ACHIEVING TECHNICAL, USABILITY, REGULATORY, AND MANUFACTURING MILESTONES

How We Help Medtech Innovators

Seeking an expert team and an efficient process to help you achieve your medtech milestones? We work with innovators at every stage - from napkin sketch concepts through detailed design and manufacturing launch. Gain medtech insights through our mini-course or book a discovery call to find out if we can help you.

MINI-COURSE
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COVERING THE RIGHT BASES FOR MEDTECH SUCCESS

Medtech Expertise

Our team of medtech experts are deployed to help innovators achieve the milestones that matter.

Design & Engineering

Our technical experts help innovators develop medical devices that achieve the functional and safety goals while meeting manufacturing requirements and cost targets.

Usability & Human Factors

Our usability experts design for intuition, ergonomics, and positive user experiences. We conduct formative and summative usability studies guide and validate designs.

Quality & Regulatory

Our quality experts are engaged throughout development to ensure that processes are followed, traceability is maintained, and regulatory documentation is created.

REDUCE EXECUTION RISK WITH THE RIGHT PLAN

Assessment & Planning

Before diving into details, we help innovators understand their current status. This often entails providing assessments around technical, usability, manufacturing, regulatory, intellectual property, and other key topics. After the risks are well-understood, our team assembles a comprehensive plan focused on achieving the right milestones that will derisk your venture.

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DESIGNING THE CONCEPT AND TESTING THE ASSUMPTIONS

Concept Design & Prototyping

Our concept design and prototyping process is focused on evaluating the critical assumptions. These assumptions may relate to technical viability, human factors or preclinical efficacy. We work with innovators to target these critical risks and create designs and prototypes that enable efficient and conclusive evaluation.

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PREPARE FOR MANUFACTURING AND V&V

Detailed Development and EVT

After the concept has been defined, our team helps innovators create the critical information that is needed for regulatory purposes and manufacturing prep. This typically includes risk analyses, tolerancing, work instructions, packaging, labeling, and supplier auditing. Prior to launching V&V, we conduct an Engineering Verification Test (EVT) build to confirm that the design achieves the baseline requirements and is ready to advance into the V&V stage.

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CONFIRMING OUTPUTS MEET INPUTS

Verification and Validation (V&V)

We help medtech innovators plan, perform, and document the critical verification and validation tests that are required for quality and regulatory purposes. Our ISO 13485 certified process ensures that the design traceability, documentation controls, and risk mitigation procedures are in-place to support 510(k) pre-market notifications, investigational device exemption (IDE) applications, and other regulatory pathways. .

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PREPARE FOR A SEAMLESS SCALE-UP

Design Transfer

Unplanned transfers from design into manufacturing can result in major slippages of timeline and unforeseen costs. We engage the right manufacturers early in the design process to obtain critical inputs related to materials, manufacturing methods, and assembly processes. At the right time, we conduct the design transfer process to ensure that know-how, documentation, and materials are properly migrated to the production team.

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STEPWISE PROCESS THROUGH THE MEDTECH PROCESS

Mini-Course on Medical Device Development

Take our FREE mini-course to learn about our ISO13485 certified process. Within this course, we share a step-by-step overview of the tasks, phases, and milestones that medtech innovators need to follow to achieve technical, regulatory, clinical, and manufacturing milestones.

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Frequently Asked Questions

CTO, PERICOR

Justin Opferman, PhD

"Once again Archimedic exceeded my expectations! Not only was our project plan completed on schedule, but their company delivered more than promised in the scope of work. As a medical device startup, every dollar matters and Archimedic's experience, creativity, and follow through has set us on the path to success. There is no company I trust more to navigate PeriCor through product development and commercialization."

VP, CONVENTUS ORTHOPAEDICS

Mike Mazzio

" Archimedic has been the only contract design house that I have had this much confidence in over my 30 year career in orthopedics. They truly worked as an extension of our in-house team."

CEO, TANGO

Wamis Singhatat

"One of Archimedic's true strengths is helping to bring new-to-the-world concepts to life. They've been a very capable and long-standing design partner of ours, from the MVP that allowed us to establish initial product-market viability to the mass-manufacturable design for commercialization. And, importantly, they understand and can work within the time and budgetary constraints faced by startups and established companies alike."

GET THE PROCESS STARTED WITH A DISCOVERY CALL

Ready to discuss your project? 

Book a time to connect with one of our medtech experts to discuss your project and determine if Archimedic is the right fit to help you achieve your goals.

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