Tag Archive for: TruMed

By Tracy Manning, DDSTUDIO Chief Strategy Officer

From “zero to commercial” in two years—a savings of at least $5 million and three-to-four years research and development—that is the return on investment BioFluidica CEO Rolf Muller, Ph.D., attributes to human-centered design.

Muller, a successful veteran of the biotechnology industry, engaged with DDSTUDIO and its human-centered design process when starting development of BioFluidica’s liquid biopsy device because experience taught him that engineering a product that functions isn’t enough to fuel success. Medical technology also needs to satisfy the wants and needs of its users in a way that stokes their desire for it.

Empathy for the end-user in their unique and complicated environment is the cornerstone of human-centered design. What does that look and feel like in the context of medical technology’s bottom-line? Muller summed it up nicely when he joined me, IntelliGuard CEO Gordon Krass, and TruMed Systems CTO Joe Milkovits, on a panel about the topic at Biocom’s Device Fest:

“Your technology may do incredible things, but if the user doesn’t use it, the technology doesn’t matter.”

The experts at Ernst and Young agree. The firm’s 2018 Pulse of the Industry report states that to succeed despite the pressures of reimbursement, rapidly evolving technologies and super-consumers, “companies must evolve their focus from product-centric to the consumer experience.”

De-mystifying Human-Centered Design

I proposed the Device Fest panel as a forum for medical device executives to share their experiences with human-centered design and explain the value they’ve found in it. The executives also addressed the misperception that human-centered design is a fuzzy concept. Far too often companies with cutting-edge technology focus on engineering a product that could be the best solution, but neglect the user’s daily rituals and emotions.

Good design isn’t just about making a product aesthetically pleasing. As DDSTUDIO CEO Charles Curbbun tells clients: “When human-centered design is done right, the product starts to disappear and the experience takes over, allowing users to get into the flow.”

Human-centered design uses five key elements to uncover the right product solution for the consumer.

  • Empathy for the consumer/user through extensive, ongoing research.
  • Cross-functional teams that align to leverage expertise and solve the right problem.
  • Multiple iterative cycles of mock-ups and rapid prototyping so the wrong ideas fail early.
  • Creativity that includes brainstorming to see problems from new angles.
  • Risk management with each iteration.

Human-Centered Design in Action

Our Biocom colleagues at Illumina, Hologic and Synthetic Genomics offer many examples of human-centered design empowering product development. Human-centered design is equally beneficial for smaller companies, said those who spoke at Device Fest.

Muller said that in a scheduled brainstorming session, BioFluidica’s team proposed ditching plans to create their own processing system for its proprietary chips that hold the patient sample. Alternatively, they could use an already FDA-approved system from Hamilton Robotics. That out-of-the-box idea worked, resulting in the massive savings in time and money.

TruMed Systems incorporated human-centered design into its first generation AccuVax Vaccine Management System, a refrigerator/freezer storage and inventory system for handling vaccines in the doctor’s office.  It has since gathered valuable data to incorporate in its second-generation product, Milkovits said. Visiting offices where AccuVax would be used was invaluable, he said.

“We learned the important difference between a 28-inch-wide machine that fits through doors and into cubicles, versus a 36-inch device that doesn’t do either,” he said. That knowledge influenced many subsequent decisions, he added. Prototypes of multiple iterations allowed nurses to provide insightful analytics. We also learned increased height would enhance capacity, while internal changes would make the machine easier to build and more reliable, he said.

IntelliGuard’s Linked Visibility Inventory System, which uses RFID technology to track and inventory drugs used in surgery, had its cross-functional product development team build empathy for hospital pharmacists and anesthesiologists through extensive research, Krass explained. Team members shadowed anesthesiologists at work, including a software engineer who spent the day in the OR, he said. One gets a real sense of how there is no room for error when you see the patient there on the operating table, he said.

This immersive research also allowed the team to learn early about the complicated legal and regulatory issues for handling drugs in the environment, which informed later decisions.

“The learning that occurred through this process is significantly better than what we could have ever done on our own,” Krass said. “You have to get into an environment and see people using the product to understand how to mitigate risk.”