The Other Side of Wireless - Connecting Medical Devices with Mobile, Cloud Computing and Analytics to Improve Health Economic Outcomes
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Discussion of the market opportunities, engineering and regulatory challenges, as well as approaches for building systems that incorporate medical devices, diagnostics and sensors with mobile, cloud computing and analytics to deliver solutions for improved health outcomes. Areas of opportunity include remote patient monitoring, early detection and prevention, extending therapies outside of a clinical environment, adherence for medication and other therapies, as well as management of chronic conditions and perioperative management. Presentation by Bernhard Kappe at MD&M East 2014 in New York on June 9th, 2014
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The Other Side of Wireless - Connecting Medical Devices with Mobile, Cloud Computing and Analytics to Improve Health Economic Outcomes
- 1. ©2014 Pathfinder Software 1 The Other Side ofWireless Connecting Wireless Devices with Mobile and Cloud Computing Bernhard Kappe, Founder and President, Pathfinder Software bkappe@pathf.com 2014
- 2. ©2014 Pathfinder Software Mobile and Cloud User Engagement Data – Analytics and Insights Wireless Devices and Sensors Verification Driven Development Accelerating Medical Product Innovation Maintenance Automation Lean Innovation Portfolio Management User Research and ConceptValidation Rapid Prototyping and Testing AutomatedTesting Traceability and Documentation Quality Management and Regulatory Strategy Feasibility Development Post Market
- 3. ©2014 Pathfinder Software Pathfinder Background 3
- 4. ©2014 Pathfinder Software What I’m Going toTalk About • WhyWireless • Examples • Challenges • How to Deal withThese Challenges 4
- 7. ©2014 Pathfinder Software The Changing Healthcare Market Emphasis onValue Based Care: • ACOs (21 in 2010, 138 in 2012, 600+ at the end of 2013)* • Medicare Advantage Star Ratings • Plans Acquiring Providers, Providers Acquiring plans • More commercial shared risk programs • Hospital Systems: 30% “toe dippers”, 30% “active changers”, 10% “leading innovators” * Fee-for-Service, now leaving the station – Next stop, value-based care Deloitte, February 2014 7
- 8. ©2014 Pathfinder Software The Changing Healthcare Market • 75% of Costs are tied to Chronic Conditions* • Better outcomes with fewer expensive hospitalizations and procedures • Prevent, delay, detect and control chronic disease * Center for Disease Control and Prevention (CDC) 8
- 9. ©2014 Pathfinder Software The Changing Healthcare Market The Current Market: • Engage Opinion Leaders -> Sell to Physicians -> Physicians go to Hospital (Pricing Power) The New Market: • Hospital Committees are making decisions based on value and outcomes. • Pressure from CMS and Insurers on reimbursement for things that don’t improve outcomes and decrease costs. 9
- 10. ©2014 Pathfinder Software The Changing Healthcare Market • Need to provide evidence of health economic benefits * • Service as a differentiator: Growing at 3 to 4 times the rate of product revenue * Fixing the Medtech Commercial Model BostonConsulting Group, July 2013 10
- 11. ©2014 Pathfinder Software Systems for Improved Health Outcomes 11
- 12. ©2014 Pathfinder Software 12
- 13. ©2014 Pathfinder Software Heart Monitoring System
- 14. ©2014 Pathfinder Software Heart Monitoring System
- 15. ©2014 Pathfinder Software Respiratory Health Management • Only 1 in 5 Asthmatics have the disease under control • 5000 deaths per year • 2 million emergency room visits per year • 500,000 hospitalizations per year • 27 million missed days of school and work each year
- 16. ©2014 Pathfinder Software Respiratory Health Management Propeller Health Platform – sensors, apps, text messages and analytics • Accurately detect impairment • Inform critical care • Increase medication adherence and self-management • Prevent serious and costly respiratory attacks
- 17. ©2014 Pathfinder Software Respiratory Health Management Data: • Inhaler • Smartphone Sensors • Weather,Air Quality Data • Feedback from Interactions Analytics: • Longitudinal and Aggregate Interactions: • Patient Reminders and Alerts • SmartThresholds for Clinicians • Sharing and Engagement
- 19. ©2014 Pathfinder Software Reducing the Cost of Chronic Diseases 19 Continuous Monitoring Continuously monitor physiological measures, enabling “aging in place” Early Detection/Prevention Analysis of Monitoring Data to provide early detection or prediction of change in health status Extend Therapies Leverage sensors and portable wireless devices to provide augmented feedback in the home Improve Adherence monitor and provide feedback to systems and participants Perioperative Management Pre and post operation monitoring and feedback to improve outcomes Manage Conditions Using data from sensors, diagnostics and devices with other inputs to enable better management
- 21. ©2014 Pathfinder Software Challenges • Hardware • System • Software • Users • Regulatory • Market 21
- 22. ©2014 Pathfinder Software Hardware Challenges • Actual Environment and Pattern of Use • Sensors, Batteries • Interference/Coexistence • Electromagnetic Compatibility 22
- 23. ©2014 Pathfinder Software System Challenges 23 • Greater Complexity • Integration • Distributed System Challenges • Privacy and Security • HIPAA Compliance • FDA Cybersecurity • App Stores
- 24. ©2014 Pathfinder Software Software Challenges • Complexity and Dependencies • Speed of Change: • Smartphones - Once AYear • Major OS Releases – Once AYear • OS Point Releases - Every Few Months • Patches – every few weeks or days CanYou Keep Up? 24
- 25. ©2014 Pathfinder Software User Challenges • More potential users • Use Error and Patient Risk • Usability Issues • A system that is not used, or used incorrectly cannot contribute to real world health outcomes or cost savings 25
- 26. ©2014 Pathfinder Software Market Challenges • Can you prove it? (Do you have data) • Can you improve it (real world outcomes) • Can you do it fast (months, not years) 26
- 27. ©2014 Pathfinder Software Regulatory Challenges • How new (and risky) is It? (Incremental Releases) • Can you show your work? (Bring Data) • What’s hot? • Mobile Medical Apps • Wireless • Human Factors, Usability • Cybersecurity • In the future: • UDIs? (Aster-d pilot) 27
- 28. ©2014 Pathfinder Software Overcoming Challenges Achieve quality and ease of use while managing complexity, uncertainty, risk and change. … and do it a lot faster. 28
- 29. ©2014 Pathfinder Software Overcoming Challenges • UnderstandYour Users and Environment • Go Modular • Prioritize High Risk Areas • Leverage Standards andTools • Test Early and Often (including Security) • Apply Agile Methods • Automate • Get Lean – Eliminate Waste • Measure and Improve 29
- 30. ©2014 Pathfinder Software UnderstandingYour Users and Environment • Observation and contextual inquiry to generate personas (there are usually many) • What else is in the environment? What do you need to (wirelessly) coexist with? Addresses Uncertainty, Complexity and Risk 30
- 31. ©2014 Pathfinder Software Leverage Standards andTools • Bluetooth Protocols and Profiles • Protocols: Low Energy, • Profiles: Health Device, MultichannelAdaptor, PAN Access, Proximity, Synchronization, etc. • HIPAA Compliant Cloud Infrastructure (Catalyze.io, Microsoft Azure, etc.) • HL7 • Continua? • iOS – Healthkit? Homekit? Benefits: Increases development speed and security, decreases uncertainty, risk and complexity 31
- 32. ©2014 Pathfinder Software Go Modular and Prioritize High Risk Areas • Functionally partition into discrete, scalable, reusable modules consisting of self contained functional elements • Rigorous use of well-defined modular interfaces (OO Descriptions) • Prioritize high risk areas (especially interfaces) Benefits: Parallel tracks for faster development, surface and mitigate risks early. 32
- 33. ©2014 Pathfinder Software Prototyping andTesting 33
- 34. ©2014 Pathfinder Software Rapid Prototyping andTesting The right features, the right design before you move to design controls Benefits: • Eliminates wasted effort during development • Making changes is faster during rapid prototyping • Feedback helps you improve features you need to and eliminate those that users don’t need • Formative testing addresses both use error and usability (for FDA and EU) 34 Assess Design Research Model Test
- 35. ©2014 Pathfinder Software Apply Agile Methods 35 • Change is inevitable • Better Manage Change and Complexity • Eliminate waste and speed development • Allows for continued feedback from end users on working software
- 36. ©2014 Pathfinder Software Apply Agile Methods:Verification Driven Development 36 • Avoids different interpretations of requirements and specification that are typical in waterfall development • This prevents “verification hell” that can double the length and cost of a project.
- 37. ©2014 Pathfinder Software Automation forTraceability andV&V • Full code coverage now includes verification/acceptance tests – part of the continuous integration environment • That means verification bug discovery, bug fix cycle goes down dramatically, and bugs don’t propagate and surface • Tools for full traceability means that you can generate full documentation for FDA submission directly from the code. Benefits: Quality at Speed 37
- 38. ©2014 Pathfinder Software Automation for Maintenance Underlying mobile and cloud platforms change in weeks and months. Maintenance using manual processes can’t keep up. AutomatedV&V and full traceability lets you run your software on the new platform, see what breaks, fix it, test it, document it, and be ready in days, not months. You’ll be ready to ship the day the new OS goes out of beta, not 5 months afterwards. 38
- 39. ©2014 Pathfinder Software Security and Privacy • Checksums and Encryption in Software • Integrate Automated RobustnessTesting into the development process (Fuzz testing - Malformed messages using various protocols) Benefits: Earlier detection of previously unknown flaws – robustness and stability issues which are hiding in the code. Reduced regulatory risk. 39
- 40. ©2014 Pathfinder Software Get Lean – EliminateWaste What processes are preventing you from moving fast enough? • Concepts and Requirements • End User Feedback Process • Efficient Pilots, IRBs and AdaptiveTrials • Quality Management 40
- 41. ©2014 Pathfinder Software Measure and Improve Work on user engagement with your platforms shouldn’t stop when you ship. Use HIPAA compliant analytics to: • Measure how your software is being used and where there are engagement issues. • Alerts you if there are any issues (bugs, changes in underlying platforms) that cause your software to malfunction. 41
- 42. ©2014 Pathfinder Software Interventions to Improve Engagement Types of interventions to test: • Interface/Usability Improvements • Additional Features • Persuasive DesignTechniques • Gamification • Social Interaction/Reinforcement • Other channels: email, phone, text 42
- 43. ©2014 Pathfinder Software Building Engagement OverTime 43 Assess Design Research Model Test Initial Sustaining
- 44. ©2014 Pathfinder Software Addressing Market Challenges • Test business model hypotheses early • Demonstrate health economic benefits • Example: Medtronic Carelink in Italy • Pilots with Region of Lombardy • Assess value of remotely monitoring patients with pacemakers • 220 hospitals, 22000 patients • Demonstrate substantial reduction in hospitalization rates and costs 44
- 46. ©2014 Pathfinder Software Systems for Improved Health Outcomes 46 Value Real World Outcomes Solutions Monitoring Early Detection/Preventi on Extend Therapies Improve Adherence Manage Conditions Perioperative Management Measure/Optimize Treatment Options
- 47. ©2014 Pathfinder Software 47 Approach Benefit Understand Users and Environment Better requirements, understanding of risk factors, less waste, faster development Go Modular and Prioritize High Risk Areas More flexibility, less waste, faster development Leverage Standards and Tools Shortens development time, reduces risk Test Early and Often Eliminates waste, shortens development Apply Agile Methods (Verification Driven) Eliminates “verification hell”, manage change Automate Shortens development, maintenance, documentation Get Lean – Eliminate Waste Prevents processes from being bottlenecks, increases speed Measure and Improve System Improvement, Real World Outcomes Small Submissions Reduces Regulatory Risk
- 48. ©2014 Pathfinder Software More Reading Bernhard Kappe bkappe@pathf.com http://pathfindersoftware.com T: 877.548.7248 F: 312.803.1941 @bernhardkappe http://pathfindersoftware.com/agile-in- an-fda-regulated-environment/
- 49. ©2014 Pathfinder Software 49 http://pathfindersoftware.com T: 877.548.7248 F: 312.803.1941 bkappe@pathf.com Accelerating Medical Innovation
Notes de l'éditeur
- I’ve grouped them in a few areas. System Challenges (for the complete thing) Challenges around the hardware components Software Challenges Users Regulatory Challenges And Market Challenges
- I am not a hardware expert, we work with partners like Insight Product Development on the hardware side. Other folks earlier today and yesterday have covered a lot of this in much greater detail. Actual Environment and Pattern of Use. Especially if it’s used by patients, like a lot of these. This can make a big difference. Adding a wireless sensor to an inhaler – the Propeller example. Can’t interfere with the inhaler’s function. It gets put in a purse, might get wet. So you need to be robust. People are likely to forget to charge it, so small sensors, low power consumption are strong considerations. Make them do as little as possible, as dead simple as possible. Battery tradeoffs. Interference and compatibility are things you need to take into consideration – other speakers have talked about this in much more depth. In the VG Bio example, some of the folks are wearing pacemakers, so shielding to prevent unwanted interference is another consideration.
- This is a more complex system, with more moving parts, and more things that can go wrong: hardware, software stack, integrations, data and algorithms. There are a lot of dependencies there. Integrations are points of failure * Data loss, distributed systems, transmission Latency can be a problem - example – neurostimulation implant used for accelerating stroke rehab. Button pressed by clinician. There was unanticipated lag in the wireless transmission. Had to do a whole new animal trial to see if the lag time was clinically important. If you have connected systems, you have security risks and privacy risks. HIPAA compliance includes security and privacy considerations. You also need to think about business associates agreements. This also includes any analytics. Google analytics, others not. Need this. FDA has cybersecurity guidance documents – others have talked about this at the conference in much more detail. They’ve put in place a lab for fuzz testing, will be a greater point of emphasis If some of what you need to do involves apps in app stores – be careful which ones you put them in, because what comes out may not be what you put in. One of our clients asked us to run a test on this for android app stores. We built and submitted a very small app in such a way that it was easy to reverse engineer what the app stores did to them. I can’t really name names here, but in some cases it was harmless. In others they put a lot of extra things into the apps.
- third party platforms Speed of change of those platforms. Maintenance Software can change faster, consumer driven device change is faster. So it will. - Smartphones and tablets from individual vendors change once a year. Major releases of operating systems are once a year, with point releases every few months, and patches potentially every few days. Other elements of the stack also change quickly. You have to think of releases in terms of months, not years. Some folks have adjusted to this, and are developing and releasing the software in shorter cycles.
- Users are tricky. If you remember that we’re all wireless that adds more complexity – there are more users of the systems than you think – potentially clinicians, technicians, patients, caregivers, etc. For patients – don’t have training, depending on patients, very varied abilities and knowledge. Children, elderly, etc. Real world issues. Not just use error, but usability important (EU, need to take that into consideration.) Real World Issues are what’s important here.
- As we alluded to earlier, the market is changing – for everyone. In the new market, the questions you need to be able to answer – do you have real world data to prove it? Once it’s out in the market, can you continue to improve outcomes and value? Can you do this fast. Some can, some can’t.
- The more different, new risks you combine – the greater your regulatory risk/challenges. Looking more at evidence, less me-too. Can you prove your claims? Evolves… A few years ago for a mobile app, part of a class II medical device, a submission was sent back with feedback that the manufacturer hadn’t validated that users would be able to go to the app store, download and install the app. Not so much of an issue now. Some of this deals with individual reviewers. Many of them dealing with what they just got trained on, so they’re going to look at this most thoroughly. The patterns for review – guidance document, feedback, gearing up and training to test. There are a number of recent guidance documents, some are starting to get ready. The mobile medical apps one – pretty straightforward (saw earlier from Fish and Richardson) Wireless Devices – recent Human Factors and Usability – looking at formative and summative usability testing, not just lip service. For the EU, you also need to look at usability, not just use error. Cybersecurity – they are now putting in place a cybersecurity lab to do fuzz testing. Will start to be more of a point of emphasis in the next year. One I’m keeping my eye on for the future – UDIs and integration with EMRs – pilot project Aster-D with medsun. Emphasis on post-market surveillance. HIPAA – separately …
- So there are a couple of common themes – achieving speed
- A series of things that you can do to manage these risks