Partner with Archimedic to streamline design, secure regulatory authorization, and drive market adoption.
Where innovation meets impact
We go beyond great design to align your device with regulatory pathways and market needs, ensuring it thrives.
> Learn MoreCASE STUDIES
MedTech Made Real
Learn how Archimedic has helped other MedTech innovators across surgical, drug delivery, diagnostic, and home health categories.
REACHING MARKET ADOPTION
Navigating the Path
Combining innovation, compliance, and strategy to streamline your journey to regulatory clearance and market adoption.
Achieving Market Adoption
Most of MedTech operates in siloes -- taking a serialized approach that may produce an innovative device but rarely reaches market adoption. Here's our take on breaking down siloes and achieving the end result that you really want.
> How We're DifferentFOCUSED MEDTECH PROGRAMS
Some ways to get started
Our engagement will be custom tailored to your unique needs, but below are some of the ways that we often help MedTech innovators get the process started.
Due Diligence
Before increasing your investment, it's always a good idea to get an inspection. Our DD process looks at technical, regulatory, and market factors to help with your go/no-go decision.
FDA Q-Sub Process
The pathway seems clear. But, have you gained clarity into predicates, references, labeling, standards, and tests? Our Q-Sub process will help you uncover this critical information to focus your project.
Discovery Research
What are the problems and anchors in the standard of care? Discovery research gives context into the psychology of stakeholders and clearly defines problems to focus your innovation efforts.
Prototyping
Are there technical, clinical, usability, or manufacturing assumptions that need vetting? Our purpose-built prototypes will help you get exactly the information you seek to move forward.
Formative HF
Need clarity around use case and user related risk? In our formative human factors studies, we'll develop the physical materials, recruit the users, draft the protocols, collect the data, and help you make sense of the results.
Strategic Planning
Need to know how all the MedTech pieces fit together? In our strategic planning process, we will help you clarify the technical, clinical, regulatory, and commercial pathways to raise funding and streamline development.
Impact Begins with Action
Your mission is clear. Let's connect to shape your device for market success and meaningful change.
> Discuss My Project
Open QMS
Elevate your quality standards with our open-source QMS designed to foster alignment and efficiency across Design, Regulatory, and Go-To-Market domains.
Design
Regulatory
Go-To-Market
LEVEL-UP IN MEDTECH
MedTech Insights
Dive into our blog for expert articles, podcasts, and resources that guide you through the complexities of MedTech-Market fit.
