If your medical device is becoming outdated, it may be time to update your product’s design to improve its functionality and usability so it remains profitable. Here are some tips on how to navigate the medical device product design process for an existing instrument.
Determining the Impact of a Medical Device Design Change
In the medical industry, a variety of scenarios trigger the idea of change throughout a device’s lifecycle, including:
- New or modified products
- New or modified manufacturing processes
- New or modified controlled documents like templates, work orders, or forms
If you’re modifying an existing product, process, or document, you should perform a change impact assessment, asking yourself:
- What impact will this product change have?
- What evidence do I need to gather to support this change?
- Who needs to be aware of or involved with this change?
How To Perform a Change Impact Assessment
Once you’ve determined the impact of your proposed changes, three components should be considered:
Medical Device Design Change Description
First, describe the medical device design changes you’re implementing. For example, state the existing material used and what you’re changing it to if you’re replacing the material.
Reason for the Change
Next, explain what triggered the proposed change to your existing device. Let’s continue to use the material change example above:
- If the existing material is deteriorating before its life expectancy, state how long it is lasting and how long the new material is expected to survive.
Change Justification
Finally, provide extensive evidence for why the change is necessary, including testing that proves the change is safe and effective or documentation that proves the change improves the device’s intended use.
Consider Form, Fit, and Function
When considering medical device design improvements, you should also determine how the changes impact your device’s form, fit, and function:
- Form refers to the product’s design.
- Fit refers to the device’s use and intended user population.
- Function refers to how the product operates and how users interact with it.
If any or all of these factors impact your design changes, consider reviewing the product’s manufacturing process to analyze the change from that point in production. A detailed review of the process allows you to develop accurate questions to ask during your product’s change impact assessment.
Change Management and Risk Connection Considerations
With change often comes risk, so it’s vital to consider potential, harmful factors that may arise with design and process improvements. To identify risks, make a product risk profile part of your device’s change impact assessment, updating your risk management file as changes occur.
Another important component of change management is performing a thorough risk analysis to ensure that you’ve identified and reduced all risks associated with the change.
Planning Regulatory Requirements for Medical Device Design Changes
Even if you’re updating your existing device’s design, you’re still required to undergo the regulatory journey. As you develop the newest version of your existing product, it’s crucial to account for new, complex regulatory requirements to avoid costly surprises and prevent time-to-market delays. Start planning for your newest medical device design’s regulatory requirements by developing a solid understanding of the latest standards and guidance documents that apply to your updated device to allow your team to allocate resources properly and avoid costly roadblocks.
FDA Trends Impacting Medical Device Design Improvements
Over the past few years, the FDA has focused on a few core improvement trends and areas that affect all medical device manufacturers:
- Usability
- Risk management
- Data security
Strict requirements have always been in place in these areas. However, standards have expanded recently so FDA gatekeepers can better enforce guidelines on existing products that don’t follow the latest, strictest regulatory requirements. You’ll likely need to take a more comprehensive approach to all three areas compared to your initial journey to product launch.
Remington, Your Medical Device Design Experts
With more than 25 years of experience, our customers consider us their single-source medical device design experts. Our team works with you directly on projects big and small, incorporating the most current, comprehensive FDA guidelines and regulations into your design and manufacturing processes. That way, you avoid costly surprises and time-to-market delays. We’re also familiar with the latest innovations in medical device designs, customizing your specifications based on your needs and the latest industry technology. To learn more about how Remington can help you update your outdated device, contact us today.
