Supporting Lifesaving Medical Technologies

Emergency-use medical device innovation is transforming healthcare and helping patients survive life-threatening situations. Among these innovations, devices like automated external defibrillators (AEDs) stand out for their technical ingenuity and direct role in saving lives during sudden cardiac arrest (SCA). The reliability of these devices is critical to a patient’s survival. Benchmark’s support of these devices exemplifies our “When It Matters” tagline.

Understanding the Life-Saving Value of AEDs

AEDs are among the most critical innovations in the medical device industry in modern history. These portable devices help restart a heart when someone suffers sudden cardiac arrest (SCA), an electrical disturbance in the heart that prevents it from beating properly.

Contrary to popular belief, AEDs are not just for use by medical personnel but are available for public use during an emergency. They are available in the public sphere and, if used quickly, can significantly improve a person’s chances of surviving an out-of-hospital SCA. However, a significant portion of the American public still needs to familiarize themselves with operating AED devices to take advantage of their lifesaving capabilities.

Confidence in Emergency Skills Among Americans (%)

Source: Sudden Cardiac Arrest Foundation

Supporting our customers in developing and manufacturing AEDs is just one example of Benchmark’s broader dedication to advancing medical device innovation across the medical technologies sector, from specific lifesaving technologies to a wide range of medical solutions.

Advancing Healthcare Through Medical Device Innovation

Critical technological advancements have changed medical device design and manufacturing over the years. Innovations in robotics, miniaturization, lab-on-chip (LOC), and more are pushing the boundaries of speed and quality of care, improving outcomes and increasing survivability during medical emergencies. However, along with these innovations comes a need for additional support across the product realization roadmap.

Many emergency medical devices must function outside the controlled conditions of an operating room, requiring ruggedization to withstand extreme temperatures and rough handling. Additionally, ease of use and simplified user interfaces are critical to ensure these devices are accessible to everyone during medical emergencies.  From design and manufacturing to testing and aftermarket services, medical device manufacturers require partners to help their innovative products meet diverse—and sometimes conflicting—requirements.

These valuable partnerships can support specific areas of the product development process or offer complete end-to-end support, from a drawing on a napkin to a fully realized medical device. But medical technologies customers must evaluate whether their engineering and manufacturing partners have the expertise they require, including:

• Regulatory Compliance: Experience and expertise in adhering to strict regulatory requirements, such as the Food and Drug Administration (FDA) regulations for medical devices. These regulations include ensuring chosen providers have certifications such as ISO 13485:2016 for quality management systems in the medical device industry.

• MedAccred Accreditation: MedAccred certifications ensure process discipline, greater operational efficiency, and continuous improvement, resulting in higher quality and lower overall cost.
  
  
• Technical Expertise: Proven capabilities in complex design engineering and manufacturing processes specific to medical technologies. Expertise in industrial or defense technologies can be a plus for emergency devices that are relied upon in diverse environments.
  
  
• Scalability and Flexibility: Capacity to scale production to meet fluctuating demand and accommodate future growth.
  
  
• Supply Chain Management: Robust management practices to mitigate component shortages or delay risks.
  
  
• Cybersecurity: Expertise in developing hardware and software designed to safeguard connected medical devices against unauthorized entry, data theft, compromises to patient safety, or interruptions in essential services.
  
  
• Customer Support and Communication: Responsive and transparent communication channels for ongoing collaboration and project management.

Medical device manufacturers often leverage a partnership with a supporting design, engineering, and manufacturing company that can provide flexible engineering and manufacturing processes to accommodate development and prototype requirements. They seek transparency and traceability throughout the supply chain to ensure product integrity and compliance.

Benchmark’s Role in Supporting Lifesaving Technology

Benchmark has a deep history in medical device manufacturing that began in 1979. This foundation in medical technologies—and the expert knowledge that comes with more than 40 years in medical device design, test, and manufacturing services—makes us the perfect partner for our customers’ innovative technologies.

We ensure that our design for excellence (DFX) reviews, test development, microelectronics, precision machining, and system-level assembly align with your specific needs. As your requirements change, you can leverage our global footprint to keep engineering and manufacturing close to home or customers for New Product Development (NPD) and New Product Introduction (NPI). And as volumes increase, you can leverage our global manufacturing locations to meet your unique needs.

Benchmark’s quality management systems and shop floor management system (known as PFS) are specifically designed to meet the manufacturing requirements of class III medical devices. This includes full component traceability, real-time process control, operator training verification, and dozens of other features that improve quality and reliability for these must-not-fail products. There is often a trade-off in manufacturing between quality and production cost. While the processes used in class III device manufacturing involve costs, automating these aspects through our PFS system is an efficient and reliable way to meet all requirements.

What differentiates Benchmark from our competitors, however, is the level of care we put into our customer relationships. In this business, developing trust and fostering a fully collaborative partnership are the keys to a successful product development outcome. Turn to Benchmark when it matters.