Design Services

At Envaste, we solve complex engineering designs for medical industry leaders, OEMs and start-up companies. This is achieved by applying our multidisciplinary expertise, collaborative teamwork, off–the-shelf technology and our proven processes.
Envaste’s contract design service allows you to bring products to the market quickly in a very efficient way. The design team is highly specialized in catheters, delivery systems, stents and associated products used in minimally invasive therapies.

As your contract partner for design services, we are committed to delivering all technology and services you require to bring your product concept into life.

At Envaste, design services are materialized through three steps:

1. Engineering Designs

We design components, sub-assemblies or complete finished devices utilizing latest CAD technology and other simulation calculators to define, specify and simulate use for all the elements that are part of the product. All design features are functionally tested in the lab, during the prototyping phase.

2. Bench Testing

Bench testing is crucial to the design and manufacturing processes. Without bench testing, manufacturers would not identify flaws in the finished devices they produce. Our approach of test early and test often allows us to gather initial design manufacturing intelligence or throughout the whole product design cycle. Our Interventional Device Testing Equipment (IDTE) allows us to comparatively test and record the performances features of the finished device including: catheters, balloons, stent delivery systems or endoscopes.

3. Regulatory Expertise

Envaste provides regulatory services assistance to comply with FDA or ISO regulations. We understand that becoming conversant with FDA or ISO regulations and successfully navigating through the regulatory requirements can be challenging. Whether your goal is to bring a new product to market or modify an existing product line, our experienced multidisciplinary team has a thorough understanding of regulatory requirement with proven track record for helping clients to comply with all regulatory requirements.

Sample of design services projects:

  • PTCA & PTA balloon catheters
  • Stent delivery systems
  • CTO catheters
  • Embolic protection systems
  • Valve repair delivery systems
  • Extraction systems
  • Aspiration catheters
  • Micro catheters