Feedback, KPIs in the FDA’s total product lifecycle help manufacturing efficiency

U.S. Food and Drug Administration (FDA) is using total product lifecycle (TPLC) to show how feedback and key performance indicators (KPIs) can make manufacturing more efficient.


Knowledge acquired in the development, manufacture, and use of one generation of product can be applied to future generations that a company plans to market. U.S. Food and Drug Administration (FDA) is using total product lifecycle (TPLC) to show how feedback and key performance indicators (KPIs) can make manufacturing more efficient, resulting in

lower-cost medical devices (see TPLC diagrams)


Axendia offers related efficiency resources

Also read from Axendia, FDA-related white papers:
- The Future of the FDA: Operating in an Electronic World ;
- Quality Management System Trends in Life Sciences ; and
- Pursuing a Future Where all Regulated Product Information is Electronic, interview with Dr Armado Oliva, FDA Deputy Director, Bioinformatics .

Providing a feedback loop between shop floor data and the design of the next generation product is indispensible in TPLC. Incorporating strategies such as robust design and designing for manufacturability enable product designers to take into consideration process capabilities. This could have a significant impact in increasing product quality while reducing manufacturing costs.
Build in quality
FDA also has been very proactive is in communicating its support for an industry-wide shift towards a focus on control theory and away from testing to document quality.
The agency defines the “desired state” as follows:

  • Product quality and performance achieved and assured by design of effective and efficient manufacturing processes;

  • Product specifications based on mechanistic understanding of how formulation and process factors impact product performance; and

  • Ability to effect continuous improvement and continuous “real time” assurance of quality.

To meet FDA’s stated “desired state,” manufacturers must attain real-time visibility into their processes to separate the wheat from the chaff. This requires deep knowledge of critical-to-quality variables and KPIs.
To move towards operational excellence, device manufacturers must identify “golden” (optimal) and “lead” (first) units, lots or batches and analyze key parameters that produced them. They must also compare and contrast such batches to identify parameters that are inconsequential to product quality. This approach can provide a deep understanding of the process to enable the development of KPIs to reduce variability, increase yields, and lower costs.
Also see April Control Engineering , "

Lower Cost Medical Devices?

Daniel R. Matlis is president of Axendia, a life-sciences and healthcare consulting and strategic advisory firm.
- Edited by Mark T. Hoske , editor in chief
Control Engineering System Integration eNewsletter
Register here to select your choice of free eNewsletters .

No comments
The Engineers' Choice Awards highlight some of the best new control, instrumentation and automation products as chosen by...
The System Integrator Giants program lists the top 100 system integrators among companies listed in CFE Media's Global System Integrator Database.
The Engineering Leaders Under 40 program identifies and gives recognition to young engineers who...
This eGuide illustrates solutions, applications and benefits of machine vision systems.
Learn how to increase device reliability in harsh environments and decrease unplanned system downtime.
This eGuide contains a series of articles and videos that considers theoretical and practical; immediate needs and a look into the future.
Make Big Data and Industrial Internet of Things work for you, 2017 Engineers' Choice Finalists, Avoid control design pitfalls, Managing IIoT processes
Engineering Leaders Under 40; System integration improving packaging operation; Process sensing; PID velocity; Cybersecurity and functional safety
Mobile HMI; PID tuning tips; Mechatronics; Intelligent project management; Cybersecurity in Russia; Engineering education; Road to IANA
This article collection contains several articles on the Industrial Internet of Things (IIoT) and how it is transforming manufacturing.

Find and connect with the most suitable service provider for your unique application. Start searching the Global System Integrator Database Now!

SCADA at the junction, Managing risk through maintenance, Moving at the speed of data
Flexible offshore fire protection; Big Data's impact on operations; Bridging the skills gap; Identifying security risks
The digital oilfield: Utilizing Big Data can yield big savings; Virtualization a real solution; Tracking SIS performance
click me