Study: Few Companies Have Adopted Total Product Life Cycle Management Program

Most medical device firms have not fully adopted a Total Product Life Cycle management program, despite its ability to improve quality and safety, and reduce product costs, according to a recent study.

A majority of the “industry insiders” who participated in the study still use serial design models such as stage gate and waterfall, concluded the analysis by life science advisory firm Axendia Inc., research analyst Cambashi Limited, and FDAnews. “While the vast majority of organizations participating in this study report having key initiatives aimed at supporting Total Product Life Cycle, most have not taken all of the steps required to achieve a true TPLC environment,” the study’s executive summary stated.

The Total Product Life Cycle (TPLC) management approach involves sharing information among various product life cycle stages and between different departments within a company. It also encourages the use of preventive actions over corrective actions, encouraging firms to develop solutions that prevent problems before they occur.

The study, titled “Total Product Lifecycle Management: Lowering Costs while Increasing Quality,” found that most medical device companies do not use software applications to help them migrate to a TPLC program. Of the 212 study participants, less than half said they use software applications such as product life cycle management, manufacturing execution systems, or quality management systems. Larger companies were more likely to use software, but a significant portion of firms still do not use software systems in a collaborative manner.

“How many of you still have typewriters on your desks?” Dan Matlis, Axendia founder and president, asked a room of OEMs and suppliers who attended the Medical Product Outsourcing Symposium in Waltham, Mass., on Oct. 27. “Most of you do because most companies still use the very expensive multi-million-dollar typewriter. You’re used to printing everything out for your records. The thinking is if it’s on paper, it’s good; if it’s electronic, it might get lost. Let’s throw out the typewriter and implement true electronic [business] systems to gain visibility.”

Such sage advice is not likely to send an avalanche of typewriters to landfills any time soon, though. According to the TPLC study, less than 10 percent of companies use and keep a fully electronic database of records to be reviewed by regulatory agencies. More than 60 percent use a hybrid paper/electronic system, and about 20 percent of the companies surveyed are die-hard fans of paper records.

Internal documents are stored in much the same way, with more than 60 percent of companies using paper records, spreadsheets or an unspecified database. Corrective and preventive action paperwork also is filed mostly on paper.

The hodge-podge of paper and home-grown information systems for official regulatory records and internal documents has contributed to the inability of medical device companies to perform product recalls in just one stage. Those who can complete a product recall in one stage are significantly more likely to use packaged software applications, the study said.