The global medical device industry is growing rapidly and positioned for sustained expansion. The global medical device market for 2019 was $448 billion, 2020 is expected to be around $443 billion and the market is expected to grow at a CAGR of 5.2%, reach more than $671 billion by 2027. The ability to meet patient demands through innovation and technology development presents challenges for device manufacturers. The competitive medical technology market requires a deliberate focus on product quality while meeting market demands.
Additionally, the sector faces barriers that are slowing down manufacturing. Failure to focus on these could lead to patient safety issues, as well as product recalls and field corrections. In addition to growingregulatory requirements, these barriers include product development and the seamless integration of vendors into the development process. A harsh approach to process development to maintain an efficient production process and manage supplier quality can have long-term consequences for a business. Additionally, the digitization of medical devices raises additional security concerns due to the possibility of patient data being compromised or the introduction of new hazards as a result of a compromised device.
The medical device industry faces an increasing number of regulatory compliance requirements that span multiple countries, business activities and roles. As the medical device industry strives to push the boundaries of innovation by inventing and launching new devices that address unmet patient needs, it faces unique compliance challenges. Additionally, compliance failures can be costly in terms of penalties, remediation costs, and reputational damage. Therefore, identifying, assessing and mitigating compliance risks is essential to building a successful compliance program and ensuring the future viability of the industry.
Demanding regulatory requirements
Medical device companies face a particularly difficult burden in complying with a plethora of rules and regulations in all aspects of their business because they operate in a highly regulated industry. The amount and complexity of regulatory requirements have exploded in recent years, and this trend is expected to continue in the future. Meeting this incredibly complicated regulatory obligation is extremely difficult, especially since non-compliance can have a significant impact on costs, company reputation and, ultimately, the lives of patients.
Every medical device manufacturer must follow laws or government standards to market their products. However, it can be difficult for some producers to keep up with regulatory changes and understand the complexity of certain standards. The EU Medical Devices Regulation represent one of the most recent major reforms in Europe (EU MDR). According to the EU, “The priority was to ensure a robust, transparent and long-lasting regulatory framework and to maintain a high level of safety, while supporting innovation.
The producer must comply with the legislation of the country in which he intends to sell his product. While some global rules may overlap, each country’s approval requires a separate submission. In addition, manufacturers should report adverse events to the appropriate regulatory body, i.e., as part of post-marketing surveillance, the FDA requires medical device report and the EU MDR imposes vigilance reports.
Additionally, the medical device industry landscape is not only complex, but can be highly inconsistent across a wide range of functions, activities, and geographies. The inconsistencies that pose a big challenge for the industry include,
- Inconsistency between regulatory bodies in different geographies
- Regulators change the focus of a mid-term inspection
- Regulators appear to misunderstand the industry’s increasingly complex regulatory challenges
There is an urgent need for regulatory harmonization in which regulatory requirements converge and industry burdens are reduced. Ever-changing regulatory benchmarks hamper compliance, but having a balanced stance with regulators can facilitate more permanent compliance tactics.
Faced with such complicated regulatory hurdles, medical device companies can adopt innovative technology to achieve effective compliance. Mature companies can incorporate contact with regulators into their innovation models to develop regulatory policies and guidelines and regulatory pathways. Those at the forefront of compliance maturity have specialized functions that represent the organization’s perspective on current compliance challenges and future innovation. Through regulatory harmonization, greater uniformity among regulators will make compliance more realistic for the industry. The industry faces the challenge of adopting a more balanced position, allowing compliance staff to focus on the most important compliance issues.
Complex Supplier Concerns
Suppliers are critical to the success of any business, and maintaining a positive bond between supplier and consumer is essential. Ideal conditions ensure that the supply chain process remains intact, resulting in the production of high quality products with little material waste. Either way, most businesses struggle with the complexities of the supply chain. The medical device sector is no exception and manufacturers face several obstacles. The first difficulty is change management: sometimes a customer neglects to establish effective change control processes with a supplier. Thus, when a supplier makes a change to a procedure, a raw material or an inspection without the agreement of the customer, it generates a non-conformity and, even more seriously, it can have an impact on patient safety. On the other hand, if a customer develops a change control that requires the vendor to obtain authorization for each change before implementation, this can lead to a multitude of process variations. Some changes may have little or no effect. Therefore, a balance of change control methods is necessary to maintain efficient operation without compromising quality or customer service.
Risk-based supplier assessment is another crucial factor. The vendor risk stratification process shows where the greatest risk lies. For example, determining which supplier has greater influence on the supply chain in terms of patient safety or supply risk. Categorization of suppliers facilitates resource management and risk monitoring. When a supplier manufactures a component or sub-assembly, the supplier’s quality system is essential to manage the manufacturing quality of the item or sub-assembly. Given the essential nature of its products, a manufacturer of medical devices can set up its own quality system at a supplier.
Artificial Intelligence (AI), digitalization and the Internet of Things (IoT) have changed industry practices. Self-monitoring, diagnosis, and better integration and connectivity between patients and clinicians have been made possible by advances in technology. With these developments, security is essential. Medical equipment captures, stores and shares data across multiple platforms. A growing number of them rely on software that is susceptible to technical errors and that can expose devices to security vulnerabilities. Hackers can access and modify medical equipment. These concerns negatively impact product quality and endanger patient safety.
Proactive monitoring of product performance in the field for software vulnerabilities is of utmost importance. Manufacturers should carefully consider cybersecurity as part of product development requirements and describe what needs to be done to maintain patient safety and mitigate associated risks, including the possible use of secure communication channels and in-store storage. cloud. According to FDA guidelinesproducers must meet pre-market and post-market cybersecurity requirements and resolve any security issues before product introduction.
Moving Forward: Modernizing Compliance
In recent years, medical device companies have come under increased pressure from a variety of sources, including increasing regulatory requirements, constant technological advancements, and significant pricing pressure. And the unprecedented events of the pandemic further justify modernizing compliance and increasing value and partnerships within companies and with external stakeholders. The medical device industry must confront emerging industry issues head-on if it is to continue to thrive.
Historically, compliance firms have focused on solutions and services and analyzing transactional data to determine what went wrong. Now is the best time for the regulatory compliance function to shift from a retrospective to a forward-looking focus, and to generate knowledge and employ methods that facilitate business success. This usually requires the modernization of the regulatory framework compliance framework and the adoption of new compliance strategies. Today’s compliance and regulatory organizations have the opportunity to improve their alignment with business objectives and regulations, as well as their responsiveness to external opportunities, challenges and pressures. Modern compliance operations must continue to be risk-aware and efficient to effectively serve their businesses through vital business partnerships.