Scott Klopfenstein will be chairing a session at the MEPTEC conference at ASU in September.

MEPTEC:
September 16th - 17th - 2009 Medical Electronics Symposium: Drivers for Technology, Health and the Economy (Tempe)Co-produced by MEPTEC and SMTA, this two-day event will bring together medical and microelectronics experts to cover a spectrum of medical technology and applications. Click Here for more information.

PADT is Looking to License and Commercialize New Technology

PADT is building on 15 years of success in the energy and aerospace sectors by investing in our medical device group – PADT Medical. Part of this investment involves developing new products founded on concepts provided by Doctors, entrepreneurs, inventors, and tech transfer offices. PADT began building its medical device capability in 2002 and formed PADT Medical as a formal group in 2006. The group has been FDA compliant since 2007 and will be certified ISO13485 in Q3, 2009.

Since late last year, we have been working to find products for PADT Medical to develop and to date we have collected and reviewed ~ 60 concepts. Four of these concepts have made it through our initial investigation and we are now pursuing the next preliminary phase of development. We hope to make it to full scale development on 1 or 2 products each year.

We are looking for two very distinct types of product opportunities: one that is simple enough for PADT to fund largely on our own, or with some Angel level support, and could conceivably be to market in 18 months; and one that is much more technically cutting edge and that we would work to gather government and VC funding for and would take ~ 4 years to bring to market. An example of a simple product that we are funding on our own is a one-piece plastic tool that would be used in hospitals for routine exams. An example of a cutting edge device that we are pursuing is an aortic graft. In the case of this graft, we have partnered with a leading doctor and entrepreneur to apply for an NIH grant to develop a proof of concept.

Simple product IP that we would be interested to review could come from almost any discipline, but cutting edge concepts would best fit us if they were endovascular, endoscopic, laparoscopic, diagnostic, natural orifice, or orthopedic in nature.

We are excited about bringing this business opportunity to doctors and entrepreneurs in Arizona and look forward to hearing your ideas and concepts. If you are interested, we invite you to contact us to further explore the potential of commercializing your IP.

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.

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.

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.

Solvent Bonding Polycarbonate to Polycarbonate - Update

It didn't work well. Unfortunately, it seems the bond created was very porous (see image below). After curing in a fume hood for 18 hours, the surface was still a bit tacky (after pulling the two pieces apart). The bond surface was abot 1/4" square and held roughly 20 lbf before seperating. It may have been stronger had it cured all the way, hard to know for sure. I only tried a few samples, so perhaps there are process tweaks I could make that would improve the efficacy of the cyclohexanone bond, but at this point it seems a less than ideal solvent for bonding polycarbonate to itself.

Solvent Bonding Polycarbonate to Polycarbonate

I encountered the need to solvent bond Polycarbonate to itself for one of the projects we're currently working on. After speaking with several vendors and reading various snippets online, I discovered that Methylene Chloride is the solvent of choice for bonding polycarbonate. Great, right? Except not so great. This is why: the method of sterilization we've chosen for our product is EtO (and we can't change it for technical reasons), and apparently EtO sterilization does not react well to anything with chlorine in it. So, the chloride part of methylene chloride presents a challenge. After further digging, a technician at Masterbond recommended a chemical called Cyclohexanone (which, I confirmed, has no chlorine in it). I've got some on order and plan on doing a test this week. I'll fill you in on the results when I have them.

Moral of the story - methylene chloride is the solvent of choice for bonding polycarbonate to itself; however, if you'll be EtO sterilizing your parts, using methylene chloride won't work and you should consider an alternative, possibly cyclohexanone.

Have A Medical Devices Idea? Recovery Act provides Funding!

If you have a concept for a medical device and need seed stage funding this could be a unique opportunity for you. The NIH recently announced that it will be awarding $200M in additional research funding due to the Recover Act (see RFA for specifics). Small business are eligible for this funding. Contact PADT Medical if you are interested in learning how we can partner with you and advantage of this unique opportunity.

Engineering the Next Generation of Artificial Hearts

PADT Medical is helping SynCardia Systems Inc. meet the anticipated demand for its artificial heart medical device. SynCardia, a Tucson-based company, manufactures the CardioWest™ temporary Total Artificial Heart (TAH-t). The TAH-t is the only temporary total artificial heart in the world that has both FDA and CE approval for the treatment of severely ill patients with end-stage biventricular failure. SynCardia anticipates increased demand for the TAH-t upon FDA approval of its portable driver technology. Recent shifts in reimbursement policy by the Centers for Medicare and Medicaid Services (CMS) are also anticipated to increase demand for the TAH-t.

SynCardia has contracted PADT to provide engineering services on the development of the next-generation of implants. According to Mike Gaul, Chief Operating Officer of SynCardia;

“PADT is providing engineering expertise to help us develop our next-generation of total artificial hearts. Their medical device testing and CFD fluid-flow modeling capabilities are providing valuable insight into the performance of these products.”

SynCardia has a small 50cc TAH-t, under development, which is targeted for patients with a body surface area (BSA) of 1.0 to 1.7, to complement the existing 70cc TAH-t, which is generally used for patients with a BSA of 1.7 or greater. In addition, SynCardia is developing Pediatric Ventricular Assist Devices (VADs). The 10cc and 30cc VADs are intended to be short term devices that in some cases allows the native heart to fully recover.

PADT is well equipped to develop innovative cardiovascular medical devices. These devices have a host of challenging design requirements including biocompatibility, fluid dynamics, and difficult geometric constraints. PADT’s experience with these challenges is proving valuable to customers like SynCardia. Contact us for more information about PADT’s expertise in the development of cardiovascular related medical devices.

Join us for the next Council Connect event on Rapid Prototyping at PADT on 2/26/2009

Here is the Agenda:

7:30AM – Registration & Continental Breakfast
8:00AM – Welcome & Introductions
Steven G Zylstra, President & CEO, Arizona Technology Council
8:10AM - Presentation: Rapid Prototyping Product Innovation
Presenter: Eric Miller, Principal, Director, Analysis & Design Technologies (PADT)
9:00 – Panelist Questions
Moderator: Eric Miller, Principal, Director, Analysis & Design Technologies (PADT)
Panelist: Rey Chu, Director of Rapid Manufacturing Technologies, PADT, Inc.
Panelist: Brad Palumbo, RP Expert, PADT Inc.
Panelist: Renee Palacios, FORTUS Channel Manager, Stratasys, Inc.
9:15AM - Tour of Rapid Prototyping Systems
9:30AM – Conference ends, Steven G Zylstra

Click here for more information and to register for the event.

Shape Setting Nitinol for a Medical Device Prototype

This week I enjoyed the excitement and frustration of shape setting Nitinol tubing for a prototype medical device used for a demonstration. I obtained samples from NDC and Memry . Both provided free samples within days. Nitinol is commonly used in medical devices because of its superelastic or shape-memory characteristics. In my application, I am taking advantage of the superelastic properties.

Shape setting Nitinol is a quick and easy process provided you have the appropriate equipment. To shape set the Nitinol, I created a fixture to securely hold the Nitinol to the desired shape. I then pre-heated an oven to 500-550°C. Next, I placed the part in the oven for 1 minute. I then removed the part and immediately quenched it in water. If you overheat the part it will reduce its superelastic properties.

The key to designing parts with Nitinol is to obtain material and start testing as soon as possible. Nitinol is NOT an easy material to design with because it does not have a linear stress-strain curve like stainless steels. Hence, most design formulas are not applicable. This week I learned that even though think-walled Nitinol tubes are flexible, they will splinter when compressed axially.

By Margaret Koga

PADT is Celebrating 15 Years of Service

PADT is celebrating 15 years of service by inviting all who are interested to join us on March 12th for an open house and celebration. Here's a flyer. Come and celebrate with us!

Posted by: Scott Klopfenstein

Developing Next-Generation Surgical Devices

PADT Medical has a growing expertise in the development of "non-invasive" and Natural Orifice Transluminal Endoscopic Surgury (NOTES) medical devices. PADT Medical was contracted to by SafeStitch Medical Devices to develop and deliver a transoral sugical device for the treatment of obesity (shown below).




This device is patented by SafeStitch Medical Devices. SafeStich offers the following description on there website about this device:

The Obesity Device is introduced through the mouth and esophagus and works by suctioning two sides of the stomach lining into position for suturing, impaling the mucosa or stomach lining, placing a row of sutures through the two sides of the stomach, as commonly done during gastric surgery, injecting adrenaline into the mucosa to elevate it for excision, excising the top layer of the entrapped stomach wall, releasing this tissue, removing the device and tightening the sutures. [link]

Here is a news article that provides additional discussion and links on the future of surgery using NOTES techniques and medical devices.

Posted By: Scott Klopfenstein

Injection Molded Parts in Days

PADT has now has the capability to deliver your injection molded prototypes in just days using “NanoTooling”. This new capability is made possible using a new Stereolithography material from Somos called NanoTool™ , which is heavily filled with non-crystalline nanoparticles.

PADT Medical recently used this approach on a Medtronic program to injection mold components made from Ticona Vectra, a biocompatible Liquid Crystal Polymer (LCP).
This new capability is another way that PADT Medical helps innovators reduce time-to-market. Parts made using NanoTool are ideal for early development testing and iterations to allow for faster convergence on design solutions.

The process to fabricate molded parts starts with a solid model of the component to fabricate. The tool is then designed by PADT engineering. The injection mold tool is then “grown” using Stereolithography prototyping equipment. Next, the tool is processed and fitted into the injection mold machine where the parts are made from any number of thermoplastic resins. This entire process is performed in house at PADT.

If you are interested in exploring this capability to accelerate your development program please contact us.

Posted by: Scott Klopfenstein