Transform your medical technology into a market-ready medical device.

Subscribe to Medtech Mindset and receive actionable tips related to usability, reliability, manufacturability, and regulatory aspects of medical device development.

Our Services

Most of our projects fall into the following 4 categories. Of course, every project is custom tailored to our client's unique needs.

Strategy

We help companies create market strategies that integrate technical, clinical, regulatory, and commercial factors.

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Design

We help companies design medical devices that achieve usability, technical and manufacturing requirements.

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Manufacturing

We help companies rapidly launch manufacturing while creating pathways to achieve scale and cost targets.

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Quality Management

Our QSIM program bundles our ISO 13485 quality management system and experienced quality personnel. 

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Hear it straight from our clients. 

Most of our business comes from word of mouth. So, we take client feedback very seriously. Here are some perspectives on Archimedic directly from the people that engage us.

Case Studies

We have depth of experience in drug delivery, diagnostics, home health, and surgical instrumentation. Below are a few examples of our client work.

Foot Ulcer Detection Smartmat

Development of a connected home-health device to detect early onset of diabetic foot ulcers. 

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Smartbelt with Airbag Protection to Protect Hips 

Development of a connected wearable device to detect hazardous falls and rapidly deploy airbags for hip protection. 

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Circulating Tumor Cell Separation System

Development of a research-use system for separating circulating tumor cells (CTC) from whole blood. 

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Suction Cautery Tool for General Surgery

Development of a single-handed electrocautery and suction device that improves surgical efficiency. 

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Epinephrine Autoinjector Mobile Phone Case

Development of an emergency use autoinjector for ensuring life-saving medication is always on-hand.

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Laparoscopic Clip Applicator

Development of a minimally-invasive device for securement of the vaginal cuff during hysterectomy procedures.

View Case Study

14

Years in business

Started in 2009 as Smithwise and changed to Archimedic following a merger in 2019.

194+

Clients since inception

Ranging from academic centers to startups and established medical device companies.

445+

Medical device projects

From surgical instrumentation to diagnostics, drug delivery  and home health products.


 

Whether you are part of a Fortune 500 or a scrappy startup..

We can help you achieve your technical, clinical, regulatory, and commercial milestones. 

View our Client List

Free Medtech Mini-Course

~20 minute duration

  • Learn about prototyping methodology and how to address technical and marketing factors.

  • Learn about the human factors process and when to conduct formative and summative studies.

  • Learn about the regulatory documentation needed, including your DHF, DMR, and DHR.

  • Learn about when to engage contract manufacturers and how to manage EVT, DVT, Pilot and Scale-Up.

> Take Mini-Course Now

Perspectives on Medtech 

Below are some recent articles published in our Medtech Mindset Newsletter. 

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

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

5 Reasons to NOT Outsource Medical Device Development

Delivering high-impact medtech tips straight to your Inbox.

Subscribe to the Medtech Mindset Newsletter to get actionable tips on usability, reliability, manufacturability, and regulatory aspects of medical device development.


 

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