By Doug Roe, Chief Editor
As healthcare shifts from hospitals to homes, medical device manufacturers have to shift their understanding of the needs of customers and/or end-users. Manufacturers must recognize that a surgeon, an x-ray technician, or a nurse has a very different skill set and use requirements than a home-use patient, and that today’s patients are more tech-savvy than in the past. Patients also want more transparency in their healthcare providers’ rationale and decision-making, as well as more say in their own treatment, which can lead to better engagement and compliance.
Diagnostics device makers serving the home point-of-care (POC) market face these development issues, and more. Beyond addressing an unmet medical need, such manufacturers must ensure that the needs of both the care provider and the patient are met if a product is to succeed. Add to that the challenge of keeping pace with the evolution of telehealth and mobile health platforms, and the uncertainty of new technology — specifically, that it doesn’t always deliver on its promise of a trouble-free solution.
So, how do you build a better mousetrap? What are the patient/provider considerations for developing an at-home POC device, and how can you leverage the ever-increasing connected health options?
I had the chance to discuss these and other challenges with Randy Pritchard, SVP of Point-of-Care at Roche Diagnostics. Pritchard has been with Roche for over 12 years and, in his current role, is responsible for all aspects of POC products’ lifecycle. Here, he talks about the thought and development processes behind Roche’s CoaguChek INRange system, the first Bluetooth-enabled PT/INR home health device, which lets patients monitor their coagulation status and Vitamin K Antagonist (VKA) therapy, and enables healthcare providers to view the results remotely.
Med Device Online: Can you give an overview of the latest generation of the INRange system?
Randy Pritchard: This is the fourth-generation CoaguChek patient self-testing system, and it is the first Bluetooth-enabled (embedded) device in this category, that we are aware. It was developed for patients who are taking Warfarin, and it is for self-testing and self-monitoring in the patient’s home.
Warfarin — in many ways similar to insulin — creates a range within your body that is critical for its effect. Too much or too little can both have highly negative impacts on the patient’s health. This device, in the hands of a patient who is working directly with their healthcare provider, can lead to significantly better outcomes then traditional monitoring. In that method, you go to a lab and get your blood drawn; the lab does the testing and sends the results to your doctor. The results to the patient come much later, usually by a phone call from the physician's office. This device enables the patient to get faster results and to be a lot more in control of their treatment.
MDO: So, one of the key drivers that led to enabling the device with Bluetooth was simplifying the process for the patient?
Pritchard: Today’s patients are looking for ways to make their healthcare process easier, but also to be more aware, and involved, in the management of their care. This device in part plays a dual role.
First, the Bluetooth communication platform removes the burden from the patient to interact with some additional communication device (a docking hub or personal computer) to transmit the data, as most home-use devices require. So that does simplify the patient experience during each use. When we started on product development five years ago, Bluetooth was fairly new. But, it was clear that it was going to be an important communication methodology, so we started building it into the design. What it really does is enable, through an easier connection, a patient's results to automatically get into the hands of their healthcare practitioner.
The second role it plays is related to patient engagement. This is a smart device that offers several interactive patient features. They can use it to set reminders for test times, it has onscreen guidance through the test process, and patients can add comments for each test to remember what they were doing during that test window that may have affected results. There also is a reporting function that offers simple-to-read, color-coded trending data, which gives patients insight into how their therapy is progressing.
Through automatic data transmission to the provider and the patient engagement applications, it allows each party to have better participation in the process of care.
MDO: If a patient is outside of their test results zone, what are the next steps in the device’s communication process?
Pritchard: There are multiple models for how this is done, depending on the device being used, availability of connectivity, and the geography of the user. This latest device currently only has the CE mark from the EU. In Europe, there are certain countries — Germany, for example — where the patient, much like a patient on insulin, is taught to take their test and, with that result, adjust their dosage if needed, and then re-test on a weekly basis. As a result there is greater therapeutic control .
In the U.S., we have a system where the result goes to a third party, called an independent diagnostic testing facility (IDTF). This IDTF is responsible for the management of the anticoagulated patient in conjunction with the doctor. The IDTF will transfer the result to the physician when the patient is out of range. The clinician takes the healthcare decision from there, and communicates directly with the patient to modify his or her medication. In the United States, CoaguChek Patient Services is the independent diagnostic testing facility (IDTF) operated by Roche Health Solutions Inc., an affiliate company of Roche Diagnostics Corporation. In other markets, due to a connected device being unavailable or a lack of connectivity, the patient gets their results and calls their healthcare provider, adding more steps to the process and straying further from the efficiency achievable in the German example.
MDO: In addition to minimizing laboratory testing and doctor visits, what other cost reductions does the device achieve?
Pritchard: When you look at costs, the real cost drivers are those major side effects and major health-related events. There is clear data indicating that when a patient self-tests, compared to routine care, it can have a significant positive impact on limiting bleeding or clotting events. The results arrive much quicker than if they’d gone to a lab, and arrive simultaneously in the hands of both patient and healthcare provider.
Avoiding those more severe issues will lead to appreciably lower overall healthcare costs.
MDO: What design or performance challenges were created by this choice of wireless communication (Bluetooth)?
Pritchard: The product development challenges are related to the mobile and connectivity environments — not so much embedding the communication technology itself. [Bluetooth is] a well-defined and well-quantified technology, and with Bluetooth you get certified that you have met their standards. The requirements are pretty well laid-out and, frankly, our industry is pretty good at taking regulations and guidelines and achieving them.
The bigger challenge with anything regulated — relative to connectivity — is what do you connect to? Is that a stable environment? How do you then transmit? Where are you sending the data? What is the operating system platform? Whether it is an iOS, Android, or Google platform, it changes regularly. Anybody that develops apps, or connects or interacts with those devices, knows that any time there is an upgrade, there are unknown consequences. For makers of connected medical devices, staying aware and ahead of those potential changes can be difficult.
MDO: What role does Roche play in managing the data collected and transmitted by this new device?
Prichard: The data that comes out of the CoaguChek instrument is encrypted to protect patient privacy.. It really is up to the healthcare infrastructure that the device transmits the data to and how that data is managed.
In the U.S., we have our own IDTF, where we act as a third party for data collection and transmission. All of the data is encrypted, and follows all requirements governed by the Healthcare Information Privacy Portability Act (HIPPA).
But privacy laws are not the same in every country of the world. So, for us, that just adds to the complexity of developing products for this new mHealth ecosystem.
MDO: How does Roche interpret the future value and potential use of the global patient data?
Pritchard: That is a highly regulated topic. The outcome will be determined by regulators and who owns the health information. It is a very complex landscape that we follow and try to understand, but ultimately, the patient owns the data. Or, the patient’s physician is the “warehouse” and keeper of that data for that patient. However that is decided, the data does have great value. That is one of the reasons we developed this device; it is getting the information into an actual usable form more easily.
If you look at other industries, for example, knowing how your system is performing, and being able to monitor that, is a huge value to both you and your customers. That knowledge enables you to ensure that your product is still providing value in the system or, if it is not, to be able to act on it quickly. This feedback could lead to lowering the overall cost to serve.
I think that the healthcare providers are the ones that are going to be able to make that data more actionable. We will then work with them on what they find. Our focus is on making sure that patients get the outcomes that they are looking for. We believe that swifter communication — getting the information to the doctors quicker — is going to have that positive effect.
MDO: Do you expect that this system is going to be available to U.S. patients soon?
Pritchard: We are in the midst of collecting the clinical data that is required. This is our fourth-generation system, so we feel like we are very knowledgeable on the needs of the market, and the FDA, specific to it. We have been well-engaged with them through the vetting process of earlier generations. We are confident we will have the data we need for approval in the U.S.