Medical device industry ramps up for CSA Act's software changes
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Medical device industry ramps up for CSA Act's software changes

Sep 18, 2023

June 6, 2023 By MDO Contributors Network Leave a Comment

Carla Neves is quality manager and medical devices product owner at Critical Manufacturing. [Photo courtesy of Critical Manufacturing]

The Computer Software Assurance (CSA) Act of 2022 aims to improve quality and cost-efficiency in validating computer systems for medical device manufacturing. Although it has not been finalized, manufacturers, software developers, and consultants have fully embraced it and are ramping up for implementation.

Transitioning to risk-based validation after more than 20 years of document intense compliance will likely dominate medical device software operations for many years to come, as will building out the manufacturing execution system (MES) infrastructure to support it and developing the innovations that the newfound flexibility will drive.

The FDA's primary objective is to increase patient access to high-quality medical devices and help manufacturers deliver those solutions faster while also complying most effectively with FDA laws and regulations. CSA will replace the FDA Computer Software Validation (CSV) guidance that the FDA initially issued in 1997, which tends to cost companies more to validate than to implement.

Fearing that this imbalance is discouraging investment in innovation, automation and quality testing, the FDA has revised its guidance around a risk-based model that concentrates validation resources on the areas that are most critical to product quality and patient safety, with hopes that it would free resources for more value-added activities. The CSA guidance also helps companies evaluate their risk factors so they know where to focus.

A key value-added activity that CSA strengthens is replacing paper documents with electronic records. This will involve using MES capabilities to generate system logs, audit trails and other software generated data in producing electronic device history records (eDHRs).

MES software does this by automatically enforcing compliance through every step of production, ensuring that the right materials are being consumed, that the right people have touched the product, that their certification is right, that materials match designs and quality, and that they are using the right equipment and tools for the job throughout the entire process.

This real-time process is the exact opposite of a typical paper-based system, which just records what is happening and depends on a QA worker to review that paper to verify that everything was done correctly.

CSA speeds product delivery by enabling release by exception, enabling automatic release unless pre-defined critical metrics have not been met. Also helping speed product release, CSA will drive greater use of agile delivery methodologies over traditional waterfall delivery sequences.

The move away from waterfall strategies will manifest itself over many years and will require companies to articulate clearly where they are following CSA guidance and where they are still following CSV. Otherwise, auditors might perceive them as cutting corners.

Working with vendors and integration partners who have knowledge of both CSV and CSA procedures will be essential for articulating where new guidance is needed to improve product development documentation, how to evaluate the relevance of existing automated tests, and where additional steps might be needed.

While one of the biggest advantages of MES software in the medical device space is to enable electronic device history records (eDHRs) for compliance purposes, MES will also help find areas of product improvement.

The data it collects for the eDHRs can convert to value by revealing previously hidden problems. It can, for example, reveal sources of micro-downtime or show scrap levels that might never show up in an initial ROI but could add up to substantial savings, uptime, and profitability improvement.

In an industry where some medical devices are patented for just a limited amount of time, that could be crucial.

MES software doesn't stand alone. Companies will be integrating MES software with ERP, machinery, sensors and people to get the full benefit.

Software vendors have been improving integration steadily making it as simple as possible, through local and web interfaces, focusing on enabling someone without programming knowledge to use it.

In addition to ERP, that integration is also to PLM, QLS, EAM and document management, and many other applications using APIs.

A recent Gartner study showed that in 2021 about 30 percent of enterprise systems were deployed on the cloud and predicted 90 percent will be on the cloud by 2025. The industry is now going through that deflection point and the timing for a more flexible validation couldn't be better.

The cloud holds the promise of increased collaboration by tearing down organizational and geographic silos. This improves data flow across the supply chain. It will mean improved validation and even faster upgrades. The Association for the Advancement of Medical Instrumentation (AAMI) just issued guidelines for medical device manufacturers who are considering cloud deployment. Not that long ago, having MES software running off-premises was all but unthinkable.

It is increasingly possible for companies to deploy secure cloud-based systems that can have huge potential benefits for patients. They can get faster deployment in the cloud without needing to set up hardware on the shop floor or in the IT closet, enabling quick ramp-up as might be needed to produce devices in a medical emergency, such as producing more ventilators to meet COVID-19 pandemic patient needs.

AI and machine learning are beginning to emerge as well. They can improve outcomes based on deeper data collection and analysis capability. Rather than just analyzing production history they can be more proactive, for example, predicting replacements and repair needs in higher-risk operations.

In addition to the technical challenges, change management will be on the mind of many medical device manufacturing software teams over the next few years. They will be challenged to communicate the benefits of the transformation and ensure that all stakeholders understand the goals and benefits of any tools they are using and the implications that CSA can have for quality, efficiency in the plant, and ultimately the health and safety of patients. They will be communicating that CSA is not just an acronym, but represents a real difference in how companies will validate computer system software.

The hope is that the resources recaptured by streamlining documentation will bring visible benefits quickly.

Once companies have their infrastructure in place, they will likely see results quickly, not just in easier compliance and fewer warning letters, but also performance across the board. They will see improved repeatability, fewer mistakes, less rework and redesign, faster time-to-market, improved competitiveness, and lower production costs.

And the FDA is betting that patients will enjoy the benefits of innovative diagnostic and treatment devices sooner.

Carla Neves is quality manager and medical devices product owner at Critical Manufacturing. Neves holds an electric and electronics engineering degree from the University of Porto and is certified as a scrum master and advanced software test analyst.

The opinions expressed in this blog post are the author's only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.

The opinions expressed in this blog post are the author's only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.