Transcript Movendos ppt

Lean and Healthy Startup
SW Startup Day
11th Dec 2013
Stefan Baggström
Topics
• Lean Startup
• Medical SW
• Lean in regulated industry?
Tools for effective health coaching
Social exclusion
Physiotherapy
Physical
activity
Nutrition
Mind balance
Coaching
Psychotherapy
Preventive healthcare
Healthy habits
Knowledge vs Behavior
Individual’s
behavior
40 %
Genes,
environment,
healthcare
 Coach’s support to your every day life
 Highly personalized training tasks
 Use with your favorite device
Customer
Coach
Arto Leppisaari
Stefan Baggström
Hannu Nieminen
Outi Kotala
Toimitusjohtaja
Teknologiajohtaja
Tutkimusjohtaja
Käyttökokemus
Hannu Mikkola
Carlos Perez
Antti Hiekkanen
Henri Terho
SW arkkitehti
SW kehitys
Myynti
SW kehitys
Yhteistyökumppanit
About me
• ~20 years in SW & telco business
• Various roles in Nokia SW
platforms and products
• 2 years in startup life
– First incubating at TUT
– Now startup co-founder & CTO
Our bookself
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Lean startup
Temporary organisation for learning.
THE product is not SW, but the whole.
It’s customer development with agile
product development:
• business models
• actionable metrics
• innocation accounting
• MVPs
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Medical device
Must conform with regulation
Must not endanger the safety or
health of the patient or other persons
Manufacturer to ensure
• Safety
• Suitability for intented use
• Performance and reliability
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Regulation
• Depends on the market, country,
type of medical device
• Example case:
SW product with medical intended use
Targeting European market
Council Directive 93/42/EEC
There are applicable harmonized
standards, which help to comply with
the directive
– In addition, the directive has
requirements for validation and
releasing
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Standard set (example)
IEC 62304 Medical device software Software life cycle processes
EN 62366 Medical devices. Application of
usability engineering to medical devices
ISO 14971 Medical Devices-Application of
risk management to medical devices
ISO 13485 Medical Devices. Quality
management systems. Requirements for
regulatory purposes
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Requirements for
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SW development process
Quality management system
Risk management process
Usability process
Clinical investigation
Validation
Registration
Placing on the market
Incident reporting
Etc.
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Regulation continued
• Directives and laws for
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Privacy
Security
Language support
…
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Unlike others?
• Other regulation applies to
airplane, railway, and many other
industries
• SW project risks: schedule & costs +
safety & essential performance
• Market area defines requirements:
EU, US, China, Russia, Australia, …
• Time to money: development time
+ validation time & approval
Customer and product development
OUR WAY
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Customer development
• Collaboration with customers
• Iterate and verify
• Problem centric as opposed to
product or technology centric
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Our journey
Jan-2012
Explore
May-2012
Business models and
product concepts
Most promising 2
1st prototype
Jan-2013
Problem / solution fit
…
Understand
2nd prototype
…
Dec-2013
Product / market fit + Sales
Commercial product
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Source: http://practicetrumpstheory.com/blog/
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Agile SW development
• SW life-cycle process
• Risk management
• Documentation
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Iterations
Sprint
Product backlog
Item 1
Item 2
Item 3
SW
release
http://scalingsoftwareagilityblog.com/the-big-picture-is-now-the-scaled-agile-framework/
Release planning included
Release plan
Rel 1
Rel 2
Rel 3
Agile development life-cycle
http://www.agilemodeling.com/essays/agileDesign.htm
Full life-cycle
Patch update/
bug fixes
Project preparation
Development
Feature complete
Release
Validation
In use
Maintenance
preparation
Validation
Release
Development in sprints
Retirement
Feature complete
Development
Risk management
• Risk analysis
– Method(s): FMEA, FTA, …
– Initial analysis + incremental
• Reports & reviews
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Documentation
• Process documentation
– SW process
– QMS document(s)
• Project documentation
– Intended use
– Plans
– Reports
• Traceability
– Reqs-impl-tests-releases-…
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All inclusive
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Top agile with?
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Traceability
Risk management
Test planning, specs & reports
Documentation
Treat all requirements alike!
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Thank you!
Stefan Baggström
[email protected]
Tel +358 50 581 6919
Source: www.juoksufoorumi.fi
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