10/06/2013

Elcam Medical Italy S.p.A.

What's New in Elcam Medical - September 2013

Spotlight on Elcam Medical’s R&D department


Elcam respectively partners with customers so to provide customized solutions to their greatest needs and challenges. “Working on customizing existing components is part of the work of our 30-person engineering department. Whether it is simply creating a customized color to support our partner’s branding or changing a taper on the luer to meet a product’s specifications, Elcam’s engineers will recommend and create a unique product to best meet your specific need” says Micha Segev, Elcam’s Engineering Department Manager.


Three projects that have recently been completed show the efforts and dedication of Elcam engineers to customize products according to customers’ needs


Disposable pressure transducer with USB connector
The Elcam disposable pressure transducer is an example of a product in which almost all its parts can be customized according to different needs of the customer, starting from the stopcock handle’s type and color, through the base & elastomer colors, customer logo, and also the connectors types. “Elcam’s flexibility in customizations is one of the company’s biggest assets. The engineering department is highly responsive in adapting their products according to the market needs.” Mr Hong Dae, Kang Sales Manager, ACE Medical. 


 


A Stopcock with a “Cut-Off”-Handle
This stopcock that features a unique handle was recently developed for Haemonetics to use with a special machine that automatically rotates the handle. This unique handle is the outcome of close cooperation between customer’s needs and requirements and the support of the engineering team in Elcam.


A new enteral feeding stopcock with a special luer that only accepts an enteral feeding syringe
The special luer will eliminate potential mistakes between IV and enteral feeding lines. In addition, the stopcock has an integrated dust cover that replaces a standard plug and prevents choking hazards. This stopcock was designed for one of the largest companies in the enteral feeding arena.


Elcam Launches a New Service : Validation and Verification (V&V) testing


Over the past few years, it has become evident that medical device companies are looking for ways to expedite approval process of new designs. The development of a new customized service, a highly effective process for Joint Validation & Verification activities is a new service Elcam is offering in order to meet this need and remove the burden from the medical device provider. This team approach rests on a number of key principles: (1) up-front assessment of risks, (2) a clear definition of the scope and extent of the validation, development and approval of SOP’s, and (3) specifications and agreed upon test execution.


“Employing Elcam’s Validation & Verification (V&V) testing services not only helped the project moved along more expediently, but it allowed our internal resources to be utilized more efficiently. Elcam was professional and comprehensive with all the required testing. We will certainly take advantage of Elcam’s V&V services for future partnership opportunities.” Jens Jörn, R&D Manager, BBraun Germany.


An Integrated V&V significantly improves approval process and time to market of the end product, while saving both sides a significant amount of resources. Please take advantage of Elcam’s new V&V service!