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Most Medical Device Companies Seen Missing Benefits of Total Product Lifecycle Practices
As new product introduction rates, majority of enterprises have a long way to go in introducing TPLC approaches, new study finds
Cambridge, MA — June 24, 2009 — Although many medical device companies have initiatives to shift to a total product lifecycle (TPLC) approach, a majority are still using serial design models, such as stage gate and waterfall, and are missing out on the opportunities to improve their cost of quality and performance to other metrics that TPLC can offer, according to a new survey from Axendia, Cambashi and FDAnews.
The findings, part of a study called "Total Product Lifecycle Management: Lowering Costs while Increasing Quality," were based on 212 responses from a range of medical device companies, with demographics closely matching the total industry. Eighty percent of respondents were executives, directors, or managers.
A majority of respondents report that new product introduction rates have been increasing, and an even larger portion said they expect dramatic increases in the next three years. Engineering changes, product costs, and corrective and preventative actions (CAPAs) are increasing for over a third of these companies as well. Most respondents see adding or extending product lines as the top opportunities for improvement.
Despite this growing need and the success of TPLC initiatives, most companies have a long way to go to adopt TPLC practices, the study reports. For example, most of these medical device companies are still using sequential, not concurrent, product development processes. Most respondents are also making products to stock, and less than a third have initiatives for Lean or global product development, or increasing design re-use.
The study shows that more than 80 percent of organizations still rely on some form of paper for their official recordkeeping. Fewer than one in 10 respondents have a fully electronic system today, and nearly half of respondents don't use electronic signatures. Over 60 percent of respondents also use paper or homegrown systems (i.e., spreadsheet or database) to document for audit findings, corrective and preventive actions (CAPAs), field issues and complaints.
Research indicates that 61 percent of respondents' companies need two or more stages to complete a successful recall. Companies able to complete a product recall in just one or two stages are more likely to be using a range of software applications.
Based on the study findings, recommendations for medical device organizations from the research team include:
The research was cosponsored by solution providers to the medical device industry, including management and technology consulting firm BearingPoint, enterprise manufacturing and quality software provider Camstar Systems, product lifecycle management (PLM) software company Dassault Systèmes Enovia with its medical device industry PLM partner Integware, and PLM and enterprise content management software provider PTC.
The final research study report will be released later this month.
The findings, part of a study called "Total Product Lifecycle Management: Lowering Costs while Increasing Quality," were based on 212 responses from a range of medical device companies, with demographics closely matching the total industry. Eighty percent of respondents were executives, directors, or managers.
A majority of respondents report that new product introduction rates have been increasing, and an even larger portion said they expect dramatic increases in the next three years. Engineering changes, product costs, and corrective and preventative actions (CAPAs) are increasing for over a third of these companies as well. Most respondents see adding or extending product lines as the top opportunities for improvement.
Despite this growing need and the success of TPLC initiatives, most companies have a long way to go to adopt TPLC practices, the study reports. For example, most of these medical device companies are still using sequential, not concurrent, product development processes. Most respondents are also making products to stock, and less than a third have initiatives for Lean or global product development, or increasing design re-use.
The study shows that more than 80 percent of organizations still rely on some form of paper for their official recordkeeping. Fewer than one in 10 respondents have a fully electronic system today, and nearly half of respondents don't use electronic signatures. Over 60 percent of respondents also use paper or homegrown systems (i.e., spreadsheet or database) to document for audit findings, corrective and preventive actions (CAPAs), field issues and complaints.
Research indicates that 61 percent of respondents' companies need two or more stages to complete a successful recall. Companies able to complete a product recall in just one or two stages are more likely to be using a range of software applications.
Based on the study findings, recommendations for medical device organizations from the research team include:
- Implement processes and systems that support transparent and closed loop feedback systems to ensure that most issues can be prevented before they become non-conformances, CAPAs or recalls, particularly in light of the increasing rate of new product introduction (NPI) and the complexity associated with medical devices.
- Use techniques and tools to assess true root cause as part of a shift to TPLC approach; CAPAs that specify "operator training" and "SOP updates" cannot be stand-ins for true root cause analysis.
- Create structured agreements and full visibility across the entire value chain to manage the escalating engineering changes in an increasingly outsourced environment.
The research was cosponsored by solution providers to the medical device industry, including management and technology consulting firm BearingPoint, enterprise manufacturing and quality software provider Camstar Systems, product lifecycle management (PLM) software company Dassault Systèmes Enovia with its medical device industry PLM partner Integware, and PLM and enterprise content management software provider PTC.
The final research study report will be released later this month.
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