Medical Device Development

What is medical device development?

Medical device development is the development of special-purpose appliances, implants, or other instruments designed to improve health outcomes. Some medical devices, such as pacemakers or insulin pumps, combine hardware with embedded software that continuously monitors and controls the device. Medical device development has improved the quality of life of millions of patients and is one of the most complex and rewarding areas of scientific discovery today.

What are medical device development best practices?

Align medical device hardware, software, and service teams. A single pane of glass solution lets teams collaborate, manage change, channel feedback into design decisions, and focus on quality.

Highly engineered medical products can have thousands of discrete requirements. A shared requirements management platform allows teams to specify and manage requirements using compliant approval processes.

Adopt a whole-team approach that provides transparent access to risks, hazards, failure modes, corrective and preventive actions (CAPA), and other risk-relevant data in a central repository. Integrate FMEA analyses into daily workflows and monitor progress. Prepare for audits with dashboards and reports that demonstrate compliance with ISO 14971, IEC 60812, and other relevant standards.

Engineering efficiency climbs sharply when teams share common libraries of information organized by logical groupings. Version-control, branch, and merge information as needed to jumpstart new projects.

Define and enforce tailor-made processes to automate the risk management lifecycle, embedding risk assessment in daily design and development processes. Custom workflows guarantee that no team members can deviate from established procedures, and accelerate company-wide response to escalations.

Medical device classifications

While there are differences in medical device classification across the USA, the EU, and other markets, regulators are generally aligned around a risk-based classification approach.

Medical devices such as bandages, oxygen masks, and tongue depressors are the lowest.

Medical devices such as syringes and catheters pose intermediate levels of risk and are subject to additional regulatory controls, such as special labeling. Some Class II devices require premarket notification and pre- and post-market surveillance.

Medical devices such as heart implants, robotic surgical systems and insulin pumps pose the highest degree of patient risk, and are subject to the highest level of controls. In addition to all of the controls of Class 1 and 2 devices, Class III devices are subject to an intensive pre-market approval process (PMA) and must demonstrate rigorous quality processes, as well as ongoing post-market surveillance.

What are the challenges of medical device development?

Requirements, risk, and test management for medical device developers

Bring quality medical technology products to the market quickly and at optimal cost with Codebeamer. Adhere to the requirements of ISO 13485, IEC 82304-1, ISO 14971, IEC 60812, IEC 62304, ISO 60601, EU MDR, FDA Title 21 CFR, and more. Design for excellence and demonstrate regulatory compliance with minimal effort.

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Frequently asked questions

Examples of embedded systems in medical devices include defibrillators, blood pressure monitoring devices, digital flow pumps, heart monitoring machines, insulin and glucose monitors and pumps, surgical robots, pacemakers, CT and PET scanners, MRIs, mammography equipment, surgical navigation systems, and much more.

Unlike other types of software development, medical devices systems typically:

Are extremely complex, requiring the integration of electrical, mechanical and software components and the collaboration of multiple requirements, design, development, and test stakeholders
Are subject to stringent and continuously evolving regulations in the markets they serve
Control parts that are not easily updated, and must operate flawlessly over the life of the device or patient
Are mission- and safety-critical, requiring the highest levels of quality, security, and reliability
Require real-time response, mandating a RTOS and programming language
Operate within a low power consumption environment
Must be manufactured to meet the highest standards of precision, cleanliness, and performance in or near the human body

Medical devices are highly regulated in order to ensure their safety, performance, and reliability. Regulatory standards and guidelines govern not only the device quality, but also the rigor of processes used to develop and monitor them. The regulatory landscape for medical device manufacturers covers every aspect of product development, from pre-market surveillance and pre-market approval to ongoing post-market surveillance. By selecting an ALM platform with built-in support for medical device standards, organizations can streamline compliance and focus on innovation.