Medical Device Development | Point of Care Testing Devices

MEDICAL DEVICE DEVELOPMENT PROCESS

Research, Product Strategy, Concept Generation

Think big. Achieve more. We will help you reimagine the future and achieve new levels of success.

Concept, Requirements, Development

Brilliant minds create beautiful messes. Our teams roll up their sleeves and dig in to create and evolve prototypes, prove technical feasibility and test user experiences.

Ximedica Process

Design Development

With proof-of-concept secured, formal design controls are introduced as we create a complete design history file suitable for regulatory submission.

Ximedica Process

Design Verification

Functionality, reliability, usability and safety factors undergo rigorous testing. Evaluation is conducted through a statistically significant, clinically relevant verification process.

Ximedica Process

Process Validation, Design Validation, New Product Introduction

Production tooling and line setup begins. Pilot units are built and tested, manufacturing and quality procedures are refined appropriate for commercialization. Market-ready products are assembled.

Ximedica Process

Pilot Launch & Manufacturing at Scale

With regulatory clearance or approval in place, production can begin with scalability for limited launches, pilot runs and full production.

With 30 years of experience and hundreds of satisfied clients in healthcare, Ximedica can launch products faster with higher market adoption. We use a human-centered, integrated process to create medical products that are thoughtfully designed, approved, manufactured and ultimately delivered to market.

Testimonials

“The Ximedica team took a challenging situation of a lengthy concept generation final review session and used innovative tools to turn it into a success, all done remotely. Ximedica ensured that all of the participants were comfortable with the collaboration software being used and were prepared for an engaging meeting. The result was a stimulating, collaborative and productive meeting which fully delivered on its objectives.“

— Byron Masi, PhD
Associate Director R&D
Global Alignment, U.S. Innovation Aesculap Inc.