Medical Device Contract Manufacturing | Medical Device Product Development

Medical Device Contract Manufacturing

Complex, single-use medical devices

We are focused exclusively in the medical device industry and provide turnkey medical product outsourcing services. Our services include product development, design for manufacturability, process development including validation, packaging validation, and sterilization management.  We work with startups, mid-size, and large medical device OEM's  to launch next generation medical devices or when transitioning legacy products to outsource medical device manufacturing.

We maintain ISO Class 8 (Class 100,000) cleanrooms in Rochester, NH (USA) and Tijuana, BC (Mexico) used for medical device assembly and sterile barrier packaging.  We build confidence in manufacturing medical devices of the highest quality by utilizing process control and LEAN manufacturing techniques that provide our clients with increased throughput, higher quality, and reduced cost of goods sold (COGS) for their medical devices.

Medical Product Development

 

 

Device Engineering

Utilizing outsourced medical device contract manufacturers can reduce your time to market by as much as 30%. Our mechanical, biomedical, and manufacturing engineers have industry experience and can work with your engineering department on your latest medical device design.  

Design for Manufacturability

 

 

 Process Development

A prototype is not a product, but utilizing your user feedback and our manufacturing skills we can take your prototype and design it so that it can be manufactured at higher volumes using a robust process at the right price.  Products designed with manufacturing engineering input provide smoother validation

Sterile Barrier Packaging

 

 

Packaging Validation

No matter the intended sterilization method for your product, the FDA requires proof that a sterile barrier can be maintained as part of your regulatory submission. Our team has experience with materials, sealing methods and test protocols and  95% of the medical devices we ship are sterile.

 

Medical device manufacturing

LEAN Manufacturing

LEAN Manufacturing

We are world class when it comes to using LEAN manufacturing techniques to maintain cost, quality, and output.  Utilizing value streams helps our clients achieve better results than traditional batch manufacturing processes.

 

Supply Chain

Leverage our network

U.S. FDA requires registered manufacturers to keep tight control over their approved vendor list (AVL).  We leverage a global supply base of audited, ISO 13485 registered manufacturers to maintain your product quality.  Tap into what we know.

 

Sterilization Management

 

Gamma, EtO, or E-Beam

Sterilization choices should be considered earlier in your development process than you think.  Phase 2 has experience in getting products through sterilization validation using multiple methods.  Let us help you work through this complex process and speed your product to market.