Case Study

Strengthening Pulsed Field Ablation Devices through Precision Firmware Redesign

Mirai Medical, a medtech company specialising in precision cancer treatment technology, engaged S3 Connected Health to address some firmware challenges they faced in the field with their proprietary and patent protected ePORE® generator, a device central to its electroporation-based Pulsed Field Ablation (PFA) therapy. The S3 Connected Health team conducted a complete firmware redevelopment project, improving device resilience, enhancing the overall reliability and performance of the ePORE® generator.
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Mirai Medical

Mirai Medical is on a mission to deliver on a future where patients avoid high-risk surgery.
To achieve this, they are using an exciting technology called pulsed field ablation (PFA) which has enormous potential in the gastrointestinal (GI) tract since this energy modality doesn’t destroy healthy tissue structures making for a safer and clinically easier to deliver treatment. Although their core focus is on GI disease, they are also treating skin cancers and have shown the broad applicability of their platform in the treatment of many other indications.

 

A clinical need for better treatment options

The technology's development stems from 20 years of clinical research in GI cancer treatment, initially focused on immunogene therapy and electrochemotherapy. 

The platform's clinical validation is substantial, with six published EndoVE® clinical studies and over 2000 successful procedures completed to date. The technology has evolved through extensive clinical experience, progressing from combination therapy with drugs like bleomycin and calcium to a more streamlined "pulse only" Pulsed Field Ablation (PFA) approach. Clinical evidence has shown that treatments can be safely delivered under standard nurse-led propofol sedation as outpatient procedures, resulting in GI cancer disease resolution and significant improvements in patient quality of life.

The ePORE® platform's PFA technology offers a safer alternative that preserves healthy tissue structures while effectively treating diseased tissue, essentially converting what would typically be a surgical procedure into a non-surgical one. 

Recent validation through pilot studies has demonstrated the technology's safety and efficacy, particularly in treating colorectal polyps. The platform shows promise for expansion into other gastrointestinal conditions such as Barrett's Esophagus and Type II diabetes, as well as cutaneous diseases, demonstrating its versatility in addressing multiple clinical needs with the same core technology.

 

 The project

Our engineering team conducted a comprehensive analysis using certified tools and processes to evaluate the ePORE® generator's usability, performance, and product issues. This analysis revealed the need for a complete firmware upgrade to address several key challenges including:

Firmware

Firmware-related reliability issues
The existing firmware had reliability issues that were leading to challenges in ensuring consistent device functionality. A robust firmware that would improve reliability while integrating with the generator’s current hardware was required.

electrical pulse1

Complex electrical pulse interactions
The generators functionality, involving precise electrical pulses, required careful integration of firmware with the hardware to prevent failures.

Safety and compliance

Rigorous safety and compliance requirements
As a medical device, the ePORE® required extensive verification to ensure firmware updates did not compromise patient safety, regulatory compliance, or introduce new risks.

Key components of our approach
Firmware redevelopment and optimization
Addition of new functionality
Verification and testing
Test automation
Firmware redevelopment and optimization
The team undertook a detailed firmware redesign to ensure that the ePORE® generator’ core functions were reliable and fully compatible with its hardware, which produces high-frequency electrical pulses. This redesign aimed to mitigate the issues identified and improve the product's resilience.
Addition of new functionality
Based on analysis of user feedback from clinicians, new functionality to fit with clinical practice, workflow integration, and patient experience was added into the generator to improve the user experience.
Verification and testing
The redevelopment process incorporated extensive testing to ensure that the new firmware functioned optimally and met all required standards. This included:
 

Functional and interface testing: To ensure that the firmware integrated seamlessly with the hardware, enabling reliable communication between components.

Safety and risk management assessment: Conducted in-depth safety assessments to confirm that the new firmware would not introduce new risks or compromise patient safety, an essential criterion for medical devices.

Compliance and regulatory testing: Ensured that the revised firmware adhered to the regulatory standards and FDA guidance documents necessary for medical devices, thereby facilitating continued market access.

Test automation
As a final step, test automation was implemented to streamline future firmware releases, ensuring continuous improvement and quality assurance for subsequent updates.
Firmware

The Outcome

The firmware redevelopment project successfully addressed the reliability challenges the ePORE® generator, was facing, enhancing its overall performance and user satisfaction. Post-project metrics highlighted the impressive impact of the new firmware, with zero returns recorded following the update, a testament to the reliability and quality improvements achieved.  Mirai Medical have now engaged S3 Connected Health once again as they look to develop the capabilities of the ePORE® therapy further.

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