Consultant presenting business analysis results

How To Choose the Right Consultant for Your Medical Device

by | Oct 31, 2020 | Blog posts

Choosing the right consultancy is a cumbersome task for any medical device organization. However, the right consultant will make up for it with valuable information.

Experience of relevant consultants can help you with regulatory compliance, device design optimization and development, testing, and accessing the market quicker.

Nowadays, there is a wide variety of medical device consulting and manufacturing service companies, large and small, with a diversified set of offerings. This article helps answer some of the most important questions when selecting the right medical device consultant.

Here is what this article covers:

What Does a Medical Device Consultant Do?

A medical device consultant provides research, product development, regulatory services, and recommendations on a variety of other relevant areas.

A medical device consultant can guide you through several areas within medical device development and regulatory compliance.

Consultants can help you implement a medical device QMS software solution, choose the best pathway for regulatory compliance, improve the quality of your core processes, and create long-lasting value.

Typically, consultants have expertise in areas such as:

Tips on Selecting the Right Consultant

Choosing the right consultant depends on several factors – project goals, company size, geographic location, budget, and more.

Ultimately, you want to pick the consultant that matches your needs the best. Here are some questions to ask yourself and things to keep in mind when selecting the right medical device consultant.

1. Decide if You Want To Work With a Consultancy or an Individual Consultant

If you decide to work with an individual consultant then you will need to do the due diligence of finding, evaluating, and choosing the right expert.

On the other hand, if you choose a consulting company, then the firm will likely assign one or more relevant consultants for you.

2. Identify Why You Need a Medical Device Consultant

Whether you hire an independent consultant or a medical device consultancy firm, you will want to be as specific as possible to match the competencies of the consultant to your needs. To find the right expert, define the project requirements, and ask yourself, “What needs to be done?”

Here are some of the most typical services medical device consultants offer:


  • Improving medical device design and product development process
  • Analyzing clinical trial data analysis and writing clinical trial protocols
  • Researching relevant literature to guide product development action plan
  • Choosing the best FDA regulatory pathway for compliance, based on your device classification, intended use, and therapeutic area
  • Preparing submissions for regulatory approval
  • Working with Marketing and Communication

At this stage, you also want to have a clearly defined project scope with outlined roles, deliverables, and timeline of the project.

The defined project scope will allow you to get the most out of the interview process and it will be useful during the design of the final consulting contract.

3. Does the Consultant’s Area of Expertise Match Your Project Goal?

The level of expertise for consultants can vary greatly, and typically the value that can be provided by the consultant drops once they get out of their area of expertise. Thus, you want to make sure that the consultant’s area of expertise matches the requirements of your project.

For example, a consultant might know all aspects of design controls or medical device complaint handling processes, but only has experience with orthopedic implants. However, you are trying to bring the new cardiac device to the market.

Although some processes might be similar both orthopedic implants and cardiac devices bring unique challenges.

Therefore, a consultant that is highly familiar with your industry and a specific product category, will be more likely to improve the overall quality of the project and take less amount of time to achieve those results.

4. Has the Consultant Worked With Your eQMS?

Whether or not the consultant has experience working with your current eQMS software should not be the most important factor when making the final decision.

Although, training your consultant on how to use your eQMS solution would only require you to invest more resources, making the real costs for the consultant even higher.

If the consultants have prior experience with your QMS software solution, they could also help you implement the best practices so that you could reap all the benefits of your eQMS.

5. Does the Consultant Have Experience With Similar Clients?

Smaller companies operate differently than larger companies. By nature, small companies, including medical device startups must be agile, which pushes them towards greater risks due to limited funding.

On the other hand, established companies have mature and advanced systems, which startups cannot implement so easily.

Consultants who worked in large medical device companies before providing independent consulting services may find it challenging to work with smaller companies.

At the same time, consultants who only have experience with smaller medical device companies might struggle with project deliverables for a large firm.

Therefore, make sure that the consultant has experience with companies of your size, so you can achieve the desired project outcome while using resources wisely.

6. Does the Consultant Work in a Favorable Geographical Location?

It is also important to consider the geographic location of the consultant. Especially if your project involves a consultant working at your location.

The consultant’s primary location might also be relevant when it comes to understanding local market conditions and requirements.

However, if your projects allow for remote work, then you should consider taking advantage of a wider talent selection. If you choose to work with a consultant remotely, project management might prove more challenging.

7. Interview the Consultants

Interviewing is an essential part of the selection process. During the interview, the consultant should be focused on the project scope and ask relevant questions about the project and the company.

Don’t just interview the consultancy’s owner or a lead consultant. Check the career background of each consultants’ team member, if possible. It might also be beneficial to include another person from your team who is highly knowledgeable of the subject, to challenge the expertise of the candidates.

8. Ask for References

Consultant’s references from past clients for whom they have done similar work is another way to ensure that the consultant is known for a high-quality service.

Make sure to check multiple references, not just one or two before making the final decision.

Bear in mind, that typically, consultants feature those clients that have a higher likelihood of giving a positive reference.

Therefore, consider connecting with some of the previous clients that are not listed as references and ask how it was to work with the consultant.

9. Pay Attention To Consultant’s Fees

At the end of the selection process, you want several consultants and/or consulting firms bidding for your project.

However, the total costs should not be the only determining factor when making the final decision. At the end of the day, the most important aspect is to get the highest possible value for your investment.

Low prices for consultancy may translate to high incurred costs later on. Therefore, choose a company that will deliver quality work even if you will have to pay more for it.

10. Does the Consultant Provide Other Services or Has an Established Network?

You might hire a consultant specifically for the upcoming FDA audit or seek help to get your medical device CE marked. Nevertheless, after the project completion, you don’t want to forget that the consultant exists and go searching for a new one whenever you have another project.

The consultant spent the time getting to know your company and the medical device you produce.

Therefore, you should consider what other useful competencies might be the consultant able to provide.

Besides, a consultant’s network is another asset you could benefit from. This is the case for consulting firms and especially for independent consultants.

Over the course of their careers, many consultants have probably worked with quite a few experts with different sets of skills. For this reason, you could benefit by choosing a medical device consultant that also has an established professional network.

This would allow you to easily get access to a particular expert you might need in future projects.

Role of the Consultant

Lastly, before you go ahead and hire a consultant, it is important to understand the consultant’s role.

The main reason why you would want to hire a medical device consultant is to provide you with valid and reliable information.

This way, a medical device consultant can supplement your knowledge and help you make better, more informed decisions.

At the end of the day, you must remember that the consultant is not a substitute for your responsibility. Therefore, you cannot solely rely on everything the consultants say.

Lists of Medical Device Consulting Firms

By now, you know that finding the right consultant for your medical device organization is not an easy task.

Fortunately, we have researched, and selected consulting firms located in different countries with experienced professionals in their respective specializations.

We included small to medium-sized consultancies specializing within areas such as Quality Assurance and Regulatory Affairs, as well as some other niche experts.

Access lists of medical device consultancies from different countries:

Final Thoughts

Many, small- to medium-sized medical device companies have great concepts.

However, they lack the experience and expertise in areas like Quality Assurance, Regulatory Affairs, Device Development, and others. Some of these tasks are usually outsourced to medical device consultants with expertise in such fields.

Although the best consultant will differ based on your specific needs, the article outlines some of the most important things you should be taking into consideration when selecting the right consultant for your medical device company.

Lastly, you have to understand that you should not entirely rely on the consultant, instead use the consultants to add to your knowledge and as a result make better decisions.

eQMS Business Case Template

Illustration of eQMS Business Case Template