Innovation in Pace with Regulation Part-I: How Medical Device Companies Can Use Cloud-Solutions to Minimize the Regulatory Burden

Regulation is frequently seen as slowing down the pace of innovation. Recent shifts in the healthcare landscape have made a move to connected care an imperative for medical device manufacturers. We explore ways in which companies can navigate the transition fulfilling regulatory requirements without impeding innovation. 

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The need for connected care solutions

The global healthcare industry is rapidly changing. Higher demands for efficiency, quality, and flexibility have forced new ways of thinking. Patients have become more confident in advocating for  their own health needs and treatment, which has led to public and private health sectors emphasizing a patient-centric approach. This has fueled a growing demand for connected care solutions. (A sector that is estimated to grow by 38% till 2027, driven mainly by patient population with chronic diseases such as cardiovascular disease, diabetes, prostate cancer and others).

Cloud services improve the reach between patients and physicians, enable scalability, speed, security, as well as improving adherence to treatment protocols leading to better patient outcomes. 

The medical devices regulatory challenge

Connected medical devices usually stand on two main pillars: the hardware device itself and a supporting back-end software system: servers and client devices for remote monitoring, patient engagement and system administration. 

Manufactures are required to meet a long list of strict compliance standards, regulations and laws: quality (ISO 13485) and privacy (ISO 27001) standards, HIPAA, GDPR, specific state regulations (e.g. CCPA), security standards (SOC 2), traceability, post market validation (MDR) and more. Complying to standards and laws is just one step towards the holy grail of FDA or CE approvals, which is a challenging process by itself. Numerous well-established principles, standards, and best practices serve as a robust framework for hardware-based medical device development, manufacturing, and maintenance. The integration of software creates new regulatory challenges for the medical device industry, ranging from development methodologies to manufacturing, post market maintenance, and upgrades, making it a significant challenge and risk.

Unlocking regulatory complexities 

Developing the systems required to connect a medical device, might appear to give companies full control over hardware and software components. However, when factoring in regulation requirements, it can become a nightmare: testing each hardware component, installing, updating and patching software, as well as complying with the updated MDR post market validation and traceability requirements. “Doing it yourself” can find companies investing endless time and resources.

Utilizing a medical-grade cloud-based infrastructure simplifies dramatically the operational load, minimizes the costs and reduces risks. A cloud software provider has a team dedicated to each step of the process. The cloud software provider will already meet relevant privacy and security standards, have their own policies, training and processes in place, and provide an SLA. In addition, achieving compliance with MDR dovetails perfectly with cloud-connectivity, making the compliance process much more agile. 

Cloud based software providers quickly respond to fast-changing market conditions and new regulatory requirements eliminating the need for medical device companies to constantly invest in education, development and regulation. 

Medical-grade Cloud-based solutions benefit and capabilities: Things to remember

• Privacy and security:  Access to personal data should be granted only to authorized personnel. This includes physical access to storage devices, computers, monitors and even hard copies. These are far less accessible in cloud software, where the physical location is remote, secure and usually redundant.
• Business Continuity and Crisis Recovery plans (BC/CR): these call for protection against flood, fire, physical breach and more. On Prem BC/CR plans usually include system redundancy in multiple sites, which multiplies the privacy and security risks. Cloud software, on the other hand, when used correctly, grants better reliability and access control. It can be easily configured for redundancy in various regions, it usually has strong built-in security tools and it is constantly updated and monitored.
• Continuous Integration and Continuous Development (CI/CD): Cloud-based platforms are utilizing built-in CI/CD tools, which enable manufacturers to easily overcome bugs and breaches by instantly applying updates and upgrades to the system. The advantages for the user are shorter Mean time to Resolution (MTTR) and improved testability.  Thanks to the smaller code changes and quicker fault isolation, the product improves rapidly through rapid feature introduction and fast turn-around on feature changes and less disruptive upgrades.
• Verification & Validation: Cloud based software usually provides agile tools for traceability matrices, documentation (SRS, STP, STD) and built-in integration with software development tools such as Jira and Git.
• Evidence collection: regulation auditors usually require evidence of enforcement of relevant security measures - multiple factor authentication, firewalls, access control etc. Collecting such evidence in cloud-based systems is far easier than On Prem, tailored software ones.
• MDR compliance:  Recently updated MDR requires medical devices manufacturers to maintain an inventory of medical devices using a UDI code for trackability.  The Directive also requires that medical devices can be proven to be working and requires that their benefits can be shown to outweigh any negatives which their operation might entail. In addition, manufactures are required to commit to having a system in place for ongoing surveillance for the efficacy of their product. Using a cloud-based system dramatically simplifies the tracking, recording and reporting needed for compliance.

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How BioT can simplify medical devices compliance and regulation processes:

BioT is a no-code and open cloud-based platform for medical device manufacturers, designed to instantly connect patients with caregivers to ensure a seamless continuum of care. The platform is deployed per device manufacturer, as a service model (Platform as a Service). It can be fully customized per manufacturer needs using no-code or low-code methods. Using BioT’s platform, patient and other sensitive data is stored encrypted and secured, complying with strict regulations (HIPAA & GDPR). Access-based attribute control is used to ensure that permissions are granularly granted only to relevant entities, each to specific and relevant data, per role - caregivers, administrators, organization owners etc. BioT streamlines the tedious registration processes by presenting its own compliance, in the same way that other complying 3rd party providers are liable to their products. Manufacturers choosing to adopt BioT as a platform sign a Data Processing Agreement (DPA) to regulate personal data processing and a Business Associate Agreement (BAA) to create a bond of liability between both parties as required by HIPAA and the FDA.

BioT complies with ISO standards and supplies manufacturers with Design History Files (DHF) required in 21 CFR part 820 of the FDA. 

Conclusion

The regulatory requirements on medical device manufacturers are many, and are likely to increase with time. However, by working with seasoned providers of medical-grade cloud-based platform, medical device manufacturers can ensure that they comply with all necessary regulations without slowing the pace of innovation.