Company insight Advanced PFA devices
Phillips Medisize, a Molex company, is a CDMO that supports medical device OEMs by enabling the development and manufacturability of pulsed field ablation (PFA) systems. By combining connectivity expertise, materials science and scalable manufacturing capabilities, the company helps translate promising electrophysiology technology into reliable, clinically ready devices.
P
ulsed field ablation (PFA) technology is rapidly changing electrophysiology by enabling safer, more durable pulmonary vein isolation with reduced collateral tissue damage. For OEMs, clinical opportunities are significant but so are the engineering and manufacturing challenges. Delivering kilovolt-level pulses through a miniaturised, single-use catheter while supporting a durable, reusable connector and cable requires a system-level approach that balances performance, sterilisation resilience and manufacturability. PFA systems impose two divergent life-cycle requirements: a cost-efficient, single-use catheter and a robust reusable connector assembly that must withstand repeated sterilisation cycles and thousands of connect-disconnect cycles. Materials, contact plating and mechanical design must be optimised for very different demands within the same product family. Addressing this split life-cycle up front avoids costly redesigns later and preserves clinical reliability.
Three technical imperatives define
PFA development: ■
Manufacturability at scale: High conductor counts and very fine gauge wires (often 46 AWG) make terminations fragile and yield-sensitive.
■
High-voltage safety: Kilovolt pulses require strict adherence to IEC 60601 creepage and clearance requirements, and physical segregation of therapy and signal paths to prevent arcing and carbon tracking.
■
Sterilisation resilience: Reusable housings, contacts and embedded electronics must survive repeated sterilisation cycles without corrosion or moisture ingress.
Each domain interacts with the others. For example, increased spacing for high voltage safety can conflict with compact form factor goals, while material choices that endure sterilisation may add cost or complexity to disposable subcomponents. Successful designs balance these trade-offs
www.medicaldevice-developments.com
Pulsed field ablation technology promises a major leap forward in arrhythmia treatment.
with validated components and clear design for manufacturability (DfM) rules.
System level, modular approach Adopting a modular, building block strategy accelerates development. Start with a portfolio of validated contact types, termination processes and fine wire configurations so early prototypes can focus on system integration rather than component qualification. Using proven modules also helps to reduce technical risk and shortens evaluation cycles for lesion performance and mapping accuracy. Rapid prototyping – combining off-the- shelf connectivity modules with 3D printed housings – lets teams move from concept to benchtop testing in weeks. This enables early optimisation of energy delivery and mechanical fit before committing to expensive tooling.
Choosing the right connector architecture early is critical. Best-practice designs physically separate high-voltage pins from dense signal arrays. Hybrid connectors are commonly used to achieve this, pairing dedicated, isolated high-voltage contacts with high-density card-edge or ribbonised signal modules. Specifying engineered plastics (for example, polyphenylsulfone or PPSU) for reusable housings and gold- plated contacts preserves conductivity through sterilisation cycles.
Manufacturing throughput often hinges
on optimising fine wire termination. Secondary processes such as ribbonising – bonding multiple conductors into a flat, prealigned cable – turn slow, error-prone manual terminations into reproducible, semiautomated workflows. These methods improve yield and ensure consistent energy delivery for complete lesion sets.
From prototype to production A working prototype is necessary but not sufficient. Commercial success demands scalable manufacturing, supply chain alignment and regulatory readiness. Partnering with a supplier that combines materials science, connectivity expertise and an ISO 13485 quality system smooths the path to FDA and MDR submissions and reduces time-to-market risk. Global manufacturing footprint and in-line testing capabilities further ensure consistent quality as volumes ramp. PFA technology promises a major leap in arrhythmia treatment but realising that promise requires thoughtful system engineering and manufacturing strategy. By combining validated connector platforms, optimised fine wire assemblies and a modular development approach, OEMs can accelerate innovation while managing technical and regulatory risk. ●
https://phillipsmedisize.com/ medtech-solutions
31
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100
