111027 AIS MiniFAB Handout

Transcription

Technological Innovations that Win
The Pathway from Concepts to Outcomes
Dr. Erol Harvey
MiniFAB (Aust) Pty Ltd
www.MiniFAB.com.au
© MiniFAB 2011
Tuesday, 8 November 11
Presentation given at NESC Meeting
(National Elite Sports Council)
Australian Institute of Sport
Canberra, Australia
9 November 2011
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MiniFAB (Aust) Pty Ltd
Private Company • Established October 2002
Team of 55 people Headquartered in Melbourne, Australia
Specialist in polymer micro-engineering
Demonstrated track record around the world
AIRBUS • AMCOR • BAYER • BIOMERIEUX • CADBURY • COOK •
CSIRO • DSTO • DUPONT • INVETECH • NXP (PHILIPS) • TEARLAB •
MASTERFOODS • MONASH
Full Development and Manufacturing facilities and capabilities
Our team are world class experts in:
Over 150 Clients
§ Micro-Bio Technology design and integration
Over 800 completed contracts
§ Microfluidics design; Electrode integration
§ Microsystem assembly and packaging
§ Manufacturing design
§ Manufacturing scale-up : prototype - pilot - volume
© MiniFAB 2011
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MiniFAB was formed in 2002 to provide specialist product development and manufacturing expertise in
polymer microengineering.
The company is now globally recognised as one of the major innovators in the design and manufacture of
miniaturised plastic medical devices such as diagnostic chips and lab-on-a-chip systems.
A contract developer and manufacturer, MiniFAB’s clients are leading players in their fields.
MiniFAB’s Clients and Partners are world-leading global
players.
MiniFAB works in close partnership with clients to deliver
innovative product solutions.
MiniFAB has an extensive international network of
collaborating research organizations and businesses
Low cost IVD
Eye diagnostic
Malaria diagnosis
Cancer detection
MiniFAB is based in Melbourne, Australia
Every project MiniFAB is involved in has partners from other places in Australia or around the world.
By constructing project teams that are the best in their class, and by involving our client intimately in the development program, we ensure that we are most
likely to come up with the most innovative solutions.
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Manufacturing facilities
ISO 13485 (2003): CAD : Class 1,000 and 10,000 cleanrooms : excimer laser : uv laser : 8” photolithography : micro milling : wire bonding :
fusion bonding : die bonding : NIL nano imprint lithography : plasma etch : sputtering : gold deposition : printing : parylene coating : large format
electroforming : injection moulding : embossing : optical microscopy : scanning electron microscopy : confocal microscopy : optical profilometry :
PCR : immunoassay : fluorescence : absorbance : spectrophotometry : flow wrapping : QMS
45,000 ft2 building - 4,000 ft2 cleanroom - 4,000 ft2 GMP facilities for: manufacturing, integration, assembly, packing for
prototype to volume manufacture
© MiniFAB 2011
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MiniFAB operates extensive facilities the are used in all stages of product development and manufacture of
miniaturised plastic devices incorporating microtechnology, nano engineering processes and
biotechnology.
Immuno-assay on chip
Electrochemical biosensor
Passive valve
Double channel system
On-chip mixing.
MiniChemLab Platform
Image: MiniFAB
© MiniFAB 2011
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An example of a disposable immunoassay chip, this plastic device is the size of a microscope slide and
simultaneously runs four ELISA assay tests.
MiniFAB’s MiniChemLab system is a versatile development platform that is easily reconfigured to run the
microfluidic chips. It is used to generate the performance data and control specifications for the devices valuable information for instrument developers to spec and design custom control instruments.
Storage of On-Board Reagents
Integrated blisters for
On-Board storage of wet
reagents
Blister
Fluidic distriibution
Image: MiniFAB
© MiniFAB 2011
Commercial in Confidence
Integrated blisters contain liquid reagents that may be actuated by the instrument, or by the user, to run
assays.
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Lab-on-a-chip - BioSensor Integration
Hybrid System Integration
for Cancer Lab-on-a-Chip
Valve
Fluidic channel
MEMS Sensor
Signal Output
Sandwich Construction
Image: MiniFAB
PC
250µm
PC
250µm
PC
250µm
PDMS
250µm
PC
250µm
PC
250µm
PC
250µm
Adhesive
© MiniFAB 2011
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An example of a hybrid system, this lab-on-a-chip biosensor was developed under the European Union
Framework 6 program “SmartHEALTH”.
The microscope slide sized device contains microfluidic elements, miniature mechanical turn-valves, and
an integrated circuit board on which is mounted a MEMS (microelectromechanical) biosensor.
The research project investigated methods for disposable chip diagnostic devices for a range of cancer
types.
Nano-fluidic biosensor
Tear Diagnostic
Polymer construction
Disposable device
50 nl fluid sample
Gold electrodes
Image: TearLab
Image: MiniFAB
© MiniFAB 2011
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MiniFAB developed and is now the exclusive manufacturer of the TearLab® nano-fluidic biosensor.
The disposable plastic chip is used to collect 50 nl of tear fluid for measurement of osmolarity. The measurement is
used for the diagnosis of Dry Eye.
Application - Tear Diagnostic
Nano-fluidic biosensor
Analysis of ocular disorder
by sampling and analyzing
50nL of tear fluid.
Example: TearLabTM
Image:
Image:Starpharma
TearLab
© MiniFAB 2011
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Image showing the non-disposable instrument of TearLab®. The nano-fluidic chip clicks onto the top of an electronic
“pen” that is brought to the patient to collect the tear fluid.
Sample is collected by capillary wicking into the nano fluidic channel that has been prepared with hydrophilic
surfaces. Once sufficient fluid is collect the pen gives an audible and visual signal to indicate collection is complete
(typically only a few seconds) and starts the measurement. Within a minute or less the information can be displayed
via the digital readout on the TearLab® instrument.
The development of a versatile, highly reproducible nano-fluidic collection device opens possibilities for collection of
other minute fluid samples without the problem of dilution of the critical bio markers under investigation. Examples
could include sweat or saliva as well as other diagnostics using tear fluid.
Application - Sports
Work in the Australian CRC for
MicroTechnology
GPS, Accelerometry, Gyroscope, Force,
Strain, MEMS integration, etc
1999 - 2006
CRC for
MicroTechnology
© MiniFAB 2011
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Many of the staff at MiniFAB have worked on sports applications while at the Australian CRC (Co-Operative
Research Centre) for MicroTechnology (1999 - 2006).
Application areas involved the use of GPS tracking for athlete monitoring in track events, rowing and swimming.
Force, strain and MEMS sensors were also integrated to equipment in rowing and boxing to gather realtime
performance data.
Catapult Sports (www.catapultsports.com) is a spin-out company from the CRC for MicroTechnology and is a global
developer, manufacturer and seller of advanced systems for the training and monitoring of elite athletes.
Messages
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The Quality Circle - your innovation system
URS - your starting point
Staged Development - your stepping stones
Partnerships - your resources
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Messages
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When asked to make this presentation, I was asked to reflect on what the secrets to Innovation success
were from the perspective of starting and building a successful development company.
While there are many individual components to such success, these four broad areas seem to be core to
much of what works:
1) The Quality Circle
2) The User Requirements and Specifications
3) Staged Development
4) Partnerships.
The rest of this talk explores the role and function of each of these elements.
Quality
Plan
Act
Review
Improve
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In the context of this talk Quality is not a “thing” it is an “action”.
There are many quality systems and sub-systems around. To work in a regulated industry such as medical
devices MiniFAB adheres to ISO13485.
Common to all quality systems is the concept of Planning - Acting - Reviewing - Improving done in a
constantly repeating cycle that is often drawn as a circle. Repeating this cycle many times leads to
continuous improvement.
Quality Planning
PLAN
Identify and define
what and how we
want to achieve
ACT
IMPROVE
Implement specific
strategies and
actions
Identify changes and
adjust strategies
REVIEW
Monitor progress
and evaluate
outcomes
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It is important to build the R&D program around a Quality Framework. The basic principle of any quality system is
around Planning - Acting - Reviewing - Improving.
It is all too easy to focus on the first two steps and forget the important second two. Even when researchers are
forced to stop and consider whether they adhere to all the elements of quality planning, it is often the case that the
review step is at best cursory and probably only specific to the area of interest of the reviewer themselves.
This can give a misleading result that the development is on target and meeting objectives, simply because the full
breadth of the objective is imprecisely defined, or not considered within the scope of the person doing the reviewing.
Quality Planning
Audits and Review
Design Qualification
User
Requirements
Plan
Validation
Review
Verification
Functional
Requirements
Performance
Qualification
Operational
Qualification
Verification
Design
Specification
Installation
Qualification
Act
Implementation
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This diagram is called the “V-Curve” (because of its shape) and also the “V&V” process (from verification and
validation).
Without the discipline of this structure it is all to easy to become trapped between high level needs and detailed
design issues without an obvious way forward. For example in the context of point-of-care medical diagnostics, if it is
not clear whether the diagnostic is aimed for the home, doctor, pathology lab, ambulance, or hospital then it cannot
be clear how big the final system can be. It is pointless and expensive designing a hand-held system for a location
that wants it to be lab based.
User Requirements are high level and specific and describe how the user will interact with the system. It may say
something about target price, the product lifetime, and what the user is expected to do with the results obtained from
the system e.g. make an accurate diagnosis.
Functional Requirements describe the “What and How” of the system. It will say something about what the sample is
(blood, urine, tears ...) and how the test will work (optical, electrical, antibody, genetic ...). Calibration methods would
also be described here.
Design Specifications, and there will be many of these for each of the subsystems, describe the detail of each
component. It will be a set of CAD drawings, electrical and material specifications, power supply and usage, reagent
description, software etc.
The developed solution must be Verified against the Requirement in a formal review step. The Regulations mandate
that this review is formally signed off i.e. somebody (s) must carry the can for this.
At the end of the process the device goes out for external trials and the results carefully compared to “truth”. Often
this is termed a Clinical Trial and forms part of the submission documentation to the Regulator (TGA in Australia or
FDA in the USA). This process is called Validation i.e. has the developer proved (validated) that the device meets
requirements
Quality Planning
© MiniFAB 2011
This is an alternative, and slightly more compact diagram illustrating the V&V process.
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Messages
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Messages
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Having detailed the importance of planning and a system-based approach to innovation, the next most
important step is to make sure that the starting point is well described.
In our jargon it is about capturing and agreeing a comprehensive User Requirements Specification (URS).
This is critical to a successful outcome, and should not be short circuited. Failure to capture all of the
specifications means that at some point along the development path somebody is likely to stand up and
say “Hey - this doesn’t do XXX the way I wanted it to”. Depending on when this happens determines the
cost in time and dollars to backtrack and address the unspecified need.
Conversely proceeding with the development without a clear understanding of what the user requirements
are means that the final product, by definition, is useless. There are many examples of researchers
rushing to prototype devices that nobody needs or wants. The lack of funding required to backtrack and fix
this problem is sometimes called “the valley of death” and arguably should never be filled if the root cause
is poor initial planning.
Requirements
What does winning look like?
Who interacts and how should they feel as a result?
What are the interfaces and how are the managed?
What is the work flow and is it intuitive?
How should the process handle faults and failures?
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As the highest level specification document, the URS aims to cover the broadest possible range of
requirements.
Here I will try to draw some analogies between the types of technical questions we would ask in medical
device innovation, and see how they might correlate with questions elite athletes and their coaches might
ask.
Firstly, what does the end result look and feel like? We call it “winning” but what does that mean to all of
the stakeholders involved. We may need to clearly define what stage or level of winning we are aiming for is it to be a national level or all the way up to olympic?
In medical devices many people interact with the instruments - and not only the ones who touch and
operate them. We need to consider the needs of the patient, the operators, the regulators, the funders, the
manager who has to sign off to buy this new classy machine. In the case of a athletic result there are
needs of funders, institutions, sponsors, event co-ordinators, as well as of course the athlete and coach.
Developing the URS is the time to explicitly capture these needs and see if they have to be addressed in
the innovation process.
Engineers always have to consider how their instrument must handle faults and what needs to be done
when predictable and unpredictable things go wrong. This critically determines how the devices are
designed and built. Probably the same needs to be done in athlete training.
User Requirements Specification
© MiniFAB 2011
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With such a wide range of inputs required to build a good URS, the endless meetings, discussions and
documents can seem daunting - unless properly managed this can become such a big task that it
becomes the objective rather than the means to achieving the objective.
One of the challenges is that not everybody may be using words to mean the same thing - they all come
from different backgrounds. For example sales and marketing people have a different way of looking at
needs compared to software engineers. We need to create methods by which various groups can each
have their needs represented and they have time to develop a clear articulation of those needs, without
taking the entire program’s time and budget up doing only that!
Mind Map Tools
© MiniFAB 2011
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If you haven’t looked at it yet, I would suggest that Mind Mapping tools be considered for the early stage,
multi-stakeholder capture of needs.
There are lots of good and inexpensive software tools available now to help generate Mind Maps in real
time. We use these a lot at MiniFAB and find it a good method to visually represent discussions that can
easily branch off in many directions, while still giving everybody in the room a sense that progress is being
made.
It is also easy to get visual feedback on whether the discussion is spending too much time on some aspect
at the cost of some other equally important area.
This is a Mind Map for this entire talk - the whole talk on a single page with all the major points given.
Really this is the only slide of the entire pack that you should ever need.
© MiniFAB 2011
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Having generated a Mind Map of all the needs and specifications, it is important to generate some more
formal documentation that can be signed off by everybody.
We find it useful to classify all requirements as being mandatory or desirable, and to discipline the team to
use language of “shall” (mandatory) or “should” (desirable).
Some requirements will not be fully known or able to be completely specified at the time of preparing the
URS. This is OK - the document should be a living document so that as understanding improves it can be
updated. At some defined point in the development program the specification must be “frozen” and signed
off otherwise nobody will ever be able to review the outcomes of the program to check that the URS has
been met.
Priority Risks
© MiniFAB 2011
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Having captured all of the issues to be included in the URS, the Mind Map is a useful tool to focus on
priority areas, we call them priority technical risks, that require work within the first stage of development.
Creating a Technical Risk Watchlist (an Excel table of the risk, the work being done, and an evaluation of
progress against milestones) can be a simple management tool for showing all the project team that
specific challenges identified in the Innovation process are being addressed and outcomes monitored.
Messages
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Messages
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The “Act” part of the Quality Circle, the Staged Development Program breaks down the process into
manageable steps.
Obviously trying to go out at the first step and win the final race is a nonsensical approach. This may seem
obvious to an elite athlete coach, but it is surprising how many innovation developers try to leap to the end
point in a single giant step. Instead the goal should be broken down into a series of well defined steps with
a clear focus on the aim and outcome of each of the steps. In our business we call the first stage of this
the Proof of Principle (PoP) stage.
While clearly useful in identifying and managing the effort involved to obtain outcomes, it is equally
important that all of the team knows exactly what each step does NOT aim to demonstrate. Failure to
clearly articulate this opens the program to easy criticism by marginal stakeholders (and funders) that the
development program is clearly deficient because you have not demonstrated ability to meet XXXX
requirement. Trying to answer every requirement at every point of the process will have you running
around in circles and never achieving anything of significance.
Staged Development Plan
Stage 0
Stage 1
Concept design approach
Stage 2
Stage 4
Stage 3
Establish manufacture
Time
Volume manufacture
Address defects
PoP
Scope
Requirements
Analysis
Key Technical
Risks
Initial Concepts
CDP
Design Approach
Demonstration :
Core Operations
Core component
function
Set up Cost
Model
Focus on critical
functions
Preliminary field
trials
Beta
PPU
integrated system
operation.
Market feedback
Suitable for in-house Distribute to market
and field trials.
Scale manufacture
Refine
manufacturing
processes to prove
approach.
Trails for internal
evaluation only
Reduce costs (I.e.
scale volume)
Core Functions
Design & Test
Alpha
Refine performance
and function
Focus on reliability &
performance
Focus on manufacture
PoP = Proof-of-Principle CDP = Concept Demonstration Prototype PPU = Pilot Production Unit
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The people who put together elite athlete training programs are leaders in breaking down goals into a series of
milestones, finally bringing each skill together at the right time to win the crucial event. It is likely that this
management practice is one in which those of us not from the sporting area can learn a lot.
The graphic shown here shows how we at MiniFAB break down the product development process, if you like the
Innovation process, for medical devices. The jargon is specific to our application, but the essence is the same: How
to reduce time and effort required for all members in the team to meet a specific objective while making sure nothing
is forgotten along the way. There are specific early stage times for creativity (concept design) and there are later
stages specifically aimed at bedding down the design into a repeatable process (manufacturing).
Having clear visibility for all the team to know which stage we are in, and when we have formally transitioned to the
next stage with its pre-arranged set of targets and metrics is very important.
Messages
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Messages
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This is probably the most important of the four innovation points highlighted in this talk. The ability of teams
and groups to develop deep and meaningful partnerships is likely the differentiating factor between a
winning team and the rest.
It probably seems obvious that partnerships are important, but what are some of the drivers that cause
people to do otherwise? Usually politics, funding and institutional insulation are major factors.
Particularly in large research programs that are funded through a competitive bidding process (government
research organisations, university funding or internal R&D of large firms), the process of winning the funds
is itself the primary objective. Having won the grant, these organisations are generally reluctant to spend
any of it outside. The more $ one brings in, the more impressive the people and equipment one has, and
the more this seems to become the ultimate objective.
Closed Innovation
Corporate Boundary
Market
Research
Projects
5
Basic
Research
10
15
Directed
Research
Product
Research
20
25
Product
Development
30
Market
adoption
years
Selfsustaining
Source: Open Innovation, Henry W. Chesbrough
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The R&D funnel is often used to depict the development activities within a firm (here the focus is on
product or service development rather than research output metrics such as publications or PhD students).
At the basic research end of the funnel there can be many projects on the go, some moving towards a
marketable product, but many not. As the development activity matures towards directed research then
product research, the funnel has fewer projects but they should be moving more consistently towards a
marketable product.
Finally, near the market adoption phase the firm probably only has the resources to get a very few
products through the output end of the funnel.
Open Innovation
Corporate Boundary
Market
Research
Projects
5
Basic
Research
10
15
Directed
Research
Product
Research
20
25
Product
Development
30
Market
adoption
years
Selfsustaining
Source: Open Innovation, Henry W. Chesbrough
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Prof. Henry W. Chesbrough has popularised the concept of an Open Innovation Funnel, depicted above.
The idea of open innovation is being embraced by organisations, large and small, around the world.
MiniFAB's business model is specifically tuned to be a participant in global open innovation.
Here there is still the same concept of large numbers of basic research projects and smaller numbers of
product development projects, however the wall of the funnel, representing the corporations own
boundaries, are drawn as being perforated. Now projects can enter or exit the innovation process at pretty
well any stage in the development cycle. Indeed it is possible for projects to leave the organisation,
undergo further development externally, then reenter the firm later on.
This opens innovation model allows access to skills and resources that are much greater than those ever
affordable to the original organisation. This increase in capacity tends to accelerate development and is
now seen as a key competitive advantage (as opposed to trying to develop the best-in-house at
everything).
Partnerships
Do not assume you can (or have to) do it all.
Use the best in the world - if you don’t somebody else is.
Borrow liberally from other industries
Use and develop your personal networks.
GOOGLE is not a competitive advantage.
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To get started in Open Innovation you need to acknowledge that you do not have to become the best in the
world at everything. Rather you need to work out how to access the best in the world, and build a
meaningful partnership.
Academics are already part of a global community, and so are elite athletes who have the advantage of
continually measuring their performance against international benchmarks. This is a powerful tool for
developing deep and productive partnerships.
It is of course a truism that if you are not working with the best in the world then somebody else is. What is
more important is what you do about it. Some will complain there are insufficient funds to buy the best in
the world, while others will try to work out a way to partner to gain access to that which they could not
afford to develop internally. This also enables us to access skills and technology from other industries,
broadening our innovation base.
At MiniFAB we have found it important to build and develop deep personal and professional networks with
like minded people around the world. We live in an age in which global communication has never been
easier. Do not assume that Google will replace what you can learn from personal networks. If you can find
the information on the web, then probably anybody else can too and so this ceases to become a
competitive advantage.
Messages
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Messages
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Application - Bionic Eye
4 year ARC funded
Development Program
Electrical micro-stimulation of
the V1 visual cortex
Monash Vision Group is funded through the Australian Research Council Research in
Bionic Vision Science and Technology Initiative (SR1000006).
© MiniFAB 2011
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As a final teaser here is some exciting work MiniFAB is doing as part of a partnership with Grey Innovation, Monash
University and the Alfred Hospital.
Under a project funded by the Australian Research Council's Bionic Vision Science and Technology Initiative, the
team is developing an implantable micro-array that will be inserted in to the visual cortex of a person who is blind.
Modern advances in micro fabrication, micro electronics, video cameras, wireless, robotic vision and neural
stimulation all come together to produce a new implant device that will provide visual information to the patient.
This activity is but one area of Medical Bionics, pioneered by the cochlear hearing implant, that will make
considerable impact on peoples lives over the next decade. While aiming to assist people in whom some part of the
natural system has failed, work in this field draws heavily on an understanding of how a fully functional human body
is expected to perform.
There can be very few resources as rich in this understanding as that of elite athletic performance - you here today
have a lot to teach us if only we can build the right partnerships.

111027 AIS MiniFAB Handout

Transcription

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