Resources and Services

Archimedic was founded in 2009, with a focus on translating novel medical concepts and nascent technologies into medical devices meeting functional, regulatory, usability, and manufacturing requirements.  The firm has grown to 16 professionals with expertise in industrial design, ergonomics, electro-mechanical engineering, DFM, and transfer into manufacturing. The Archimedic team includes specialists in product configuration concept development, use case prototyping for formative human factors studies, functional bread-boarding for performance and reliability testing, industrial design encompassing form development and brand integration, design for manufacturability and assembly (DFMA), Alpha/Beta prototyping, supply chain development, pre-production device building, verification & validation (V&V), and design transfer into production.  Much of their work has been to support development of new and improved technology for various laparoscopic, interventional and open surgical procedures.  Moreover, Archimedic routinely conducts risk management inclusive of design control and design history file (DHF) management for device programs.

Archimedic has also been selected by the PPDC as its product development partner in the Early Stage Device Support Program.  The program is a new opportunity designed to provide professional support to guide product development planning and other activities for early stage projects.  Ten projects have been in the program thus far and come from small companies and institutions such as Children's Hospital of Philadelphia, University of Pennsylvania, University of Pittsburgh, Children's National Medical Center, and Stanford University.  The projects include a rapid opioid screen, simple vessel loop procedure kit, guidewire safety system, software guided needle, alternative system for knee repair sugery, safer method for upgrading cardiac therapies, improved dialysis catheter, dressing to accelerate wound healing, personal oral aspirator, and adjustable artery band.

The Center for Simulation, Advanced Education and Innovation at CHOP facilitates the translation of scientific discoveries into practical implementation for both research and clinical care. Centralized classroom and skills lab training, satellite skills labs, and unit-based "virtual" lab exercises adjacent to patient care settings are routinely conducted. The Center for Simulation, Advanced Education and Innovation at CHOP offers more than 950 teaching sessions with at least 11,000 attendees, including education encompassing recognition of shock and/or cardiac/respiratory failure, vascular access, chest tube care and hemodynamic monitoring, advanced and difficult airway assessment and intervention, pacemaker evaluation, EKG interpretation, critical incident debriefing, and crew resource management. The staff includes multidisciplinary center directors, full-time administrative staff, full-time clinical educators, and additional volunteer faculty.

NAMSA is the only medical research organization (MRO) focused exclusively on device, including combination products and in vitro diagnostics.  In its 50 years, NAMSA has contributed to bringing thousands of medical devices to patients in need.  With backgrounds that include careers at small start-up companies, large industry leaders, FDA and other regulatory agencies prior to joining NAMSA, the breadth and depth of expertise available at NAMSA is unparalleled.  NAMSA’s Associates are also active participants in shaping the broader medical device industry – participating on numerous ISO working groups with respect to biological and clinical safety.  NAMSA Associates are active on AvaMed working groups, and the Medical Device Innovation Consortium – a joint FDA-industry organization focused on innovations in the medical device space.