Now more than ever, people are carrying their computers at their fingertips and managing nearly every aspect of their lives online – including their health. Meanwhile, the medtech and pharmaceutical industries are looking for ways to help people stay on top of their treatment regimens and improve outcomes.
Many companies believe that by combining their medical devices or drug-delivery systems with connected capabilities, they can boost patient compliance and learn more about the products they have on the market. But developing a connected drug-delivery system comes with a unique set of challenges.
Drug Delivery Business News editor Sarah Faulkner spoke with Jim Turner, director of software engineering at Sunrise Labs, about how companies should go about developing a connected drug-delivery device. Here are some of the key takeaways:
Define your product – it is do-able?
The first step in developing a connected drug-delivery device, according to Turner, is defining the product and determining if it’s feasible.
“Is this a product that I really want to build? What is it? As you’re starting out, you may or may not know exactly what you want,” he explained.
Companies need to assess whether or not they can prototype the system quickly, Turner said, so they can evaluate if the system is even do-able in the first place.
Once they’ve emerged from the feasibility and product definition stage, companies should consider creating a document tree, he added. There are a lot of interconnected parts in a drug-delivery system, including mechanical, electrical and software assets, all of which have specific requirements and needs.
Design and development:
The design and development phase is “where the rubber meets the road,” Turner said, adding that at this point in the process, companies should have the larger potential problems worked out.
“Hopefully, you’ve retired the risks. There are always going to be technical challenges that you’re going to find when you’re going through the design and development [phase], but the major ones you’ve retired earlier. If you haven’t, you need to put time into that to retire those, because you will run into snags.”
It’s at this stage in development that companies need to consider their end-user and what sort of technology they will be familiar with. For example, an older patient population may be more comfortable using a web-based application rather than a solution that requires a smartphone.
If a smartphone is going to be a part of the connected drug-delivery system, there are a number of factors to take into account, Turner explained: Which operating system should you use? Which carrier are you designing for?
Collecting and organizing data:
Creating a connected drug-delivery system means thinking about data – and oftentimes, a lot of it. From the very start, companies should be thinking about what data they want to collect, where they want the data to go and what they want to do with that data.
“All the data in the world won’t do you any good if you can’t really deal with all of that data,” Turner said.
More often than not, companies are collecting data and feeding it back to the user. But patients and clinicians aren’t always interested in raw data and it’s often not usable in that form. Instead, companies should think about collecting data and organizing it into trends from which patients can glean valuable information, Turner added.
Cybersecurity:
Cybersecurity is on everyone’s mind these days, particularly as it relates to healthcare. Earlier this year, Merck narrowed its full-year financial outlook in the wake of an international cyber attack that stalled its manufacturing operations.
For companies developing a connected medical device, Turner noted that it’s not optional – they have to consider cybersecurity.
“It’s going to happen, so what’s the risk to your patient? What’s the risk to your clinician? What’s the risk to HIPPA? These are all things that you have to pay attention to.”
Companies should perform assessments to understand potential security risks and their impacts on the product’s future user, Turner recommended.
Planning for trouble:
Connected drug-delivery systems are complex and there are numerous opportunities for problems to arise. Companies are faced with the challenge of anticipating potential problems and planning for technology that could be obsolete in a matter of years.
“You’re going to have bugs. I’d like to think that there’s going to be no bugs in my software, but it’s not going to happen,” Turner said.
“So you have to prepare for that, but you have to think about how bad is this situation? Can I do a periodic update? You may actually change the design of the device, electrically or mechanically, which will require an update. So, think about your maintenance plan and your support plan.”
