Medical device manufacturers have consistently focused on bringing innovative products to market. To achieve this, most companies have implemented sequential design and manufacturing processes to ensure regulatory compliance and the highest possible quality.
Current shifts in financial, regulatory and globalization landscapes have made sequential processes inadequate. Today's environment calls for closed-loop product management strategies that can keep up with the increasing innovation tempo and complexity of medical devices while at the same time, lower cost, increase quality, and facilitate compliance with regulatory requirements.
The solution may well come from an unexpected source, the Food and Drug Administration's (FDA) Center for Device and Radiological Health (CDRH). According to the Center's most recent Strategic Plan, CDRH's Vision is to "Ensure the health of the public throughout the Total Product Life Cycle (TPLC)."
To determine the industry's adoption of the Total Product Life Cycle (TPLC) approach advocated by CDRH, Axendia, in cooperation with Cambashi and FDANews, recently conducted a major research project on this subject.
A total of 212 industry insiders from a wide range of medical device and diagnostic companies participated in this research.
This article highlights findings and analysis from the research report entitled "Total Product Lifecycle Management: Lowering Costs while Increasing Quality."
According to the Agency, in a TPLC environment decisions rely on information from the entire product lifecycle. The benefits of TPLC can be best achieved by leveraging appropriate information technology to share and communicate information across all stages of the lifecycle, enabling internal and external collaboration for improved decision-making.
TPLC provides regulators assurance of:
From the industry's perspective, TPLC management is a collaborative and concurrent approach that allows medical device manufacturers to leverage information for better decision-making, thus yielding more effective, higher quality, and safer medical devices. Better product outcomes are accomplished while simultaneously supporting shorter innovation cycles that are driven by information that is more complete.
Our research shows that although more than half of the respondents have a total product lifecycle (TPLC) Initiative, the majority of medical device firms are still using serial design models, such as stage gate and waterfall. In addition, most companies have not shifted their core processes and systems to support a TPLC approach.
The study found that companies that have adopted TPLC, quality by design, and voice-of-the-customer initiatives are far more likely to have improved their cost of quality and performance to other key metrics than those who have not yet adopted TPLC.
According to our findings, the majority of medical device companies surveyed do not yet 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 $1B, one in four does not currently use QMS (quality management systems), MES (manufacturing execution systems), BI (business intelligence) or PLM (product lifecycle management).
Another key finding is that quality processes are often disjointed and do not often attain the true root causes for non-conformances. For example, 'operator training' and 'update standard operating procedures' are the two actions medical device companies most regularly assign to close out a CAPA (corrective and preventative action), yet these actions rarely eliminate the root causes of the problem, which are more likely to be process or product design issues. The study findings show that quality analysis is also difficult. Over 50% of respondents believe that 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.
As a result, many medical device companies are not able to eliminate key quality problems and costs. On average, only 20% of respondents reported a decrease in engineering changes, CAPAs, non-conformances, audit observations and findings, and adverse events, while only 30% reported declining product costs and recalls. In addition, most companies have not seen 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.
TPLC provides a strong foundation for managing every stage of a product's lifecycle more effectively, as well as across product platforms and succeeding generations. Executing a TPLC approach would result in accelerated time-to-market at lower costs and higher quality. Regulatory compliance would be a natural outcome of that improved and well-documented lifecycle collaboration process.
Daniel R. Matlis is the Founder and President of Axendia - a trusted advisor to Life-Science executives on business, technology, and regulatory issues.
Dan's nearly 20 year career in life-sciences industry has included projects in research & development, manufacturing, regulatory compliance, business development and information technology.
He started his professional career at a Johnson & Johnson's Ethicon Company. There he was the Technical Owner for Computer Integrated Manufacturing, Automation & IT Engineering standards and Computer System Compliance.
Prior to founding Axendia, Dan was Vice President and General Manager at Stelex, Inc. - a leading consultancy to life-science companies.
Dan is the chief contributor and editor of Life-Science Panorama - a publication for industry executives covering business, regulatory and technology issues.
For more information, visit www.axendia.com or contact us at firstname.lastname@example.org. To stay informed on Industry trends, read Axendia's Life-Science Panorama, a Journal for Industry Executives, at http://lsp.axendia.com