Saturday, June 27, 2009

MedApps Receives FDA Approval for Telehealth Solution


Another PADT customer to recently achieve a significant milestone is Scottsdale-based MedApps, Inc. In its June 5th Press Release, the company reports;

“MedApps, Inc. has been granted a 510(k) market clearance by the U.S. Food and Drug Administration for its expanded, flexible telehealth solution. The MedApps system is designed to link patients, families and healthcare professionals by providing a convenient way to remotely collect, transmit, store and report timely and accurate health information - anywhere. The MedApps system features the HealthPAL, a small portable personal health device, to collect and transmit readings from glucose meters, blood pressure monitors, weight scales and pulse oximeters.”


When MedApps needed to fabricate prototypes and prepare for full-scale production they turned to PADT. Bruce Bowers, VP of Manufacturing at MedApps stated “PADT has helped us with prototyping and small run support of our enclosures. Now we move into the higher volume demand with PADT to enjoy mutual growth. This is getting very exciting for the teams”. PADT is excited about the future of MedApps and we are looking forward to seeing their new technology help reduce healthcare costs and improve compliance.”

PADT Medical helps innovative medical device companies, like MedApps, that are commercializing new products and need rapid prototyping and low-cost manufacturing solutions. Our in-house capabilities, combined with our list of approved off-shore suppliers, provide our medical device customers a one-stop seamless transition from development to production. Contact us to learn more about how you can achieve early milestones with your innovative medical device concept.

Saturday, June 20, 2009

SafeStitch Medical Inc., Receives FDA Approval for Its SMART Dilator


It brings us great satisfaction when we are able to help our medical device customers achieve significant product development milestones. One such milestone was recently achieved by SafeStitch Medical when the FDA approved the Smart Dilator medical device. In its April edition, Gastroenterology and Endoscopy News reports that the SMARTTM Dilator is the “first esophageal dilator that indicates the amount of pressure being applied at the esophageal stricture, hopefully reducing the incidence of esophageal perforation.”

SafeStitch Medical approached PADT to help design and develop early prototypes of the SMARTTM Dilator product concept. We worked closely with the SafeStitch’s clinical, engineering, and regulatory team to establish product and design requirements through early prototype testing. The early development work was performed within PADT’s FDA Compliant Quality System and the Design History File was subsequently transferred to SafeStitch for final development and fabrication of the SMARTTM Dilator product.

PADT Medical helps emerging medical device companies, like SafeStitch Medical, that are commercializing new products and need outside engineering expertise to help develop their innovative device concepts. We enable reduced time-to-market by utilizing our established quality system, computer simulation, and rapid prototype testing to quickly converge on design solutions. Contact us to learn more about how you can achieve early milestones with your innovative medical device concept.

Saturday, June 13, 2009

Accelerate Your Product Development with Fortus Rapid Prototyping Technology





Fortus FDM technology, created by Stratasys, can accelerate your product development process by enabling earlier form, fit, and function testing of your medical device.

Engineers at Medtronic’s Sofamor Danek use the Fortus Technology to quickly bring concepts from the minds of Doctors to 3D prototype. “We often see one or two VIP surgeons per day,” says design engineer Richard Franks. “They come in with a problem to solve in the morning. They explain their need to an engineer, the engineer will model a solution on ProEngineer and then make a prototype. “

The Fortus technology enables device developers to rapidly produce components using medical grade thermoplastics. The technology is similar to other FDM machines in that it is an additive prototyping process that melts and extrudes a ribbon of material that is built up one layer at a time. The Fortus offers the following improvements over existing FDM technologies:

Biocompatible (ISO 10993-1 certified) Polycarbonate and ABS materials
Many grades of thermoplastic including Polycarbonate, ABS, Polyphenylsulfone, and Ultem
A production capable process that produces durable parts
Low cost: Polycarbonate is $3.60/in3 and Ultem is $7.00/in3


PADT now distributes the Fortus here in the Southwest and employs the technology to support product development for customers in the medical industry. The Fortus is the latest technologies that PADT has added to its RP resources, which include Stereolithography (SLA), Selective Laser Sintering (SLS), Fused Deposition Modeling (FDM), and rapid injection molding. Contact us for more information about the Fortus technology or how PADT Medical uses RP technology to accelerate your medical device development.