Lean SW Startup in Regulated Medical Business
-
Upload
stefan-baggstroem -
Category
Business
-
view
247 -
download
0
description
Transcript of Lean SW Startup in Regulated Medical Business
![Page 1: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/1.jpg)
Lean and Healthy Startup
SW Startup Day11th Dec 2013
Stefan Baggström
![Page 2: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/2.jpg)
Topics
• Lean Startup• Medical SW • Lean in regulated industry?
![Page 3: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/3.jpg)
Tools for effective health coaching
![Page 4: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/4.jpg)
Nutrition
Physicalactivity
Physiotherapy
Psychotherapy
Social exclusion
Mind balance
Preventive healthcareHealthy
habits
Coaching
![Page 5: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/5.jpg)
Knowledge vs Behavior
Individual’s behavior
40 %
Genes, environment,
healthcare
![Page 6: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/6.jpg)
Coach
Customer
Coach’s support to your every day life Highly personalized training tasks
Use with your favorite device
![Page 7: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/7.jpg)
Arto Leppisaari
Toimitusjohtaja
Stefan Baggström
Teknologiajohtaja
Hannu Nieminen Tutkimusjohtaja
Outi KotalaKäyttökokemus
Yhteistyökumppanit
Hannu Mikkola
SW arkkitehti
Carlos PerezSW kehitys
Antti HiekkanenMyynti
Henri TerhoSW kehitys
![Page 8: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/8.jpg)
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
![Page 9: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/9.jpg)
Our bookself
04/10/2023 © Movendos 2013 9
![Page 10: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/10.jpg)
04/10/2023 © Movendos 2013 10
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
![Page 11: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/11.jpg)
04/10/2023 © Movendos 2013 11
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
![Page 12: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/12.jpg)
04/10/2023 © Movendos 2013 12
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
![Page 13: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/13.jpg)
04/10/2023 © Movendos 2013 13
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
![Page 14: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/14.jpg)
04/10/2023 © Movendos 2013 14
Requirements for
• SW development process• Quality management system• Risk management process• Usability process• Clinical investigation• Validation• Registration• Placing on the market• Incident reporting• Etc.
![Page 15: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/15.jpg)
04/10/2023 © Movendos 2013 15
Regulation continued
• Directives and laws for– Privacy– Security– Language support– …
![Page 16: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/16.jpg)
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
![Page 17: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/17.jpg)
04/10/2023 © Movendos 2013 17
OUR WAYCustomer and product development
![Page 18: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/18.jpg)
04/10/2023 © Movendos 2013 18
Customer development
• Collaboration with customers• Iterate and verify• Problem centric as opposed
to product or technology centric
![Page 19: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/19.jpg)
04/10/2023 © Movendos 2013 19
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
…
![Page 20: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/20.jpg)
04/10/2023 © Movendos 2013 20
Source: http://practicetrumpstheory.com/blog/
![Page 21: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/21.jpg)
04/10/2023 © Movendos 2013 21
Agile SW development
• SW life-cycle process• Risk management• Documentation
![Page 22: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/22.jpg)
Sprint
Item 1Item 2Item 3
Product backlog
SW release
Iterations
![Page 23: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/23.jpg)
http://scalingsoftwareagilityblog.com/the-big-picture-is-now-the-scaled-agile-framework/
![Page 24: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/24.jpg)
Release planning included
Rel 1Rel 2Rel 3
Release plan
![Page 25: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/25.jpg)
Agile development life-cycle
http://www.agilemodeling.com/essays/agileDesign.htm
![Page 26: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/26.jpg)
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
![Page 27: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/27.jpg)
04/10/2023 © Movendos 2013 27
Risk management
• Risk analysis– Method(s): FMEA, FTA, …– Initial analysis + incremental
• Reports & reviews
![Page 28: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/28.jpg)
04/10/2023 © Movendos 2013 28
Documentation
• Process documentation– SW process– QMS document(s)
• Project documentation– Intended use– Plans– Reports
• Traceability– Reqs-impl-tests-releases-…
![Page 29: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/29.jpg)
04/10/2023 © Movendos 2013 29
All inclusive
![Page 30: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/30.jpg)
04/10/2023 © Movendos 2013 30
Top agile with?
• Traceability• Risk management• Test planning, specs & reports• Documentation
Treat all requirements alike!
![Page 32: Lean SW Startup in Regulated Medical Business](https://reader035.fdocuments.us/reader035/viewer/2022062511/54c22c364a795904628b45a7/html5/thumbnails/32.jpg)
04/10/2023 © Movendos 2013 32
Source: www.juoksufoorumi.fi