This article presents five reasons why risk management is important and information on how to ensure you make risk-free medical devices.
As a MedTech manufacturer, you have the legal obligation to do medical device risk management. This means evaluating the potential risks due to the use of your medical device against the potential benefits of it. And rather than making a subjective judgement, you must use formal and systematic methods to demonstrate that the benefits outweigh the risks and obtain regulatory approval. But besides being a legal requirement, risk management is important also because it enables you to make safer products and reduces the costs of design and development by identifying the safety-critical aspects of the design early in the product development process. So, without further ado, let’s learn more about each of the reasons why you need to do risk management.
Depending on where you want to sell a product, different regulatory requirements apply. For instance, in the United States, the FDA regulates all medical devices and recognized ISO 14971:2007 as a suitable standard for risk management on June 27th, 2016. Thus, compliance with the stated standard is sufficient proof of product safety for the FDA.
However, in the European Union, you must use a standard published in the Official Journal (OJ). EN ISO 14971:2020 is a harmonized standard. You can use it to show conformance with the essential product requirements of the MDD 93/42/EEC or MDR 2017/745. Each country in the EU has a competent authority that approves medical devices for commercialization. If your product receives such approval, it means that it has CE marking.
Another good reason why risk management is important is related to the legal consequences of selling non-compliant products. As a medical device manufacturer, you must avoid product recalls. Product recalls occur after safety violations and are very costly. They may expose you to lawsuits and considerably hefty fines, settlement costs and legal fees. Furthermore, your reputation as a medical device manufacturer will be ruined, and future sales hampered.
A primary benefit of risk management is acquiring knowledge of the risks of a medical device, where the risks are, and how substantial they are. By knowing all that, the product development team can focus their resources on high-risk areas. Moreover, good risk management practices can help detect design flaws early in the product development phase. The sooner you correct a design flaw, the less expensive it is to fix it. Additionally, it would help if you considered ALAP/AFAP, i.e., reducing risks to as low/far as possible. Lacking knowledge of the risks of the various aspects of the product design, you risk going overboard and overengineering the product, particularly in the low-risk areas of the design.
Risk management is important also because the users of your medical device trust you with their lives. They expect that you do your utmost to make medical devices that are as safe as possible. So, it is your moral and ethical duty to apply good risk management practices and deliver the safest possible products to your end-users.
A very unexpected side benefit of proper risk management is improved communication. Often, the product development teams become siloed, i.e. there is poor communication among the various departments (e.g. electrical engineering, clinical, sterilization). But because risk management is a team effort, it tends to bring the different departments to the table to work together toward safer products. For instance, some of the most useful and enlightening discussions happen during the risk management work meetings.
Developing risk-free products depends a lot on making sure your products comply with all applicable national and international laws, regulations and standards. Lacking compliance with one or several product safety requirements means overall product non-compliance and eventual product recall.
The best way to ensure the ongoing compliant status of any product is by using software solutions, such as a sound compliance management system. A good compliance software will enable you to streamline most of your product compliance tasks, monitor the regulatory framework for updates and changes to standards, and ensure collaboration and coordination between all teams involved in the product development process. It is also recommendable that the software solution grants access to a supplier portal for managing SCIP compliance duties.