3D Modeling of CT Scans for 3D Printing | Dustin Headley

Dustin Headley will introduce participants to methods and practices to convert medical CT (computed tomography) scans into editable 3D mesh geometries and refine them into 3D printable geometries.

Digital design development will be executed in Rhinoceros 3D, showing how to clean, trim, heal and close the mesh for 3D printing. Headley also will also provide an introduction to relevant 3D printing technologies, how to work with tolerances within specific prototyping machines and how to repair/setup geometry for 3D printing. 

Results will be ready for deployment on 3D printing equipment for participants to take back to work, or for deployment via online resources.

Advances in Surgical Simulation: Unique Approaches to Developing Anatomy Models for Device Evaluation | Cory Kimball | Omar Vakharia

This will be an interactive lab where participants will have the ability to experience various types of anatomical simulators in a replicated surgical use environment.  Cory Kimball, IDSA, and Omar Vakharia, IDSA, of Ethicon’s Industrial Design/Human Factors Center of Excellence—a subsidiary of Johnson & Johnson—will discuss the techniques utilized to test medical product concepts. 

Learn how patient imaging data is utilized to create virtual simulators, inanimate models and animate adaptations to replicate human anatomy— methods proven to reduce device use error, shorten product development time and minimize the need for in vivo testing.

Beyond Data Visualization: Using Visual Tools to Drive Usability | Karen Radewald

Karen Radewald, visual designer at Karten Design, will present the power of visualization to drive usability in medical design. Citing real world examples, Radewald will explain how visual tools—beyond “traditional” data visualization—can allow innovators to understand and interpret complex processes and experiences, while giving them a deeper understanding of the ecosystem of healthcare players, and ultimately empowering them to create more meaningful, usable products.

Radewald will share strategies for visualizing design research in a way that makes it actionable for multiple stakeholders in the medical device design process. Her discussion will cover:

  • the benefit of analyzing and presenting design research visually;
  • examples of actionable visual tools that go beyond data visualization;
  • using visuals to define and understand the medical design user/patient ecosystem;
  • strategies for extending the longevity of design research;
  • and opportunities for medical design developers to leverage visualization to inform meaningful innovation.

Chicken and the Egg: Developing Input Requirements for First of a Kind Medical Systems | Tor Alden

Tor Alden will focus on the research and discovery challenges required for adoption of first of a kind complex medical systems that need to follow regulated documentation controls for FDA. There is a need for increased collaboration in the design of complex systems in the medical and lifescience device development. The ability to capture user needs and balance them with technical requirements runs concurrently with the development of the requirement documents. All too often there is a question of what comes first. How companies navigate through the front end of next generation devices is critical in establishing a well-written requirement document. Additionally, a wide variety of information from contextual inquiry needs to be transferred to various disciplines. In some cases, trade offs are required based on initial technical and use requirements. In most cases, the design team must transition the research under design control to capturing workflows, process and user needs to multiple disciplines, including industrial design, user experience, user interface and engineering.  The information acquired must feed into URS, PRD and SRS documents. There is a “chicken and egg” approach that requires immersion into the technology as well as new unmet needs and opportunities. 

Designing for Ebola | John Anastasiadis

Design is playing an important role in fighting Ebola and advancing care in West Africa.

John Anastasiadis, manager of industrial design & human Factors at Johnson & Johnson, will share his experience with usability and design research at an Ebola treatment center in Port Loko, Sierra Leone.

Anastasiadis will communicate challenges associated with preparing for and conducting design research in West Africa.  He’ll also highlight the importance of understanding differences between Western healthcare systems and those of developing nations.

Designing through Data: How Formative Testing and Summative Testing Lead to Understanding User Needs and Creating Successful Products | Stephen Nelson

Stephen Nelson, IDSA, will focus on formative and summative user testing as they relate to medical device design in a large organization, with case studies from digital interface design and physical hardware design.

Nelson will show the use of prototyping as a tool to gain deep understanding of customers’ needs for the product, and their workflow, in methods and rationale between formative and summative testing, and how they relate to the documentation needed to submit a product for regulatory approval.  He hopes to spark a conversation about the place of design within the development of a medical device.

Driving the Next Generation of Medical Innovation | Charles Austen Angell, FIDSA

We are seeing an epidemic in preventable diseases. The medical community is struggling to keep up with the way modern consumers interact with consumer health care services. Important advances in wearable technology are being introduced to help manage positive behavior change, but the adoption is lowest in the highest risk populations. 

To further complicate the issue, as the importance of consumer driven health goes up, consumer comprehension of health care information is facing new cultural challenges. A recent Columbia University study indicates that in the course a modern day people need to make an average of 70 important decisions. For many people, this leads to a state of diminished mental efficacy known as decision fatigue. The result is poor information comprehension and poor decision making in consumers, creating hereto unseen barriers in health literacy among the population and consumer health care interactions. 
Austen Angell, FIDSA, and IDSA Board of Directors’ Chair Emeritus, will discuss his firm Modern Edge’s view of how service design and industrial design are transforming medical services and the development of consumer medical and wellness devices—driving positive trends in compliance, efficacy and adoption.

Engaging Empathy and Making: 3D Printed Prosthetic Skins | Dustin Headley

Dustin Headley will cover the development and fabrication of an array of prosthetic skins for 6 patients with leg amputations at Kansas State University. 27 students were divided into 7 teams and subsequently assigned a patient. This project represented the students’ introduction into 3D modeling and fabrication processes, including 3D scanning, laser cutting, CNC milling and 3D printing. Students engaged the patients via interview and later presented the developed designs to them. The instructor used 3D scanning technology to scan both the patient’s intact limb and prosthesis to enable the mirroring of the geometry in the computer and the mapping of connection details between the skin and prosthesis. A diversity of materials and connection details were explored in the process. The resulting knowledge from the project informs fabrication techniques and tolerances associated with the identified fabrication methods.

Evolving Healthcare Design for All: Co-design and Collaboration with Patients

In this keynote presentation, Larry Chu, MD, will discuss the process Stanford Medicine X uses to co-design health care in collaboration with patients. This talk with be co-presented with Stanford Medicine X ePatient-in-Residence, Michael Seres, a Crohn's disease patient who designed and co-founded a company to produce a digital ostomy self-tracking device for patients.

How Digital Fabrication Delivers Customized Client Solutions | Stephen Hopkins

Flexibility in product design and manufacturing has steadily risen since Henry Ford’s Model T, when consumers could pick any color—as long as it was black. In the last decade, there has been a mainstreaming in advanced digital fabrication processes such as 3D printing, CNC milling and rapid prototyping. Designers now have the freedom to explore complex shapes, regardless of difficulty in construction or schedule constraints.

Stephen Hopkins, IDSA, will cover case studies in digital fabrication and prototyping in solutions for clients. He’ll focus on The University of California-San Diego Jacobs Medical Center, where mass customization techniques were utilized in patient rooms. Hopkins also will provide resources to improve the knowledge and abilities of attendees, enabling them to deliver customized solutions.

How the Internet of Things is Changing (and will Change) Healthcare Product Development | Hugh Dubberly | Steve Wilcox, PhD

In the information revolution, healthcare adoption tends to lag behind other industries. Now, as a new revolution approaches, medical device makers and pharmaceutical companies are beginning to pilot projects with smart, connected devices. This trend signals huge changes in the nature of medical devices—and changes the way they are designed, developed, tested, approved and deployed.

Hugh Dubberly and Stephen Wilcox, PhD, find that a new generation of HCPs (and patients) are beginning to expect devices to connect. Instead, products must now be seen as members of complex product-service ecologies. Data collection, integration, analysis, prediction and visualization are becoming core competencies. The impact on designers goes far beyond graphical user interfaces and app development. Designers must now think in terms of systems and platforms.

Looks Matter: Protect Your Medical Designs with Intellectual Property While Creating Valuable Assets | Christopher V. Carani

Attorney Christopher V. Carani, A/IDSA, focuses on the protection and enforcement of medical designs through the use of intellectual property laws, including design patents, trademark and copyright. Attendees will learn about: what aspects of medical devices can be protected by designs patents, trademarks or copyrights—including not only traditional industrial design, but also UX, graphic user interfaces and icons; how to avoid infringing other's design-related IP rights; and how to enforce/license design-related IP rights. 

Making Change Easier: Applying Behavioral Science to Design

"Behavior change" often comes up in today's medical design briefs. We want patients to better manage chronic conditions and change habits, or persuade healthcare workers to hand wash more to reduce hospital acquired infections. Designers often give products attributes that may not be thought of as behavior change, such as making it easier for a surgeon to adopt a new procedure. At the core of user-centered design is a desire to work with users the way they actually want to behave—rather than wagging fingers at them.

Bill Evans, IDSA, finds that the science of behavior change has evolved rapidly in recent decades with new research tools like real-time brain scanning and the emergence of behavioral economics as a sub-discipline. He will review advances relevant to product design—giving insights to help designers of both physical and digital medical products cut through the hype to get to approaches that are more likely to win over willpower.

Panel Discussion | Formative Design Techniques- Generative Insights from Clinicians | Sean Hägen

Sean Hägen will be moderating a panel discussion on generative techniques for eliciting design inputs in the healthcare space. How do you enable the type-A commando personality, so common among clinicians, to share their aspirations and unmet needs. What are the most creative means by which you’ve elicited feedback or idea generation from a user?


Panel Discussion | Medical Design Development Opinions from Leading Design Consultancies & Corporations | Mary Beth Privitera

There are many valid reasons industrial design is involved in medical design development.  While its contribution to medical devices is recognized by various awards, there are still challenges faced by ID.

For example, how do we justify ID contributions in the light of design control? Or defend our position amongst core scientists?  How do we know when it is appropriate to hire an ID firm and how are we sure it’s the correct one to meet our needs?  

This enlightening panel discussion, moderated by Mary Beth Privitera, will tackle these questions and provide insights into key issues faced by ID in the development of medical design, while inviting audience participation.

Product Development Collaboration: A Design for Success

Join Productive Plastics Principal and VP of Sales John Zerillo for breakfast as he explores the importance and benefits of product development collaboration among original equipment manufacturing (OEM), design and manufacturing resources.

Zerillo will explore case studies on how faster time-to-market; fewer development pitfalls; and seamless design-to-finished product compatibility are achievable outcomes—resulting from collaborative efforts that begin in the early design stages of a project.

Reducing Hospital Acquired Infections Using ‘Critical Design Thinking Strategies’ While Envisioning New Medical Equipment Design | Pepe Velasquez

It is every medical design professional’s desire to improve the delivery of service within healthcare environments. Critical to achieving this goal is a thorough investigation of the hospital 'system.’ Systems design, design thinking and strategy along with educating oneself in advanced medical technology and materials will contribute to the improvement of these desired outcomes. This includes the understanding of the many user interactions with medical equipment during a typical use lifecycle and the options of sterilization procedures available for medical tool reprocessing. Considering that 1.7 million patients are infected each year during hospitalizations, there is a clear need to rethink hospital design and the equipment that runs through it. Pepe Velasquez's presentation will introduce the concept of the ‘burden of responsible knowledge’ which will compel design, and research and development professionals to acknowledge that they must educate themselves in vastly changing technologies whilst conceptualizing new medical tools and surgical techniques.  

Reimagining Aging: A Fireside Chat with a Geriatrician | Stuart Karten | Scott Kaiser, MD

Every day, 10,000 baby boomers in the United States turn 65 years old. There is a growing sense of apprehension about how this aging population will impact our already-strained healthcare system. As product developers, we are faced with an extraordinary opportunity to redefine what it means to age. In this casual “fireside chat,” we’ll hear from Scott Kaiser, MD, a Harvard-trained geriatrician and chief innovation officer who is committed to developing innovative care delivery models that improve the health and quality of life of older adults. Hosted by Stuart Karten, principal of Karten Design, this discussion will give us unparalleled insight into the “Silver Tsunami," explaining trends, sharing strategies and identifying opportunities for medical device developers to help seniors age the way they want to—with style and control.