Medical Device Design & Development Innovative Processes, Reliable Outcomes.
Design & Development
We are involved in the design and development of medical devices. Our team follows a multi-stage design process to provide the best products for our clients. This proven approach helps structure the product development workflow and ensures maximum collaboration at every stage. Throughout the process, we maintain regular communication with our clients, providing consistent and timely production schedules while thoroughly documenting each step of the development.
We utilize the latest tools and technologies to co-develop groundbreaking medical device designs, creating robust, safe, effective, and budget-friendly products. We develop manufacturing processes that ensure efficiency throughout the entire product lifecycle, from launch to market introduction. We also validate the entire product development process—from bottom-up creation to parallel line transfer.
Design for manufacturing
The products we produce go through a strict quality control process, and can be delivered in a timely manner without defects. The capabilities we provide in the reliability/manufacturability design phase include:
1. Early involvement of process and manufacturing engineers;
2. Perfect design and transfer internal procedures;
3. Early contact with customers and supply chains;
4. Cross-functional review of manufacturing processes;
5. Equipment selection;
6. Lean methods and lean tools, such as 3P;
7. Statistical data analysis;
8. Process appraisal begins before certification;
9. For complex catheters - make use of in-house capital equipment and previously developed process experience
Product Development
Diagsensor Medical has deep clinical experience developing and manufacturing complex catheter and medical device systems for demanding applications. We offer a breadth of product development capabilities that encompass everything from refinement of concepts and processes to test method development and design verification:
Product Development and Process Development:
Concept refinement
Iterative loop testing and prototyping
Design confirmation
Design freeze/testing and documentation
Design Verification
Characterization testing
Engineering analyses (DOE, tolerance analyses, FEA, etc.)
Review of historical data
Animal and/or cadaver studies
Design confirmation testing
Product performance testing
Biocompatibility testing
Accelerated aging shelf-life testing
Real-time shelf-life testing
Packaging verification testing
Test Method Development
FEA
Reliability testing
Limit testing
Limited conditioning (humidity, temperature, etc.)
Bubble emission package testing
Tray/pouch seal testing
Ex-vivo testing
Sterilization validation
Material biocompatibility testing
Dye penetrant package testing
Full package conditioning/ship testing/aging
Surface analysis
SEM material analysis
Concept and Prototype Design
By combining experienced engineering resources with human factors and industrial design expertise, Diagsensor Medical is in a unique position to assist you through your concept development. Our world class ideation and prototyping capabilities include:
Voice of the Customer Research
Storyboarding and Communication Tool Development
Authoring the Problem Statement
Concept Development and Selection
Bench Top Test Models
Rapid Prototyping
Medical device concept design and evaluation
Complex Parts Design (Solidworks)
Complete conduit delivery system
Handle and mechanism design
Drawing package development and design documentation
Structured stage gate development process
Manufacturing fixture design and documentation
Complete transfer of product intellectual property rights
Design validation, validation and pre-production
Initiate the transition from R&D to commercial production
Mass production
Medical device development services
Minimally invasive treatment and diagnostic medical products for:
electrophysiology
Peripheral blood vessel
Interventional cardiology
Interventional pulmonology
One-time use endoscopy/gastroenterology
Development of pipe guide manufacturing process
Supply chain selection, management and technical oversight
Development, implementation and reporting of in vivo study protocols
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Watch the video，Learn more about our products and services.Diagsensor is dedicated to the research and development of ultra-micro sensors for vital signs monitoring
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