimum lift)– How long can it fly for? (Weight vs. battery life)
How far can it fly? (Range per unit load and unit power)– How far can it fly? (Range per unit load and unit power)– Etc.
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Example 2: COVID-19 ventilator challengePoC WB6
PoC Questionb ld l l h b
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• Can we build a simple ventilator that combines a pressure-controlled continuous mandatory ventilation mode
(PC-CMV) and( ) settable breathing rates and expiration/inspiration time ratios
• intended as a last resort to ventilate COVID-19 patients. Th d i h ld• The design should minimize the use of technical components Use components that are common in industry Use components that are common in industry
• so its construction may be possible in times of logistical disruption or in areas with reduced access to technical materials and at a moderate costmaterials and at a moderate cost.
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Result: PoC VentilatorPoC WB6WB6
Project funded by the European Union PoC
Commercial certified ventilatorPoC WB6WB6
Project funded by the European Union PoC
Adding value 2: Regulatory approach[‘Quality/ performance standards’ /‘certification’]
PoC WB6 [ Quality/ performance standards / certification ]
• BS EN 60601-1:2006+A12:2014 Medical electrical equipment. Part 1: General requirements for basic safety and essential performance
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General requirements for basic safety and essential performance• BS EN 60601-1-2:2007 Medical electrical equipment. Part 1-2: General
requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and testsg p y q
• BS EN 60601-1-6:2010+A1:2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability
• BS EN 60601-1-8:2007+A11:2017 Medical electrical equipment. Part 1-8: General requirements for basic safety and essential performance -Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemssystems in medical electrical equipment and medical electrical systems
• ISO 80601-2-70 Medical electrical equipment. Part 1-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipmentbreathing therapy equipment
• Comparison table ISO 9001:2015/IATF 16949:2016 and ISO 13485:2016
Project funded by the European Union PoC
PoC Summary (I)PoC WB6
• PoC is one stage that an idea will pass through
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g p gon its journey towards a marketable innovation.
• PoC lies at level 3 of the Technology Readiness Level (TRL)Level (TRL).
• It typically follows from where government funded research finishesfunded research finishes.
It will be followed by the technology being fully validated in a lab (TRL4) and then the relevant environment (TRL5).
Project funded by the European Union PoC
PoC Summary (II)PoC WB6
Development activities that typically occur at
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p yp ythe PoC stage include:D i i b ildi d t ti t t• Designing, building and testing prototypes– This may involve the use of 3D printers
• Designing, building and testing a minimum viable product (MVP)viable product (MVP)– This will be used to seek feedback from
technology users and adopterstechnology users and adopters
Project funded by the European Union PoC
Adding valuePoC WB6
• Activities at PoC stage also seek to ‘add value’
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gto the technology for an adopter.Th t i ll i l• These typically involve securing a monopoly right e.g. a patentPreparing for certification or accreditation to meet
industry standards.y
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Exploring ‘route to market’PoC WB6
PoC stage is also used to:
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• ‘Benchmark’ (compare) the technology against other ‘solutions’
The objective is to identify a unique selling point (USP) or– The objective is to identify a unique selling point (USP) or the ‘Unique Value Proposition’.
• Explore markets for the product or service includingp p g– size, structure, trends and drivers.
• identify early technology adopters – this may require a MPV
• Understand supply chainsI ti l t id tif th h ill f t d– In particular, to identify those who will manufacture and distribute a device as well as those who will buy it and use it.
Project funded by the European Union PoC
For more informationPoC WB6WB6
Closing date for PoC Applications: 24th June 2020Project funded by the European Union PoC
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