The pace of medical device innovation continues to accelerate as advanced materials and new manufacturing techniques have been incorporated into the product development lifecycle. Historically, this process has been driven by the industry itself, from large OEMs to eager start-ups looking to solve unmet challenges. During the past year, however, the FDA has publicized new “policies to drive innovation in medical product development by taking novel approaches to regulation.”* This much welcomed streamlining of important regulatory measures means a new era of innovation lies ahead.
Medical device companies, both large and small, require partners through their entire design and manufacturing process who can help move products through the approval pathways. Unlike other industries, the medical device market demands that partners understand the process of recommending the appropriate materials and developing a process that not only works in the lab, but during the ramp up to full-scale production.
At Topflight, we’ve had the privilege of working with many innovative companies who have relied upon our team to ensure their products can be manufactured each and every time to meet exacting regulatory requirements. Topflight is ISO 13485:2016 and ISO 9001:2015 certified, with a comprehensive testing lab to ensure that products are manufactured each and every time to exact customer specifications. We understand that once a product has gone through premarket approval and notification processes, there is no room for inconsistency or variability.
This assurance begins in the engineering and prototyping phase where designing a product manufacturability begins with evaluation and qualification of the materials being considered for the device. From there, we test the performance on pre-commercial quantities of parts before you commit to expensive production tooling and setup costs. It’s in the early stages where selecting the right partner will ensure successful progression through the early gates in the development process.
If you’re beginning a new product or need to find a partner who better understands the medical device market, please consider reaching out to our product engineering team to discuss your project.