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Your Partner for Medical Device Development

Archimedic helps companies reduce risk and accelerate time to market for new medical devices.

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100% Focused in MedTech

Since 2009, Archimedic has been helping companies develop drug delivery, surgical, diagnostic, and home health medical devices. Our work spans regulatory strategy, concept development, industrial design, human factors, prototyping, production engineering, design control, V&V, and manufacturing transfer.

Ultra-Compact CPAP Machine

Suction Cauterization Device

Circulating Tumor Cell (CTC) Isolator

Foot Ulcer Detection Device

Airbag Hip Protection Device

Autoinjector Mobile Phone Case

Pediatric Airway Secretion Management Tool

Laparoscopic Clip Applicator

Intra-Aural 3D Scanning Device

Platelet Rich Plasma (PRP) Cell Separator

Cardiac Remote Monitoring Device

-80 ⁰C Adipose Tissue Storage Device

Self Administered Cervical Screening Device

Minimally Invasive Pericardial Access Port

Minimally Invasive Pericardial Access Port

Connected Medication Management System

Spinal Fusion Implant

Pharmaceutical Raman Spectroscopy Analyzer

Plug-and-play MedTech expertise to accelerate your device development

At Archimedic, we provide drug delivery expertise and an ISO 13485 certified QMS to help companies transform concepts into reliable medical devices.

> About Archimedic

What do our clients say?

Wondering if we can help you Advance your MedTech Venture?

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How we support MedTech

Our programs are custom tailored to your unique requirements, but below are some of the ways we can help advance your MedTech program.

Regulatory

Standards and predicate research, pathway definition, indications for use statements, product labeling, pre-submission (Q-Sub) meetings, regulatory submissions

> Regulatory Support

Quality

Requirements definition, risk management, design control, documentation control, design history file (DHF) management, device master record (DMR) generation.

> Quality Support

Human Factors

Task mapping, heuristic evaluations, formative studies, user related risk analyses (URRA), instructions for use (IFU), threshold analyses, summative studies, usability file.

> Human Factors Support

Engineering

Concept development, mechanism design, electromechanical design, plastic part design, finite element analysis (FEA), design for manufacturability & assembly (DFMA).

> Engineering Support

Industrial Design

User experience design, ergonomic modeling, aesthetic development, brand integration, usability mockups, visual models, color-material-finish specification.

> Industrial Design Support

Prototyping

Mechanism prototypes, electrical breadboards, ergonomic mockups, Alpha/beta prototypes, packaging prototypes, rapid tooling samples.

> Prototyping Support

Testing

Feasibility testing, test method and protocol development, characterization testing, gage R&R, design verification testing (DVT), external test house management, test reporting.

> Testing Support

Manufacturing

Key supplier research and auditing, supply chain development, quoting, design transfer, first article inspections, process debugging, clinical unit builds, pilot runs.

> Manufacturing Support

Program Management

Team alignment, issues resolution, action item management, timeline and budget tracking, meeting facilitation, external vendor management.

> Program Management Support

Need a Partner to Raise Funding and Execute? 

Explore equity-based partnership through our venture studio model.

> MedTech Venture Studio

Our Perspectives on MedTech

We don't deny it -- our views are different than convention. Get our take on the MedTech Mindset blog. Here are some of our recent posts.

5 Steps to Prepare for an Early and Informative Q-Sub with FDA

May 18, 2023

EVT - It's like TSA precheck for Verification & Validation

May 02, 2023

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