Medical device companies have been slow to adopt Total Product Lifecycle (TPLC) management practices, according to a new study.
The U.S. Food and Drug Administration has been promoting TPLC as a key initiative to speed time-to-market, improve quality and safety and lower the cost of medical devices.TPLC enables firms to drive progress and manage all information from the concept and design of a product's lifecycle through commercialization and ongoing safety monitoring.
The study, released by the life science advisory firm Axendia and research analyst Cambashi, in conjunction with FDAnews, showed that more than half of the 212 medical device practitioners who participated had a TPLC initiative, but most had not shifted processes and systems to a TPLC approach. Instead, the majority are still using serial design models, such as stage gate and waterfall.
For those companies that have adopted TPLC, quality by design and voice-of-the-customer initiatives, research showed that they are far more likely to have improved their cost of quality and performance to other key metrics.
The study also showed that a majority of medical device companies don't use software applications to support their shift to TPLC methodologies. The two exceptions are ERP for business transaction management and EDMS (electronic document management systems) as a vault for regulatory, product and other documents. Although larger organizations are far more likely to use software than smaller ones, even among those with revenues in excess of $1 billion, one in four does not currently use QMS (quality management systems), MES (manufacturing execution systems), BI (business intelligence) or PLM (product lifecycle management).
The two actions medical device companies most regularly assign to close out a CAPA (corrective and preventative action) are 'operator training' and 'update standard operating procedures,' the study indicated, yet these actions rarely eliminate the root causes of the problem, which are more likely to be process or product design issues.
The study indicated quality analysis is also difficult. More than half of the respondents believe their companies are not able to conduct a thorough review of how raw materials, components or subassemblies, suppliers, product design changes, process changes, CAPA results or risk profiles impact processes or product quality.
On average, only 20 percent of respondents reported a decrease in engineering changes, CAPAs, non-conformances, audit observations and findings and adverse events, while only 30 percent reported declining product costs and recalls. The study showed this has resulted in most companies not seeing improvements in time to complete a recall, cost of regulatory action due to poor quality, reportable adverse events, customer reject rate, time to market, or new product introduction times.
The report recommends that companies leverage improved multi-department coordination and collaboration to improve product quality, reduce cost and boost overall business success. This will require using appropriate software applications that enhance visibility, data access, analysis and process improvement. Companies can also leverage integrated information systems to attain a single version of the truth, thereby minimizing regulatory burdens, the study said.
