Addressing product development and regulatory hurdles, medical device and IVD manufacturers are advised to assess capabilities and seek external expertise for market success.
As the saying goes, time is money. For medical device and in vitro diagnostic (IVD) manufacturers, whether start-ups or established multinational firms, it is crucial to carefully balance the time invested in product development against available resources. The longer it takes to bring a new product to market or maintain an existing one, the greater the risk of depleting those resources. This can result in a new product never reaching the market or an existing product being pulled, preventing the manufacturer from recouping and expanding on their investment. More importantly, this would prevent the product from delivering its intended clinical benefits.
Regulatory challenges, such as adhering to the Medical Device Regulations (MDR) and In Vitro Diagnostic Device Regulations (IVDR) in the European Union, combined with increased cybersecurity scrutiny from global regulators, make it increasingly difficult for manufacturers to meet market launch and recertification deadlines. At Pure Global, we consistently hear from our medical device and IVD manufacturer clients that their teams often struggle with the capacity to efficiently manage the ever-growing number of regulatory hurdles. While they may have the expertise to address these challenges, the time required to familiarize themselves with new regulations, like the Medical Device Regulations (MDR) and In Vitro Diagnostic Device Regulations (IVDR) in the European Union, and to build compliant processes in an ever-evolving landscape, can cause them to fall behind their competitors.
In the world of regulatory affairs, past success does not guarantee future outcomes. A medical device that once "cruised through" the FDA 510(k) process may not necessarily find the same ease today, especially under the evolving framework of Medical Device Regulations (MDR).
If you are a medical device or IVD manufacturer, Pure Global recommends that you take a careful look at your internal capacity to manage and understand new and ongoing regulatory demands. For example, do you have a full understanding of the clinical data you will need to collect for your EU Post-Market Clinical Follow-up under MDR? Do you have the expertise or manpower to design, set up, run, and analyze results from any required clinical studies like for MDR’s Post-Market Clinical Follow-up? Does your regulatory and engineering staff have the know-how to assess and mitigate current and ongoing cybersecurity risks of your software-based devices?
If you’ve identified gaps in coverage or expertise for any critical global regulatory demands, consider seeking support from an external source rather than tackling it on your own. Engaging a firm that specializes in medical device regulatory consulting can help fill those gaps effectively. A consulting firm with a comprehensive set of services and experience with similar products and challenges can assist with issues such as conducting a single regulatory submission, developing a global regulatory strategy for a fleet of products, or even managing part or all of your regulatory operations.
Feel free to visit our website for more information or contact us to discuss your specific challenges and how Pure Global’s medical device regulatory consulting services can help.
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