Lean SW Startup in Regulated Medical Business
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Lean and Healthy Startup SW Startup Day 11th Dec 2013 Stefan Baggström
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How to be lean in regulated industry? Case Movendos - A SW startup developing tools for effective health coaching. Presented in SW Startup Day at TUT on 11th Dec 2013.
Transcript of Lean SW Startup in Regulated Medical Business
Lean and Healthy Startup
SW Startup Day11th Dec 2013
Stefan Baggström
Topics
• Lean Startup• Medical SW • Lean in regulated industry?
Tools for effective health coaching
Nutrition
Physicalactivity
Physiotherapy
Psychotherapy
Social exclusion
Mind balance
Preventive healthcareHealthy
habits
Coaching
Knowledge vs Behavior
Individual’s behavior
40 %
Genes, environment,
healthcare
Coach
Customer
Coach’s support to your every day life Highly personalized training tasks
Use with your favorite device
Arto Leppisaari
Toimitusjohtaja
Stefan Baggström
Teknologiajohtaja
Hannu Nieminen Tutkimusjohtaja
Outi KotalaKäyttökokemus
Yhteistyökumppanit
Hannu Mikkola
SW arkkitehti
Carlos PerezSW kehitys
Antti HiekkanenMyynti
Henri TerhoSW kehitys
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
• 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– Privacy– Security– Language support– …
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
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OUR WAYCustomer and product development
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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 journeyExplore
Business models and product
conceptsMost promising 2
Understand
…2nd prototype
Problem / solution fit
Commercial product
Product / market fit + Sales
Jan-2012
May-2012
Jan-2013
Dec-2013
…
1st prototype
…
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Source: http://practicetrumpstheory.com/blog/
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Agile SW development
• SW life-cycle process• Risk management• Documentation
Sprint
Item 1Item 2Item 3
Product backlog
SW release
Iterations
http://scalingsoftwareagilityblog.com/the-big-picture-is-now-the-scaled-agile-framework/
Release planning included
Rel 1Rel 2Rel 3
Release plan
Agile development life-cycle
http://www.agilemodeling.com/essays/agileDesign.htm
Development in sprints
Full life-cycle
Project preparation Feature complete Release Validation In use
Maintenance preparation
Feature completeRelease
Validation
Development
Development
Retirement
Patch update/bug fixes
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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?
• Traceability• Risk management• Test planning, specs & reports• Documentation
Treat all requirements alike!
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Source: www.juoksufoorumi.fi
