The worldwide medical device sector is rapidly expanding and positioned for sustained expansion. The global medical device market for 2019 was $448 billion, 2020 should be around $443 billion, and the market should grow at a CAGR of 5.2%, reaching more than $671 billion by 2027. The possibility to meet the demands of patients through innovation and developing technology presents device makers with hurdles. The competitive medical technology market necessitates a deliberate concentration on product quality while meeting market requirements.
Additionally, the sector confronts obstacles that slow down manufacturing. Not concentrating on these might result in patient safety concerns, as well as product recalls and field corrections. In addition to growingregulatory requirements, these obstacles include product development and seamlessly incorporating suppliers into the development process. A harsh approach to process development to maintain an efficient production process and to manage supplier quality might have long-term consequences for a business. In addition, the digitalization of medical devices raises additional security concerns owing to the possibility of patient data being compromised or the introduction of new hazards as an outcome of a compromised device.
The medical device sector must deal with a growing number of regulatory compliance requirements that span several countries, business activities, and roles. As the medical device industry strives to push the limits of innovation by inventing and launching new devices that meet unmet patient needs, it faces unique compliance problems. In addition, compliance failures can be costly in terms of penalties, remediation costs and reputational harm. Consequently, identifying, assessing, and reducing compliance risks are crucial for building a successful compliance program and assuring the industry's future viability.
Challenging regulatory requirements
Medical device firms face a particularly difficult burden in complying with a plethora of rules and regulations across all facets of their business since they operate in a highly regulated industry. The quantity and complexity of regulatory requirements has skyrocketed in recent years, and this trend is expected to continue in the future. Responding to this incredibly complicated regulatory obligation is exceedingly difficult, especially as noncompliance may have a significant impact on costs, company reputation, and, ultimately, the lives of patients.
Every maker of medical devices must adhere to government laws or standards to market their products. However, it can be challenging for certain producers to keep up with regulatory changes and comprehend the intricacy of some standards. The EU Medical Device Regulations represent one of the most recent significant reforms in Europe (EU MDR). According to the EU, “The priority was to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation.”
The producer must comply with the legislation of the nation in which it intends to sell its product. Although certain worldwide rules may overlap, each country's approval requires a separate proposal. In addition, manufacturers must report adverse occurrences to the appropriate regulatory agency, i.e., as part of postmarket monitoring, the FDA requires Medical Device Reporting and the EU MDR mandates vigilance reporting.
Moreover, the medical device industry landscape is not just complex, but can be highly inconsistent across a wide range of functions, activities, and geographies. The inconsistencies that pose a great challenge for the for the industry include,
- Inconsistency between regulatory bodies in different geographies
- Regulators changing the focus of an inspection mid-way
- Regulators appearing to lack an understanding of the increasingly complex regulatory challenges on the industry
There is an urgent need for regulatory harmonization in which regulatory requirements converge and industry burdens are reduced. Constantly shifting regulatory benchmarks impede compliance, however 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. Companies that have reached maturity can incorporate contact with regulators into their innovation models to develop regulatory policies and guidelines and regulatory routes. Those at the vanguard of compliance maturity have specialized duties that represent the organization's perspective on current compliance difficulties and future innovation. Through regulatory harmonization, more uniformity amongst regulators will make compliance more realistic for the sector. The industry must rise to the challenge to adopt a more balanced stance, permitting compliance personnel to concentrate on the most significant compliance issues.
Complex supplier concerns
Suppliers are critical to the success of any business, and it is vital to maintain a positive connection between the provider and the consumer. Ideal conditions guarantee that the supply chain process remains intact, resulting in the production of high-quality goods with little material waste. Regardless, most firms 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: Occasionally, a client neglects to establish effective change control processes with a supplier. Therefore, when a supplier makes a modification to a procedure, raw material, or inspection without customer agreement, it generates noncompliance, and more critically, it can have an impact on patient safety. In contrast, if a client develops a change control requiring the supplier to acquire clearance for every modification prior to implementation, this might result in a multitude of process variations. Some alterations may have minor or no effect. Therefore, a balance between change control methods is required to maintain an effective operation without compromising quality or customer service.
The risk-based evaluation of suppliers is another crucial factor. The supplier risk stratification process indicates where the greatest risk exists. For instance, determining which supplier has a 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 subassembly, the supplier's quality system is vital for managing the manufacturing quality of the item or subassembly. Given the essential nature of its products, a medical device maker may install its own quality system at a supplier.
Artificial intelligence (AI), digitization, and Internet of things (IoT) have altered the industry's practices. Self-monitoring, diagnosis, and better integration and connectivity between patients and clinicians have been made possible by technological advances. With these developments, security is required. Medical equipment capture, store, and share data across several platforms. A rising number of them rely on software that is susceptible to technical errors and may put devices to the risk of security breaches. Hackers can access and alter medical equipment. These concerns have a negative impact on product quality and put patient safety at risk.
The proactive monitoring of product field performance for software vulnerabilities is of the greatest importance. Manufacturers should carefully examine cybersecurity as part of product development requirements and outline what must be done to maintain patient safety and mitigate associated risks, including the possible use of secure communication routes and cloud storage. According to FDA instructions, producers must adhere to cybersecurity pre- and post-market requirements and resolve any security problems prior to product introduction.
Advancing into the future: Modernizing compliance
In recent years, the medical device enterprises have been subjected to 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 provide even more justification for modernizing compliance and elevating the value and partnerships within the companies and with external stakeholders. The medical device industry must face the industry's new problems head-on if they are to continue to thrive.
Historically, compliance businesses have concentrated on solutions and services and transactional data analysis to determine what went wrong. Now is the best time for the regulatory compliance function to transition from a focus on hindsight to one on foresight, and to generate knowledge and employ methods that facilitate business success. This typically necessitates the modernization of the regulatory compliance framework and the adoption of new compliance strategies. Today's compliance and regulatory organizations have the chance to improve their alignment with business goals 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 serve their enterprises effectively through vital business partnerships.