Axendia, Cambashi, and FDAnews have presented findings from their research "Total Product Lifecycle Management: Lowering Costs while Increasing Quality." The data shows that although many organizations 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. Companies that have adopted TPLC, quality by design, and voice-of-the-customer initiatives are more likely to have improved their cost of quality and performance to other metrics.
The findings are based on 212 responses from a wide range of medical device companies, with demographics closely matching the total industry. Eighty percent of respondents are executives, directors, or managers. Most respondents see adding or extending product lines as the top opportunities for improvement. A majority of respondents report that new product introduction rates have been increasing and an even larger portion 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.
Despite this growing need and the success of TPLC initiatives, most companies have a long way to go to adopt TPLC practices. 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 over 80% 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% of respondents also use paper or homegrown systems (i.e., spreadsheet, database) to document for audit findings, CAPAs, field issues, and complaints.
Research indicates that 61% 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 is co-sponsored by major solution providers to the Medical Device industry. These companies have contributed to ensuring that the industry learns as much as possible about the path toward more effective practices in TPLC. Research Sponsors for the study are: management and technology consulting firm, BearingPoint (www.bearingpoint.com), enterprise manufacturing and quality software provider, Camstar Systems (www.camstar.com ), product lifecycle management (PLM) software innovator, Dassault Systèmes Enovia (www.3ds.com) with its medical device industry PLM partner Integware, (www.integware.com), and PLM and enterprise content management software provider, PTC (www.ptc.com).
The final research study report "Total Product Lifecycle Management: Lowering Costs while Increasing Quality" will be released later this month. Respondents to the survey will receive copies immediately on release.