MediShield™ Biocompatible Coating

Innovative hydrogel coating that limits the Foreign Body Response and significantly extends the life of implanted devices and biosensors — by resisting protein adsorption, cell attachment, and bacterial adhesion.

Anti-fouling ISO 10993 Tested ISO 22196 Bacteria Test Non-Degradable Glucose Permeable
What is a biocompatible anti-fouling coating?

A biocompatible anti-fouling coating is a surface treatment applied to implantable or indwelling medical devices to prevent biofouling — the undesired accumulation of proteins, cells, and bacteria on the device surface. Biofouling initiates the Foreign Body Response: the body's immune system recognizes the device as foreign, triggers protein adsorption, cellular attachment, and potentially fibrous encapsulation, which degrades device performance and can cause infection. Anti-fouling hydrogel coatings resist this cascade at the first step — protein adsorption — preventing subsequent cell and bacterial adhesion. In continuous glucose monitoring (CGM) sensors and other biosensors, biocompatible coatings serve the dual function of suppressing biofouling while maintaining permeability to the analyte being measured. MediShield™ Biocompatible Coating is a plasma-deposited hydrogel validated under ISO 10993 and ISO 22196 — tested against both S. aureus and E. coli with no detectable bacterial adhesion.

The Challenge

Why implanted devices need biocompatible surface coatings

For implantable and indwelling medical devices and biosensors, biofouling is a significant challenge that can lead to device malfunction, foreign body responses, and infection. The biofouling process typically begins with nonspecific protein adsorption onto the device surface, followed by cellular attachment to the adsorbed proteins.

To mitigate biofouling, hydrogel coatings are commonly applied to resist protein adsorption. By minimizing protein binding, subsequent cell adhesion is significantly reduced, thereby limiting biofouling. As a result, these coatings help improve device performance, reliability, and safety during in vivo use.

Medical Surface has developed the MediShield™ Biocompatible Coatings (an innovative hydrogel coating) to effectively limit the Foreign Body Response and to significantly extend the life of implanted devices and biosensors.

MediShield Biocompatible Coating
Protein binding resistance data

MediShield™ Biocompatible Coating vs. traditional hydrogel — significantly reduced protein binding

Exceptionally Low Protein Binding

The binding of host proteins to the surface of implanted medical devices is recognized to be the beginning of the biofouling process. MediShield™ Biocompatible Coatings have been specifically designed to resist protein adsorption and has significantly reduced protein binding compared to traditional coated hydrogels.

Significantly lower protein adsorption vs. standard hydrogel coatings
Reduces the initiation of the biofouling cascade

Resistance to Cellular Adhesion

The adsorption of host proteins onto the implant surface, including complement related proteins, leads to an initial inflammatory response at the implant site. Monocytes and macrophages recruit other cells, resulting in the adhesion of cells to the implanted device. MediShield™ Biocompatible Coatings have been shown to resist adhesion of cells during prolonged period of contacting blood samples.

Demonstrated resistance to monocyte and macrophage adhesion
Reduces inflammatory response at the implant site
Tested under prolonged blood contact conditions
Cell adhesion resistance data

Cell adhesion test — MediShield™ coated surface (red) vs. uncoated control (blue) under blood contact conditions

Bacterial adhesion resistance data

ISO 22196 bacterial adhesion test — S. aureus and E. coli. No detectable bacteria found on MediShield™ coated surface.

Resistance to Bacterial Adhesion

MediShield™ Biocompatible Coatings have been tested for the ability to resist bacterial adhesion. Tests were performed according to ISO 22196. Two types of bacteria were tested: S. aureus and E. coli. In both cases, no detectable bacteria were found to adhere on MediShield™ coated surface.

Tested per ISO 22196
No detectable S. aureus adhesion
No detectable E. coli adhesion

Permeability to Glucose

Biosensor coatings not only need to create an effective barrier against host cells and proteins, but also need to be permeable to host analytes that are being measured. MediShield™ Biocompatible Coatings have been shown to be highly permeable to glucose, which is essential to glucose biosensor functionality.

In this test, uncoated and coated dialysis membranes (3.5kD MWCO) were compared side-by-side for permeability to glucose. MediShield™ Biocompatible Coatings have been found to have no significant effect on the permeation of glucose across the dialysis membrane.

No significant restriction to glucose permeation
Compatible with implanted glucose sensors (CGM)
Stackable with GLM coating for combined anti-fouling + analyte control
Glucose permeation data

Glucose permeation through MediShield™ Biocompatible Coating vs. uncoated control — no significant difference

Enhance your device surface with our coatings.

Contact us to discuss your application and request a feasibility study.