Wilson Sonsini Goodrich & Rosati Medical Device Conference

We will be attending the Wilson Sonsini Medical Device Conference on June 23rd and 24th in San Jose. Here is the website for more information about the conference. We hope to see you there.

Three Ways PADT Medical Help Commercialize Medical Technology

Our presentation at the Southwest Bioscience Expo last week was based around the following graphic that illustrates how we support the medical devices industry. At our core is Product Development Services. There are plenty of details on our website and blog about our experience in this area.

In the past couple of years we've added two additional levels to help commercialize new medical device innovations. Collocation and Integration is a service that we provide to early stage medical device companies that want the benefits of having a product development team and infrastructure without having to invest time and money to establish them. We currently have one medical device company collocated and we are actively looking for other companies to bring in.

Medical Technology Investments and Partnerships is our latest expansion. We are actively looking for intellectual property that we can license and productize. We are also looking for opportunities to partnership in the establishment of new medical device companies. In fact, we cofounded a new medical device company this spring.

Please contact us if you are looking for medical device Product Development Services, Collocation and Integration, or Medical Technology Investment and Partnerships. We have a rapidly growing expertise in medical device technology commercialization and would enjoy the opportunity to discuss how we can best help you take your innovations to market.

PADT Reaches 60 Employees

Great customers, exciting projects, and top-notch talent have helped us grow to reach 60 employees for the first time since PADT was started in 1994. Thank you all!

Presenting at AZBio's Southwest Bioscience Expo 2010

We have been selected to be one of the presenting companies at this year's AZBio conference. Our presentation is an overview of our capabilities and past projects in product development. We will also discuss our investment approach the types of IP we are looking to license. The conference is on May 21st in Tucson, Arizona. Click here from more information on the conference.

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.

PADT Customer, SynCardia, Receive FDA Approval for IDE

SynCardia Systems (Tucson, AZ) has received a FDA approval for an Investigational Device Exemption (IDE), which allows them to perform clinical trials using their new Freedom Driver system (full article). Here's a link to PADT's previous posting about supporting SynCardia.

Do I Need to Submit a New 510k for This Change?

One of the common questions we face when modifying the design of a medical device is whether a new 510k is required because of the change. To answer this question we make extensive use of the FDA 510(k) Memorandum #K97-1 . This document includes a flowchart that helps developers determine if a new 510k is required or if is sufficient to document the changes in the Design History File (DHF).

Understanding this memo can provide valuable insights when developing your original 510k submission so that it cover future design modifications. Please contact us if you are developing a medical device and need support with your 510k submission strategy.