John Timberlake has been commercializing diabetes drugs and devices for 25 years. Over the course of his career, one theme has always stood out: if you want people to use your product, it has to be made with the end-user in mind.
The mantra of patient-centric design also rang true with Timberlake’s fellow panelist, Dr. Stephanie Habif of Tandem Diabetes Care (NSDQ:TNDM) – a California-based company that makes the t:slim X2 insulin pump.
“Taking a patient-centric approach is a critical part in understanding how to develop your products and the interaction you want your users to have with those products,” she said.
‘Patient-centric design’ is a catchy phrase in today’s medtech ecosystem, often tossed about with little action to ground it. But Habif and Timberlake emphasized repeatedly that beginning the device development process with the end user’s needs in mind is fundamental.
“There’s a lot of great technology out there looking for a patient indication. That’s not really the way to do it,” Timberlake said.
Habif, senior director of behavioral sciences at Tandem Diabetes Care, pointed to the work of patient-reported outcomes and usability studies as ways to hear directly from the people that will ultimately rely on a company’s devices to manage their condition.
“Whether we ask customers to report on therapeutic outcomes, whether we ask them to report on satisfaction with their experience – whatever it may be, we make sure that our entire organization is set up to have a direct line of communication in a structured and measurable way so that we’re regularly gathering patient-reported outcomes from the people using our devices. It keeps us honest because customers provide honest feedback, and we really appreciate that,” she said.
Listening to the ‘DIY’ diabetes community
The diabetes patient community, especially those with Type 1 diabetes, have made themselves heard through online advocacy and social media – particularly the #WeAreNotWaiting movement, which consists of people managing their condition using open source code to combine insulin pumps and glucose monitors.
Although the people using these systems are acting outside the bounds of FDA-approved products, Habif sees them as a useful force, providing device companies and healthcare providers with insights into what features are most important to end users.
“The impact of that type of movement on commercial organizations, in my opinion, is that it really forces us to push the innovation timeline. It teaches us what people truly need and want, and it forces us to stay honest,” she said. “People who advocate are very, very passionate about what it is that they are trying to tell you. So I think there’s a really healthy relationship between the DIY community and the patient advocacy groups and the commercial organizations – and I see that relationship only getting better and enhancing as time goes on.”
What’s driving the movement for device connectivity?
As with the rest of the medical device industry, diabetes devices are increasingly becoming connected. Timberlake said Valeritas is working on a Bluetooth accessory called SIM that will snap on to its V-Go insulin delivery device to connect patients’ devices and doctors.
But, Timberlake noted, data is nothing without analysis.
“Data is useless; information is powerful,” he said. “You have to understand what information [patients and doctors] can handle, what they want and what they can use.”
Habif added that people with diabetes already have to juggle so much information to effectively manage their diabetes – its the job of device companies to ensure that their products aren’t adding to that burden, she said.
“I think the payers are playing a, really big role in the move towards connectivity because of the shift to value-based healthcare. And so, if the dollar is going to follow the outcome, we need the infrastructure to be able to read and make sense of those outcomes for payment purposes, for reimbursement purposes. Within the landscape of healthcare, that’s a big driver of connectivity and data,” Habif added.
The importance of trust
Whether a patient lives with Type 1 or Type 2 diabetes, they have to rely on drugs and/or devices to manage their condition. For Timberlake, this represents an enormous responsibility.
“We have to create a manufacturing process which is flawless. Because when I put my head down on the pillow at night, I want to make sure that every V-Go that’s on a patient is accurate and will do no harm,” he said.
Habif pointed out that introducing a new process for disease management takes time – half of the people who use t:slim X2 insulin pumps are new to pump therapy, she said.
“If you’re somebody who has had to learn how to manage Type 1 diabetes, most of what you’ve had to learn has been manual. You’ve had to learn how to calculate the amount of carbohydrates that you’re eating, to figure out how much insulin you should be bolusing, or what amount of basal insulin you require. If you’re somebody who’s used multiple daily injections, you’ve learned how to handle a syringe and get the insulin into your body. It’s all been a very manual management process,” Habif said.
“And now we’re asking you to use a modern-looking black box device that has algorithm-enabled software to put on your body and do all of that for you. That’s a big leap.”