A renowned oral and maxillofacial surgeon from Phoenix, Arizona approached Parker's Porter Instrument Division in 2011 with a prototype design for an improved nitrous oxide mask. Robert Guyette, D.M.D., M.D. set out to create a mask that allowed better access to the oral cavity during dental procedures since current masks were bulky and often uncomfortable for his patients. Dr. Guyette was familiar with the Porter brand and approached Parker as a potential partner.
Watch this video to hear Dr. Guyette talk about his experience:
Engineering development approach
Employees at Porter quickly formed two high performance teams to lead engineering development and value stream mapping for the new product line to be manufactured at its Hatfield, Pennsylvania location. The manufacturing line was designed, developed, and installed in about three months by multi-functional teams including Engineering, Porter's in-house Model Shop, Process Engineering, and Manufacturing employees.
Since the product is a class one medical device, deployment of the entire production line was carefully monitored and documented under strict Design Validation and Verification methods that are recorded under formal Design Control Guidelines that comply with FDA Quality System Regulation ISO 13485, and CE Mark Medical Directive Directive 93/42/EEC, as well as ISO 9001.
Low profile nasal mask solution
The result is the Silhouette low profile nasal mask; an anatomically accurate, low profile, lightweight mask that fits comfortably over the patient’s nose while providing excellent access to all areas of the mouth. Silhouette is a single use nasal mask and breathing circuit designed with lightweight tubing and an adhesive strip across the bridge of the nose that creates an unprecedented seal enabling a predictable analgesia experience. The product was commercially launched on March 1, 2015 after an initial introduction at the Chicago Dental Show in February.
The unique design offers many advantages over traditional nasal hoods, including:
Unobstructed access to the oral cavity
A more predictable nitrous experience
Adhesive strip to secure the mask in place
Enhanced scavenging efficiency for reduced N2O exposure
Disposable mask and circuit for improved infection control
Four size options for a perfect fit on all patients
This new product line supports Parker Porter’s strategy to expand its market presence beyond dental applications to include hospitals and physicians’ offices that use nitrous oxide for pain management and minimal sedation. Increasing patient comfort with its streamlined design, the new Silhouette low profile nasal mask can accommodate many medical applications where nitrous oxide is used.
SILHOUETTE is a revolutionary new nitrous oxide nasal mask designed by a dentist for dentists. It eliminates the hassles many dentists associate with using nitrous oxide. The result is a compact and comfortable nasal mask that's nearly invisible and creates a safe and predictable experience for both the dentist and the patient.
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