This article provides an overview of product safety with regard to the development of a medical device. For information on this topic for drug development, please see Healthcare product safety: Drug development.
The product safety of a medical device is one of the primary questions to address in healthcare product development. Regulatory agencies worldwide are responsible to safeguard public health. No matter how effective a healthcare product is, if the company developing it cannot prove that its benefits (effectiveness) outweigh the risks (safety), the medical device will not receive regulatory clearance or regulatory approval. Product-related safety is also one of the major reasons for product recalls, label changes (for example, increased warnings) and licence withdrawals or suspensions for marketed medical devices.1
During the regulatory review of a medical device, scientific evidence is submitted to support the product safety. Depending on its classification, evidence may come from non-clinical data (for example, bench studies), animal studies and/or clinical studies. Ultimately, the probable benefits should outweigh the risk of injury or illness from product use. Obviously, the safety of the medical device plays a major role in such benefit-risk assessment.1
When developing a medical device, the amount and type of product safety information required will vary depending on factors such as what the device is as well as its classification, intended use and targeted jurisdictions. The information to support device safety may include, but is not limited to, the areas outlined below.
Throughout the medical device lifecycle, establish, document and maintain an ongoing process for:
This process shall include risk analysis, risk evaluation, risk control as well as production and post-production information.2
Identify possible hazards with the device design under both normal and fault conditions, including those resulting from user/human error. Unacceptable risks should be reduced to acceptable levels via mitigations such as redesigning the medical device (for example, adding an alarm or changing the material), changing the manufacturing process, or including warnings or precautions in the product label.1,2
Non-clinical tests1,3 may include:
If required, animal studies should be conducted in accordance with Good Laboratory Practices (GLP) using an appropriate study design. For instance, for an absorbable hemostatic device, animal testing may be required to evaluate and monitor complications such as infection, hematoma, coagulopathy or increased wound-healing time.4
Depending on the medical device classification, your product and the targeted jurisdictions, clinical evaluation and/or clinical trials may be required to evaluate the safety of the device in human use.
The safety evaluation of a medical device is an ongoing process and does not end with regulatory approval to market the healthcare product, or its clearance. Post-marketing activities related to monitoring the safety of the medical device may include:
If the risk-benefit ratio changes with new safety evidence from post-marketing activities, the medical device label or design may need to change, or the product may even need to be withdrawn to protect user safety.
*The U.S. Food & Drug Administration (FDA) has issued a guidance document called Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” It replaces #G87-1 #8294 [blue book memo]). In addition to the tests recommended in the ISO standard, the FDA has identified additional tests that may be applicable for your medical device. Consider these as you design studies for products that are intended for the US market.
The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.
Published: October 17, 2012