Medical Device Development Services
WHAT WE DO
We assist our customers by combining the following core capabilities; Project Management, Product Design, Advanced Simulation, and Rapid Prototyping. PADT offers these capabilities to support our customers in the research and development phases of product development. PADT also offers manufacturing implementation services with either customer approved vendors and/or our approved vendor network.
In the area of Project Management, PADT has a strategic focus on three industries; Medical Devices, Semiconductor, and Energy. In the medical device industry, we have contributed to the development of a broad spectrum of device types. The following list of past projects highlights the types of medical devices we have worked on and the many different ways that we contribute.
- Transoral Surgical Devices – Concept design, prototype fabrication, and testing.
- Laparoscopic Electrocautery Device – Concept design of improved instrument handle.
- Ophthalmic Diagnostic Device – System design of automated eye scanner.
- Endoscopic Surgical Instrument – Concept design, prototype fabrication, and testing.
- Heart Valve Stent – Structural and flow simulation of an implanted heart valve stent.
- Breast Biopsy Probe – Structural simulation of probe while obtaining biopsy samples.
- Miniature Infusion Pump – Concept design, simulation, and feasibility testing.
- Blood Filter Device – Flow simulation red blood cell filtering
- Implantable Pacemaker – Structural simulation for optimizing the use of adhesives.
- Bone Paste Delivery Device – Concept design and prototype testing.
- Drug Delivery Device – Structural simulation of an elastic tip valve.
- Pediatric Dental Drill – concept design and aerodynamic study of improved drill.
- Heart Valve Implant – Blood flow simulation for heart valve implant design.
- Bone Implant – Simulation of blood flow through bone with implanted devices.
- Safety Needle – Concept design and material selection for safety needle concept.
- Infusion Pump – Structural simulation to optimize seal design
- Bone Screw – Structural Simulation to optimize bone screw placement.
- Blood Flow Verification Device – Feasibility study of novel ultrasound device.
- Pneumatic Surgical Device – Design, simulation, prototype fabrication, and testing.
- Heated Catheter – Flow and heat transfer simulation of novel heated catheter device.
- Ultrasound Probe – Prototype fabrication of various probe concepts
- Bypass Catheter – Flow simulation of medicine diffusion in custom bypass catheter.
- Endoscopic Cautery Device – Concept design and testing of new cautery device.
HOW WE DO IT
For medical devices, PADT approaches product development using a phased and controlled approach that is based on FDA regulations (21 CFR 820). PADT specializes in the Research and Development Phases and organizes the process into the seven-step process illustrated below
PADT is committed to maintaining confidentiality for our customers. We understand the importance of intellectual property in the medical device industry and we work closely with our customers to ensure that innovative designs are kept confidential.
The outputs of the development process satisfy requirements for FDA compliance, which includes the design history, validation and verification records, and instructions for device manufacturing and quality inspection.
TOOLS THAT WE USE
PADT utilizes the latest development tools available to enable engineers to achieve optimal design solutions and to turn innovative concepts into functional products. Our expertise at using a combination of Design, Simulation, and Rapid Prototyping tools enables us to quickly iterate and test design concepts and ultimately reduce cost and lead time for our customers. The following table lists some of the tools we use for product development.
Our project engineers make use of practical management tools and direct and frequent communication with our customers to ensure that the development process is proceeding in a timely and efficient manner. Project engineers take the technical lead on programs and also have financial responsibility to ensure that the customer’s product and project requirements are translated into the design.
STARTING OUT
The process begins with an assessment of your product development needs to see how we can best contribute to your efforts. The next step is to establish a non-disclosure agreement so your product details can be discussed and the scope of work can be defined. Once the project scope is understood, PADT will prepare a cost and schedule estimate and begin the project upon approval. Please contact us to learn more about the potential ways that we can contribute to your programs.
CONTACT INFORMATION
Scott Klopfenstein
Manager, Medical Devices Group
Phoenix Analysis & Design Technologies , Inc.
Arizona State University Research Park
7755 S. Research Drive, Suite 110
Tempe, Arizona 85284
480-813-4884 (Phone), 480-813-4807 (Fax), 602-721-7409 ( Mobile)
scottk@padtmedical.com
