Key Challenges and Solutions for Medtech Companies
Due to the challenges incurred by the narrow treatment window for acute ischemic stroke (AIS) patients, medtech and IT companies, health care providers, and policy makers are working together to increasingly utilize telestroke systems, artificial intelligence (AI), and strategic policies to get patients treated faster and expand access to stroke treatment.
Below, we will explore the finer details of these challenges as well as the various solutions that are emerging to overcome them.
Background: Challenges of Traditional AIS Treatment Patterns
Traditionally, IV thrombolysis was the standard treatment for AIS; in recent years, however, neurovascular thrombectomy has been increasingly viewed as a better alternative. Results from the MR CLEAN trial, released in 2015, demonstrated the benefits of neurovascular thrombectomy over IV thrombolysis in the treatment of AIS. Now that the effectiveness of neurovascular thrombectomy has been proven, the focus has shifted toward expanding patient access as rapidly as possible.
This is particularly challenging due to the highly time-sensitive nature of treatment; stroke patients are essentially in a race against time to undergo thrombectomy before the narrow treatment window closes—in fact, a common refrain in discussions surrounding AIS is the phrase “time is brain”, meaning that the speed of treatment is directly related to the extent of damage to the patient. This problem is further complicated by the fact that neurovascular thrombectomy is most often performed in large comprehensive stroke centers (CSCs); these centers are fully furnished with all the required equipment to treat AIS patients, and emergency medical services (EMS) will send suspected AIS patients in the vicinity directly to these facilities. However, CSCs are typically located in densely populated areas, making AIS cases in rural and suburban areas especially difficult to manage. Moreover, the lengthy diagnostic–imaging-assisted process of patient selection and the scarcity of experienced interventional neuroradiologists only amplify the difficulty of ensuring timely and effective treatment.
However, these challenges reveal opportunities for improvement in various facets of current stroke treatment processes; such an environment provides numerous parties, including traditional medical device companies as well as players in IT and diagnostic imaging, with substantial potential for growth, should they be able to capitalize on current unmet needs and align their growth strategies with rapidly evolving stroke treatment pathways. A concerted effort from all of these parties, as well as policy makers, physicians, and EMS, is critical to improve stroke patients’ access to life-saving treatment.
Our research has allowed us to identify some of major challenges facing stroke treatment practices today, as well as how innovation and cross-industry collaboration have attempted to address these challenges and how it may do so in the future; although these challenges can be observed in many geographies worldwide, much of the solutions discussed below revolve specifically around the US.
- Challenges—Limited treatment options outside of urban centers, uncertainty surrounding treatment availability, and overcrowded stroke centers
- CSCs are almost always located in large population centers, making it challenging for patients in rural and suburban to receive timely treatment. As a result, many facilities in the US are certified as primary stroke centers (PSCs), and these facilities are located closer to suburban and rural areas in order to treat patients within recommended treatment window.
- Some PSCs may be able to offer neurovascular thrombectomy, but not all of them do; while this offers AIS patients an alternative treatment setting when CSCs are out of reach, the uncertainty surrounding whether a PSC provides neurovascular thrombectomy or not often leads EMS to bypass these facilities and send a patient directly to the closest CSC, where there is no such uncertainty. As a result, CSCs are very frequently overcrowded and operating above their capacity.
- Another reason behind the overcrowding of CSCs is the difficulty faced by EMS staff in discerning whether a patient actually needs neurovascular thrombectomy without the resources that are typically only available at CSCs, including the necessary diagnostic tools or the expertise of interventional neuroradiologists.
- Policy-Oriented Solutions—Expanding the availability of stroke centers in rural and suburban areas
- To combat CSC overcrowding caused by uncertainty surrounding the availability of thrombectomy in PSCs, The Joint Commission established a new type of hospital certification, known as thrombectomy-capable stroke centers (TSC), in January 2018. TSCs are facilities located in rural areas that have the capability of providing thrombectomies. Throughout 2018, 18 US facilities became certified as TSCs.
- Although some have criticized this certification, arguing that centers providing neurovascular thrombectomy must be able to meet a certain threshold of procedures to provide practitioners with enough practice to gain a strong command of these highly complex and difficult procedures, the availability of stroke treatment in rural areas is crucial to ensuring timely treatment to patients in those areas and can determine whether a stroke patient survives or how much damage is incurred to their brain.
- Technology-Oriented Solutions—Increasing utilization of MSUs, telestroke systems, AI, and personal monitoring devices
- Furthermore, CSC overcrowding caused by EMS staff’s inability to properly diagnose stroke patients can be mitigated by the use of new technologies, such as mobile stroke units (MSUs) and telemedicine. MSUs—which are ambulances that are equipped with stroke-related equipment such as a portable CT scanner and a telestroke system—enable patients with suspected stroke to undergo a CT scan while on route to the hospital.
- Not only does this allow for accurate diagnosis that helps in determining where to send the patient, it also affords the MSU personnel the capability to send the resulting images directly to the interventional neuroradiologists at the target facility, allowing the physicians there to prepare for a patient’s specific needs before they arrive, which saves valuable time for AIS patients.
- In addition, in geographies and regions where patients have very limited access to costly and complex treatments such as neurovascular thrombectomy, telestroke systems and communication apps can also be utilized so that well-trained neurologists in CSCs can provide support to less experienced physicians in rural facilities.
- Continued integration of other innovative technologies into stroke treatment pathways will further ensure excellence of practice in the future. For example, Viz.ai—an artificial intelligence (AI) company—offers Viz LVO, which is an AI-powered triage system designed specifically for AIS; the system—which is designed to “automatically analyze computed tomography angiography (CTA) images to identify suspected large vessel occlusion” and notify specialists through a mobile device, thereby ensuring the catheterization lab is ready before the patient’s arrival—won the 2018 Best New Radiology Software on AuntMinnie.com, which is the largest community website for radiologists worldwide. In late 2018, Viz.ai became designated as a compatible vendor for the AHA/ASA Get With The Guidelines (GWTG) Stroke registry, demonstrating the growing significance of improved communication systems in streamlining AIS patient transfer pathways.
- Moreover, other innovative technologies can also assist in improving stroke prevention. Patients with atrial fibrillation (AF) are at a high risk of ischemic stroke; therefore, portable monitoring devices—which are becoming more accessible as health care becomes increasingly integrated into personal electronic devices such as smartphones, smart watches, and electronic fitness devices—can be utilized to monitor AF patients, allowing for timely medical management and possibly the prevention of the onset of ischemic stroke.
- For example, Apple and Johnson & Johnson are partnering to launch a large-scale trial to investigate the potential of the ECG and irregular heartbeat notification functions on the Apple watch in preventing stroke and improving patient outcomes. Positive results may potentially support the Apple watch receiving some coverage under Medicare and insurance companies.
Opportunities Presented By Improved Stroke Guidelines
Innovation in stroke infrastructure and diagnostic capabilities has already extended recommended treatment windows for AIS and thereby improved stroke patient outcomes. More particularly, in late 2017, positive results from the DAWN trial showed that treatment remained effective for stroke patients after 6 hours of ischemia onset, leading the AHA/ASA to update its guidelines and extend the recommended treatment window for neurovascular thrombectomy from within 6 hours to within 24 hours of ischemia onset. Additionally, in October 2018, results from the EXTEND trial were presented at the World Stroke Congress, showing the safety and effectiveness of thrombolysis with tissue plasminogen activator (tPA) beyond the previous indication of within 4.5 hours of ischemic attack.
These extended windows of treatment afford medical device, pharmaceutical, and IT companies, as well as providers of endovascular solutions and interventional neuroradiologists, with a tremendous opportunity to find ways to recanalize cerebral vessels at higher speeds. Potential solutions are numerous, ranging from developing new devices and software to adjusting existing treatment processes to align with a continuously growing understanding of clots and AIS.
Going forward, diagnostic imaging, AI, and telemedicine will continue to play an ever-larger role in AIS treatment; companies and healthcare providers that are able to align their visions with the currently unmet needs in the stroke space will be able to provide a substantially improved outlook for AIS patients and will be well positioned for future growth.
Looking forward, medtech companies in this space should continue to consider the following questions going forward:
- What role can players in this space adopt to support the ongoing transformation of stroke treatment pathways?
- Are these players well prepared to engage in strategic partnerships with IT companies and stroke centers?
- What lessons can be learnt from the ongoing shift in stroke treatment that can be adapted for other markets?
Interested in more data and expert perspectives around stroke innovation?