Lecture material set for the TUT course SGN-57406 'Standards, Interoperability and Regulation in Health Informatics'.
This presentation discusses the requirements coming from regulation for the SW development process, and presents one tailored SW life cycle process suitable for medical device SW development.
12. Our team
Arto Leppisaari
Stefan Baggström
Hannu Nieminen
CEO
CTO
Research
Hannu Mikkola
SW architect
Our partners
Carlos Perez
SW developer
13. 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
48. Is medical field unlike others?
• Regulation applies also to
airplane, railway, and many other
industries
• SW project risks typically deal with
schedule & costs
– Add safety & essential performance
risks for medical devices
• Time to money: typically it’s
development & verification time
– Add time required for validation &
approval for medical devices
• Clinical validation requires it’s own
time & effort
57. Movendos - 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
Hyvinvointivalmennus on hyvin kokonaisvaltaista ja pitää sisällään monenlaista valmennusta.Ravintoon ja liikuntaan liittyvät terveelliset elämäntavat mutta myöskin mielenhallintaan liittyvät asiat, psykoterapia ja nuorten syrjäytyminen.Näissä kaikissa kyse valmentajan ja valmennettavan välisestä kommunikaatiosta ja pienistä, päivittäisistä valmennus tehtävistä.
Explored possibilities to productize research results. Explored opportunities with non-profits and commercial companies. Product concepts and business models for 20+ ideas, selected 2 most promising, and eventually carried on with 1.Very small pilot with 1st proto. Small pilot with 2nd proto.Now seeking for quantative product / market fit.
SW is a medical device? Starts with the intended use, …
Yes, but similarities to other regulated industries. But unlike born-global, conquer-the-world-over-night, type of apps
No business plan survives the 1st contact with customerDo smallest possible that solves the problem, verify need & usage, improve if needed.We are focused on solving problems the coaches have. Helping them to reach their full potential. Products and technologies come and go.
What if you do the solution box last?Iterate on the segments, channels and all.
We all do this?
You do this?
Our take…
There is more around the sprints.Preparation of the project, releasing, production and retirement.Credits to Scott Ambler.
Similaratities to Scott’s model, but also Validation milestone and maintenance process.
One needs to have intended use documented first…FMEA = Failure Mode Effect AnalysisFTA = Fault tree analysis