Technological advances are revolutionizing the medical device industry, not only increasing the number of connected medical devices available to market but strengthening their role in healthcare. This year alone, sales are estimated to be $475 billion in the US, increasing to $595 billion by 2024. The medical device industry is expected to grow at an expected rate of 5.6 percent CAGR until 2024.
Developments in wireless technology, smaller devices, and computing power are changing the landscape of the interconnectedness of devices. The data collected, analyzed, and shared from medical devices with healthcare organizations is allowing for better patient outcomes, lowering of costs, and presenting an additional revenue source. Properly integrating and disseminating patient information will only strengthen future growth in MedTech.
The following are some major trends attributed to technological advances, presenting new opportunities as well as challenges for medical device companies.
Integrating with IoMT (Internet of Medical Things) to become a healthcare partner
Significant innovations in new technologies are driving medical devices that generate data into care pathways, creating alliances with IoMT systems. These devices that provide and analyze data are aiding healthcare organizations to improve patient outcomes, lower costs, and improve efficiency. The role of MedTech is now even more important, serving as a value based partner rather than just a developer and supplier of devices. The IoMT market is expected to grow to $159.1 billion by 2022, which is a compound annual growth rate of 30.8%.
Medical device companies are taking a look at their business models and identifying ways to integrate IoMT in order to serve as partners for payors, healthcare providers, and patients. By harnessing the data and making it meaningful to healthcare providers, a new value-based program can be monetized.
According to Deliotte’s Reserach2Guidance, medical device companies are starting to utilize the IoMT connected infrastructure:
31% are offering data distribution channels as a service
39% are incorporating data as an added value to justify pricing
43% are using data to drive business decisions
For IoMT to successfully integrate into MedTech, proper integration between all parties across the IoMT ecosystem should be in place. Medical devices need to generate, analyze, and send accurate data to reveal the condition of patients and the effectiveness of the treatments in order to show true value.
Creating integrated platforms will allow for the information to be collected, shared, and accessed in an efficient and secured way. The key for successful IoMT is the accuracy and fluid transfer of the data providing an analysis of health conditions for healthcare systems and patients. The goal is to improve patient outcomes while reducing costs. These service-based solutions offer valued based care, making medical device companies a partner in healthcare rather than just a manufacturer or supplier.
Data as Another Source of Revenue
MedTech is discovering an opportunity to create another revenue stream with data. Software as a medical device (SaMD) is transforming healthcare, empowering patients to be better informed and involved in their own health conditions. Patients with chronic conditions that require monitoring can obtain the data and share it with other healthcare professionals. Those that are willing to share data can help improve their treatments and help medical device companies enhance their products. Currently 40% of patients are willing to share personal data for medical research, while 35% are willing to share it with medical device manufacturers according to a survey. This presents an opportunity for medical device companies to monetize the sharing of data, where patients own the data and proprietary tools are then used to distribute them to interested parties.
According to a survey by Deloitte Center for Health Solutions and AvaMed, all the medical device companies questioned are investing in medical device connectivity. Out of the group, 68% are creating payment structures to include SaMD. The portfolio of products, supporting services, and software technology surrounding patient data will produce better patient outcomes, lower costs, and aid in efficient patient treatments.
As SaMD technology becomes less costly, more accessible, and sophisticated, it will influence healthcare delivery, research, and allow for more personalized treatment. There are some obstacles that need to be considered. Of the medical device companies surveyed, 77% stated combining data with new technology will be challenging. Medical device companies will also need to source a workforce with skills set to innovate the development of medical device software solutions. Additionally, regulation will be pressed into being agile and ready to address privacy concerns at all levels of information dissemination.
Heightened Threat of Cybersecurity
The threat of cybersecurity is now in the forefront for medical devices, with numerous exchanges of information and accessibility between healthcare providers, manufacturers, and suppliers. Medical device security can be be implemented not only during the conceptual and developmental stages but extended throughout the product’s lifecycle in order to prevent cyberattacks. Though larger companies claim they are better prepared to handle cybersecurity issues, smaller companies need to react quickly and work together to minimize any harm to the flow of information.
The FDA recognizes that medical devices share the responsibility of cybersecurity threat across the ecosystem but specifically holds manufacturers primarily responsible for managing cybersecurity risks within their products. A security ‘playbook’ was created last year to assist healthcare delivery organizations to respond to threats of cybersecurity. There have not been any cases to date on attacks on medical devices. FDA commissioner Scott Gottlieb stated in October 2018, “The FDA isn’t aware of any reports of an unauthorized user exploiting a cybersecurity vulnerability in a medical device that is in use by a patient, but the risk of such an attack persists.” Medical device companies should be prepared to provide documentation of processes implemented to the FDA showing that cybersecurity risks are being managed.
In the EU, an agreement was made to the Cybersecurity Act in December of 2018, reinforcing the directive of the European Union Agency for Network and Information and Security (ENISA). The propose was to aid member states is fighting cybersecurity threats and attacks. It also addressed certification for certain information technologies regarding those that included medical devices.
Advancement in technology and the growth of information sharing through medical devices are reshaping the landscape of healthcare. The world needs to be prepared to not only utilize the data to enhance patient outcomes but to safeguard their privacy. It will take regulatory agencies and medical device companies to work together to create an infrastructure with defined expectations. Those medical device companies who are already investing on the technology, infrastructure, and partnerships amongst healthcare organizations have the potential for further exponential growth.
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