Bringing a medical device to market is an intricate and demanding endeavour. From the initial concept to product classification, and ultimately securing approval in your target market, these essential steps can pose significant challenges for both established entities and emerging enterprises in the medical device sector.
Navigating the ever-changing landscape of medical device regulations adds another layer of complexity to the industry. In the United States, device approvals are overseen by the Food and Drug Administration (FDA), which employs a distinct regulatory framework. Similarly, in the European Union, the Medical Device Regulation (MDR) governs the sector. This scenario is replicated globally, with countries such as Brazil, Australia, and Japan each upholding their unique regulatory standards. Brazil’s National Health Surveillance Agency (ANVISA), Australia’s Therapeutic Goods Administration (TGA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are responsible for their respective regions, each enforcing specific compliance requirements. This constant evolution in regulatory governance, typical in a dynamic industry, makes compliance an even more challenging task. Companies of all sizes and specialisations within the medical device industry face continual hurdles in achieving approval in their respective markets, necessitating a thorough understanding of diverse international regulations.
In this dynamic environment, the value of external expertise becomes increasingly apparent. Outsourcing, a time and cost-efficient strategy employed in various industries, enables companies, particularly smaller ones, to concentrate on their core competencies while entrusting specialised yet time-intensive tasks to the experts.
In this blog I sheds light on the advantages of partnering with a regulatory affairs consultant delving into the expansive role a consultant can play throughout the approval process, the economic benefits of such a partnership, and the distinct expertise that a Deviceology consultant brings to your enterprise.
The Role of Regulatory Affairs in Medical Device Development
Many medical device companies adopt a last-minute approach to regulatory affairs, involving their internal teams or a consultant only at the advanced stages of product development, after key decisions have been made. This approach is akin to ‘checking a box’. They’re prepared to initiate the regulatory submission process, and then they engage the regulatory expert; this isn’t the optimal approach.
Regulatory affairs specialists should be integral throughout the product’s conception, design, development, and submission phases. A strategic approach from the outset, evolving alongside the project’s progression, is crucial. The regulatory consultant needs to be involved early and frequently, focusing on understanding unmet needs, design requirements, initial outputs, indications, and intended use. Tasks for a regulatory consultant engaged early in the process could encompass:
1. Research: Identifying competitors, understanding their products’ functionalities, and their indications and intended uses.
2. Positioning & Strategy: Establishing how this new product will be distinguished from a regulatory standpoint.
3. Conceptualisation & Design: Setting guidelines to ensure regulatory compliance, process cost-efficiency, and optimal outcomes. Formulating the regulatory plan.
4. Development Process: Determining the necessary verification and/or validation tests for a seamless regulatory submission process. Establishing equivalence if that forms part of the market access strategy.
5. Submission & Compliance Assurance: Preparing the required documentation for final regulatory submission and managing communications with regulatory bodies. Keeping abreast of recent regulatory changes.
Understanding the role of a regulatory affairs consultant is essential: they can either manage the regulatory affairs and compliance obligations from end to end or supplement and support the internal team. Their involvement isn’t limited to replacing an existing internal regulatory team; instead, it focuses on enhancing and assisting the team’s efforts. Whether a company needs comprehensive assistance or support in specific areas of the regulatory process, engaging a skilled consultant from the outset proves to be a strategically effective approach.
How a Regulatory Affairs Consultant Minimises Risk and Saves Costs
The above list is a simple overview of the regulatory affairs and compliance process and doesn’t cover all the variances unique to different companies, teams and markets. Regulatory affairs is a complex field, with ever-changing regulations, presenting numerous potential pitfalls.
Mistakes in this field, especially those made late in the process, can be costly. A misstep, particularly in selecting a regulatory path or in strategic planning, often results in significant developmental delays. Redirecting towards approval can be expensive in terms of time, effort, and financial resources.
The stakes are considerable, but they shouldn’t overwhelm medical device companies. Involving a regulatory affairs consultant early allows them to leverage their expertise at critical decision points, guiding the project towards compliance and approval. Adjusting project strategy just before regulatory submission or switching gears at the last moment can be avoided with an experienced consultant’s foresight and guidance.
The goal is a streamlined path to approval, both in terms of time and cost, while navigating potential pitfalls. A consultant’s broader and deeper experience can keep the internal team informed and proactive regarding regulations and best practices.
What Sets Deviceology’s Approach Apart from Other Regulatory Consultants?
Deviceology’s consultants are equipped to support every aspect of the regulatory affairs process. They possess expertise in both pre- and commercialisation procedures and have a comprehensive understanding of the current regulatory environment. Our consultants complement existing resources fitting into the product development cycle as needed.
Engagement duration and team composition are tailored to each project’s market, scope, and requirements. Some projects may require a single consultant, while others benefit from a more extensive team.
Deviceology’s approach is unique in its emphasis on the regulatory consultant’s role and the integrated, team-based strategy relative to other disciplines. Our methodology ensures that regulatory affairs are a key consideration from the outset. Through hands-on guidance in developing new medical devices, we aim for the most efficient and effective path to market for the company
Deviceology’s solutions are adaptable to diverse business needs, offering a cost-effective way to navigate the complexities and risks of medical device regulatory affairs. Our team is not only equipped to assist in the current regulatory environment but also poised to evolve as the industry and governing bodies do, ensuring your company’s adaptability. Connect with a Deviceology expert consultant today to see how we can help.
