Achieving Patient Safety and Security in Medical Device Development

This blog is based on and adapted from the keynote address Ama gave on the 27th?of April, 2023, at the 2023 Women’s Engineering Society Annual Conference. The 2023 theme for the Women's Engineering Society is 'Making Safety Seen'. This blog post explores some ways of how this is done in the world of medical engineering and the development of medical devices.

All content are the thoughts of the author alone.?

NB. Unlike the original address, all references to the NeutroCheck? solution have been removed.?

Introduction?

Medical Engineering is the application of engineering principles in the advancement of medicine and healthcare. It spans the development of therapies, equipment, processes, software and devices. One of the underpinning principles of medical device development and the regulations that govern these processes is ensuring?Patient Safety.

The concept of?Patient Safety?aims to prevent and reduce risks, errors and harm that occur to patients during the provision of health care. A cornerstone of the discipline is a continuous improvement based on learning from errors and adverse events.?

- World Health Organisation?

This means that at the heart of patient safety and security is Risk Management. Risk management is an ongoing process that continues throughout the device's life cycle, from initial design and development to post-market surveillance and feedback from patients and healthcare providers.

Patient safety enabled by a medical innovation may mean;?

·??????Users being alive and well?

·??????Effective use first time and always

·??????Alleviation of illness or impairment?

·??????Timely diagnosis (at home or an institution)?

·??????No unplanned/unexpected injury

·??????Mitigation against foreseeable malfunction?

Patient Security, on the other hand, may or may not be directly related to the patient’s medical state of being but may contribute to patient safety. Patient security may mean;

·??????An empowered patient?

·??????Patient's peace of mind?

·??????Security of Personal Identifiable Information (data security)?

·??????Patient confidence/ assurance in the use of device/ functionality

· Minimised financial loss to the patient?

·??????Restoration of ‘normal’ life

How can patient safety and security be achieved in medical device development??

Patient safety and security are key if medical innovations are to be effective and commercially successful. Attaining this in any medical device innovation is multi-faceted and must be embedded across a range of areas. These include;?

Regulation and Quality Management?

Product Design?

User Centricity?

Performance Testing and Feedback?

Data & Data Security?

Through this blog, you’ll see that these different areas are largely enmeshed with each other and collectively ensure patient safety and security.?

Regulation and Quality Management?

Let’s talk about regulation first. Regulations for medical devices form the framework and foundation upon which innovation and technologies are built.?

While there is significant overlap, regulatory requirements are different based on the target market, type of medical device, and, subsequently, the risk posed to the patient. Medical devices are sub-categorised as in-vitro diagnostic devices (specifically for tests used on biological samples to determine the status of a person's health) or medical devices (all other devices).??

Both regulation and quality management are essential components in ensuring patient safety in medical device development. Regulatory bodies, such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, the Food and Drug Administration (FDA) in the United States, and the European Medicines Agency (EMA) in Europe, set standards and guidelines for the design, testing, and manufacture of medical devices. Compliance with these regulations is mandatory and requires adherence to rigorous quality management practices.?

Quality management systems, such as ISO 13485 and 21 CFR Part 820, can establish a culture of quality and safety, thereby ensuring that medical devices on the market are safe and effective for patients.?

Below are some examples of regulations and standards that medical device manufacturers need to adhere to:?

• Quality Management Systems: ISO 13485/FDA 21 CFR Part 820
• EU Medical Device Regulation, EU In-Vitro Diagnostic Regulation, and UK MDR 2002?
• ISO 14971: Risk Management?
• ISO 62366: Usability Engineering?
• ISO 62304: Software Life Cycle Processes?
• ISO 82304-1, 2: Health Software??
• ISO 60601-1, 2: Medical Electrical Equipment?

User-centered design?

User-centered design aims to develop products that meet the needs, preferences, and abilities of users and can be used to ensure patient safety. An innovative, ground-breaking product may never be used or make an impact in the lives of its intended users if it is not designed with them in mind.?

By engaging with patients, healthcare providers, and other stakeholders throughout the design process, medical device developers can gain a deep understanding of the needs and requirements of users. This understanding can inform the development of devices that are more intuitive, easy to use, and effective in addressing patient needs. Potential hazards or risks associated with the device can also be identified early in the design process and mitigated through design solutions.?

Ultimately, user-centered design can lead to the development of medical devices that are safer, more effective, and more user-friendly, which can improve patient outcomes and satisfaction.

Product Development and Performance Testing?

Intertwined with user-centered design is the process of product development itself—the journey from user and stakeholder needs to a final product in the hands of the end user. The medical device development process (Figure?2) is fairly similar to other product development processes, with an emphasis on continuous assessment and improvement via stage-gated design reviews and performance testing. The entire process, including the reviews and testing guidance (such as what parameters need to be assessed), is governed by regulations and standards that ensure repeatability, reliability, quality, efficacy, and safety in the final product.?

Even after the product reaches the hands of the end user, further assessments and performance monitoring are enforced by the introduction of post-market surveillance activities that ensure patient safety continues to be the focus even after market and regulatory approval.?

Data and Information Security?

The use of data analytics, machine learning (ML), and artificial intelligence (AI) has the potential to improve patient safety in medical device development. These technologies can analyse large amounts of data to identify trends, patterns, and potential safety concerns associated with medical devices. By leveraging ML and AI, medical device manufacturers can develop predictive models that can identify patients who may be at increased risk of a condition or adverse event.?

This utilisation of data can help manufacturers and healthcare providers identify risk-prone areas for improvement in the device's use, design, performance, and safety, encouraging modifications and mitigations to improve patient safety.?

As mentioned, data analytics, machine learning, and AI can process large amounts of data. This, therefore, means increased collection and/or transmission of sensitive patient information (such as name, age, health condition, treatment, etc.) via medical devices or health applications. It is essential, then, that data security be considered critically as part of the medical device development life cycle to ensure patient safety and security are achieved.

While there is still a lot to do in this area, thankfully, regulation and some health authorities are catching up and putting in place checks to ensure patient data is protected. Data security can be attained by implementing security controls, following best development practices, and complying with standard guidelines. GDPR, the NHS Data Safety and Protection Toolkit, HIPAA, NIST, ISO 27001, ISO 27018, and ISO 82304—to name a few—all provide guidance and instruction sets for protecting patient data.?

Summary?

Achieving patient safety and security in medical device development is a non-negotiable requirement for manufacturers, regulators, and ultimately the end users (i.e., patients and healthcare professionals) whom these innovations are intended to help or support.