ARTICLE FOCUS:

• Building an effective design process
• Risk management
• Ensuring accountability

Innovation is the lifeblood of medical device manufacturers. While most organizations are focused on creating the next generation lifesaving product, manufacturers also must think about compliance and the diversity of standards and guidelines for each regulatory body in the different geographies in which they market their devices. Approval in one geography may not make the device eligible for use in others. And although the US, Japan, and EU manufacture about 85% of world’s medical devices, each country has different design control and approval processes.

Regulatory authorities worldwide are being extremely diligent, given the plethora of technologies, the transparency of information sharing (thanks to the ubiquitous Internet), and the advent of social media. It can take years to design and market a product considering the rigorous testing and approval process. Given that 80% of a medical device manufacturer’s revenue is generated out of products introduced in the last five years, it becomes all the more important that products are developed efficiently and that companies go through the regulatory approval cycle with minimal hurdles. A well-designed product engineering process with the right regulatory controls can help medical device designers shorten their product time to market and can also help make the product more usable and maintainable in terms of the next release. The consequence of not having robust processes often results in device recalls and removal from the market resulting in loss of revenue, but more importantly, diminished customer and market credibility.

Medical devices are categorized by a class type (Class I, II, III as per the FDA and Class I, IIa, IIb, III as per the EU Medical Devices Directive) based on the level of risk that a device failure could pose to a patient. This in turn guides the extent and type of scrutiny that needs to be applied for the development and market launch of that particular device.

Such classification also determines the level of design control, documentation, and testing required by regulatory bodies to obtain clearance for marketing the product. In the US, QSR 21 CFR Part 820 defines the design controls and process to be followed whereas the EU Medical Devices Directive and ISO 13485 guide the device classification and the kinds of controls required in medical device design for the EU. Most established medical device manufacturers have a well-defined design and validation process along with a robust quality management system to ensure that the whole design process is planned and managed in a systematic and repeatable manner.

Figure 1. Click on image to view larger

Figure 1 shows a flowchart defining the structure and steps in medical device design covering all life cycle stages including design transfer, postmarket surveillance, and changes.

Effective design process
An effective design process should ensure that risk management, verification, and validation are built right from the start of the project and should be carried out during all phases of the development life cycle.

Early identification of potential risks and issues in the product gives the project teams an opportunity to to adjust the design or process or to add control measures to mitigate the likelihood of occurrence of potential hazards.

Risk management is central to the implementation of processes that are compliant to regulatory standards. The design process should include risk analysis, risk evaluation, and risk control as per the ISO 14971 standard. This standard provides the framework for risk management in medical device design, development, and manufacturing as well as for monitoring the safety and performance of the device after sale.