Medical SW development process - lecture material / case Movendos Oy
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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.
Medical SW development process - lecture material / case Movendos Oy
- 1. SW development process in regulated health tech area Course: TUT/SGN-57406 Stefan Baggstr?m 28th Jan 2014
- 2. Motivation ? Previous lectures were mostly about standards, regulation and related backgrounds ? This is about practice, i.e. development of medical products ? Focus on SW development process 1/28/2014 ? Movendos 2013 2
- 3. Topics Movendos intro SW development today Requirements from regulation Movendos SW development process 1/28/2014 ? Movendos 2013 3
- 4. Movendos intro This section sets the context of this presentation. It describes the company, it¡¯s products and team. 1/28/2014 ? Movendos 2013 4
- 5. Tools for effective health coaching
- 6. Social exclusion Physiotherapy Physical activity Nutrition Mind balance Coaching Psychotherapy Preventive healthcare Healthy habits
- 7. Knowledge vs Behavior Individual¡¯s behavior 40 % Genes, environm ent, healthcare
- 8. ? Coach¡¯s support to your every day life ? Highly personalized training tasks ? Use with your favorite device Customer Coach
- 9. System view Amazon Web Services Elastic Beanstalk Application Container S3 Customer EC2 Professional RDS / MySQL SES 1/28/2014 ? Movendos 2013 9
- 10. Back end: Elasticbeanstalk application with default container 1/28/2014 ? Movendos 2013 10
- 11. Front end: Responsive single page web application Web user interface Index.html - Application shell Backbone.js / marionette.js - MVC - REST API communication DOM Cascading style sheets (CSS) HTML templates 1/28/2014 ? Movendos 2013 11
- 12. Our team Arto Leppisaari Stefan Baggstr?m 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 ¨C First incubating at TUT ¨C Now startup co-founder & CTO
- 14. 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 ¡ Jan-2014 Product / market fit + Sales Commercial product 1/28/2014 ? Movendos 2013 ¡ 14
- 15. Key take aways ? Movendos developes tools for effective health coaching ? Web application can be a medical device based on it¡¯s intended use 1/28/2014 ? Movendos 2013 15
- 16. SW development This section offers a glimbse into some of the today¡¯s SW development practises. These practises are used for developing different kind of products for various business fields. 1/28/2014 ? Movendos 2013 16
- 17. SW development <-> regulation ? Things to keep in mind: ¨C It¡¯s not just your own code that matters ¨C Development processes evolve over time ¨C Iterative product development with customer collaboration is here to stay ¨C Directives and standards were done some time ago based on old mainstream best practices 1/28/2014 ? Movendos 2013 17
- 18. SW development buzz words ? Agile, scrum, kanban, ¡ ? Continuous integration, deployment, ¡ ? Open source SW, libraries, frameworks, ¡ ? Clouds, IaaS, PaaS, SaaS, ¡ 1/28/2014 ? Movendos 2013 18
- 19. SW development buzz words Web, mobile, cross platform, ¡ Licenses, patents, contracts,¡ Continuous updates, beta, ¡ Customer expectations for great UX (got used to iPhones/iPads)¡ ? New technologies are emerging with increasing rate¡ ? ? ? ? 1/28/2014 ? Movendos 2013 19
- 20. Basic elements of SW process http://cloverleafsolutions.com/methods/software-development-lifecycle.html 1/28/2014 ? Movendos 2013 20
- 21. Some of the SW development methodologies http://cloverleafsolutions.com/methods/software-development-lifecycle.html 1/28/2014 ? Movendos 2013 21
- 22. Agile a¡¯la Scrum Source: http://analytical-mind.com/tag/scrum/ 1/28/2014 ? Movendos 201 22
- 23. Agile a¡¯la Kanban http://blog.crisp.se/2009/11/16/henrikkniberg/1258359420000 1/28/2014 ? Movendos 2013 23
- 24. Continuous integration a¡¯la Jenkins http://www.ranorex.com/blog/wp-content/uploads/2012/08/Integrate-In-Jenkins.png 1/28/2014 ? Movendos 2013 24
- 25. DevOps, Continuous delivery http://www.collab.net/solutions/devops 1/28/2014 ? Movendos 2013 25
- 26. Updates, updates, updates¡ ? Safety related regulation: A change in a product is considered as added risk for safety ¨C Best to develop single version, deploy it and never update? ? Security and privacy related practices: ¨C Always update the product to mitigate risks and to fix uncovered vulnerabilities ? Interworking between systems: ¨C Best practise is to update when others update ? Consider medical devices connected to hospital networks and Internet: ¨C Updates or not to update? ? Testing always preceeds deployment of an update 1/28/2014 ? Movendos 2013 26
- 27. http://www.cloudstrategies.com/2010/05/cloud-spectrum-iaas-paas-saas/ 1/28/2014 ? Movendos 2013 27
- 32. User experience Some aspects of good UX: ? Easy to use ? Easy to navigate ? Find information fast ? Load fast ? No crashes But end users are expecting more! 1/28/2014 ? Movendos 2013 32
- 33. Complexity multiplies (from code chunk into system) 1 3 1/28/2014 3 9 ? Movendos 2013 33
- 34. Some piece of code public void handleMessagesFromDatabase() { if (!applicationContextReady){ return; } List<NewMessage> messages = newMessageRepository.findUnsentNonPriorityMessages(); // Stop if there are no more messages if (messages.isEmpty()){ return; } for(NewMessage message : messages){ if(emailIsValid(message.getToUser().getEmail())){ queueStandardEmail(message); } else{ onSendFailure(message, EmailSendStatus.INVALID_EMAIL_ADDRESS); } } } 1/28/2014 ? Movendos 2013 34
- 35. From small code chunk to full blown system ? Multiple size by 10k, 100k or 1M to build a sub system ? Go further and integrate all subsystems into the system ? Note, the code comes into the project also from used: ¨C Libraries ¨C OS, runtime, ¡ ¨C Compiler, IDE, version control, ¡ 1/28/2014 ? Movendos 2013 35
- 36. Working as a small dev team Source: http://www.romanpichler.com/blog/tag/teamwork/page/2/ 1/28/2014 ? Movendos 2013 36
- 37. Brook¡¯s law: ¡°Putting more people on a late job makes it later.¡± http://www.pmhut.com/estimating-software-effort 1/28/2014 ? Movendos 2013 37
- 38. Working concurrently Source: http://websites-development.com/blog/git-methodology 1/28/2014 ? Movendos 2013 38
- 39. Deliverables (kind of a minimum set) ? ? ? ? ? ? Requirements in product and sprint backlogs Design documents Test cases: unit, integration, system tests Test reports Bug reports Versioned, reviewed, integrated and running code 1/28/2014 ? Movendos 2013 39
- 40. From piece of code into product Functional *3 into system *3 with team *9 into product 1/28/2014 ? Movendos 2013 40
- 41. Key take aways ? SW development processes evolve over time ? Use of SOUP (software of unknown pedigree / provenance) increases ? Use of web apps increases over native apps (many runtimes) ? Users demand good usability ? SW development is complex in many dimensions 1/28/2014 ? Movendos 2013 41
- 42. Requirements from regulation This section describes the regulatory constraints set for SW product development. One concrete example case explained. 1/28/2014 ? Movendos 2013 42
- 43. 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 1/28/2014 ? Movendos 2013 43
- 44. Medical Device/SW 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 ¨C In addition, the directive has requirements for validation and releasing ¨C ¨C ¨C ¨C 1/28/2014 ? Movendos 2013 44
- 45. 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 1/28/2014 ? Movendos 2013 45
- 46. Standards set requirements for ? ? ? ? ? ? ? ? ? ? SW development process Quality management system Risk management process Usability process Clinical investigation Validation Registration Placing on the market Problem resolution Etc. 1/28/2014 ? Movendos 2013 46
- 47. Regulation continued ? There are directives and laws for ¨C ¨C ¨C ¨C Privacy Security Language support ¡ ? These may set complementary, but also contradicting requirements for vendors 1/28/2014 ? Movendos 2013 47
- 48. Is medical field unlike others? ? Regulation applies also to airplane, railway, and many other industries ? SW project risks typically deal with schedule & costs ¨C Add safety & essential performance risks for medical devices ? Time to money: typically it¡¯s development & verification time ¨C Add time required for validation & approval for medical devices ? Clinical validation requires it¡¯s own time & effort
- 49. Movendos SW development process This section explains how Movendos developes SW. It¡¯s our way of applying state of the art practices, and our way of working with the constraints set by the regulation. 1/28/2014 ? Movendos 2013 49
- 50. Customer development ? Collaboration with customers ? Iterate and verify ? Problem centric as opposed to product or technology centric ? Performed in parallel with product development 1/28/2014 ? Movendos 2013 50
- 52. Movendos SW development Let¡¯s focus on these aspects ? SW development process ? Risk management ? Documentation 1/28/2014 ? Movendos 2013 52
- 53. Just sprints¡? Sprint Product backlog Item 1 Item 2 Item 3 SW release
- 54. Definitely too much for a startup¡ http://scalingsoftwareagilityblog.com/the-big-picture-is-now-the-scaled-agile-framework/
- 55. We have release planning included Release plan Rel 1 Rel 2 Rel 3
- 56. Agile development life-cycle the whole from begin to end http://www.agilemodeling.com/essays/agileDesign.htm
- 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
- 58. Risk management ? Risk analysis ¨C Methods: Failure Mode Effect Analysis (FMEA), Fault Tree Analysis (FTA), or some other feasible way ¨C Initial analysis + incremental ? Reports & reviews 1/28/2014 ? Movendos 2013 58
- 59. Risk management in more detail ? Initial risk analysis ? Risk analysis for each sprint backlog item ? Update risk magement report for each major milestone ? Corrective and preventive actions based on findings ? Reporting of hazards to customers and officials 1/28/2014 ? Movendos 2013 59
- 60. Documentation ? Process documentation ¨C SW process ¨C Quality Management System document(s) ? Project documentation ¨C Intended use ¨C Plans ¨C Reports ? Traceability ¨C Requirements-implementation-testsreleases-¡ 1/28/2014 ? Movendos 2013 60
- 61. Documents in more detail ? ? ? ? ? ? ? ? ? ? Quality Management System SW development process Product¡¯s intended use Project plan Requirement specification = product backlog Product architecture Usability and UX/UI design documents Test plans and reports Validation documents Problem reports (and bug reports) 1/28/2014 ? Movendos 2013 61
- 62. Project documentation ? Example: 1st milestone ¨C Project plan ¨C Intended use ¨C Risk management plan + risk analysis ¨C Initial usability analysis ¨C Verification plan ¨C Initial architecture ¨C SW components plan ¨C Initial product backlog 1/28/2014 ? Movendos 2013 62
- 63. Traceability Full traceability is required: ¡±Why was this SW change made and how it was verified?¡± You need to have links between: Requirements, design documents, test plans, tests, code, test reports, change notes Everything should be in version control: code, docs, tests, tools, environment configurations, etc. 1/28/2014 ? Movendos 2013 63
- 64. Verification & Validation ? Verification shall be performed ¡ to ensure that the design and development outputs have met the design and development input requirements. ? Design and development validation shall be performed to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. 1/28/2014 ? Movendos 2013 64
- 65. All inclusive 1/28/2014 ? Movendos 2013 65
- 66. Developing medical SW - Top agile with? ? ? ? ? ? Traceability Risk management Test planning, specs & reports Documentation Verification, Validation Treat all requirements alike! 1/28/2014 ? Movendos 2013 66
- 67. Thank you! Stefan Baggstr?m stefan.baggstrom@movendos.com Tel +358 50 581 6919
Editor's Notes
- Hyvinvointivalmennus on hyvin kokonaisvaltaista ja pit?? sis?ll??n monenlaista valmennusta.Ravintoon ja liikuntaan liittyv?t terveelliset el?m?ntavat mutta my?skin mielenhallintaan liittyv?t asiat, psykoterapia ja nuorten syrj?ytyminen.N?iss? kaikissa kyse valmentajan ja valmennettavan v?lisest? kommunikaatiosta ja pienist?, p?ivitt?isist? valmennus teht?vist?.
- 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
- Do you all have these already? Lean or not?