By Doug Roe, Chief Editor
This Q&A is the final in a five-part series examining industry opportunities in the drug delivery device space. Part 1 explored the overall market opportunity and some of the product design-related challenges. Part 2 investigated the often conflicting guidance from CDER and CDRH. Part 3 exposed the silos that can be created by maintaining separate drug and device quality systems. Part 4 explored how the supply chain concepts of vertical integration could be applied to drive a complete combination product strategy.
Unless you are with a group of IT professionals, a mention of the Internet of Things (IoT) often draws a response similar to that my dog gives when I ask her an unfamiliar question: a slight, quizzical tilt of the head to one side, and then the eyes begin to glaze over. Some people respond, “Do you mean mHealth?” “Like… connected healthcare?” “Is that related to wearables and smart devices?” Yes, yes, and yes — All of these concepts will be part of the IoT, existing under its worldwide cloud.
Today, there are over 5 billion devices already connected to the IoT. The analyst firm Gartner predicts that, by 2020, there will be about 21 billion connected devices. Depending on the speed of technology advancement and the rate at which security and privacy challenges can be overcome, other experts are estimating that number could be upwards of 50 billion. Business Insider predicts that 646 million of those IoT-connected devices will be used for healthcare.
So, what is the IoT and how can medtech effectively leverage its use? Consider the following example:
Your new smart-car will be filled with chips and sensors, monitoring all of its systems and performance. All of a sudden, a sensor detects a potential alternator failure and, depending on the systems set up by the automobile manufacturer, a series of events is about to occur:
The car will notify you of the possible problem with an alarm/warning light while simultaneously transmitting that data directly to the manufacturer, whose customer support system will locate your warranty, contact information, and repair history. The manufacturer then will send to you — via phone app or heads-up display in the car — a warning about the possible issue, a prediction of urgency, and directions to authorized repair shops in your area. You then select a location, the manufacturer’s inventory system ships the part, and you resolve the problem before the failure occurs. But the process doesn’t end there….
The manufacturer will automatically store the data relayed from your vehicle — and all of the data sent from its thousands of other vehicles — to aid in real-time forecasting for replacement part demand, as well as postmarket surveillance. All of this information will be processed and defined through interconnected devices (device-to-device) via the IoT.
Per a recent IoT report from Mckinsey & Company: “The Internet of Things has the potential to fundamentally shift the way we interact with our surroundings. The ability to monitor and manage objects in the physical world electronically makes it possible to bring data-driven decision making to new realms of human activity, to save time for people and businesses, and to improve lives.”
To learn more about how the IoT will impact medtech as a whole, and drug delivery in particular, I sat down with Stephen Wilcox, principal and founder of Design Science, Inc. A pioneer in the field of product design research, Wilcox has been working in product development for over 30 years, during which he was an early adopter of the concepts of applying environment to design and establishing human factors approaches. Wilcox is the co-author (with Michael Wiklund) of Designing Usability Into Medical Products, which explores the advantages of instituting user-centered design for all medical products and connected systems.
We discussed his thoughts on trends in the drug delivery device market, how he sees the evolution of the IoT transforming healthcare technology, and what implications the technology holds for device developers.
Med Device Online: What technology advancements will be most transformative for device design?
Stephen Wilcox: We are at the beginning of a revolution – the IoT – that is going to change everything. A healthcare example would be a sensor that is part of a connected device. It is recording and tracking behavior that is saved to a database. That data can serve many functions. Patients can access it to see how they are doing, physicians can access it to monitor adherence, and the system itself can evaluate the data and send a reminder to the patient to aid in compliance.
Now, imagine many of these devices and databases, all interconnected. With that volume of information about a patient, it transitions from just monitoring to diagnosing and, eventually, to prescribing. With that system of connectivity, a physician could interpret a condition and prescribe the appropriate medicine, which would then automatically be loaded into an infusion pump and delivered, on-demand, to a patient.
Delivery platforms will become part of a larger system we call product service ecology.
MDO: Which delivery device platforms do you expect to have the most growth in 2016 and beyond?
Wilcox: We expect continued and escalating innovation in various delivery device designs. Second- and third-generation products that safely and effectively allow for larger volumes and higher doses of a drug, as well as new “smart” delivery devices that can transmit and receive usage data, will set the trends in the near future.
From a platform perspective, one area that should see large growth is inhalation. There are numerous forms of both wet and dry inhalation products, designed to address many indications, currently in development.
We believe the IoT will accelerate and also complicate the strong shift we already are seeing toward combination devices.
MDO: What are some of the key challenges facing companies that are expanding competencies into these delivery device platforms?
Wilcox: Do those companies have the skills to understand, manage, and then address connected health considerations? System and software engineers will be a requirement. Current IT architecture and operating models will need to be updated. Also, database development and database management will take on a much greater importance as companies begin to capture, store, and analyze the large volumes of corresponding data being created.
Data and system security will become a large area of concern for all connected companies. Building and/or growing your security team will be a necessity. Many of those positions draw from a scarce talent pool and are thus hard to fill; others have yet to be defined. These expanding security considerations will also need to be incorporated into all new product design and development. Who will play the role of making sure that translation happens? Is that employee part of your team today?
Remember, in a few years, all companies, not just device makers, will be pursuing these competencies. You should be creating your plan to meet these needs today.
MDO: How can companies drive innovation in delivery device design?
Wilcox: Companies need to take a holistic approach to the patient therapy lifecycle and incorporate an understanding of all the interconnected products, software, and systems that will be involved. Then, innovation will come from how a solution can best be integrated.
Everybody is going to have to master this impending IoT reality — a change from independent devices to platforms and systems. This is a brave new world that will require new thinking and new approaches.