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.

Saving Time with Established Procedures

One way to help reduce the time and cost of developing a new medical device is to start with established protocols and procedures. When starting from scratch, even the first step of documenting customer/user requirements for a product can seem daunting. Established medical device companies will have a quality system that includes procedures, protocols, and templates that help guide and simplify the product development process. Additionally, established companies have staff that understands these procedures and how all the pieces fit together to make for smooth and controlled development process. However, this is not the case for a medical device startup. So what can early stage device companies do to help navigate the development process without established processes and procedures?

In my view, this is where outsourcing product development to company that has established procedures and development teams can add significant value to a medical device startup. I’ve seen first-hand how startups can struggle through product development because they don’t have established procedures and prior success using them. I’ve also seen how we’ve been able to add significant value to early stage companies by leveraging our established procedures and know-how. For example, we have established procedures for design planning, requirements management, biocompatibility, sterilization, packaging, risk management, electromagnetic compliance, etc.

At PADT Medical, we specialize in working with early stage companies. We are currently working exclusively with investment backed startups. In addition to providing engineering services and human-use prototypes, we can seamlessly integrate your product development in our Quality System to ensure a smooth and controlled development process that satisfies FDA regulatory requirements. Please contact us to learn more about how we work with early stage medical device companies.

See Us at the Arizona Health & Medical Expo

Come and visit us at the Arizona Health & Medical Expo on March 25th. We will be at Booth 22. Click here for more information about the event.