Best Practices for Medical Device Companies include Customer Focus, Risk-based Approaches, Formal Collaboration, Application Software Use

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Most manufacturers still lag in adopting formal processes and systems to reduce risk.

FDAnews and Cambashi Inc. today released an Industry Directions report: Risk Management: Best Practices for Medical Device Profitability, presenting the findings at the Medical Device Quality Congress currently in progress in Cambridge, MA. This study finds companies that improved both revenue and profitability are more likely to adopt all of the practices and software applications that facilitate keeping risk minimal to both patients and the business.

Of the 221 respondents, over half claim that their companies have experienced growth in both revenues and profits over the past three years. This group of growth companies shows a marked difference along several dimensions:

  • Growth companies are more likely to understand that their market success depends on focusing on the customer perspective: product quality, customer service and flexibility in their manufacturing operation.
  • Growth companies are more likely to have formal processes in place to ensure collaboration not only within a department, but between departments, facilities and with external trading partners including suppliers, customers, and other partners.
  • Growth companies are far more likely to use applicable software applications, from ERP to quality management (QMS), electronic document management (EDMS), governance, risk and compliance (GRC), product lifecycle management (PLM), manufacturing intelligence or plant dashboards, and manufacturing execution system (MES).

Most medical device companies compete primarily on the basis of innovation and product capabilities. They see the need to invest in risk planning and analysis to minimize the risks inherent in a changing R&D environment. However, some of the core business strategies companies have adopted appear to create challenges. Half of the respondents have been through a merger or acquisition in the past five years, and they see more likelihood of problems in every area except regulatory compliance over the next three years.

Innovation creates its own challenges. Over half of the medical device companies in this study offer more than five product families, and over 60% offer more than five variants on the bulk of their products. The innate complexity of products and their variants makes every area of the business more complex. Each configuration creates the potential for variability, and creates a need to perform more risk analyses and manage more items and documentation in every area.

Industry leaders are leveraging software technologies to help them manage this increasingly complex environment. However, less than half of respondents use any software application other than ERP, and less than two-thirds even have ERP in production use today. Most respondents using software are enjoying benefits as a result. Yet, one-third have no plans to buy applications such as MES, PLM, and supplier relationship management (SRM) that most users agree are highly beneficial. The study shows companies that delay making these technology investments also lag in financial performance.

The research sponsors that made this study possible are: Camstar Systems (, IBS America (, IQMS (, MasterControl (, and Pilgrim Software (

About FDAnews
FDAnews publishes domestic and international regulatory, legislative and business news and information for executives in industries regulated by the U.S. Food and Drug Administration. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books, management reports and conferences to stay in compliance with international standards and FDA's complex and ever-changing regulations to get their products to market faster and boost profits. FDAnews brings you the knowledge you need, when you need it. To learn more, visit:

About Cambashi
Cambashi, based in Cambridge UK and Cummaquid MA USA, provides independent research and analysis of the business reasons to use IT in industry worldwide. It specializes in engineering, enterprise, plant and supply chain applications and the infrastructure to enable industrial firms to use IT effectively. Cambashi publishes market size estimates in the engineering applications Market Observatory and industry issue research studies in the Cambashi Reports Industry Directions series. Its clients vary in size from small to large and include most of the leading software vendors and many pioneering IT users. Cambashi is a member of CATN, an international association of consultants. To learn more, visit:

Matt Salt
(703) 538-7600

Cambashi Inc.
Julie Fraser
(508) 362-3480


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