Medical Device Development

A medical device class refers to the amount of risk involved to the patient. Medical devices, such as bandages, oxygen masks, tongue depressors, and even basic surgical tools, are considered lowest risk under Class I but still have general controls set forth by the Food and Drug Administration (FDA) to maintain quality and safety for consumers.

The general controls consider:

• Good manufacturing practices
• Standards and reporting adverse events to FDA
• Registration
• General recordkeeping requirements

These FDA controls ensure that devices are still safe and effective once they’ve gone to market. If the device is considered generic enough to be exempted from FDA clearance for US marketing, such as stethoscopes and bedpans, there is no need for pre-market approval. These devices must be listed by the FDA and their establishments registered. Class I comprises 47% of devices and 95% of those devices do not have to go through the regulatory process.

Class II devices, which comprise 43% of all medical devices, including syringes, catheters, blood pressure cuffs, and some software used for diagnostic tools, have a higher level of risk than Class I, which requires additional regulation. For Class II devices, researchers and developers must complete premarket notification to show that their device is different than those already on the market and prove that the device is safe and effective through evidence from human clinical trials to gain premarket approval.

Due to the riskier nature of Class II devices, they are subject to special controls. These special controls involve:

• Labeling requirements (information that must be included on a product label)
• Device specific mandatory performance standards
• Device specific testing requirements

Additionally, these devices are subject to the general controls for Class I.

Because Class III devices carry the greatest risk, Class III requires both premarket and postmarket surveillance. Only 10% of devices fall under Class III classification and include devices that usually sustain or support life or can be implanted into the human body, like heart implants or insulin pumps. Like Class II, Class III requires premarket approval, as well as general controls. The path to market requires stringent regulations and close monitoring throughout human clinical trials.

According to the Food and Drug Administration (FDA), the body that regulates medical devices in the United States, a medical device is “any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate, diagnose disease in man.” Examples range from extremely simple tools, like tongue depressors or stethoscopes, to more complex devices like pacemakers or robotic surgical devices. Devices differ from pharmaceuticals because they don’t involve chemical activation or need to be metabolized or applied to the skin.

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.