Selecting and working with medtech regulatory approval consultants

Wendy Levine
July 14, 2023
Selecting and working with medtech regulatory approval consultants

Medical device organizations often use consultants to assist with regulatory approval projects. Regulatory consultants, however, have a wide variety of experiences and capabilities, and can add value to many types of regulatory projects. It is important to find a consultant that not only has the expertise to work on the project you need assistance with, but is also the right match for your team and your organization. 

Selection criteria

Using a combination of referrals and research, you should be able to develop a short list of consultants that you would like to further evaluate. Consultants that have worked on similar projects or with similar organizations should be at the top of your list. Before you finalize that short list, however, and as you prepare to talk to consultants about potentially engaging with your organization, put together a requirements list that includes your needs in the following areas.

  • Experience with similar organizations - The more closely a consultant’s specific experience matches your organization, the more quickly they will be able to add value to your project. Ask how much experience they have working with organizations your size and in your country, as well as experience in the countries in which you are marketing products.
  • Regulatory expertise – The type of project will dictate the specific regulatory expertise your consultant needs. For example, are you looking for a consultant with experience bringing a product to market in a specific country, experience addressing a particular quality issue, or expertise with a particular RIM or eQMS system?
  • Size and scope - Regulatory consultants vary in size ranging from large, international organizations to smaller firms to single, independent consultants. There are advantages and disadvantages to working with consultants in each of these categories. For example, a large organization will be able to provide a wide range of services and experts but may come with higher administrative costs and hourly rates. Smaller consulting firms can often offer a more tailored and flexible approach.
  • Cost – When discussing costs, be sure to look at the expected overall project cost. While larger firms may have higher average hourly rates, they may also provide less-experienced consultants for some project tasks. Smaller firms may offer more flexible payment terms and be more willing to negotiate rates and fees.
  • Communication style – Discuss the methods and timing for communication with the consultant and ensure that they match your expectations.

To ensure a good match between your organization and a regulatory consultant, evaluate team capabilities and discuss any additional expectations you will have for the consultant with your executive sponsors and management team. Ultimately, the best way to ensure a good match is to talk with other organizations that have used the consultant for similar projects.

Contractors vs Consultants  

Contractors are similar to consultants but are more often used to fill the gap between the resources you have and the resources you need to stay on top of all regulatory activities within your organization. Contractors perform work that is assigned to them and they are not typically expected to manage projects, while consultants are most often hired on a project basis and are expected to bring their unique expertise to your project.

Getting the most out of the relationship with your regulatory consultant

Your organization will benefit more from a consultant if you actively manage the relationship by:

  • Taking advantage of the consultant’s expertise – Don't miss the opportunity to learn from your consultant and consider giving them some leeway to point out issues they see that might be beyond the scope of the existing project.
  • Maximizing your consultant's time – Clearly identify expectations with the consultant to ensure that they are spending time where they can add the most value and help you achieve the project’s goals as quickly as possible.
  • Timing your consulting engagements – In many cases, a good regulatory consultant will be able to provide the greatest value when they work with you from the start of the project.
  • Resources for the consultant – Regulatory consultants will need access to data, information, and systems - appropriate to their work on your project. Establishing access ahead of time can provide a smoother transition for the consultant and ensures that proper security procedures are followed.

Engagement types

The project scope and objectives will help you to define the type of consultant engagement. Types of consulting agreements include:

  • Fixed projects – Fixed projects may be billed hourly or on a project basis, but typically have built-in payment milestones. Fixed projects will have a specific end goal that is easily defined and measured.
  • Advisory engagements – Also referred to as “open-ended” agreements, advisory engagements allow you to access consultant resources and expertise on an as-needed basis. While somewhat open, these types of engagements should include caps on cost and an end date.
  • Resource augmentation – When your regulatory team isn’t large enough to handle the current workload, consultants or contractors can be used to augment your existing capabilities. These agreements are usually very specific in terms of the services provided and you should still carefully define the consultant’s role and scope of work.

If you are working with a regulatory consultant on a RIM selection project, read more about selecting a RIM system for your medical device company.

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