With the coronavirus pandemic, Brexit and the upcoming introduction of new EU regulations, it appears hiring medical device consultants may be more critical than ever in 2021. Ramya Sriram, senior content marketing manager at Kolabtree – a leading platform for hiring experts on demand – discusses the best way to go about doing this.


Medical device consultants provide a wealth of benefits for small medtech businesses that need to take an agile approach to scaling up.

The medtech industry is dominated by small businesses: in Europe alone, 95% of the sector is dominated by SMEs.

The industry is innovating rapidly, introducing products that promise a better quality of life, advanced diagnoses and improved patient outcomes.

However, many small firms need external support for navigating the complex journey to market – which involves several challenges including regulatory compliance, clinical evaluation and literature searches.

Thanks to the freelance revolution, it is now easier for companies to hire a medical device consultant on demand.


What do medical device consultants do?

A medical device consultant works either independently or as part of a consulting firm.

Medical device consultants work with manufacturers to advise on a range of areas that simplify the process of bringing a device to market.

Senior medical device consultants are typically experienced professionals with 15-20 years of experience in several areas of medical device development and compliance.

However, early career researchers and experts are also able to advise on aspects such as clinical trials and biostatistics.

For example, a regulatory affairs consultant can help you choose the best US FDA pathway for regulatory compliance, based on your device classification, intended use and therapeutic area.

A literature search freelance expert can help you study all the existing relevant literature which will guide your product development roadmap.

It is essential that you pick the right expert for your project who can deliver confidently – but how do you decide who the best candidate is for your needs?

Here are some tips that ensure you pick the right candidate for the job.


Why do you need medical device consultants?

You may need the help of a consultant or freelancer at several stages of your medical device development pipeline.

As medical devices are heavily regulated, and the route to market is typically long and complicated, hiring an expert helps you reduce the chances of your device being rejected.

Thanks to the growing remote work culture, qualified and experienced experts are making themselves available for consulting projects to businesses of all sizes. Some of the services medical device consultants offer are:

  • Optimising medical device design and development
  • Advising the best regulatory pathway depending on classification and therapeutic area
  • Preparing submissions for regulatory approval like FDA 510(k) or CERs for MDR
  • Carrying out comprehensive literature searches
  • Analysing clinical trial data and writing clinical trial protocols
  • Writing grant proposals to funding bodies like the NIH SBIR programme
  • Communicating the product to stakeholders via high-authority website content, such as blog articles, PR or white papers


Companies now have easy access to medical device consultants for hire, which enables them to ensure their product is safe, backed by reliable data, and in line with country-specific guidelines.


How much do medical consulting services cost?

Going by jobs posted on Glassdoor, the salary of a medical device consultant roughly averages $60,000 per year.

Many small businesses may not be able to afford to pay their staff this kind of salary, especially if they don’t have a year-round need.

A company on Glassdoor lists its starting salary for orthopaedic medical device consultants as $79,000.

Hiring an experienced and qualified expert is a valuable investment, which promises rewarding returns and reduces the risk of product recall.

The cost of hiring a freelance biomedical engineer or contractor depends on the kind of job you need to get done, and final deliverables expected from the freelancer.

A freelance regulatory writer, for example, may charge anywhere between $300 and $5,000 to prepare a regulatory document – depending on whether you need the full document or specific sections of it.

On Kolabtree, clients have hired clinical evaluation report writers to create a CER from scratch, but you can also work with a biostatistician who can verify the clinical data in the report.

Data from Kolabtree shows that hiring a freelance medical device consultant can save costs of up to 40%.


How to write a job post for medical device consultants

Writing a clear job post is one of the most important aspects of hiring the best suited candidate.

If you have a clear expectation, budget and timeline in mind, that’s half the job done for you. Here is a five-step approach to creating a job post for a medical device consultant:


1. Project description or scope of work

Provide a clear brief that defines what you’re looking to get done.

Include deliverables required, the scope of work, and mention any specific skills that you require the expert to have.

If you need statistical analysis done using the programming language ‘R’, mention it in the job posting.

You can also request for experience in a specific domain. For example, if you are hiring an FDA 510(k) submissions consultant, you might want to check if they’ve worked on similar applications in the past and what their success rate has been like.

Finally, you should always mention what stage of the product cycle your device is at so that freelancers can estimate the work required, especially if you’re looking for help with regulatory compliance.


2. Project duration

Define how long you expect the project to take, and whether you’re in a hurry to hire someone or willing to wait.

This will help freelancers understand whether they have the bandwidth and availability to take up your project.

Most clients receive quotes within 24 hours of posting their project on Kolabtree.


3. Budget

Set an approximate fee range for the project and, if it’s negotiable, mention it in your project.

You can choose whether you want to pay per project or per hour, based on your scope of work and how well-defined the project is.

Medical writers can charge between $40 and $60 per hour, while medical device product design consultants can charge $300 per hour for complex projects.


4. Expertise required

Depending on the requirement, you may need to hire a specific kind of consultant like a product development consultant, a regulatory compliance consultant or an experienced medical writer.

You might also want to work with an expert specialised in a specific therapy area, such as a cardiology researcher or a neuroscientist.


5. Privacy

While hiring a consultant or freelancer, make sure that you do not compromise on the confidentiality of your project.

Kolabtree allows you to restrict visibility of your project and personally handpick freelancers whom you’d like to get quotes from.

You can share non-disclosure agreements (NDAs) and custom agreements with freelancers even before you disclose your project details, making it easy and painless for you to maintain confidentiality.


Example job description for freelance medical device consultants

If you’re looking for FDA submission support, your sample job post may look like the following:

“Class II medical device company looking for an experienced regulatory consultant to prepare a 510(k) submission for FDA clearance. We need a freelancer to get started as soon as possible and finish the project in three months. Further details will be disclosed once the freelancer signs an NDA.”

Alternatively, if you’re looking for a medical content writer, you may say:

“I have a Class III medical device that’s about to be launched in the market. Looking for scientific writers with a background in cardiology, who can write medically-accurate, compelling copy for our blog and PR material, communicating the launch to all our stakeholders. We need six blog articles in total and two press releases. Please upload samples of your work when you apply for the project. The budget is flexible, I’m open to negotiation.”

Outsourcing can also help you focus on activities that grow your business, such as streamlining operations or launching new products.

By working with experts, you can reduce time to market and launch a safe, effective and compliant product with confidence.