Bringing a new medical device to market is not an easy process. To get this far, you’ve already made a significant investment in time and resources, and you still have a lot more work to do before you’re ready to launch.
The red tape you’ll have to get through is intimidating, and you need someone with experience to help you get through it without wasting resources and time that you don’t have to spare. You’re still engineering your new device, but now it’s time to start getting your systems up to snuff so you can pass inspection.
There are tons of medical device consulting services out there that can help you navigate all of the upcoming hurdles — but is hiring one a good choice for your company?
To help you make an informed decision, we’re going to explore the pros and cons of hiring a medical device consulting service.
Medical Device Consulting Services: The Pros and Cons
If you’re not yet ready for a full-time Quality Assurance (QA) or Regulatory Affairs (RA) staff member, then outsourcing to a medical device consulting firm can be a great choice. Many quality management consulting firms have a wide range of expertise from development through commercialization for the medical device, pharmaceutical, and biotechnical industries.
Medical device consulting companies can help you develop phase-appropriate Quality Management Systems (QMS) that comply with up-to-date regulations, guidelines, and standards. They can also help you avoid the pitfalls of implementing too much too fast.
However, there are tons of consulting firms out there, and many of them aren’t worth the paper their resume is printed on. Finding the best FDA consultant for medical devices can be a real challenge. Before you move forward, it’s important to understand the pros and cons of hiring a consultant.
Pro 1: Speedy Approval
The testing of medical devices to determine if they meet the standards of the various regulatory agencies can be grueling. The right consulting company can help you with software and validation testing, policy and procedural controls, quality agreements, and even predicate device research.
You'll get approval faster when you have an experienced consultant that understands what you need and how to navigate you through it. They have experience and existing processes built around strategy development, regulatory meetings, submissions, registration, and more.
Instead of having to learn everything from scratch and reinvent the wheel, you can lean on their expertise and proven processes to navigate the process much faster than you would be able to alone.
Pro 2: Compressing Time
Consultants come with all the necessary tools that you need to meet compliance requirements. They can offer a holistic approach designed to meet compliance requirements in less time while reducing risks and costs.
You will be able to leverage the consultant’s prior experience and knowledge to overcome obstacles faster without the lengthy learning curves that a novice on your team would have to work through.
Professional consultants know where slowdowns and potential mistakes are likely to occur in your processes. They can help you head those off before they slow you down or cause you to make costly errors.
Pro 3: Up-to-Date Knowledge
You have a lot on your plate already with a business to run and a new device to build. It will be nearly impossible for you to stay up-to-date on the latest FDA and ISO regulations that might impact your device.
For example, many companies are already having to make adjustments to meet the demands of the new EU medical device regulation timeline that came into force in 2017. Learning all of the new rules can be time-consuming for you and your team.
However, a consultant lives and breathes regulations every day. The success of their business is built upon the success of their clients. Because of this, you can trust a professional consultant to stay abreast of the latest requirements.
Con 1: Overlapping Expertise
Your team may already include people with the expertise that you need. If so, then hiring a consultant would be unnecessary. Before you decide to move forward, take the time to talk with your current team members to see if you already have someone with the right qualifications and experience to help you.
Also, if your device is a low-risk medical device, your requirements will be considerably less stringent. Hiring a consultant may be overkill.
RELATED READING: The 5 Best Medical Device Quality Assurance Training Options
Con 2: Lack of Device Knowledge
If you are developing a brand-new device that nobody has seen before, then it may be challenging to find someone with relevant experience.
You might find that it’s more worthwhile to assign someone on your team to this role, since they have already participated in the market research and development of your device. They will need to get up-to-speed on the FDA and ISO requirements, but that might be easier and more cost-effective than taking the time to educate a consultant on your device.
Con 3: Cost
The cost of hiring a medical device consultant can vary widely based on their experience and qualifications. You may see rates ranging from $75 per hour for a specialist, $250 per hour or more for someone with a broad range of experience, or up to $500 per hour for someone that used to work at the FDA.
Consultants may be costly, but so is your time. To make an informed decision, you have to weigh the cost and time involved with training someone on your team to do the job against hiring a consultant that won’t require that training.
Quality Management Is Essential
Whether you hire a consultant or utilize someone on staff, you still have a lot of hoops to jump through before you can bring your device to market.
With the right tools, you can focus on quality instead of burying yourself in tools, systems, and disconnected data. To help you prepare for the audits to come and build a high-quality device that can survive the rigorous assessments ahead, we’ve compiled some of our best quality-improvement tips into one ebook.
Download your free copy of 7 Things You Can Do Now to Improve Quality in Medical Device Product Development.