Radwave's electromagnetic minimally invasive and robotic surgical tracking platform was custom designed for integration into existing surgical devices and the clinical environment. The modular platform allows rapid customization to meet OR specifications, and the field-generating antenna--which can be tuned to accommodate various sensing volumes--remains translucent amid fluoroscopy. Its frequencies can be adjusted to avoid interference with the many connected devices populating the OR environment. It's a custom machine for the OR in every sense of the word.
Naturally, such a specialized device requires specialized components. That's why engineered electronics manufacturer TT Electronics was recruited for the job. The company designs and manufactures custom sensors for a wide range of medical equipment, including surgical navigation. Radwave and TT's complete navigation system can itself be customized for tracking a broad spectrum of minimally invasive diagnostic and therapeutic surgical procedures without a clear line of sight.
"Through our collaboration, this technology has incredible potential to disrupt an industry and ultimately improve patient outcomes ..." TT Electronics EVP Michael Leahan told the press.
Groundbreaking technologies like Radwave and TT's aren't possible without manufacturing partners providing specialized electronics to power, move, maintain, or otherwise enhance them. There is consequently much fervor for medical device makers to partner with a medical electronics maker well-versed in custom products. So, in order to gather valuable insights about custom electronics design and manufacturing for medical devices, MPO spoke to half a dozen industry experts over the past few weeks:
Drew Bratton, director of business development at P1 Technologies, a Roanoke, Va.-based manufacturer of injection molded products and interconnect cables used by the medical industry.
Charlie Cassano, technical sales executive at Solenoid Solutions, an Erie, Pa.-based provider of 2-way and 3-way solenoid valves, valve manifolds, and custom valves.
Rob Clippard, chief marketing officer of Clippard Instrument Laboratory, a Cincinnati, Ohio-based designer and manufacturer of miniature fluid control solutions.
Dave Howard, business development manager at KNF Neuberger, a Trenton, N.J.-based designer, manufacturer, and distributor of diaphragm pumps and systems for handling gases and liquids.
Steven Lassen, senior customer applications engineer at LEMO USA, a Rohnert Park, Calif.-based designer and manufacturer of precision custom connection and cable solutions.
Jimmy Logsdon, marketing manager at Linemaster Switch Corporation, a Woodstock, Conn.-based designer and manufacturer of medical and industrial foot controls.
Sam Brusco: What factors must be taken into consideration when designing custom electronic components for medical devices?
Drew Bratton: First and foremost, understanding the level and risk to the patient helps classify the device into the FDA ranking system and ensure the level or review is appropriate. To list some of the inputs to our design and development process; functional, electrical, software, environmental performances, physical characteristics, user and patient safety considerations, and target cost. We have invested in developing an integrated system to guide development of complete custom medical devices following ISO 13485 guidelines to ensure no inputs are left unreviewed.
Charlie Cassano: Size constraints and power consumption are typically driving factors that designers look at first. The smaller you can make a component...