With our client-specific approach, an understanding of regulatory requirements, and our commitment to scientific excellence and efficiency, we help medical device companies worldwide accelerate the product development.
In recent years, devices (drug-eluting stents, artificial organs, biosensors, catheters, scaffolds for tissue engineering, heart valves, etc.) have been developed for implantation into patients. When these devices are implanted into the body, the body can react to the implantation in a variety of ways. It is important to assess, as well as optimize, the short-term or long-term biocompatibility of implantable devices and tissue engineering products. ISO Standard 10993, Biological Evaluation of Medical Devices, serves as our minimum standard guideline. Testing at MLM Medical Labs is performed in compliance with current Good Laboratory Practice (cGLP) guidelines.
Biocompatibility is defined as the interaction between a medical device and the biologic systems of the subject exposed to the device. An evaluation of biocompatibility is one component of the overall safety assessment of an implantable device. Biocompatibility of devices is investigated using a variety of techniques including in vitro and ex vivo tests, and animal models.
The biocompatibility of a device depends on several factors, including:
- Chemical and physical properties of its component materials
- Biologic tissue that will be exposed to the device, e.g., blood
- Duration of that exposure (temporary vs. permanent implants)
MLM will collaborate with you to determine your regulatory goals and compliance risks in planning a biocompatibility testing program. Services will were expanded in 2013 to include preclinical ex vivo testing by utilizing a new state-of-the-art vivarium located near our facility.
Our testing program includes:
Biocompatibility of short-term or long-term implantable devices
The biocompatibility of an implantable device, that is placed within the vascular system for transient diagnostic or therapeutic purposes, refers to the ability of the device to carry out its intended function within flowing blood, with minimal interaction between the device and the blood that would adversely affect device performance, and without inducing adverse activation of cellular or plasma protein pathways, such as coagulation.
Biocompatibility of tissue engineering products
The biocompatibility of a tissue engineering product refers to the capability to perform as a substrate that will support the desired cellular activity, including the facilitation of molecular and mechanical pathways, in order to optimize tissue regeneration, without causing any undesirable effects in cell targets, or inducing any adverse local or systemic responses in the subject, such as inflammation.