Featured Product
This Week in Quality Digest Live
Health Care Features
Etienne Nichols
How to give yourself a little more space when things happen
Chris Bush
Penalties for noncompliance can be steep, so it’s essential to understand what’s required
Jennifer Chu
Findings point to faster way to find bacteria in food, water, and clinical samples
Smaller, less expensive, and portable MRI systems promise to expand healthcare delivery
Lindsey Walker
A CMMS provides better asset management, streamlined risk assessments, and improved emergency preparedness

More Features

Health Care News
Showcasing the latest in digital transformation for validation professionals in life sciences
An expansion of its medical-device cybersecurity solution as independent services to all health systems
Purchase combines goals and complementary capabilities
Better compliance, outbreak forecasting, and prediction of pathogens such as listeria or salmonella
Links ZEISS research and capabilities in automated, high-resolution 3D imaging and analysis
Creates one of the most comprehensive regulatory SaaS platforms for the industry
Resistant to high-pressure environments, and their 3/8-in. diameter size fits tight spaces
Easy, reliable leak testing with methylene blue
New medical product from Canon’s Video Sensing Division

More News

Jon Speer

Health Care

Three Tips For Incorporating Risk Management During Medical Device Product Development

Fix issues that expose you to risk when it’s less expensive and time-consuming

Published: Thursday, October 13, 2022 - 12:03

Medical device product development and risk management are often treated as entirely separate processes. Sure, there is usually acknowledgement and understanding that these two processes are related. But it is important to realize that product development and risk management share more than that.

In fact, these processes both have the same overall purpose and intent: to make sure medical devices are designed, developed, and manufactured to be both safe and effective.

That’s why I wanted to provide you with three hugely helpful tips for incorporating risk management throughout the product development processes.

1. Set the stage for medical device risk management with a clearly defined intended use statement

If you’re looking to integrate risk management into your entire medical device development approach, why not start at the beginning?

Though it only comprises a few short sentences, your intended use statement is really the gateway to your device’s entire life cycle. This definition will be used heavily in determining a regulatory pathway, establishing user needs, directing product development, and setting the proper design controls.

But it also should be the starting point for your approach to risk management. In fact, defining the scope of your product risk management is impossible without an intended use statement.

That’s because this statement allows you to identify hazards and hazardous situations pertaining to the use of your medical device. From there, you’ll be able to analyze, evaluate, assess, and control risks of your medical device, all thanks to the intended use statement.

Another significant aspect of the intended use statement is its application in establishing a risk management plan. This planning document describes foreseeable risk management activities throughout a product life cycle.

In order for the plan to be effective and actionable, stakeholders should thoroughly define the roles and responsibilities, as well as the personnel assigned to the risk management team. Here, manufacturers can leverage their intended use statement to establish the scope to which risk management activities will be necessary.

The risk management plan also includes criteria for your medical device’s risk acceptability, which should be commensurate with the intended use. That’s why putting in the proper time and effort in generating this definition is of utmost importance.

2. Leverage the risk management process to drive product development

Just how user needs and design controls should “flow” into one another, the same can absolutely be said about risk management and product development.

Rather than treating the process like a checkbox you’re looking to tick, your medical device risk management system can be used as a tool to improve development activities and create an overall greater product.  

The international standard ISO 14971 defines risk as a total product life cycle process, and identifies seven high-level steps to adopting this risk-based approach. Those are:

• Risk management planning—identifying the timing and risk activities planned

• Risk analysis—taking the intended use of your product and identifying hazards and hazardous situations. Once identified, you then estimate the risks of each hazardous situation.

• Risk evaluation—determining acceptability of the estimated risks

• Risk control—identifying ways to reduce risks to an acceptable level and verifying the controls are effective

• Overall residual risk acceptability—evaluating the risks of the entire, finished device

• The risk management report—capturing the results of the risk activities

• Production/post-production—ensuring you have provisions in place after market release and design transfer to feed back into risk management

Rather than viewing these activities as a linear progression, I’d like to suggest you treat your risk management process in a more cyclical manner during product development.

Instead of creating a risk management plan one day, followed by a risk analysis, and then risk evaluation, use risk management as a tool to help you.

Take a first pass from “beginning to end” near the start of a product development process. Use the risk estimates, evaluation, and controls as a means to help drive your medical device product development efforts. As product development tasks and activities are checked off the list, revisit the risk management activities to confirm and update.

Doing so will mean that you are truly taking a risk-based approach with product development.

3. Keep risk management and design controls connected at the hip

The relationship between design controls and risk management is a close-knit one. Even looking at their most basic definitions, the similarities are rather striking.

Design controls are intended to demonstrate that a medical device is safe for use, specifically by providing empirical evidence that the product has been:

• Designed to address the needs of users and patients

• Designed to meet inputs and requirements

• Proven to meet applicable standards

• Tested to meet performance criteria

Risk management identifies, evaluates, analyzes, assesses, and mitigates potential product issues, simply from a slightly different perspective.

Integrating risk management into your design controls and development activities can be accomplished by linking both sides of this coin. Even at a cursory glance, there are several activities that could benefit immediately from the addition of risk management:

• Project planning—A risk management plan should describe the strategic approach to identifying and controlling risk in the product development life cycle. This plan could be a part of the product development or project management plan.

• Design input—Existing safety standards and safety requirements identified in risk assessments are key design inputs.

• Design output—Risk reduction measures introduced into product design are essential design outputs.

• Design verification—Design verification should affirm that all safety requirements are covered by the risk reduction measures in the design.

• Design validation—Design validation should demonstrate that all safety requirements can be consistently met.

As with all risk management activities, remember that documentation is an ultimate key to success. You can download a free template of a risk management plan here.

How the right QMS can make or break your medical device risk management

Risk management should be an all-or-nothing process, and applying it to your entire organization’s products is a huge undertaking without the right quality management solution.

By integrating the risk management process into your entire QMS, you can fix issues that expose you to risk when it’s less expensive and time-consuming to do so. Risk management will no longer be a discouraging process with little visibility.

First published Sept. 30, 2022, on Greenlight Guru


About The Author

Jon Speer’s picture

Jon Speer

Jon Speer is the founder and vice president of quality assurance and regulatory affairs at Greenlight Guru, a software company that produces the only medical device quality management software solution. Device makers in more than 50 countries use Greenlight Guru to get safer products to market faster. Speer has served more than 20 years in the medical device industry and helped dozens of devices get to market. As a thought leader and speaker, he regularly contributes to numerous industry publications. He is also the host of Global Medical Device Podcast.