Case Study 1 | Conducting Ethnographic Research in the Operating Room | Lee, Carmella & Wilcox, Stephen

The primary focus of the workshop was on how to use ethnographic research to support the development of medical devices, particularly surgical instruments. Carmella Lee and Stephen Wilcox showed the proprietary video system that they’ve developed and demonstrate how to set up in the OR and how to capture high quality multiple-channel, high resolution video. The system includes cameras that are handheld, tripod-mounted, on an overhead boom and head-mounted.

Case Study 2 | Conducting Contextual Inquiry in the Emergency Department | Privitera, Mary Beth & Peets, Jami

This Contextual Inquiry Workshop primarily focused on how to conduct contextual inquiry in an extreme environment where reality surpasses imagination. We walked through the general process of executing a CI study followed by an examination of its specifics within an Emergency Department. We discussed the inherent challenges of patient enrollment and patient consent. Other topics included access, proper conduct on site, field work preparation and data analysis.



Case Study 3 | Conducting Contextual Inquiry in the Cath Lab | Hagen, Sean

This Contextual Inquiry Workshop primarily focuseed on how to conduct contextual inquiry in a dangerous environment where lead is worn to protect you from x-ray radiation. We reviewed the general process of planning and executing a study in the Cath Lab and Control Room, including safety precautions, multi-modal video analysis, patient and clinician privacy, crisis management and appropriate conduct.

Case Study 4 | Insight Translation: For the Design Team and The FDA | Guarraia, Mark & Roche, Elizabeth

This hands-on session demonstrated how insights gathered during research turn into both design criteria and data that feed the design history file. The session leaders provided a brief overview of the documentation the FDA expects—and needs—to see (UFMEA, requirements documents, etc). From there, participants worked in small groups to synthesize the discoveries and insights from their contextual inquiry session. They then defined the unique roles involved in the procedure and each contributed toward a detailed task flow.

Case Study 5 | Innovation Generation | Cesa, Joe & Palermo, Philip

The group used a collaborative charrette session to ideate and rapidly capture ideas into an actionable design proposal based on prioritized requirements from previous sessions—Contextual Inquiry and Insight Translation. Attendees participated in activities to conceptualize, build upon, prioritize and refine many ideas into a single synthesized concept idea. This output was then utilized for further design refinement, development and prototyping during the Interaction Design session. 

Case Study 6 | Interaction Design | Karn, Keith & Horan, Bill

This Usability Design/UX workshop exposed participants to parallel development of physical and digital interactions. Team members executed on insights drawn from Workshops 1 and 2, the requirements translation of Workshop 3 and the synthesis of Workshop 4 in designing the interaction experience for the proposed solution. These designs were built in the form of low-fidelity digital prototypes that formed the basis for subsequent Workshops 6 and 7 – IFU development and usability testing. 

This hands-on workshop focused on sketching out the proposed interaction design, determining the appropriate level of fidelity to get the job done and building the prototype. We considered factors such as determining the extent to which user tasks need to be represented in the prototype in order to facilitate stakeholder buy-in and user feedback. 

Case Study 7 | Risk Assessment | Phillips, Sean

Many development teams dread the thought of performing risk assessment, as it appears tedious and non-creative. While both are potentially true, strategic implementation of risk assessment helps teams to think creatively about how to solve use risks that could cause harm. In this workshop, Continuum’s Sean Phillips considered key aspects of ISO 14971:2012 Application of Risk Management to Medical Devices.

Case Study 8 | IFU/Quick Reference Guide Development | Wiklund, Michael & Strochlic

Instructions for use (IFUs) and quick reference guides (QRGs) often play a critical role in ensuring the safe and effective use of medical devices. These documents not only help novice users perform tasks correctly, but also help experienced users stay on track with tasks performed infrequently, including those associated with emergencies and those associated with device troubleshooting. Accordingly, it is worth the investment to develop high-quality IFUs and QRGs.

Case Study 9 | Usability Testing | Wiklund, Michael & Strochlic, Allison

Usability testing is central to producing a medical device that is safe and effective, as well as commercially successful. This is why many countries have established regulations and uphold consensus standards calling for usability testing. Moreover, many countries call for manufacturers seeking regulatory approval of a given medical device to submit evidence that the device is not subject to potentially harmful use errors; evidence that comes from conducting a so-called summative usability test.

Case Study Track | Hy-Green Case Study | Karnick, Robert

Each year, Healthcare Associated Infection (HAI) affects an estimated 1,730,000 patients, killing 99,000. HAI also extends hospital time and dramatically increases hospital bills (on average, post-surgical infections increase medical expenses by 120%). Robert Karnick from ROBRADY design presented a case study for the development of the Hy-Green Intelligent Hand Hygiene System.  

The Hy-Green system represents an innovative combination of devices working in concept to improve healthcare by monitoring and recording hand washing by hospital employees. Then the hygiene event is transmitted to a central database while also communicating with the healthcare worker to provide feedback of compliance or with a warning notification.

While working on the program, ROBRADY faced a broad spectrum of challenges, from the technological to the logistical, and even the psychological. Learn how ROBRADY developed the Hy-Green system, blending observational research with technology development to create a simple solution that effectively and efficiency confronts a leading cause of death in the United States.

5 in 5: mHealth and Medical Web App UI | Evans, Bill

What kinds of medical information-oriented products will designers be working on in 5 years' time? How can we rise to the patient and clinician ‘engagement’ challenges? Based on years of FDA/EU regulated UI design experience, a Silicon Valley-based designer gave us his predictions and recounted 5 lessons from the device UI world to help designers understand and meet these challenges:

  • Usability isn’t just, "Can you use it?" but, "WILL you use it?" - your product’s first hurdle may be reluctant users.

  • Data isn’t useful if it isn’t actionable - how can designers shift the emphasis to better engage front-line clinicians and patients?

  • 'Sharing' data - the practicalities and challenges beyond HIPAA concerns.

  • User testing from start to finish - designers already do this. What are the issues specific to this kind of usability challenge?

  • Small is beautiful - what kinds of rapid prototyping and small scale tests are likely to lead to success?

Disruptive Design | Mike, Hanuchik & Merrick, Kossack

Usability is important, but the realities of designing an elegant workflow involve difficult tradeoffs and challenging group dynamics. Aesthetics are often seen as a frilly “nice to have,” but if incorporated thoughtfully, aesthetics can profoundly contribute to the usability of a product. In this talk, Hanuschik and Kossack presented their experience implementing a design framework in an engineering-driven culture. They don’t propose to have all the answers, but they presented more of a “the good, the bad and the ugly” dialogue about their experience developing the latest generation of the da Vinci Surgical System.

High Tech Tools To Capture the User Experience: Google Glass and 3D Printing | Stephenson, Katherine

As medical devices continue to develop in technical complexity, designers are looking to increasingly high tech methods to capture and enhance the user experience. Kate Stephenson presented some of the latest work from Stanford University’s Center for Design Research. Current projects include the use of Google Glass in a pre-clinical study for wound care image capture and documentation and the use of CAD and 3D printing by non engineers as a form of high fidelity design communication.

Human Factors of Handheld Medical Product Design | Rutter, Bryce

Over 95 percent of all medical products used by clinicians and patients involve the use of the hands in some fashion. Repairing a torn retina requires extreme precision from ophthalmic surgeons manipulating microsurgical instruments fractions of a millimeter. Similarly, a knee replacement demands the same precision from orthopedic surgeons while carrying out physically rigorous and high-impact movements. Outside of the hospital, patients suffering from rheumatoid arthritis with highly compromised hand function give themselves injections. Effectively accomplishing these tasks is not trivial and argued by many to be one of the most complex operations humans perform. It requires seamless coordination and control of 14 joints and 29 degrees of freedom per hand, interlaced with real-time kinesthetic feedback. In this session we looked at how hands work, what they afford, how we control them and highlight critical success factors in the design of handheld medical instruments and devices.

Keynote | Designing Healthcare of the Future: Disease to Wellness to Swellness | Marsh, MD, Clay

To sustainably improve the health of our population, health and healthy choices in communities need to become the norm. This presentation discussed our approach to this goal targeting the dimensions of health that include exercise, food, sleep, stress, social networks and family. We believe that the areas of Design and Design Thinking are critical to construct health ecosystems and optimize user experiences.  These complex systems are asymmetric, where a few agents or elements are more important than others. Ecosystem design allows us to initially target the high value areas of exercise, and envision how to construct an ecosystem that makes healthy choices and health the norm by bending the world around the person. This presentation discussed how we are trying to construct this ecosystem with designers, focusing on optimizing the user experience at the interface level, and layering this experience set with precision tools to navigate individual decisions and nudge community decisions and offerings. 

Keynote | Life and Death and Devices: Lessons from the Creation of a Critical Care Physician | Bonomo, MD, Jordan

This presentation described the training of a modern "resuscitationist” and emergency physician through the indelible lessons taught in residency and fellowship. From the perspective of medical devices we call upon daily, we followed a critically injured patient through the pre-hospital helicopter EMS environment, the Emergency Department, the unique care received in the OR and ICU and ultimately organ donation.  This journey focused on the vast arsenal of equipment involved in critical care and resuscitation and the challenges clinicians face daily in providing high-level, high-stakes critical and resuscitative care. This journey included mindful debate of the cost of medicine and the failings of ultra-early prognostication. We touched on newly developed strategies of using advanced resuscitation devices to increase organ donation and the future of the interface between devices and the ethics of dying (and living) in the modern world of ultra high-speed medicine.

Livable Design: Going Beyond Usability | Van Varick, Rob

The healthcare industry has gained the focused attention of the design community. Patient experiences are improving and consumer expectations are rising. While safety and functionality must remain the top priority in healthcare, we should ask ourselves, “how can we do more?” Yes, we are delving deeper into research, human factors, ergonomics, simulation and more.  However, we must allow empathy to inform our designs: emotion, the feelings of comfort, familiarity and dignity lead to superior design solutions that humanize the healthcare experience.  Healthcare designers must continue to up their game. Rob Van Varick presented recent work of the Michael Graves Design Group to show how the usability spectrum that focuses on universal design and empathy leads to “Livable Design.”  

Navigating the Transition from Clinic to Home | Johnson, Carolynn

Healthcare is undergoing a remarkable shift as treatments envisioned as taking place only in hospitals and clinics move into the home. This paradigm shift represents a daunting challenge for medical equipment designers and manufacturers. Transitioning treatments into the home cannot be accomplished merely through a simplified user manual and patient training – not when the consequences of mistakes can be deadly. Instead, this transition requires recognition, understanding and mitigation of a vast number of fundamental differences between home and clinical healthcare. 

This workshop guided participants through a clinic-to-home product transition through an illustrative case study. Participants worked in small groups to develop user profiles and used cases to illustrate the differences between the home and clinic. They then presented those profiles and discussed in terms of the impact those differences should have on design. Participants then engaged in small-group ideation sessions to redesign the equipment for in-home use.