Get to Market Quickly with
High Quality, Innovative Products
Delivered at a Competitive Cost

Medical Device Industry Challenges

Rising medical device recalls and cost and public nature of these events will force medical device manufacturers to focus on quality and reliability throughout product design and  manufacturing


Rising Product Recalls

  • Increasing product recalls call for additional measures from OEMs to ensure they are at par with their competition. Medical device manufacturers must warrant top notch product quality to avoid product recalls.
  • Revenue declines due to delays in time-to-market, as well as lost sales and market share, Reputational capital and brand equity losses.
Increasing Product Complexity

Increasing Product Complexity

  • Medical devices are becoming more and more complex due to inclusions of software & innovative technologies
  • As medical devices become more and more connected to the internet, smartphones, electronic health data, and facility networks, they become more vulnerable
Stringent Compliance Standards

Stringent Compliance Standards

  • Complying with Unique Device Identification (UDI) and EU Medical Device Regulations (MDR) is another stressor for medical devices companies at an already challenging time, potentially affecting both top and bottom-line growth
  • The increased complexity and volume of medical device marketing submissions has increased the time taken by the FDA approval by 55%

How DFMPro Can Help

With DFMPro, Medical device manufacturers can focus on getting to market quickly with high quality, innovative products delivered at a competitive cost

Develop High Quality Medical Devices Faster
  • Designing first time right, avoid downstream manufacturability issues and rework
  • Quickly validate quality & safety requirements / standards
  • Improve Time-to-Market
Be efficient in R&D and Product Development to Acclimatize Changing Regulatory Environment and Bringing in Innovation
  • Knowledge capture & standardization at organizational level resulting in continuous process improvement and reuse
  • Scalable framework for capturing and disseminating manufacturing knowledge upstream
Improve collaboration with global suppliers and Operational Efficiency
  • Capture supplier capabilities and Improve design collaboration between departments, suppliers and vendors


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