Medical device companies face a daunting set of challenges when complying with federal regulations and safety standards. Tracing and tracking the specifications needed to get products through the FDA screening process is unavoidably strict. Companies must be aware of these requirements throughout every stage of the design process if they hope to release a successful product without lengthy and costly delays and revisions.
For medical devices, ISO 14971 is the standard used worldwide for designing with safety in mind. It provides developers direction on how to assess risks while offering a framework for the most important features and functions of the device. Companies that don’t comply with the ISO standard are setting themselves up for disappointments from an FDA audit, and delays in shipping the product that often culminate in an expensive and extensive reworking of the processes, documentation, and testing.
How can companies mitigate these risks and design with safety in mind? Here are four focus areas we’ve found effective.
Designate a Safety Engineer
Choose someone on the design team who is well-versed in ISO 14971 to have primary oversight responsibility for safety. Is there a systems engineer with a passion for safety-based decision-making? Once the safety engineer is selected, it’s important to create a cross-functional team and set up a series of checks and balances to ensure compliance with FDA standards. Have the team create a flowchart for each device designed and follow it. Details can change based on the specific device, but the process should be consistent.
Hire a Usability Specialist
A usability specialist has the expertise needed to assess how a product will be used (and potentially misused) in the clinic or home. The specialist should work with the systems engineers and rest of the team to devise a task analysis that details the device’s intended purpose, along with all potential secondary uses. Demonstrating potential errors and mitigating the most safety-critical ones should be one of the team’s key focuses.
The usability specialist should also oversee the development of a usable, easily understandable set of instructions for operating the device. They should detail every function of the product in language that practically eliminates the likelihood of mistaken misuse. The specialist should have enough insight and knowledge to address any common errors or potential operational confusion.
One of the last steps in product development is validation. The usability specialist should go out into the clinical environment to validate how that device works as designed and note any potential issues. This process provides crucial insights into potential user errors when the public uses the product.
Conduct a DFMEA
A Design Failure Mode and Effect Analysis (DFMEA) is a systematic way to evaluate potential system, product, or process failures. It’s important to determine how even the smallest failure could cause the device to totally fail and possibly harm someone. Part of this analysis includes outlining the device’s essential functions. What must the device do to meet its intended purpose? What needs to be considered to ensure basic safety isn’t compromised? What might be the device’s secondary uses? Developers need to ensure they’re developing every subsystem to the best of their ability as a small, poorly designed secondary system could lead to the entire device malfunctioning.
Define Essential Performance
All medical devices need to have their essential performance identified. Essential performance is defined in IEC 60601 1 Third Edition as follows: the performance necessary to achieve freedom from unacceptable risk. Essentially if the function cannot be performed, the device is no longer suitable for its intended use. For example, if an AED is cannot provide a shock to a patient, it is unsuitable.This means a product’s behavior must not cause harm to a person, place, or thing if something goes wrong. It is not about a part working properly, but rather the behavior of many parts working together to create essential performance.
To ensure manufacturers can design, build, and bring to market a safe device, processes must be defined for the product life cycle. Identifying and mitigating risk is essential to completing the device requirements. In addition to risk management, developers must ensure clean and understandable instructions for use by trained medical professionals or the general public, depending on the device.
Finally, documentation for the design and manufacturing of the device must be complete and maintained in a formal release system. This lets others trace how the device was designed and manufactured. By employing a comprehensive system and always designing with safety in mind, manufacturers can help ensure a smooth and efficient approval and go-to-market process for their products.
Base2 Solutions is a software engineering services firm that helps companies in highly-regulated industries—including medical devices, aerospace, and defense—develop reliable and complex interconnected systems.
