Medical Device Manufacturing—Challenges and Opportunities

Life Sciences Technology Adoption

Medical device manufacturers face challenges that stem from competing priorities set by supply chain vendors, consumers and the government. These pressures not only affect each manufacturer's R&D budget and bottom line, they first and foremost affect critical day-to-day activities such as master planning and shop floor processes that lead to revenue-generation. In this article I will explore three big challenges that are directly impacting medical device manufacturers’ ability to successfully operate their manufacturing processes.

• Continued quality and compliance with mounting regulatory requirements
• Reduction of costs to offset margin pressures and meet competitive pricing
• Increased ability to speed up and stabilize new product introductions based on shifting consumer demands

With these challenges come opportunities for manufacturers to innovate, simplify and improve their processes in order to meet and exceed consumer demands and increasing regulation. To achieve this, manufacturers who leverage technology solutions like Enterprise Resource Planning (ERP) systems may be equipped with the technology necessary to successfully manage the ever-changing market demands with increased visibility, efficiency, and flexibility utilizing tools specifically built to address the challenges that meet them.

Life Sciences Compliance

The pressures facing Medical device manufacturers manifest themselves in how decisions are made in the master planning process, on the shop floor, and in vendor interactions throughout the supply chain. In coping with day-to-day activities, manufacturers are finding themselves responding to demands from multiple sources that include: fellow supply chain vendors, government entities, and ultimately a shifting end consumer. These competing priorities affect the entire planning and production process of these medical devices – requiring manufacturers to be more agile, efficient, and productive than ever before.

In a recent report developed by Ernst & Young, Guy Nohra of Alta Partners shares, "the medical technology sector is weathering a perfect storm caused by three concurrent trends: the move toward value-based health care, growing regulatory pressures, and resource constraints within the industry itself."

In Emergo Group's Medical Device Industry Survey, over 1,000 Presidents/CEOs/COOs/Managing Directors of Medical Device manufacturers in North America validate Nohra's point by indicating their top three challenges were the changing regulatory environment, new product development and pricing pressure respectively.

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