When developing Pulsed Field Ablation (PFA) devices or other innovative medical technologies, the choice between off-the-shelf (OTS) equipment and custom automation can make or break your manufacturing process. Here’s what you need to know to stay ahead of the competition.
The PFA Market Opportunity — and the Manufacturing Bottleneck
Atrial fibrillation (AFib) affects millions of patients, and PFA technology is enabling breakthrough treatment results. Many novel devices have been approved by the Food & Drug Administration (FDA) in recent years, and as success rates have climbed, market demand has exploded.
For device manufacturers, this means one thing: whoever scales production first wins market share.
But there’s a critical problem. Most PFA devices are still manufactured using highly manual processes that require specialized, skilled labor. To meet surging demand through traditional manufacturing, developers would need to hire and train hundreds of workers — talent that simply doesn’t exist at the required scale or speed.
The numbers don’t work. Even if you find enough skilled technicians, the timeline and costs become prohibitive. You need to account for:
- 3-6 months to recruit and train each technician to full productivity
- Ongoing quality variability across manual operators
- Labor costs that scale linearly (or worse) with volume
- Competitors automating while you’re still hiring
Forward-thinking developers are already implementing strategic automation solutions to capture market share. The question isn’t whether you should automate. It’s how to automate strategically and fast enough to win the market race — without sacrificing the precision and quality that regulatory compliance and patient safety require.
Off‑the‑Shelf vs. Custom Equipment: What Makes Sense For Your Device Program?
To scale strategically, PFA manufacturers need to understand when standard equipment works — and when it becomes an obstacle. Here’s how to evaluate your options under time pressure.
Where Standard OTS Equipment Fits in a Scaling Strategy
For processes where repeatability is more important than flexibility, OTS systems are often the preferred starting point because they are:
- Affordable and accessible — lower upfront cost than custom systems
- Simple and reliable — ideal for mature, single-function operations and standard device workflows
- Easy to validate — robust, existing documentation proves functionality
Common OTS machines include:
- Benchtop automation
- Indexing tables
- Laser welding and cutting equipment
- Standard assembly modules
- Inspection systems
Why Speed to Market Demands a Strategic Automation Approach
OTS machines may be fine for simple catheter assembly, but for many PFA devices, where the technology is evolving quickly, and manufacturing is becoming increasingly complex, yet the timeline is critical, those purchases are often misaligned.
Typically designed for a single function, standard OTS machines can limit throughput when products are complex and spatial tolerances are tight. Delicate production tasks common in emerging PFA technologies often exceed the capabilities of traditional workflows. Additionally, OTS equipment lacks the flexibility needed to accommodate complex designs or efficiently streamline multiple processes, and pre-packaged software cannot readily integrate with modern databases.
Finally, the greater the number of machines involved, the higher the costs teams need to plan for. With fragmented automation, there’s increased potential for downtime, more operator variability, and additional maintenance – all of which impact ROI.
Scaling PFA Production: Why Manual Processes Hit a Wall
Many PFA development programs face specific manufacturing challenges when scaling production workflows. Typical challenges across next-generation catheter designs include:
- Delicate distal tip geometries
- Complex electrode configurations that require precise placement
- Multi-step, sequential process maps
These complexities demand automation that is designed around the device, not the other way around. In PFA device manufacturing, a single custom machine can replace multiple OTS units — each of which would otherwise require dedicated manual operators — improving production efficiency and consistency.
The Case for Custom Automation and Systems Engineering
Custom automation solves challenges that standard OTS machines can’t. A single automated solution can integrate multi-step processes, handle the delicate components typical of advanced PFA device designs with precision, and support in-line inspection and data collection. By implementing automation early in R&D, companies can keep production adaptable and ready for the future of PFA technology innovation.
#1 Build In Software & Tooling Flexibility
Engineers can tailor systems so PFA device manufacturing machines evolve alongside the product design, rather than locking the developer into rigid tools. Custom software enables:
- Parameter adjustments for new SKUs or processes
- Stronger traceability for FDA and legal compliance
- Seamless integration with internal databases or Manufacturing Execution System (MES)
This flexibility extends to hardware as well. Although many PFA devices require micron-level precision, this level of accuracy can be achieved through various approaches depending on the application. For many positioning tasks, cost-effective solutions such as electric actuators and other pneumatic controls can be integrated directly into custom equipment design. Experts can help you select the right components for a practical balance of precision and affordability, allowing you to meet manufacturing requirements without having to rely on expensive off-the-shelf robotic systems.
Tip: Outline positioning needs early to build the most cost-efficient manufacturing program.
#2 Protect Intellectual Property (IP) & Competitive Advantage
To protect proprietary product features, emerging device developers need to maintain repeatability without third-party oversight of their precision engineering processes.
Instead of purchasing from competition-oriented OTS integration suppliers, which often provide “black box” or locked software, choose a custom automation partner to give your research team critical troubleshooting control and coding autonomy.
#3 Design for the Evolving Product Lifecycle
Future-proof PFA device development requires modular design and scalable automation architecture. As demand grows and product components change, developers need to incrementally increase production throughput while maintaining design intent. The right manufacturing partner can build empty stations for future workflows and accelerate any manufacturing expansion plans.
A phased, custom approach to automation ensures machines and systems are compatible with product volume forecasts. Investing in upgradeable tooling helps mitigate financial risk as PFA device technology evolves over time. It’s important to stay ready to adapt without replacing machines.
The PFA Market Won’t Wait. Integrate Automation Early to Streamline New Product Introduction (NPI)
For emerging research teams with fewer R&D resources and time, the key takeaway is: While OTS machines can handle most catheter manufacturing steps, your novel PFA design specifications may require custom, scalable automation solutions to avoid overbuilding, production delays, and regulatory or performance failures.
Accelerate Your Commercial Timeline Without Compromising Quality
Build for future scalability by integrating automation that leverages the specific device innovation and operational realities from the earliest design phase onward. The right balance of OTS equipment and custom tools helps developers meet production and cost targets, protect IP, and minimize risk after the device goes to market.
Evaluate Workflows, Budget, and Goals With an End-to-End Partner
To leverage your market window, you need a manufacturing partner who can work side by side with your team to rapidly assess development challenges, develop custom semi-automation or station-based strategies, and implement changes efficiently.
When you’re evaluating if your team has the technical resources to operate and maintain standard OTS machines, remember that smart manufacturing decisions can enable — or threaten — the next generation of medical devices.