I’m a huge fan of athletics. I enjoy watching sports professionals sphere toss, basket bounce and shoulder pad grab. I’m going to use a sports metaphor to talk about how product lifecycle management solutions help medical device and life science companies achieve compliance.
Did anyone watch Super Bowl LI? Is it me or are baseball teams punting a lot less on first downs? If the FDA changed the rules of baseball so that you couldn’t deflate the ball, you would want the whole team – coaches, players, trainers and owners – to know that rule well in advance—right?
Similarly, in the medical device field, if you break rules of ever-changing and increasingly complex compliance mandates — whether intentionally or by sheer ignorance of requirements — you don’t just get a red flag penalty… you go bankrupt.
To this point, I really enjoyed reading a recent IDC Business Strategy Excerpt, titled “Business Strategy: PLM for Life Science Manufacturers — Operational Excellence Through Product Life-Cycle Management.”
In this paper, IDC conducted an interview with an Arena customer to create a case study that provides illustrative examples of how life science companies are using PLM technology to improve efficiency, collaboration, innovation, and quality. The paper also highlighted how PLM keeps supply chain teams on the same page so they are all working together to ensure compliance and better aware of compliance requirements. Click here to read the whole excerpt. Read below for a few highlights from the paper.
Arena Solutions PLM Automates FDA Submissions for Emerging Medical Device Developer
“In late 2014, a Midwestern U.S. developer and maker of innovative medical devices faced a challenge that threatened the company's future. After a surprise audit of the company's quality systems, the ISO 13485 auditors found the paper-based quality system to be insufficient and gave the management team six months to correct all findings and conduct a return audit. The audit team found that the company was following documented processes but not closing out corrective actions and nonconforming material reports routinely. Final sign offs were frequently missing or incomplete, and there was no automated system in place to flag open cases.
The COO and founder of the medical device company decided to search for a solution that could be implemented in time for the return audit and within the company's budget. At the time, 12 different devices were under development at multiple sites, which indicated that a cloud-based solution would be ideal due to the multiple remote teams collaborating on development and quality reporting efforts. After evaluating several options, the company decided on a cloud-based Arena Solutions PLM solution, which promised to automate the filing of FDA submissions, corrective and preventive actions (CAPAs), and design history files (DHFs).
The medical device developer went live on the Arena PLM system only six weeks before they scheduled a return audit. In those six weeks, bills of materials (BOMs), quality document templates, and DHFs (some containing up to 350 entries) were entered in the PLM system. When the ISO 13485 auditors returned, the team could conduct the audit completely within Arena PLM.”
The paper suggests that the life science industry is “playing PLM catch-up” compared to other industries. The paper concludes by stating that “PLM is offering life science companies a framework that can improve processes, quality, and ultimately patient safety in many ways, and that a wide variety of solutions and expertise are available to match available PLM software and technology to the many different needs of life science companies.”
Click here to read more. Comment below to let me know if this post was helpful or if you have other blog post topic suggestions for me. Or call Arena at (650) 513-3500 for more information on how our all-in-one product development platform can help you. Ready? Play ball!