How are you influencing ER/surgical devices?

Mark Faulhaber
Director, Global Engineering, Standex Electronics

Medical devices that must be sterilized between uses present numerous challenges. In addition to the use of medical grade components (plastics and potting materials) that can withstand the heat of sterilization, there are also considerations for thermal expansion and contractions during the cooling process. And the electronic components themselves must be up to the challenge of an autoclave, or properly shielded.

The manufacturer of a bone shaver, used in numerous medical environments, recently approached Standex seeking help for these concerns. Extensive experience within the medical device arena provided background on these materials and how they function together through the thermal cycle. A key component within the device is a magnetic reed switch, which includes a fragile glass cylinder. Our engineering team proposed the Standex 4.7 mm reed switch that was small enough to fit into the design “window” with tight electrical characteristics, yet with a robust design that would stand up to repeated autoclaving sessions. The resulting design is durable enough for autoclave sterilization, making them a viable alternative to disposable medical devices.

Dr. Xiangyi (Cheryl) Liu
Medical Device Industry Lead, SIMULIA

As the surgical device industry strives to improve recovery times and provide less trauma and higher quality of life for the patients, demands for minimally invasive surgery and better wound closure options are on the rise. To reduce both device failure and injury to the patient, surgical device manufacturers are using computer-based simulation during the design phase to evaluate physical performance of minimally invasive devices, such as catheters and guidewires, as well as the interaction of the devices with the human body. For more invasive procedures, device makers are using simulations to optimize designs of alternative wound closures to achieve higher wound stability with minimal scarring.

SIMULIA’s realistic simulation solutions are used on a day-to-day basis by designers and analysts of surgical devices ranging from orthopedic and cardiovascular devices to drug delivery and surgical equipment. By replacing expensive and time-consuming physical testing with virtual testing, SIMULIA’s suite of nonlinear finite element analysis, multiphysics simulation, and design optimization solutions assist surgical device manufacturers to evaluate and optimize product performance, reduce the risk of device failure, and improve time-to–market while reducing overall product development cost.

James Wilson
Senior, Continuum’s Advanced Systems Group

We are focused on taking a collaborative approach to identifying the unique challenges of the stakeholders who work in critical care and high acuity environments. A typical nurse is 5’ 6” tall, 47 years old, has failing eyesight, and performs multiple tasks at once. Access to patient data is critical for them to provide effective patient care but they are often limited by antiquated systems that are not designed with them in mind.

An example of the impact of this approach is Continuum’s recent collaboration with Mindray to create the V Series line of patient monitors, designed to provide critical information and easy access to healthcare professionals in the most chaotic environments. The V Series solution was conceived, tested, and proven in a true environment by the end-users who understand the complexities and workflows. It addresses the need for more effective care without information overload and unnecessary alarms; it simply focuses on the most critical information. The Mindray V Series are the first patient monitors to use a vertical display, which allows for more information to be displayed in a clear, easily readable format in a way that takes up less space in crowded critical care rooms.

Donna Sandfox
Product Manager, Omron Electronic Components LLC

Omron Electronic Components is a component supplier to the medical device industry, providing products such as sensors, connectors, relays, and switches. Additionally, we offer an OEM NiBP module that makes it relatively easy to add blood pressure measurement functionality to medical devices. This module is used in Omron Healthcare’s professional grade vital monitors and their 401K data can be referenced, simplifying the FDA approval process.

Another area where we have been influencing the design of surgical devices is in the area of minimally invasive surgical equipment, where the measurement of gases, such as argon, is accomplished with Omron MEMS flow sensors. Our factory engineers are able to support the designers of this equipment by providing calibration data and/or custom calibrations for the different gases used in these applications. They also provide design assistance through the use of computational fluid dynamics modeling software. This analysis gives the designers some basic dimensional parameters when they are using a small flow sensor in a bypass design to measure a larger flow rate. It can also be used to estimate the pressure drop when more than one design approach around the sensor is being considered.