Achieving Milestones: PADT Purchases Building to Create Space for Collocating Startups

PADT is pleased to announce that it is one step closer to achieving its vision to incubate medical device startups within its R&D facility in the ASU Research Park. PADT has purchased the building that it has resided in for the last 8 years. With the purchase of the 48,000 sq ft facilities, PADT Medical can help investment-backed medical device companies reduce time and cost to market by collocating and seamlessly integrating with PADT's product development staff and infrastructure.

"The ASU Research Park is a superb location for us. The purchase lowers our operating costs and enables more freedom to offer incubation space to local startups," according to Ward Rand, President of PADT.

PADT has been working to partner with local startups that fit with PADT's business model and being able to offer space is a part of that effort. Collocating at PADT provides seamless access to the following:

• Infrastructural support: Office space, conference rooms, telephone and web service, accounting support, etc.


• Engineering support including: Design/engineering expertise, CAD, FEA simulation, prototyping, instrumentation, testing, clean room, and final assembly.


• Commercialization support: Funding, strategic planning, manufacturing implementation, access to ISO 13485 compliant quality system.

To learn more about how your medical device startup company can benefit from collocating at PADT, please contact Scott Klopfenstein.

Product Success Story: Puttycise® Occupational Therapy Tools

Carolyn Mittelsteadt, inventor and founder of Puttycise® (http://www.puttycise.com/), is a licensed occupational therapist who approached PADT about 18 months ago for product development support. "I first went to PADT with rough concepts of my Puttycise tools and ideas. PADT helped me through the entire product development process, starting with prototyping models, to a pilot production run using silicone molds, and finally larger production runs using injection molding."

The Puttycise® tools are used in the treatment of a wide range of pathologies ranging from burn and traumatic upper extremity injuries to neuro-rehabilitation post cerebrovascular accident (CVA) or traumatic brain injury (TBI). The Puttycise® system consists of 5 tools which all function by inserting the base into a resistant putty. The tool is pushed, pulled or turned through the putty to produce the specified exercise. Each piece is specially designed to maximize function and versatility.

Some of the major challenges associated with this product development dealt with design for manufacturability (DFM). Early prototypes were made using PADT's in-house stereolithography (SLA) capability. Then, pilot production was done using silicone molds and the parts were cast from a thermosetting Urethane. The final product set required certain features and textures but had to be compatible with high-volume production. These designs are injection-molded Acrylonitrile Butadiene Styrene (ABS) and manufactured with steel tooling in Taiwan.

"PADT provided close support and advice during the entire process. It was challenging to decide on the final details, such as plastic type, wall thickness, texture, and gluing method, as these details significantly affected our end product. I appreciate the expertise at PADT for advising me and ultimately producing a high-quality product."

PADT Medical helps entrepreneurs achieve early and critical milestones and supports product commercialization from concept through clinical trials and into production implementation. To learn more about the development of this device or to learn how PADT Medical can help entrepreneurs and inventors commercialize new products, please contact Scott Klopfenstein

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.

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.

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

Incubate Your Startup Company at PADT

If you’re an entrepreneur looking for product development expertise and facilities to launch your company, consider incubating here at PADT. We are actively looking for startup companies that need a partner to develop and commercialize their innovative products. Specifically, we are looking for startup companies that will benefit from locating at our facility and taking advantage of the full spectrum of our product development expertise. If you are interested, we invite you to contact us to further explore this opportunity.

Since 1994, PADT has provided engineering and prototyping. However, to fuel our growth and support the commercialization of new technologies, PADT now is additionally looking for - and investing in - emerging companies. In the last year PADT has invested in two strong, local companies - KMI and Celerative. We are now looking to expand the way we help startups succeed by offering to incubate them here at our facility in the ASU Research Park.

This is a great opportunity for technology based startups that have an exciting business concept, enabling intellectual property, and the management expertise to make it happen. We will invest in your startup and partner in your success by providing the following support:

• Infrastructural support: Office space, conference rooms, telephone and web service, accounting support, etc.
• Engineering support including: design/engineering expertise, CAD, FEA simulation, prototyping, instrumentation, testing, and final assembly
• Commercialization support: Funding, strategic planning, manufacturing implementation, access to ISO 13485 compliant quality system.

To be considered, your company will have the following characteristics:

• An experienced management team with strength in marketing and financing
• A need for product development and engineering expertise.
• A clear business plan and rollout strategy for entering a substantial market.
• Attracting angel level investment in addition to PADT’s contribution.
• A product or medical device that has significant technical challenges - ideally one that benefits from our FDA compliant quality system.

We are excited about bringing this business opportunity to 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 opportunity of incubating your startup company with us.

Simulating Your Next Back Surgery

The day is coming when your spine surgery will be performed virtually using advanced computer simulation to practice and plan for the real thing. PADT Medical is currently working with Neil Crawford, PhD at the Barrow Neurological Institute (BNI) to develop the Virtual Spine Surgeon software system. The program, which is funded by the National Institute of Biomedical Imaging And Bioengineering (NIBIB), has the ultimate goal to "improve the outcome of surgery, shorten the time under anesthesia, and improve the confidence of the patient and surgeon". PADT is providing software development, finite element modeling, and rapid prototyping expertise to help construct a system that will convert pre-operative images (CT or MRI) into a patient specific model that can be used to suggest refinements to the surgery and ultimately create templates and drill guides for intraoperative use.

Screen Grab from Virtual Spine Surgeon program.

Increasingly, finite element modeling is being used to predict surgical outcomes and device performance. Contact us If you are interested learning more about how we can help you accelerate your medical device development program using finite element modeling.

Working with Contract Service Suppliers

Please join us next week at Dave & Buster's for the monthly Peer-to-Peer luncheon. We will be participating in the discussion about Contract Service Providers. The first luncheon received positive reviews and we look forward to making it even better. Here is more information about the event.

AZBio's Greater Phoenix Peer2Peer Lunch Series

On the second Thursday of each month, senior representatives of bioscience companies are invited to participate in round-table discussions at Dave & Buster's in Tempe. This is your opportunity to interact with colleagues, share your experiences and/or have your questions answered by experienced peers in your industry.

Thursday, October 9: How do bioscience companies select and manage contract service providers to maximize their value to the organization?

Increasingly bioscience companies rely on contract service providers to perform a range of specialized services. According to Drug Development and Discovery Magazine, "The forces driving the decision to outsource research services are the lack of in-house technology, the desire to accomplish the project more quickly, and the lack of in-house staff. A lack of in-house technology and expertise, along with the need to accomplish research quickly spurs the decision to outsource projects."

Unfortunately, bioscience companies often fail to realize the potential benefits of working with a contract service provider. Why does this happen and what can we do about it? The purpose of this luncheon is to share and discuss methods that you have found helpful when selecting and managing contract service providers.

Here are some questions for discussion:

1. What important factors do you consider when selecting a service provider?
2. How do you maintain good communication with a contract service provider?
3. How do you ensure that service providers deliver on schedule?
4. How do you ensure service providers satisfy your quality expectations?
5. How do you build long-term relationships with service providers?

This is your opportunity to interact with colleagues and to have your questions answered by experienced peers in your industry. Please email questions you would like to get covered during this lunch to natascha@azbio.org or call 602-495-2938.

Space is limited - reserve your seat by registering here or visiting our website at http://www.azbio.org/

See you there.

10+ Years of Bioscience Success

PADT Medical was recently recognized at the AZBio Annual Awards Dinner for over 10 years of participation in Arizona's Bioscience Industry. We are proud of this accomplishment and we look forward to many more years of helping innovators take their medical device concept to market. To learn more about ways we support bioscience companies visit our website at www.padtmedical.com.

PADT Invests in Kinetic Muscles

Last month, PADT invested in an exciting emerging company called Kinetic Muscles Inc. (KMI).  KMI is a Tempe based medical device company that has been working to develop a more effective treatment for stroke survivors.  Founded in 2001 by Jim and Ed Koeneman, KMI has been working steadily to develop and prove its technology and has received several prestigious awards - including Medical Device Company of the year from the Arizona Bioindustry Association.  
 
In 2007, KMI conducted a nationwide launch of their the "Hand Mentor Pro™".  The Hand Mentor™ helps stroke survivors regain use of their hand and wrist by engaging them in a series of game-like repetitive exercises that increasingly challenges the patient to move their hand on their own.  The product is based on the principal of neuroplasticity - which simply implies that a stroke impaired brain can relearn how to control the muscles with proper stimulation, effort, and time. 
 
KMI is now developing a number of additional rehabilitation products all targeting the $65 Billion dollar stroke market and based on the same technology resident in the Hand Mentor.  Simultaneously, KMI is expanding its marketing effort in the US and overseas to generate rapid growth.  To support this expansion, KMI is now accepting Angel and Venture Capital funding.  For more information, please contact KMI's CEO, Grant Farrell, gfarrell@kineticmuscles.com.

It’s Show Time

PADT Medical will be exhibiting in two medical device conferences this fall and we encourage you to come and visit us. On September 10^th and 11^th we will be exhibiting at the BIOMEDDevices conference in San Jose, CA. This conference is a comprehensive resource for medical device and biopharmaceutical development and manufacturing.

On October 29^th and 30^th, we will be exhibiting at the Third Annual Annual California Medical Device Forum in Orange County, CA. This conference is expected to draw over 500 participants from across the U.S. The past two years have been an exciting mix of entrepreneurs, start-ups, large companies, venture capitalists, the university sector and strategic advisors. The conference is organized by OCTANe, an organization is fueling "innovation development" in Orange County and Southern California. By connecting people, capital and technology, OCTANe accelerates entrepreneurs and company development for Orange County's biomedical and information technology community.

We hope to see you there.

PADT Medical Sponsors AZBio Peer-2-Peer Luncheon Series

PADT Medical is sponsoring a Peer-2-Peer Luncheon series focused on issues faced by Bioscience companies based in Arizona. Every first Thursday of the month, senior representatives of bioscience companies are invited to participate in round-table discussions. The topic for September 11th centers on "Developing your Target Product Profile". The luncheon will be hosted at Dave & Buster's in Tempe. We encourage you and your colleagues to participate in the series. To learn more about the luncheon series and to reserve your seat click here.

PADT Medical is an active member of the Arizona BioIndustry Association (AZBio). AZBio seeks to unify, empower and advance its member organizations, who collectively form Arizona's bioscience community. As the unified voice of the bioscience industry in Arizona, AZBio strives to make Arizona a place where bioscience companies can grow and succeed. Click here for more information about AZBio.

Track Record of Success

We thought we'd start by providing some background on us. First of all, I'm Scott Klopfenstein, and I'm a project manager at PADT Medical. I'll be joined in this blog by others on the team who are similarly dedicated to your success.

It takes an experienced and balanced development team to develop new medical and biomedical devices. The regulated medical device market imposes unique requirements and challenges on those who are developing new products. Our clients have told us that working with people who understand these challenges is essential to their success.

Developing this expertise is one of the key drivers behind PADT Medical. We are totally dedicated to our clients' success.

We are a specialized group within Phoenix Analysis & Design Technologies (PADT) that is dedicated to medical device development. PADT has been involved with medical device programs from 1994 with the goal of becoming the premier engineering services company in the Southwest.

Our experience and expertise are instrumental in helping our clients succeed. We also provide other support that we'll be discussing as we go along that sets us apart from all others.

As you consider working with companies to help bring your innovations to market, be sure to evaluate their level of experience in medical devices. Ask these questions: (1) What percent of their business is related to medical devices, and (2) do they have a mature quality system?

If the company has a track record of success in medical devices and their quality system is reportedly QSR compliant, then evaluate them further to see if they are good fit. We always aim to be a great fit with our clients!

Getting Started

Welcome to the PADT Medical Devices blog. Our purpose is to provide useful information about the development of medical devices to emerging medical device companies that are commercializing new products.

Our entire team at PADT Medical is focused on reducing time-to-market by utilizing computer simulation and rapid prototype testing to quickly converge on design solutions. This enables our innovative clients to better achieve design goals, implement manufacturing and more rapidly take their concepts to market.

In the coming posts we hope to provide commentary, tools, and tips that highlight how we help make this possible.