Tech Report: Cambridge Consultants tweak NDO Surgical's flagship medical device
Silicon Fen pioneers Cambridge Consultants took a good product and made it better.
In 2004 US-based NDO Surgical was awarded the prestigious Medical Design Excellence Award for its FDA-approved Plicator endoscopic device (pictured), which treats gastroesophageal reflux disease (GERD) such as heartburn.
A year later the privately-owned Massachusetts medical device maker called in Cambridge Consultants' Boston Office to test new technologies that would make the product more rugged and extend its life in the field. They wanted a leg up to better compete in the estimated $9.3 billion US market for non-invasive procedures to treat GERD.
GERD is a catch-all condition referring to assorted symptoms including heartburn, regurgitation, chest pain, hoarseness, wheezing and coughing due to tissue damage from the chronic reflux of stomach contents into the esophagus.
The existing Plicator device, first approved by the FDA in 2003, has been enthusiastically adopted by surgeons as the endoluminal therapy of choice and has been displacing other treatment options because of its ease of use and clinical performance.
The Plicator allows physicians to enter the stomach, via the esophagus, then flex and accurately position an implant at the gastroesophageal junction, restoring the anti-reflux barrier. No surgery or incisions are needed and the procedure is performed under conscious sedation.
With increased market penetration and improving sales, NDO Surgical wanted to extend the lifetime of each instrument to support an increased number of safe and reliable uses before the need for instrument refurbishment.
While the Plicator implant concept is ingenious in its simplicity, the delivery device is a complex system. It uses many design features of endoscopes employing flexible joints and controls so that physicians can introduce it through a patient’s throat and manipulate it once inside the stomach. The device consists of many linkages, pulleys and levers that are assembled and covered by several polymeric sealing boots. The boots and their joints must remain liquid-tight, and retain their flexibility under repeated exposure to aggressive disinfection solutions at elevated temperatures, while not adding any extra resistance or bulk to the working mechanisms.
Cambridge Consultants - started 45 years ago and credited as a key catalyst in what has became the Cambridge Phenomenon - prototyped, tested and developed approaches such as RF (radio frequency) and laser welding, as well as optimizing mainstream techniques, like solvent bonding, for improving the seals protecting the underlying mechanisms.
All its recommendations were made with an eye to meeting FDA biocompatibility requirements. At the same time, the firm modified NDO Surgical’s original design in areas around the joints where the boots come together to accommodate the unique requirements of each of the sealing methods.
The CC team handed over CAD models, detailed drawings, production system specifications, adhesives selections and solvent bonding recipes for NDO Surgical’s ownership and use going forward.
"Results to date are extremely promising," Andrew Diston, senior VP and MD of Cambridge Consultants’ Boston office, said. "NDO Surgical anticipates a reduction in manufacturing cost as well as a reduction in device returns for refurbishment."
All the Cambridge firm's improvements are expected to be introduced to the market in 2006.
"Although we have a design that works well, we engaged Cambridge Consultants to push the envelope in these critical areas," said Tom Bromander, VP, Engineering at NDO Surgical. "Their contribution will translate to an improved, more reliable product which translates directly to the bottom line. Safety and reliability at a lower cost is what we were looking for."
