Three Tips for Integrating Risk Management During Medical Device Product Development


Health care

Three Tips for Integrating Risk Management During Medical Device Product Development

Resolve issues that put you at risk when it costs less and takes less time

Posted: Thursday, October 13, 2022 – 12:03 PM

Mmedical device product development and risk management are often treated as entirely separate processes. Of course, there is usually a recognition and understanding that these two processes are linked. But it’s important to realize that product development and risk management share more than that.

In fact, both of these processes have the same goal and intent: to ensure that medical devices are designed, developed and manufactured to be both safe and effective.

That’s why I wanted to provide you with three extremely useful tips for integrating risk management throughout product development processes.

1. Set the Stage for Medical Device Risk Management with a Clearly Defined Statement of Intended Use

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

Although only a few short sentences long, your intended use statement is really the gateway to your device’s entire lifecycle. This definition will be widely used to determine a regulatory path, establish user needs, direct product development, and define appropriate design controls.

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

Indeed, this declaration enables you to identify the dangers and dangerous situations associated with the use of your medical device. From there, you will be able to analyze, assess, assess and control the risks of your medical device, all thanks to the declaration of intended use.

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

For the plan to be effective and achievable, the stakeholders must define in detail the roles and responsibilities, as well as the personnel assigned to the risk management team. Here, manufacturers can leverage their statement of intended use to establish the scope to which risk management activities will be required.

The risk management plan also includes criteria for accepting the risks of your medical device, which must be proportional to the intended use. This is why it is of the utmost importance to devote the necessary time and effort to generating this definition.

2. Leverage the risk management process to drive product development

Just how much user needs and design controls must “creep” on top of each other, the same can absolutely be said for risk management and product development.

Rather than treating the process as a checkbox that you seek to check off, your medical device risk management system can be used as a tool to improve development activities and create an overall better performing product.

The international standard ISO14971 defines risk as a total product lifecycle process and identifies seven high-level steps to take this risk-based approach. Those are:

• Risk management planning: identification of schedule and planned risk activities

• Hazard Analysis—take the intended use of your product and identify hazards and hazardous situations. Once identified, you then estimate the risks of each dangerous situation.

• Risk assessment: determining the acceptability of the estimated risks

• Risk control: identify ways to reduce risks to an acceptable level and verify that controls are effective

• Overall acceptability of the residual risk: risk assessment of the entire finished device

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

• Production/post-production: ensure you have post-market and design transfer arrangements in place to feed into risk management

Rather than viewing these activities as a linear progression, I’d like to suggest that you treat your risk management process more cyclically when developing products.

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

Make a first “start to finish” pass near the beginning of a product development process. Use risk estimates, evaluation, and controls to help guide 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.

This means that you truly take a risk-based approach with product development.

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

The relation between design of controls and risk management is a close connection. Even looking at their most basic definitions, the similarities are rather striking.

Design controls aim to demonstrate that a medical device can be used safely, in particular by providing empirical evidence that the product has been:

• Designed to meet the needs of users and patients

• Designed to meet inputs and requirements

• Tested to meet applicable standards

• Tested to meet performance criteria

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

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

• Project planning: A risk management plan should describe the strategic approach to identifying and controlling risks in the product development cycle. This plan can be part of the product development or project management plan.

• Design elements—Existing security standards and security requirements identified in risk assessments are essential design elements.

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

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

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

As with all risk management activities, remember that documentation is the ultimate key to success. You can download a risk management plan template for free 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 all of your organization’s products is a massive undertaking without the right quality management solution.

By integrating the risk management process into your overall quality management system, you can address issues that put you at risk when it costs less and takes less time. Risk management will no longer be a daunting process with little visibility.

First published September 30, 2022 at Green Light Guru.


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