Medical Device Materials And Design

The development of a medical device from the concept phase to full-scale production involves multiple steps that vary based on the novelty and complexity of the finished product.

The process also requires checkpoints for testing and validating the new device and its components materials as well as functionality and performance testing.

Manufacturers of medical devices have the responsibility to support product label claims of reusability by providing written instruction for use, cleaning, disinfection, testing, packaging, and sterilization of their products.

These obligations are under the Health Canada, FDA and European medical device regulations.

You are the expert in making the device functional and perform the intended use; we are the experts in determining cleanability and sterilizability of the device. Many innovative medical devices did not make it to market because they cannot be properly cleaned and sterilized.

Let us help you ensure your device can be safely used by staff and patients

SteriLab™ consulting team is active participant in the development of medical device standards and has the capabilities to assist manufacturers and research institutes in the areas of reusable and single-use medical device materials and design. SteriLab™ has access to wealth of knowledge with respect to medical device performance under various cleaning and sterilization processes performed at SteriPro's reprocessing facility. Issues with materials and designs of different types of medical devices have been documented. This will be made available to you along with recommendations for device materials and designs for optimum cleanability and sterilizability.

Device Materials

Surface properties of any materials can significantly affect its protein binding ability, wettability and biocompatibility. Cleaning and sterilization processes can significantly alter the surface properties through chemical reactions such as oxidation, alkylation and reduction.

This can cause leaching of chemicals from polymers and can make metals weak, dull, rust or discolored.

Device design

The device must be designed to meet end-users needs from a functionality standpoint and also with consideration for reprocessing. The ability to effectively clean and sterilize a device affects both the safety and efficacy of the device.

Overly complex designs make it difficult for the users to adequately clean and reprocess the device.

It is critical to ensure that your device can be safely and effectively reprocessed and this begins with the materials selection and design for the device.

As a result, it is imperative to involve SteriLabs™ team at the early stages of the development of a device in order to address all materials and designs characteristics that affect the ability of end users to clean, disinfect and sterilize the device adequately.

For further information about these services or to receive a quotation, please contact us and fill out this form

let's get started

Medical device testing and development requirements can be complicated; our experts are on hand to help inform you of every aspect of this.

We are here to help answer your questions

First Name

Last Name

Organization

Phone number

Is the product a medical device?

What is the intended use of the product?

Briefly describe the service you are interested in.