Transforming Realtime Intravascular Image-Guided Intervention for Chronic Total Occlusion

Company: Simpson Interventions

Industry: Medical Devices

Use Case: Image-Guided Coronary Interventions

Services Used: Software, Firmware, Electronic Design

Results:

• Implemented validation and verification strategy to meet rigorous clinical standards
• Received Breakthrough Device Designation by FDA
• Streamlined development process that adhered to budget and timelines

Customer Introduction

Simpson Interventions, a startup specializing in cardiovascular interventional technology, is developing an advanced OCT (Optical Coherence Tomography) -guided interventional catheter system designed to improve treatment outcomes for patients with chronic total occlusion (CTO)—a total blockage in the coronary arteries. The technology is to be deployed minimally invasively through percutaneous coronary intervention (PCI) procedures. The device aims to enhance navigational capabilities and procedural predictability through the blockage, potentially avoiding the need for invasive bypass surgery. However, they required additional expertise in the crucial verification and validation processes necessary for medical devices.

Problem/Goal

• Comply with regulatory requirements for medical software.
  
  All software development will meet FDA and other regulatory standards without sacrificing project timelines.

• Needed additional expertise for software verification and validation.
  
  Establish verification and validation processes that ensure the safety and efficacy of the image-guided system.
• Budget, specialized personnel, and timeline constraints.
  
  Efficiently use resources to develop and test the image-guided system, ensuring timely market entry and regulatory approval.

Solution

Simpson Interventions chose Voler Systems for this project due to its proven expertise in navigating the regulatory environment of medical device development.

Voler Systems delivered the following solutions:

• Consulted on navigating the medical device regulatory landscape, ensuring compliance throughout the software development lifecycle.
• Crafted a tailored test plan, validation and verification protocols, and risk analysis processors for first-in-human trials.
• Prioritized essential development and regulatory activities to maximize resources and product development timeframe.

Results & Benefits

• Enhanced regulatory compliance and efficiency, expediting the regulatory review, reducing time to market, and avoiding costly delays.
• Assisted in implementing a comprehensive verification and validation strategy for the image-guided system, ensuring safety and efficacy.
• Guided development process within budget and timeline constraints, preventing resource drain and fostering ongoing innovation.

Inspiration

At Voler Systems, we empower healthcare innovators to transform visions into life-saving realities. We take pride in guiding startups like Simpson Interventions through the intricate process of medical device development.

“Voler Systems’ expertise in navigating the regulatory maze accelerated our path to market and was instrumental in the successful development of our OCT imaging system.”

Explore how Voler Systems can accelerate your medical device’s journey from concept to market. Contact us today to get started.