While medical device manufacturers face a new world that’s full of opportunities, uncertainty lies ahead too. Businesses are facing an increasingly competitive scenario, healthcare dynamics are evolving, reimbursement rules are becoming more intricate, and new regulations and standards are emerging. This challenging environment requires medical device companies to innovate more quickly, streamline their operations, and reduce costs.

As a leading provider of ISO certification for healthcare, we discuss three modern challenges medical device manufacturers must know about:

1. Cybersecurity

IoT (Internet of Things), digitization, and AI (artificial intelligence) have altered the industry’s practices. Technological advances have made diagnosis, self-monitoring, and better connectivity and integration between clinicians and patients possible, requiring more security. Medical equipment capture, store, and share data across multiple platforms. Most of them rely on software that isn’t just susceptible to technical errors but may put devices at risk of security breaches. Hackers may access and modify medical equipment. These concerns put patient safety at risk and negatively affect the quality of products.

Proactively monitoring the product field performance for software vulnerabilities is extremely important. Manufacturers must carefully examine cybersecurity as part of product development requirements while outlining what should be done to maintain patient safety and reduce associated risks, including the possible use of cloud storage and secure communication routes. According to FDA instructions, producers must comply with the pre and post-market requirements of cybersecurity while resolving any security problems before the product is introduced.

2. Supplier concerns

Suppliers are critical to the success of any business, and it’s important to maintain a positive connection between the consumer and the provider. Perfect conditions guarantee that the process of the supply chain remains intact, leading to the creation of high-quality goods with less material waste. Still, many organizations struggle with the intricacies of the supply chain — and the medical device sector isn’t an exception. One difficulty is ‘change management.’ Sometimes, a client doesn’t want to establish an effective change control process with a supplier. Thus, when a supplier modifies an inspection, raw material, or procedure without customer agreement, it produces noncompliance and can affect patient safety.

On the other hand, if a client develops a change control needing the supplier to obtain clearance for all modifications before implementation, this might lead to a number of process variations. Some changes may have little to no effect. Therefore, a balance between change control methods is needed to maintain a productive operation without compromising customer service or quality.

Another crucial factor is the risk-based evaluation of suppliers. The process of supplier risk stratification signifies where the greatest risk exists. For example, finding out which supplier has a greater influence on the supply chain regarding supply risk or patient safety. Categorizing suppliers facilitates risk monitoring and resource management. When a supplier manufactures a subassembly or component, the quality system of the supplier is important for managing the manufacturing quality of the subassembly or the item. A medical device maker may use its own quality system at a supplier due to the essential nature of its products.

3. Challenging regulatory requirements

Since medical device firms operate in a highly regulated industry, they face a difficult burden in adhering to various rules and regulations across every facet of their business. The complexity and quantity of regulatory requirements have been amplified of late, and this trend will continue in the future. Responding to this complex regulatory obligation is very difficult, especially as nonconformity may substantially impact the company’s reputation, costs, and the lives of parents.

All makers of medical devices should comply with government standards/laws to market their products. However, keeping up with regulatory changes and comprehending the complexity of certain standards can be difficult for certain producers.

The producer should adhere to the legislation of the nation in which it aims to sell its product. While certain universal rules may overlap, the approval of every country requires a distinct proposal. Plus, manufacturers must report hostile occurrences to the relevant regulatory agency, that is, as part of post-market monitoring.

In addition, the medical device industry landscape isn’t just complex but can be inconsistent across various geographies, activities, and functions. The inconsistencies that pose a big challenge for the industry comprise:

• Regulators appear to lack an understanding of the increasingly intricate regulatory challenges in the industry
• Regulators suddenly shifting the focus of an inspection
• Inconsistency between regulatory bodies in various geographies

BCS offers ISO certification for healthcare

BCS prides itself on its quality, affordably priced customer service, which is the key to your organization’s quick ISO certification and registration process.

Get in touch with their ISO consultants for more information!