Ever since the boon of the healthcare industry as one of the largest industries in the world market, multiple medical device companies have been designing and developing devices that are enhancing human lives. However, considering that healthcare is one of the highly regulated industries, it doesn’t come as a surprise that medical device companies often need guidance on how to get through the various regulations of different countries. We will further explain the roles and responsibilities of a Regulatory Affairs Consultant and since this is an important role we would shed some light on how to select a Consultant that is right for you.

What is the role of a regulatory affairs consultant?

Regulatory affairs consultants help healthcare organizations adhere to regulatory requirements and their role is very critical in bringing new devices to the market and maintaining compliance for the ones on the market. Typically, they advise senior management and assist in the development of processes and programs to ensure organization-wide compliance with regulations and standards applicable to the product developed by the organization.

A regulatory professional aids in the review of device labeling, promotional materials, batch records, specification documents, risk analysis, usability, clinical, or test reports to make sure they are all in compliance with all applicable regulations and standards. A lot of the time they provide assistance to project teams on premarket approvals, regulatory requirements, labeling requirements, and clinical trial compliance requirements. Aside from that, they figure out what kinds of regulatory filings or internal paperwork are essential in instances like planned device modifications or new labeling requirements. Typical job duties include the following:

  • Explain the rules, policies, or procedures
  • Ensure that regulations are followed
  • Provide regulatory and compliance advice to others
  • Conduct a technical review of data or reports
  • Organize regulatory documentation efforts
  • Recognize and interpret pertinent regulatory guidelines

Regulatory Consultants and Outsourcing:

The following have a big influence on the outsourcing of several regulatory deliverables: 

  1. Regulatory compliance challenges like always changing regulations, new and updated guidelines, and modified standards
  2. Digital transformation where teams from different locations can collaborate and work together effectively 
  3. Practical feasibility, where the involvement of not just the Advisors but also an Executor or a team of Executors is needed to translate a strategy or advice into measurable output
  4. A need for cost savings to be implemented in certain areas because of the huge cost investment in research and development and clinical trials
  5. The focus of medical device companies, especially the start-ups or mid-sized companies, should be their core technology development and R&D, and regulations are often a distraction that comes with a long learning curve
  6. Even though a medical device company may have employees who might be from a biomedical background, learning about regulatory requirements and compliance during the development phase or while attempting to meet the post-market requirements, can be an arduous task 
  7. Medical device companies neither can spend the time nor the money in an iterative process and things need to be done correctly in one go

Given all the aforementioned factors, it’s no surprise that medical device companies are increasingly seeking advice from experts and looking to outsource the execution of several regulatory deliverables or submissions to companies like Elexes.

There is no doubt that outsourcing to a Regulatory Consultant can benefit the companies, however, it is fundamental for medical device companies to know what kind of Regulatory Consultants they should be working with. This brings us to a simple but yet critical question:

How to select your next Regulatory Consultant and what are the advantages of outsourcing?

Knowledge base: 

The Regulatory Consultant must have a good knowledge base, which means they should be aware of the regulations and policies of countries that are potential markets for medical devices. Moreover, they should be well acquainted and must keep abreast with the latest updates and amendments made to international standards like recently the MDR, IVDR, Software regulations, etc. The Regulatory Consultant should be able to tailor the quickest and safest way to the market for a medical device company leveraging their knowledge base.

Willingness and promptness: 

Medical device development is a challenging task with many unpredictable twists that can lead to significant delays. In order to achieve a big goal, collaboration and communication are key. Having a team that is prompt in responding to all your questions and is willing to provide the most feasible and practical solutions in a short period of time is of the essence.

An organization that is system-dependent: 

While there might be many Regulatory Consultants that can assist companies in bringing their devices to the market, it is beneficial to know whether the consulting firm has a robust system using which they can formulate the right plans and procedures to attain compliance. Depending on a reliable system, which is constantly updated and revised, is efficient not only for them as consultants but primarily for the medical device companies who are their clients.

A mix of Advisors and Executors: 

Select a company that can provide both Advisors and Executors. Instead of having multiple Leaders or Advisors, it is wise to have an Industry and Device Expert as an Advisor who shall work on strategy with the Stakeholders or can be in house Director or VP level personnel who can provide the overall approach and set standards, accountabilities, and chain of command. While the execution can be performed by a dedicated team. It is not just sufficient to give advice, but it is all the more vital to translate the given advice into executable action items and walk the talk. Now, more than ever the medical device industry has realized the importance of execution rather than mere planning and is hence realizing the importance of executors along with the Advisors. Splitting Advisory and Execution, gives companies a huge cost advantage and yet the required output. It is essential to know that there should be multiple executors, coordinators, and timeline managers in contrast to just one or two Advisors who shall primarily only provide expert inputs.

Everything under one roof: 

When selecting a regulatory consulting firm, it is of interest to consider if they have knowledge and experience with markets across the world. Involving such a Consultant can significantly help reduce the efforts for getting a medical device company to various other markets, as from the beginning the Consultant can leverage their experience and build systems that are internationally accepted.

Today, the involvement of regulatory consultants is crucial, not only from the perspective of marketing your medical device but also from a business standpoint where you maintain your company’s reputation by establishing compliance at the post-market stage. Companies can no longer be restricted to only one market. With competitiveness on the rise, it’s valuable for medical device companies to diversify their business and explore both domestic and international markets. Partner with the right Consultants, integrate them into your team and avoid potential pitfalls and help in expediting the journey of a new product to the market and maintain compliance with the ones on the market.  

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