MedCity News May 28, 2024
Three tips to succeed in a highly regulated environment
Medical devices take multiple years and millions of dollars to bring to market. Regulations play a huge role: medtech manufacturers must meet a range of requirements to get devices approved – or risk wasting their investment.
The high cost of failure encourages many manufacturers to embrace a methodical, regulation-first approach to development. But the tradeoff is patient care. The slower the pace of development and approval, the longer patients go without treatment options that could dramatically impact their lives.
Manufacturers need a way to get products to market faster without creating regulatory risk. Even so, many hesitate to embrace an Agile methodology: it can feel too breakneck for a highly regulated...
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