How Much Does Medical Device Regulatory Consulting Cost in 2020?

    How much do medical device regulatory consulting firms charge? That's the first question to ask when trying to answer the bigger question, "Are they worth their fees?"

    One global device manufacturer contracted with Intertek to consult on their product launch and achieved a 50% reduction in time to market while staying in budget. So, consulting partnerships can result in positive outcomes for manufacturers, but only if the initial price is right.

    As you might imagine, the answers to cost and ROI questions depend on a few variables for medical device manufacturers, which we’ll detail below.

    What Do Medical Device Regulatory Consulting Firms Charge in 2020?

    The cost of medical device regulatory consulting services can vary, but typically range between $125-450 per hour. Generally, this service costs at least $1,500 per day, and most consultancies require a minimum engagement, such as five days of service. Rates can vary depending on a number of factors, including the consultant’s expertise and experience, geography, and project goals.

    At Qualio, we’ve worked with a lot of medical device manufacturers, and we’ve learned what a successful consulting partnership looks like.

    Cost isn’t everything, but it’s a big consideration. Qualio specializes in working with medical device startups and scale-ups. We realize that small companies are cost-sensitive, and it’s crucial that any consulting partnership is affordable and leads to a clear ROI.

    Factors That Impact Cost

    The average minimum cost of a consultant with specialized expertise in medical device regulatory affairs is $5,000 to $18,000, assuming the consultancy has a minimum retainer of 40 hours and an hourly rate, which falls into the national average of $125-400 per hour. However, what’s the difference between consultants at the minimum and maximum ends of this range? Numerous factors can impact consultants' cost.

    Learn more in The Pros and Cons of Medical Device Consulting.

    Type of Consultant

    Make sure a regulatory consultant is truly what you need before you pursue help in this area. If you’re trying to develop a regulatory strategy or prepare for an FDA meeting, this may be the right choice. However, if you’re trying to perform QA activities to prepare for an FDA inspection, your use case may support a lower-cost type of consultancy, such as an eQMS expert.

    Geographic Location

    Simple economics can play a role in a consultant’s pricing. If you live in an area where cost-of-living is higher, chances are the costs of most business services is also higher. Competition can have both a positive and negative impact on consultant pricing. If you’re in a remote area with few expert consultants, the local options may charge a premium due to a lack of competition.

    Additional Costs

    A consultant’s cost may include additional charges which vary mostly depending on the nature of your project. This can include costs for onboarding and discovery, software, or a consultant’s travel.

    Pricing Model

    Consultants can offer varying pricing models, which mostly impact the minimum retainer required. The three most common pricing models are:

    • Hourly
    • Project
    • Performance

    A consultant may bill clients for each hour worked by providing an itemized invoice, or require a minimum retainer. Some consultants charge according to project outcomes with a performance-based pricing model. In other cases, some consultancies may offer a lower rate for small business consulting that’s available to startup clients.

    Goal of Consulting Engagement

    The goals of your consulting engagement can have an impact on costs and returns, since they influence the type of expertise and the length of engagement. Some common use cases for a medical device regulatory consultant include:

    • Developing a regulatory strategy
    • Preparing for FDA meetings
    • Developing an FDA submission
    • FDA Registration & listing
    • Quality management and compliance consulting
    • Risk management consulting

    In addition to the goal of the consulting engagement, the complexity of your product will influence cost. For example, preparing an FDA submission for a Class 3 medical device is a much more intensive project than a Class 1 registration.

    Learn more in Who's the Best Medical Device Consultant?

    Length of Engagement

    While you can estimate the cost of a consulting partnership in advance, it’s generally hard to know the precise costs. Most consultants will give you an estimate, and a warning that you could exceed this range, depending on the complexity of your partnership and factors that fall outside the consultant’s expertise, such as a consultant who discovers compliance issues that must be corrected before an FDA meeting.

    The best way to estimate the length of your engagement is to speak with multiple consultants and ask about their success rates on projects similar to your own. How quickly did they accomplish the goals, and how often are they able to complete projects within the cost scope of an initial estimate?

    Experience in Your Industry

    Generally, a consultant’s cost is higher if they have relevant industry experience. Consultants with significant experience in the medical device vertical can command a premium, as can consultants with experience helping many firms prepare for a successful FDA submission. Other types of specialized expertise that lead to higher costs can include a consultant who specializes in software-as-a-device products, combination type products, or consultants who specialize in complex submissions for Class III medical devices.

    Thinking Through ROI

    Regardless of the cost of a regulatory consultant, medical device firms need to be confident about the return on investment. The pressure for a positive ROI is higher when you’re a bootstrapped startup with no extra funds. A failed consulting engagement could be a cost from which your company never recovers.

    An increasing number of consultants use performance-based pricing. According to one recent study, 19 percent of consultants base their costs on project outcomes. Finding a consultancy with a performance-based pricing model can insulate your business against the risks of a poor ROI. In addition to prioritizing consultants with small business or performance-based pricing, be vigilant about background checking potential candidates to make sure their hourly rate is commensurate with experience and proven results.

    Finally, you can reduce the cost of a consulting engagement by making sure you’re prepared to work with someone on strategy or fine-tuning an FDA medical device submission before the project commences. A cloud-based eQMS like Qualio can help you achieve a quality-driven culture and end-to-end transparency, so your consultant has everything they need to help you meet project goals right from the start.

    To learn more about Qualio, click here.