When Digital Meets Medical: The Next Generation Clinical Trial
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The document discusses new methodologies for combining design research and clinical research when developing digital medical products. It introduces two new methods: RCS (Research for Component Selection) which allows for usability testing and engineering experiments under a clinical protocol umbrella; and CLUE (Clinical User Experience) which allows design researchers to work directly with clinical trial participants to test products in real-world use. The document argues that these new methods enable insights to be gained earlier in the product development process by blending design and clinical research approaches in a structured yet nimble way.
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When Digital Meets Medical: The Next Generation Clinical Trial
- 1. WHEN DIGITAL MEETS MEDICAL: THE NEXT GENERATION CLINICAL TRIAL Celine Pering NOVEMBER 07, 2014 MEDICAL DEVICE DESIGN CONFERENCE, IDSA
- 2. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 2 Small ingestible sensor Sensor is embedded within your medication
- 3. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 3 Part of a multi touch-point system Patient Patch Your Medication See Daily Patterns Via a Mobile Device Patient Doctor
- 4. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 4 A complex ecosystem of stakeholders
- 5. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 5 Cross-pollinating clinical research with consumer research can open up a whole new discipline ripe for exploration
- 6. 1 CALL TO ACTION
- 7. There is a new product paradigm occurring at the intersection of the medical and consumer worlds Photo Credit: Google
- 8. Patients don’t know the line between unregulated and regulated apps Photo Credit: Health Xchange
- 9. Yet these devices are trying to influence health behavior Photo Credit. Todd Hamilton
- 10. These are two very different industries
- 11. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 11 These are two very different industries Consumer Products Medical Devices
- 12. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 12 Self-directed purchase These are two very different industries Consumer Products Prescribed Medical Devices
- 13. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 13 Self-directed purchase Payor is the end user These are two very different industries Consumer Products Prescribed Payor is a separate stakeholder Medical Devices
- 14. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 14 Self-directed purchase Payor is the end user Straightforward path These are two very different industries Consumer Products Prescribed Payor is a separate stakeholder Interdependent ecosystem Medical Devices
- 15. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 15 Self-directed purchase Payor is the end user Straightforward path Lightning fast These are two very different industries Consumer Products Prescribed Payor is a separate stakeholder Interdependent ecosystem Slow moving Medical Devices
- 16. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 16 Self-directed purchase Payor is the end user Straightforward path Lightning fast Partially regulated These are two very different industries Consumer Products Prescribed Payor is a separate stakeholder Interdependent ecosystem Slow moving Heavily regulated Medical Devices
- 17. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 17 Self-directed purchase Payor is the end user Straightforward path Lightning fast Partially regulated Status symbol These are two very different industries Consumer Products Prescribed Payor is a separate stakeholder Interdependent ecosystem Slow moving Heavily regulated Stigmatizing symbol Medical Devices
- 18. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 18 Self-directed purchase Payor is the end user Straightforward path Lightning fast Partially regulated Status symbol These are two very different industries Consumer Products Prescribed Payor is a separate stakeholder Interdependent ecosystem Slow moving Heavily regulated Stigmatizing symbol Medical Devices
- 19. These industries also use very different research methodologies
- 20. A mature field based on a long history of drug development Clinical research Saving Lives Safety Checks and Balances Regulation Targeted Medicine 1740 1930 1940 1970 1990 2000 Future Sailor Scurvy James Lind FDA Formed Elixir Sulfanilamide War Crimes Nuremberg Trial Pharma Growth Stronger Patents Personalization Technology Advancement
- 21. Design problems are quickly becoming more complex Product design Saving Lives Safety Checks and Balances Regulation Targeted Medicine 1740 1930 Physical, Singular Products Social Systems 1940 1970 1990 2000 Future Genius Design Philip Stark Sailor Scurvy James Lind FDA Formed Elixir Sulfanilamide War Crimes Nuremberg Trial Pharma Growth Stronger Patents Personalization Technology Advancement Industrial Design Henry Dreyfuss Design Thinking d.school Product Design Smart Design Social Innovation Social Problems
- 22. Evolving at a fast pace while regulation is still being defined Medical device regulation Saving Lives Safety Checks and Balances Regulation Targeted Medicine 1740 1930 Physical, Singular Products Social Systems 1940 1970 1990 2000 Future Genius Design Philip Stark Sailor Scurvy James Lind FDA Formed Elixir Sulfanilamide War Crimes Nuremberg Trial Pharma Growth Stronger Patents Personalization Technology Advancement Industrial Design Henry Dreyfuss Design Thinking d.school Product Design Smart Design Social Innovation Social Problems Medical Device Act Dalkon Shield IUD HF Requirements FDA Regulations Regulatory Gray Area mHealth, today
- 23. Working at the cutting edge presents new opportunities Today Saving Lives Safety Checks and Balances Regulation Targeted Medicine 1740 1930 Physical, Singular Products Social Systems 1940 1970 1990 2000 Future Genius Design Philip Stark Sailor Scurvy James Lind FDA Formed Elixir Sulfanilamide War Crimes Nuremberg Trial Pharma Growth Stronger Patents Personalization Technology Advancement Industrial Design Henry Dreyfuss Design Thinking d.school Product Design Smart Design Social Innovation Social Problems Medical Device Act Dalkon Shield IUD HF Requirements FDA Regulations Regulatory Gray Area mHealth, today
- 24. 1 CALL TO ACTION 2 OPPOSITE ENDS OF THE SPECTRUM
- 25. Exploring the world, discovering nuanced differences and subtle similarities Photo Credit: Jan Chipchase
- 26. Design research is experiencing its Wild West Photo Credit: Jan Chipchase
- 27. In contrast, ethics committees assess compliance in clinical research Photo Credit: Credit Willis Ryder Arnold
- 28. Interpreting written regulation is time intensive Photo Credit: GoPixPic
- 29. Generative Opposite ends of the spectrum Design Research Evaluative Clinical Research
- 30. Generative Empathetic Opposite ends of the spectrum Design Research Evaluative Prescriptive Clinical Research
- 31. Generative Empathetic Adaptive Opposite ends of the spectrum Design Research Evaluative Prescriptive Systematic Clinical Research
- 32. Generative Empathetic Adaptive Personal Opposite ends of the spectrum Design Research Evaluative Prescriptive Systematic Double-blind Clinical Research
- 33. Generative Empathetic Adaptive Personal Opposite ends of the spectrum Design Research Evaluative Prescriptive Systematic Double-blind Clinical Research
- 34. Intersection presents a new opportunity Design Research + Clinical Research = ?
- 35. 1 CALL TO ACTION EXPLORATION AS A METAPHOR 3 2 OPPOSITE ENDS OF THE SPECTRUM
- 36. We are charting new territory using skills from existing practices Photo Credit: National Geographic
- 37. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 37 Boundaries 12345 Principles These 5 major principles enabled us to cross-pollinate best practices Stretching Collaboration Umbrellas Constraints
- 38. 1 Where do the boundaries exist when disciplines are mixed? Can you take photos? Can you know people’s names? PRINCIPLES Boundaries Photo Credit: Christine Genius
- 39. 2 This work is not business as usual. This requires stretching past comfort zones all around and getting your extended team onboard. PRINCIPLES Stretching
- 40. 3 Sharing the study design across departments helps cross-pollinate ideas. PRINCIPLES Collaboration
- 41. 4 Strategic protocol umbrellas help provide wiggle room. By setting these up in advance, sub-studies are quicker to conduct and get faster IRB approval. PRINCIPLES Umbrellas
- 42. 5 Work within the constraints. There are ways to be creative even within restrictive bounds. PRINCIPLES Constraints
- 43. 1 CALL TO ACTION 3 EXPLORATION AS A METAPHOR 4A NEW DISCIPLINE 2 OPPOSITE ENDS OF THE SPECTRUM
- 44. A simplified design process Design Freeze 510K Commercial Launch Research Development Evidence Development
- 45. There is an opportunity to commingle methods before products are put into the formal clinical process Design Research Clinical Research
- 46. We have developed two new methods that enable the convergence of design and clinical research Design Research Clinical Research Methodology #2 “CLUE” Methodology #1 “RCS”
- 47. “RCS” studies (Research for Component Selection) An umbrella clinical protocol used for usability testing or engineering experimentation
- 48. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 48 QUESTIONS: “RCS” Methodology: Research for Component Selection 1 What form factor stays on the body longest? What feels the most comfortable? How does the wear experience change over time? CHALLENGE: Anything that is stuck on the body needs IRB approval. There is no replacement for living human skin.
- 49. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 49 SAMPLE FINDINGS: “RCS” Methodology: Exploring the effectiveness of different prototypes 1 Wear time of prototype is 4 days compared to 7 days with the control. The “banana slug” was the least favorite. Too rigid. The more flexible form factor was preferred.
- 50. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 50 CONTEXTUALIZED: “RCS” Methodology: Working with prototypes, quickly and cheaply 1 User Preference Testing RCS Clinical Research ON THE BODY REAL USE R&D
- 51. “CLUE” studies (Clinical User Experience) Allow design researchers to work directly with clinical trial participants, allowing us to quickly try out the market
- 52. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 52 QUESTIONS: “CLUE” Methodology: Clinical User Experience 2 How does this “beta” product work in real, live use? Do people understand it “in the wild?” What is the vulnerable population’s experience using the product? CHALLENGE: This is very expensive research.
- 53. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 53 SAMPLE FINDINGS: “CLUE” Methodology: Understanding emotions, attitudes and behaviors 2 Frustration with the on-boarding experience “Green light” provides re-assurance Concern about discretion with a slinky black dress
- 54. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 54 SAMPLE FINDINGS: “CLUE” Methodology: Mapping the emotional experience 2 Emotional highs and lows
- 55. When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 Twitter @ProteusDH 55 CONTEXTUALIZED: “CLUE” Methodology: Gaining insight into real use while still in a clinical context 2 Ethnography CLUE Clinical Research ON THE BODY REAL USE ATTITUDES & BEHAVIOR R&D
- 56. 1 CALL TO ACTION 3 EXPLORATION AS A METAPHOR 4A NEW DISCIPLINE 5 TAKEAWAYS 2 OPPOSITE ENDS OF THE SPECTRUM
- 57. This is a form of integrating insight and evidence-building methods
- 58. Staying ahead of the curve by being nimble, yet structured
- 59. And thinking through the implications of our methods before problems occur
- 60. Seeing the opportunity in the ambiguity
- 61. Contact me: Interested in forming a workgroup to compare best practices? Celine Pering Director, Human Factors and User Research cpering@proteusdh.com Proteus Digital Health 2600 Bridge Parkway, Suite 101 Redwood City, CA 94065
- 62. Thank You! Celine Pering Director, Human Factors and User Research cpering@proteusdh.com Proteus Digital Health 2600 Bridge Parkway, Suite 101 Redwood City, CA 94065