Since its introduction in 2012 as part of the Safety and Innovation Act (FDASIA), patient-focused drug development has catalysed a profound transformation in the medical sector, leading to a paradigm shift towards a more patient-centric approach.
This shift is evident in the emergence of personalised medicine, where treatments are tailored to individual patients based on their unique characteristics and needs. Healthcare processes have been reshaped by incorporating patient feedback, allowing for a more collaborative and inclusive decision-making process.
This has led to a recognition of the importance of user engagement and as such industry leaders have adapted their products accordingly, even extending to traditionally healthcare professional-exclusive devices like pacemakers.
These devices have been revolutionised through the integration of connected devices and digital health products, enabling users to interact with apps linked to their medical devices, among other advancements. This newfound connectivity empowers individuals to take a more active role in managing their own health, fostering greater independence and autonomy and signals a new and exciting world of remote, connected healthcare.
Understanding Patient Centred Medtech
Patient centricity entails an approach to healthcare that places patients and end-users at the core of decision-making processes, prioritising their needs, preferences, and experiences. In the realm of medical technology, this is a relatively novel approach, as historically, the end-user perspective of medical devices was often overlooked.
This disregard for the end-user’s perspective resulted in patients having limited agency in their own care, being compelled to accept choices made on their behalf by doctors. As a consequence, suboptimal outcomes and patient dissatisfaction became more prevalent. The medtech industry has acknowledged these challenges and is now pivoting towards a patient-centric approach. This shift is driven by the realisation that this strategy has the potential to significantly enhance healthcare outcomes and experiences.
The Impact of Covid-19
The Covid-19 pandemic served as an additional catalyst for the acceleration of patient centricity. The strain placed on hospitals during the pandemic led to bed capacity dipping 20% below the risk threshold in the NHS and saw 80% of hospitals in the US reach capacity during the peak of the Omicron variant.
Nurses were under immense pressure to diagnose and discharge patients swiftly, while grappling with the complex and diverse array of symptoms exhibited by individuals. This surge in demand for faster and more accurate patient monitoring and diagnosis within medical units, emergency departments, and isolated outpatient settings became evident.
The resulting apprehension among healthcare institutions about being thrust into such disarray again has fueled remarkable growth, as well as projected growth, in related markets such as Remote Patient Monitoring (RPM) estimated to reach $175.2 billion by 2027 and Home Diagnostics projected to reach $8.52 billion by 2031.
This burgeoning growth signifies the adoption of personal medical devices that enable patients to remain in the comfort of their homes while being remotely monitored by healthcare professionals. In addition to alleviating strain on hospital beds, this empowers patients with a level of autonomy unattainable through traditional diagnostic and monitoring methods.
Designing Patient Centred Medtech Solutions
The integration of patient-centric design into the product development process is becoming increasingly prevalent, focusing on creating user-friendly and convenient products. By actively involving users in the design phase, medical device companies can gather valuable feedback and suggestions to make necessary improvements before bringing their solutions to market. This results in the development of intuitive and user-centric devices that meet the specific needs of end-users.
An exemplary case of a company implementing a patient-centric approach is MolecularYou, a Canadian biotechnology research firm. They have created a blood test kit and accompanying app designed for health assessment. This innovative solution generates personalised health reports utilising over 200 biomarkers, allowing individuals to gain insights into their current and future health risks.
Going beyond conventional assessments, MolecularYou identifies early biomarkers that fall outside the normal range. By detecting these deviations, the company can provide interventions and action plans to help individuals normalise their biomarkers before chronic symptoms or diseases manifest. Through the integration of research on nutrition and exercise modification, MolecularYou equips users with comprehensive analyses of their health, enabling them to proactively manage their well-being as they age.
Other medical devices that are increasingly focused on the patient include:
- Wearables: These devices can track various health parameters such as heart rate, sleep patterns, physical activity, calorie expenditure, blood oxygen levels, stress levels, menstrual cycles, and even specific health conditions like glucose levels for individuals with diabetes.
- Robotics: Medical robotics offer assistive and rehabilitative functionalities, aiding individuals in regaining mobility, performing daily tasks, and improving their quality of life.
- 3D Printing: The advent of 3D printing has revolutionised healthcare by enabling the creation of custom prosthetics, orthotics, organ replacements, and implants, providing patients with personalised solutions that cater to their unique anatomy and requirements.
Challenges and Barriers
The journey towards patient-centricity in medtech is not without challenges. As healthcare shifts towards empowering patients, medtech companies face obstacles that necessitate careful consideration and strategic solutions.
Digital health occupies the intersection between medicine and technology, subject to multiple regulatory and legal frameworks, as well as working groups within governing bodies. The current regulatory guidelines fail to adequately address the complexities of rapidly developing digital health solutions. This regulatory uncertainty poses a barrier to creating patient-centric solutions, as there is no clear framework in place for obtaining approval for such products.
Overcoming this challenge requires a shift in the mindset of medical device companies. Rather than pursuing minimal evidence to secure device approval, medtech companies must consider how they can ensure the safety and effectiveness of their products for healthcare consumers. This shift aligns with the broader change from prioritising the product itself to improving outcomes, emphasising the importance of placing the consumer at the core of product design and providing evidence that demonstrates safety and improved outcomes.
Perceived regulatory barriers can be transformed into a competitive advantage within the medtech industry. However, this necessitates companies becoming comfortable operating without a well-established regulatory framework and collaborating with regulatory bodies to develop new guidance. To truly revolutionise digital health, medtech companies must develop a technology strategy with a robust digital foundation, adopt a user-first mentality, and be open to collaboration with strategic partners.
Switching to Remote Care
As the demand for at-home care continues to rise, Medtech companies must proactively plan to pivot their offerings to meet this evolving need. This necessitates adapting Medtech strategies, as indicated by over 75% of surveyed executives in the medical product outsourcing industry who expect significant reorientation of their company’s long-term strategy to accommodate the expansion of care settings and delivery models.
Healthcare is shifting away from traditional hospital settings and towards ambulatory and at-home care. However, the necessary platforms and capabilities to fully enable this transition are not yet fully established. Remote care heavily relies on technology and connectivity, thus Medtech businesses must ensure that their devices are compatible with various communication networks and address any issues related to network reliability and connectivity gaps.
The successful adoption of remote care hinges on providing a positive user experience. Consequently, Medtech companies will need to invest in additional talent with expertise in design and technology. Leveraging this talent will enable the design of intuitive and user-friendly platforms that both patients and healthcare providers can easily navigate. Moreover, expertise in technology will be essential to train healthcare professionals and patients on effectively utilising remote devices.
Patient-centric medical devices, with their increased connectivity and data exchange capabilities, pose an elevated risk of cyber attacks in healthcare. The advent of the Internet of Things (IoT), which enables devices to communicate, send, receive, and generate valuable data over the internet, opens up new avenues for hackers to intercept sensitive information and disrupt healthcare systems. Each connected medical device becomes an additional entry point for unauthorised access by hackers. Cyber attacks are particularly concerning as they can endanger patients’ lives by manipulating medical device functionality or interfering with healthcare systems.
According to cybersecurity firm Sensato, medical devices exhibit an average of 6.2 vulnerabilities per device. Older medical devices are especially susceptible to cyber attacks due to being designed in an era when the threat of such attacks was virtually non-existent. These devices lack the robust security systems present in more modern counterparts, making it easier for hackers to gain control over them.
Despite this vulnerability, many hospitals still rely on older medical devices for patient treatment. Replacing an entire inventory of outdated devices is prohibitively expensive for many hospitals, which is why older devices remain in circulation. Furthermore, a survey by the Ponemon Institute revealed that only 36% of healthcare delivery organisations consider themselves effective in tracking the location of all medical devices, rendering it impossible to protect them from hackers.
Medtech companies need to assume greater responsibility for the security of their patient-centric medical technologies to ensure healthcare systems remain impervious to infiltration by malicious hackers. However, accomplishing this goal will require significant time, which may impede product development, increase production costs, and potentially affect the attainment of regulatory approval.
Future Trends and Opportunities
The trajectory of healthcare unmistakably points toward a digital future. The digital health industry, currently valued at approximately $175 billion, is projected to reach a staggering $1.5 trillion by 2030.
In an increasingly interconnected healthcare landscape, the future of patient care is characterised by unprecedented connectivity, facilitated by a vast array of globally available health apps. With over 350,000 health apps in existence and around 70% of patient groups utilising at least one app to manage their health conditions, digital devices have emerged as critical tools in delivering care and empowering patients.
These apps often work in conjunction with wearables, which themselves are poised for tremendous growth and expected to reach a market value of £81.89 billion by 2028. Wearables, along with wireless sensors, digital patient monitoring systems, and digital drug tracking platforms, have the potential to revolutionise the clinical trials process.
Medtech companies have an exciting opportunity to streamline clinical trials by embracing cutting-edge technologies. Through decentralised trials, they can overcome traditional physical limitations and reduce costs. The rising demand for remote patient monitoring and home diagnostics also presents a chance to provide virtual consultations and empower patients to take charge of their health. By leveraging genomic data, wearable sensors, and AI analytics, medtech companies can offer personalised treatments, optimising patient outcomes.
Achieving patient centricity requires collaboration among stakeholders to foster innovation, interoperability, and data sharing. Together, we can reshape health care with intelligent and personalised care.
The field of medtech is undergoing a transformative shift towards a patient-centric future that prioritises the needs and experiences of users. This transformation is being fueled by advancements in areas such as wearables, robotics, 3D printing, and telehealth, which enable personalised diagnostics and treatments that enhance patient outcomes and experiences. These technologies also empower individuals to take an active role in managing their own health.
The healthcare industry as a whole is experiencing a digital revolution, and medtech companies are embracing this change by moving away from centralised research sites. Instead, they are embracing decentralisation through approaches such as decentralised clinical trials and remote patient monitoring systems, which aim to increase patient satisfaction.
Medtech companies that embrace patient-centricity as a fundamental value and leverage emerging technologies to address patient needs will be at the forefront of shaping the future of healthcare. In this future, patients will be active partners in their own health and well-being.
A Final Thought from AveryFairbank
“While innovation and technological advancements are undeniably critical in the rise of patient-centred medtech, what truly underpins this evolution is talent. It is the ability to navigate challenges, embrace opportunities, and above all, empathise with patients that elevates a solution from merely functional to genuinely transformative.
The future of healthcare isn’t just about creating smart devices; it’s about cultivating smart, patient-centric problem solvers. This unique fusion of technological acumen and human understanding is where the real ‘magic’ happens. Our role in this paradigm shift isn’t just to witness or adapt, but to actively facilitate this merger of talent and technology for a healthcare future that truly puts the patient at the heart of all we do.” – Charlie Fairbank CEO
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