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!

Stefan Baggströmstefan.baggstrom@movendos.com

Tel +358 50 581 6919

Thank you!

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Source: www.juoksufoorumi.fi