Medical Device Design & Manufacturing
25+ Years of Medical Device Development Experience
PDT, an Astronics Company, provides turnkey medical device development and contract manufacturing services that encompass a broad range of end user communities and applications. PDT partners with disruptive startups and large corporations to solve complex problems, develop user-friendly solutions, and improve patient outcomes. From concept development through the most complex technical implementation, PDT can provide exceptional results for your medical device program. Our portfolio spans connected health devices, patient monitoring, therapeutic devices, surgical instruments, laboratory equipment, diagnostics systems, point-of-care testing (POCT), infection prevention and testing, drug delivery devices, assistive technologies, and disposables.
PDT understands the challenges our clients face with new product development. Our team appreciates the need to integrate front-end creative insight into the procedural rigors of medical device design, development, and contract manufacturing. PDT was among the first ISO 13485 certified product development firms in the world with quality, control, and documentation procedures fully integrated into all disciplines. Astronics expanded its ISO 13485 certification for contract manufacturing.
PDT follows 60601 guidelines for efficient regulatory agency and Ministries of Health approvals. Through extensive design documentation, our team can support all FDA submission opportunities. Integrated risk assessment, Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), Verification & Validation (V&V) testing will guide your program through production with complete support in design transfer to our local 167,000 square foot manufacturing facility.
2net Medical Device Connectivity Hub
Cardiac Bedside Electro-Stimulation Therapy
Connected Auto-Injector & Drug Delivery Systems
Connected Blood Glucose Meter (BGM) Systems
Connected Deep Brain Stimulation (DBS) System
Electrosurgical RF Generators & Accessories
Excimer-based Laser Ablation System
Immunoprecipitation Sample Processor
Large Volume Pump (LVP) Infusion Systems
Negative Pressure Wound Therapy (NPWT)
Patient Monitoring Equipment
Portable Ambulatory Infusion Pumps
Rapid Acceleration of Diagnostics (RADx)
UV Disinfection & Sterilization Equipment
Western Blot Analysis Ecosystem
Wireless Vital Signs Monitor