How Healthcare Transformation can evolve in the coming years

The relentless journey of digitalization has touched every sector of the economy, including healthcare. If we look at healthcare as a microcosm then there has been a lot of progress made in the past decades. The development of new medicines and diagnostic tools has revolutionized the sector for the better. This has led to a significant decline in the mortality and morbidity rates globally. Importantly, pestilences like smallpox or plague have become a thing of the past. However, with tremendous progress in various fields, new challenges too seem to have plagued the sector. These include the germination of drug resistant microbes and the gaining prominence of lifestyle diseases such as hypertension, diabetes, obesity, and stress, among others. Further, cancer continues to wreak havoc across demographics with a comprehensive cure remaining elusive.

The buzz around healthcare transformation through digitalization has brought in a slew of benefits. This includes managing the burgeoning healthcare sector with AI-enabled medical devices, telemedicine, or blockchain-driven electronic health records. Digitalization in hospitals and nursing homes has brought about a comprehensive improvement in their delivery of services. For example, a computer-based system creates electronic records of patients arriving at the hospital and then manages them seamlessly, right from the admission stage to the eventual discharge. Also, various types of apps tailor-made to monitor the health of individuals have become commonplace.

Medical practitioners have become dependent on the smooth functioning of medical devices to diagnose and treat patients. With so much at stake, glitches in such devices or tools can play havoc with the lives of patients. This is where healthcare app testing should become an integral part of the software development pipeline. Let us understand how healthcare transformation is going to evolve in the coming years.

How digital transformation in healthcare can benefit people

The technology and knowledge intensive healthcare sector has seen end-users using apps to derive benefits like connecting to a doctor, buying medicines, or doing diagnostics tests, among others.

Connecting to the doctor: This can often be a matter of life and death as the right doctor can diagnose an ailment quickly and begin the treatment process. However, customers often lack the wherewithal to evaluate the parameters of a healthcare provider. But with healthcare app testing, patients can use a robust app to make informed decisions about their health. Imagine making an appointment with your doctor for a house call or clinic visit from your smartphone, the same way you would book an Uber cab.

Leveraging big data: Big data can analyze trends or patterns from sets of data received through channels such as online transactions, social media, and eCommerce. These can accrue a number of benefits such as:

·         Low rate of medication errors: After analyzing the patients’ records, the software can identify incongruities in terms of prescriptions and patients’ health. These can alert medical professionals to take corrective measures and offer an effective treatment. The quality of such software can be enhanced through healthcare software testing.

·         Preventive care: A large number of people flock to various departments and add to the already existing pool of patients. Many a time, these people do not require to be there in the first place. Big data analysis can identify such people and prevent them from crowding the wrong department. Thus, healthcare testing services can ensure such software applications with interfaces to big data perform accurately.

·         Accurate staffing: Healthcare facilities can be overwhelmed at times with a large influx of patients. By undertaking big data analysis, healthcare service providers can predict such influx and optimize the allocation of workforce. This way the waiting time for patients at various departments can be reduced drastically.

·         Wearable medical devices: Healthcare application testing can preempt the malfunctioning or inaccuracies of wearable devices, which collect health-related data from patients. The wearable device market is likely to be around $27 billion by 2024 (Source: marketwatch.com). The devices come in the form of heart rate sensors, sweat meters, oximeters, and exercise trackers, among others. These devices offer a personalized healthcare experience to the patients and help insurance companies to rate a patient’s risk for illness.

Conclusion

The healthcare industry is undergoing a tectonic shift in favor of technology. This will lead to better diagnosis and treatment of ailments. Moreover, healthcare apps are helping patients to know more about their diseases and the likely treatment protocols to be followed. Patients draw a lot of information from various apps or websites, which were earlier the exclusive preserve of the medical professionals. Healthcare application testing helps in identifying glitches in the applications and ensure they deliver the right outcomes.

What is the compliance perspective of Medical Devices testing

The role of medical devices in screening, diagnostics, and treatment has become critical. Modern medical devices have sophisticated components with digital interfaces. These help to derive meaningful inferences from the data emanating from patients’ vital stats. Since speed and quality lie at the core of the functioning of medical devices, they need to comply with quality standards and regulations. Also, since the functioning of medical devices is regulated by the built-in software, the same should adhere to basic safety guidelines or protocols.

Further, the rate of failure of medical devices has been found to be increasing by the day leading to the establishment of IEC 62304.

What is IEC 62304?

It is the international regulatory standard defining the SDLC requirements of software driving medical devices. The standard was established as it was felt that product testing alone will not ensure the safety of patients, especially when there is a software present. The standard requires every aspect of the SDLC to be scrutinized. These include development, configuration, risk management, maintenance, security, and problem resolution.

IEC 62304 offers a standard framework for the manufacturers of medical devices to design software. By conforming to this standard, manufacturers can fulfill the requirements of medical devices testing thereby generating trust. Also, since the standard is harmonized with the medical device directive practiced in the European Union, it has been acknowledged as a benchmark. The devices adhering to IEC 62304 include

•     Diagnosing, monitoring, or treating patients under medical supervision
•     Contacting the patient - physical or electrical
•     Transferring energy to/from the patient
•     Monitoring or detecting such energy transfer

Digitization in healthcare can have many dimensions. These include monitoring the performance of applications, leveraging the digital ecosystems for the stakeholders, and calculating the quantum of investments to drive digital transformation. The healthcare sector is being transformed with the infusion of new technologies (wearables included) and treatment/diagnostics methodologies. Since devices incorporating new technologies need to deliver results with precision, they should undergo rigorous medical devices testing. Let us discuss the reasons for validating medical devices through comprehensive Quality Assurance.

• Security: Medical devices contain sensitive data about patients’ health, which if breached, can lead to severe consequences. It is only through rigorous healthcare software testing that devices can be made hack-proof. The measures may include identifying vulnerabilities, validating and authenticating user log-ins, performing penetrating testing against firewalls, or encrypting data. Also, medical devices need to adhere to stringent quality standards such as the Health Insurance Portability and Accountability Act (HIPAA). This ensures the protection of patients’ health-related data and information.
• Usability: This is a crucial testing requirement as devices are handled by healthcare professionals while discharging their duties. Since many professionals may find it difficult to handle the features and functionalities of devices, the same should be made simpler. This is where usability testing using automation can help to simplify and enhance the user experience.
• Big data: The healthcare sector deals with a humongous quantum of data based on which inferences are drawn about the health condition of patients. These inferences are further leveraged to plan the right treatment strategy or develop a product. Big data analytics can help to derive the right inferences from the data quickly and accurately. It can help professionals to make informed decisions related to research and development, drug inventions, or curing ailments.
• Device interoperability: Medical devices need to connect and interoperate to deliver the required outcome and user experience. Since the healthcare sector needs to ensure data privacy, security, and regulatory compliance, the role of medical devices testing specialists becomes crucial. So, healthcare testing services need to apply technical expertise, resources, and time to ensure quality, compliance, and business profitability.

The testing of medical devices impinges on meeting the regulatory requirement. Moreover, navigating the regulatory ecosystem is crucial for the successful launch of medical devices or products. It ensures the adherence of devices to attributes like performance, safety, and security. Also, with the increased complexity of treatment protocols, the standards of quality and safety of medical devices should be enhanced. These include adherence to Electromagnetic Compatibility (EMC) testing for devices with power supply and electronic components. The quicker these standards are complied with, the faster companies can expect their products to become market-ready.

Conclusion

The healthcare sector deals with patients’ data and information on a daily basis. To ensure the security of these, the medical devices testing experts ought to ensure interoperability and flawless performance of such devices. This is where adherence to regulatory protocols becomes important to deliver better customer experience and market adoption.

This article is already published on dev.to.