5 August, 2014 by Chris Hammond, Director of Insight & Innovation, Kaleidoscope and Sean J. Barnett, MD, MS, FACS, FAAP, Chief Medical Officer, Kaleidoscope
| While designers are embedded in a clinical environment,
embedding a clinician on-staff with a design team
also improves the availability of feedback.
Overcoming regulatory pitfalls of medical device development with early clinical involvement.
For medical product development, the rigors of input gathering and iterative concept testing may slow down innovation process and subsequently increase costs. Building on user-centered design principles, creating an Embedded Design Team with clinicians and design professionals in a co-creation atmosphere provides a revolutionary way to drive speed to market.
For companies today, meeting regulatory guidance of the U.S. Food and Drug Administration (FDA) and international standard organizations is about improving patient safety by applying principles of user-centered design and demonstrating them adequately throughout the process. Regulatory guidance requires design input from clinicians at frequent touch points to mitigate the risks to patient safety. But, every clinician touch point has costs—in terms of both money and time.
In the past, historical design approaches included voice of the consumer input early in the process and then later at validation. Creating an Embedded Clinician/Design Team by embedding designers in a clinical environment or embedding clinicians on a design team takes user-centered methodologies to the next level. Here are five ways to enhance medical product development with an Embedded Team:
1. Start with the Users
consumer good like soap or laundry detergent,” says Barnett. “However, the majority have never performed or even seen a sleeve gastrectomy for example. Embedding designers helps build their understanding. And the earlier in the product development cycle the better.”
By embedding designers in the medical environment for observation, empathy is greatly enhanced. Kaleidoscope’s Chief Medical Officer and practicing Pediatric Surgeon Sean Barnett, MD, MS shares the importance of understanding the physician’s ecosystem and needs. “When you are in the consumer goods space, most people have purchased or used a
Embedding works both ways. While designers are embedded in a clinical environment, embedding a clinician on-staff with a design team also improves the availability of feedback. “Clinicians get excited to work on new products as there is never a shortage of problems to solve. Often the biggest hurdle is creating an interactive environment between the end-user and the designer. With this model, the biomedical engineers can walk down the hall and get clinical feedback immediately,” says Barnett. “That’s golden.”
2. Build Things Early
Whether using an Embedded Clinician/Design Model or even an historical model, it helps to build things as quickly as possible. “After deep upfront research, it is important to move quickly
to concept development,” says Chris Hammond, Director of Insights and Innovation at Kaleidoscope. “Create artifacts for users to respond to. Put things in clinicians’ hands. We are asking people about the future, something they have not seen yet. You’ve got to show it to them.”
From a regulatory standpoint, it is important to document and track these touch points and changes in design requirements. “Regulatory pathways take care of themselves. Plus, we have a better understanding of tasks and how best to achieve goals,” says Hammond.
3. Iterate Fast
Set short cycles and don’t set expectations. Step back and ask questions with users frequently to help mitigate risk. For example, Kaleidoscope wanted to understand the intuitiveness of a medical device with a user-interface screen for a global medical technology company.
“It’s not always feasible to embed a clinician, so we created an interactive, collaborative five-day process,” says Hammond.
“In the first few days, the team worked deeply with a series of nurses and doctors to create, test and refine an interactive prototype,” says Hammond. “The working sessions were much more effective because of the early and deep clinical involvement. Issues like the need for a “home icon” on all screens and the problems of using the same interface for both home and clinical use were discovered and resolved. Our user-centered validation held on the fifth day went smoothly. Spending more money upfront made costs much more predictable downstream.”
4. Design for the Ecosystem
Designing medical products is about much more than a single physician using a single device. An embedded clinician can help represent the needs of all stakeholders including patients, doctors, nurses, technicians and supply professionals. In another Embedded Design Team example, Kaleidoscope partnered with a regional children’s hospital
. “We set up a broad needs-based approach for the under-served pediatric market and embedded Kaleidoscope designers and engineers within the hospital,” says Barnett. Meshing design professionals and clinicians created a nimble team that was able to discuss problems, talk the same language and come up with solutions quickly.
5. Create Environments for Collaboration
“We have been in business for almost 25 years, working with big Fortune 100 companies and understand what it takes to bring a product to market,” says Hammond. “We saw that clinical access was a challenge for companies. For example, Company-XYZ shows up with a contract but the surgeon doesn’t want to sign it because they are worried about their intellectual property and their time. They are busy taking care of patients. What is unique about Embedded Teams is that clinicians help drive the process and can see the positive impact on the industry that they are making as a whole.”
Embedded Teams add agility to product development but don’t replace the need for formal formative user testing with a broad sampling of users. “There may be bias,” says Hammond. “Embedded Teams make formal testing more effective and many issues are resolved beforehand.”
About Kaleidoscope Innovation and Product Design
Headquartered in Cincinnati, Kaleidoscope is a global innovation and product-design firm with five locations and more than 80 employees. We transform business through Purpose Driven Innovation™ by leveraging our expertise at the intersection of consumer insights, technology and health and wellness.
Learn more about our medical product development capabilities.
Sean Barnett MD, MS, FACS, FAAP
A board certified adult and pediatric general surgeon, engineer, anatomist and scientist, Dr. Sean Barnett brings a multimodal approach to medical-device design and thinking. He completed his general surgery training and fellowship in surgical infectious disease at the University of Minnesota as well as a fellowship in general and thoracic pediatric surgery at Cincinnati Children’s Hospital Medical Center. During his tenure at Cincinnati Children’s Hospital, he served on staff as a general, core trauma and bariatric surgeon as well as an Assistant Professor of Surgery through the University Of Cincinnati College Of Medicine. Additionally, Dr. Barnett presided over the Operating Room Equipment and Standards Committee and the Innovation Consortium where he collaborated with numerous companies including Kaleidoscope. As Chief Medical Officer at Kaleidoscope, Dr. Barnett provides a wealth of clinical and corporate medical knowledge and leadership. He remains clinically active and is an Associate Professor of Surgery at the Boonshoft School of Medicine.
Chris Hammond is passionate about the opportunity space between research and design. He grew up in a family of engineers but quickly developed a love of creating and sketching. After ten years of working in the corporate sphere, he joined the team as a Senior Designer. Now he now heads up Kaleidoscope's insight and innovation team, and aims to lead with courage, integrity, and empathy.