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.

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