TEST EQUIPMENT CUSTOMIZATION AND DESIGN

ViVitro Labs test equipment design powerhouse provides engineering services to customers requiring state of the art equipment solutions to test innovative cardiovascular devices. ViVitro Labs leverages its test equipment platform of pumps, motors, controllers, data acquisition system, software and fixtures to provide efficient turnkey test equipment solutions.

Our product development process is designed to deliver reliable and efficient test equipment solutions to meet novel device requirements in support of R&D, manufacturing, quality assurance and training activities.

Recent Projects
Our Process
Advantages

Recent customized test equipment design by ViVitro Labs:

Other customized test equipment designed by our customers (public domain):

ViVitro labs works closely with customers to define their requirements for custom medical device testing equipment. An expert in testing cardiovascular devices, we help bring many “un-written” requirements into the final design to ensure the tester exceeds expectations. It is important to note that any engineering work conducted as part of an equipment customization does not require compliance with ISO 13485 or ISO 17025.

The customization process may start with an initial feasibility study in our laboratory. This allows for a fast and cost effective proof of concept to be developed. Depending on the complexity of the tester, initial prototypes may be made from fast manufacturing processes such as 3D printing, bread boards, and LabVIEW software. Once this functionality is confirmed final machined parts, PCBs, and software can be fabricated and tested. ViVitro Labs uses a rigorous verification and validation process to ensure designs meet user requirements. Support can also be provided with the system including user manuals and on-site training. Custom medical device testing equipment can be designed for any budget for companies at any stage of development, these can be working prototypes to polished turn-key solutions. ViVitro is able to change and adapt the custom testing equipment as a company and design mature.

ViVitro utilizes our in-house industry experts, resources from our parent company, StarFish Medical, and external consultants as required to meet the constraints of a particular custom medical device testing equipment. ViVitro products are designed to be highly versatile and have been used in many different applications to test a wide range of medical devices. Read more here how ViVitro equipment and customized solutions have helped these cardiovascular pioneers achieve their goals.

Building in-house equipment to address the specific testing needs of innovative devices is more complicated than it seems. Here are eight reasons why you should consider outsourcing the development of your customized test equipment:

Modularity
The ViVitro Labs equipment platform is made of off-the-shelf modular components that connect together to provide a robust system base. Our pulsatile flow pump, controllers, data acquisition system, and software have been used in many applications and a variety of conditions.

Development Time Optimization
ViVitro Labs modular components decrease base system development time significantly allowing engineering efforts to concentrate on customizing innovative fixtures and supports. Avoid spending unnecessary time developing actuators and software routines on Lab View.

Simplicity
ViVitro Labs modular components are more user friendly with human factors engineering that makes them easier to use than in-house systems. This is especially important for generating fast, repeatable, and consistent testing results. Simplicity is an inherent ViVitro Labs design criteria from device mounting to data acquisition system, and software.

Reliability and Qualification
ViVitro Labs designs customized equipment with test equipment qualification (IQOQPQ) in mind. We address the uncertainty of measurements made by our own equipment and provide a robust path for test method validation. Compare data generated in your lab against data generate by an independent ISO 17025 accredited test lab. If the equipment is also replicated, customers can conduct interlaboratory comparative studies to validate test methods.

Design Robustness
ViVitro Labs modular components and software are consistent from product to product. ViVitro Labs customized equipment uses modular components that have proper design and production files to guarantee traceability. Systems are manufactured in a controlled environment with specific quality control point to guarantee reliability. Equipment can be replaced with identical units and components without jeopardizing data used for device validation and submission. Lack of design and production control on test equipment created in-house often incur a hidden cost when upgrades, repairs or replacements are needed.

Repairs
ViVitro Labs provides technical support and after-market services to organizations around the world that address equipment issues quickly. ViVitro Labs inventories repair parts for equipment that is not retired.

Turnkey
Customized test equipment is delivered turnkey including on-site or remote functional training, qualification, test protocol, test methods and technical documentation. Data sets to meet specs and address device requirements are generated before equipment is transferred to a client site.

Prioritize Resources
Using in-house medical device engineering resources to develop customized test equipment diverts your engineering resources from critical device development activities. One-off machining costs for a “prototype”, and overhead costs (like documentation and user manuals which are often overlooked) make ViVitro Labs modular system components a very cost effective way to accelerate your development.