The medtech industry is in a constant state of flux. Medical device consultant rates are also subject to change, like everything else in the industry. In 2020, it’s important to be prepared for a successful consulting partnership by understanding the potential costs and benefits of a consultant’s services.

After earning a European CE Mark, CVRx was facing a complex regulatory pathway to FDA approval for its cardiovascular implant product. The medical device startup turned to the consultants at NAMSA to conduct a fast, effective clinical trial for FDA submission.

“We’re very agile, being a small company, but we’re also very dependent on NAMSA to help supplement our small team,” says CVRx Vice President of Global Clinical Research Liz Galle. Hiring consultants to manage a “pivotal” clinical trial helped CVRx achieve time savings and greater cost efficiency.

Consulting costs can vary significantly depending on the complexity of your device and your project goals. This variation means it can be nearly impossible to pinpoint exact costs for the right consultant. However, it's smart to research the average costs of consultants. In addition, let’s examine what your company could gain if a medical device consultant comes through with exceptional value.

Medical Device Consultant Rates: What You'll Pay

Medical device consultant rates for 2020 can range from $75 to $300 per hour, depending on the consultant's education and experience. Most medtech consulting firms charge an average of $150 to $200 per hour, which does not include any costs associated with materials or travel. Hiring a specialist in regulatory or clinical trials is almost always costlier than a generalist consultant.

Experience and expertise are two major factors in determining a MedTech consultant’s rates. A former FDA employee or a lawyer is likely to cost $300 to $500 an hour. However, education and knowledge aren’t the only factors that influence cost. Consultant rates can also vary based on geography, the length of an engagement, and the consultant's specific pricing model.

Related reading: What to Look for in Quality Management Consulting Services (And When You Really Need Them)

A recent industry survey uncovered a surprising amount of variation in how consulting fees are structured. Nearly 36% of consultants bill per hour and 40% offer monthly retainer options. Your consultant may also offer a sliding scale discount to startups. 23% of consultants are willing to offer performance-based pricing.

The right medical device consultant’s rates are a launchpad to value. Partnering with the perfect expert can help you achieve faster time-to-market, resolve compliance woes, or win a competitive advantage. New call-to-action

What You Should Get

A consultant’s experience matters, but it’s not the single most important factor to consider. Value is determined by results, and a consultant's value does not always correlate to the cost.

The best way to hire a valuable consultant is to be honest about your project goals. Verify a potential consultant's experience based on their track record of delivering value on similar projects.

Learn more: Who’s the Best FDA Consultant for Medical Device Manufacturers? (Reviews)

Faster Approval and Time to Market

Speed to market is a critical competitive advantage in the medical device vertical. However, speed is certainly not guaranteed. Bringing a medical device to market in the U.S. takes three to seven years on average.

A consultant can help you achieve faster regulatory approval and time to market, especially if you’re proactive about planning for your device submission. A regulatory strategy can create a clear roadmap for a successful submission.

An experienced medical device consultant can provide support from the earliest product design stage in creating a regulatory strategy that lays out your probable pathway to market approval. Consultants can also speed up results by providing support for clinical trials, compliance audits, or submissions.

Get Regulatory Bodies Off Your Back (Quickly)

The compliance climate for medical device manufacturers is more complex than ever. Falling short of the agency’s requirements can result in a stressful warning or failed audit and a limited amount of time to correct compliance issues. The cost of failing an FDA audit is surprisingly expensive. Non-compliance is a strong indicator of future quality problems, which cost the medical device industry $36 billion each year.

A 483 observation letter about CAPA or purchasing problems is a regulatory headache and a signal of possible quality issues to come. A consultant can help you correct a laundry list of issues on a tight timeline, and ideally, help you get regulatory bodies off your back permanently.

Regulatory remediation services should help your company dig deeper than satisfying compliance requirements to understand weaknesses in your quality management system (QMS). A high-value medical device consultant will approach regulatory issues as an opportunity to make lasting improvements to your quality system.

Related: The 6 Best Medical Device Regulatory Consulting Services

A More Confident (and Happy) Team

Workplace stress is a global epidemic. According to a recent study, some of the most common reasons workers experience debilitating stress include:

  • Job demands
  • Lack of support
  • Unreasonable workload
  • Long hours
  • Insufficient skills
  • Changes to duty
  • Tight deadlines

Workplace stress can have a serious physiological impact on personnel, causing issues such as depression, anxiety, and irritability.

A stressed-out team could also compromise product quality and customer happiness. Stress has a negative impact on performance, quality results, and safety in numerous industries.

A consultant’s fees can be worth every penny if your company is able to minimize employee stress. Hiring a third-party expert to direct your quality assurance or clinical trials can ensure your talent isn’t overwhelmed with excessive work or responsibility. Outsourcing projects which can’t reasonably be handled internally can protect your culture and quality results.

An Advantage Over the Competition

Achieving an advantage in the medical device industry requires manufacturers to be realistic about risks, according to McKinsey. This means defending your organization against competition and remaining flexible. Companies need to be prepared to constantly reevaluate their product business models and make changes to provide safer, more innovative products at lower costs.

Competitive advantage can be easily lost in the hyper-competitive device industry. It can be difficult for startups and scale-ups to recover after common challenges such as compliance woes, product safety issues, or quality problems. A consultant can help you achieve and maintain an advantage by solving these common threats.

Startups and scale-ups need to be realistic about their strengths and weaknesses. The right consultant can address threats to your advantage quickly. Sometimes, the decision to outsource quality assurance or clinical research to an expert instead of handling it in-house is the best way to maintain a market advantage.

Medical Device Consulting Rates in 2020 Aren’t Cheap

It’s easy to get sticker shock when you think about average medical device consultant rates. Just 40 hours of support from a mid-range device consultant can run you $8,000. Consulting rates aren’t cheap, especially if you’re hiring a former FDA inspector or a cybersecurity risk expert.

Consulting rates are an investment, however, and they’re potentially a downright bargain. A quality management consultant could be $3 million cheaper than a preventable product recall down the road. A consultant who can help you achieve faster time-to-market or regulatory compliance could be a valuable investment.

As the first cloud quality management software built specifically for medical device manufacturers with 5-500 employees, Qualio has worked with hundreds of life sciences startups and scale-ups. If you need a recommendation on a medical device consultant, click here to start a conversation today.

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Published by Robert Fenton February 11, 2020
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