The Secret to Success for Medical Device Manufacturers
Working Effectively with Testing and Certification Agencies
24 October 2023
With the ever-increasing pace of today's medical device industry, manufacturers are under growing pressure to develop innovative products and technologies that not only address evolving healthcare and patient needs, but also adhere to strict regulatory and safety standards requirements. To navigate this complex landscape, effective collaboration with testing and certification agencies becomes key to the overall success of a product launch.
Although it can seem daunting as a medical device manufacturer, I've gathered a list of ways to improve collaboration and strengthen the relationship between a manufacturer and testing provider.
As with any relationship, starting with clear and open communication is always the first step to success. Whether discussing project timelines, potential challenges, or specific testing requirements, it's crucial to maintain a two-way open dialogue. This ensures both parties are aligned in their expectations and overall objectives.
It can be tempting to wait until your product and documentation are perfect and ready-to-go before engaging with the test lab. However, early engagement can identify potential compliance issues or design challenges, saving both time and money in the long run. Reach out and involve your testing and certification partner at the onset of the product development cycle. Intertek can provide preliminary design reviews, pre-testing, training, and guidance – all to set you up for a smooth testing and certification process.
It can feel like a full-time job to keep up with the continuous changes in standards, regulatory and compliance requirements, and global regulations that apply to medical devices and systems. One way to lessen that burden is to utilize resources available and tap into the thought leadership and educational information provided by the test house. Engaging in trainings, attending workshop sessions, and consuming webinars and thought-leadership material can aid your understanding and help you stay up to date.
Along with utilizing the resources available, one of the best ways to partner with the test house is to leverage the expertise that resides with their technical experts and staff. Testing and certification agencies, like Intertek, possess a wealth of knowledge and years of experience testing and certifying medical devices. While the manufacturer will always be the expert in their products, Intertek has the ability to apply the standards and make it accessible for the evaluation. Tapping into this expertise can provide manufacturers with insights that go beyond just compliance, such as market trends and technological advancements.
Regular Reviews and Feedback
Lastly, one of the most vital aspects of overall collaboration and communication between the test lab and manufacturer is maintaining regular reviews and feedback. Constructive feedback can be a game-changer. Whether it's feedback on the testing process, provided documentation and reference materials, or any other aspect, a continuous feedback loop helps in refining processes and achieving better outcomes.Working together to establish a schedule for regular project reviews not only ensures that the project stays on track but also provides opportunities to address concerns and recalibrate strategies if needed.
In conclusion, the path to creating successful medical devices in today's complex environment is paved with collaboration. By understanding each other's strengths, utilizing available knowledge and expertise, and maintaining open communication, manufacturers and testing agencies can join hands to not just meet but exceed industry standards, ensuring the delivery of safe, compliant, and groundbreaking medical devices to the market.