The FDA will send out three 483 observation letters today — will one of them be going to you?

The process you have to go through to bring a medical device to market has been around for a long time. From initial design to release into the market, the steps haven’t changed much. However, the regulations that you have to follow to pass each step can change every week.

You have an important job to do. Your device can change lives and it needs to make it to market before your competitors beat you there. But how do you win the game when the rules can change from one week to the next?

Working with a medical device compliance consulting firm could help put you ahead. However, you have to be careful to select the right experienced consultant — not just a smooth talker. We'll show you the questions to ask to make sure you hire the best consultant for your needs.

11 Questions to Ask a Medical Device Compliance Consulting Firm

Risk mitigation and speed to market are critical in the medical device space. You have a lot of work to do and a limited amount of time to get it done before someone else takes over your share in a demanding market.

You don’t have time for regulatory bodies to send you back to the drawing board. You need to get a jump on the DA medical device approval timeline and navigate each hurdle like a seasoned pro.

Fortunately, you don’t have to be a pro to survive the gauntlet. You just need to hire one. Ask these questions to help you narrow down your choices.

1. Have You Helped a Company Pass Our Regulatory Standards?

Regulatory standards can vary drastically for different types of devices and their intended usages. It can be extremely beneficial to you if your consultant has experience with the exact standards that are going to apply to you. Make sure you dig deeper into their answer and ask for more details about how they overcame some of their more challenging roadblocks for their clients. New call-to-action

2. Have You Worked With a Company in Our Industry?

Medical devices are manufactured across a wide array of industries. From cross-industry devices like heart monitors to devices made for specific uses in specific industries like cochlear implants.

If your consultant has experience with your industry, it’s going to be easier for them to understand how your device is going to be used in that field. You’ll spend less time educating them and more time working on moving forward.

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

3. Have You Worked With a Company on Similar Devices?

Sometimes your device might not be that much different from other devices already on the market. If you can find a consultant that has experience with devices that are reasonably similar to yours, that can speed up the learning curve even more.

They’ll already have a deeper understanding of the requirements and hurdles that your device will face and can navigate you through even faster.

4. Have You Worked With a Company in Our Situation?

If you are hiring a consultant for a specific situation, take the time to make sure they have experience. From routine 510(k) approvals to prepping for FDA audits, you need to know that they have a deep understanding of what is going to be required for you to reach success.

5. Have You Worked With our eQMS?

You are facing lots of red tape and challenges on your path to market. Teaching your consultant how to use your eQMS software shouldn’t be another thing on your to-do list.

If they already have experience using your software, they can advise you on best practices to utilize it to the fullest and reach compliance sooner.

While it's best if your consultant knows their way around your quality management software, this isn't a deal-breaker. For smaller companies, ease of use is a must-have feature. Your software should be easy for the consultant to pick up quickly even if they don't have previous experience. The Qualio QMS platform is built for medical device companies with 5-500 employees. Our customers love how easy it is to learn and use. To learn more about what makes Qualio the leader for medical device startups and scale-ups, click here.

6. Have You Worked With Similar-Sized Companies?

Smaller companies are going to function differently than larger companies. You still have the same path to compliance with regulations, but you have a varying amount of resources and capital to work with to get you there.

If you are a small company that needs to be creative with how you allocate staff and budgets, then you need a consultant who knows how to make the most of each asset. Likewise, if you’re a larger company with deeper pockets, they should know how to use your resources wisely to outpace your competitors.

7. Have You Worked With Companies at Our Stage of the Product Lifecycle?

There is a big difference between a company that’s bringing their first device to market and one that has released dozens. If you’re new, you need a consultant that understands your pain points and is willing to take the time to educate you through the regulatory processes.

However, if you’ve already brought several devices to market, you’re likely won't need as much hand-holding. You need a consultant that can jump in and start making things happen to get you to market fast and improve quality standards.

8. What Is Your Success Criteria?

When you hire a consultant, it’s important to keep the big picture in mind. Do you simply need their services to jump through a hoop or two and reach compliance or are you looking for someone that can act more as a strategic partner?

If you want to build a culture of quality that will give you a competitive advantage, then you want a consultant with experience and desire to put quality first across your entire device lifecycle.

9. How Do You Price Your Services?

Price is a very valid question. After all, you need to know what you’re going to have to spend to get results. But, don’t just leave it at that.

It’s more important to make sure that you’re getting the value you need for your investment.

If you have a device that’s going to present unique challenges, you may need to hire that $900/hour consultant to get it to market on time and hit your profit projections. However, if you find someone at a lower price point that you think you can work with and has the experience you need them to have, then go for it.

Make sure that you’re doing your due diligence and choosing a company that will deliver quality work even if that means you pay more for it.

10. How Many Submissions Have You Worked on Recently?

Although it’s important to find a consultant with experience in your industry and type of device, it’s also crucial for them to be up-to-speed on the latest regulatory processes and changes.

The regulations that you’re facing are constantly changing. You need a consultant with the experience to navigate you through them. They should have recent experience that's relevant to you.

11. What Other Services Do You Provide?

Your most pressing need may be to survive an FDA audit or get your device through a premarket disclosure. You obviously want a consultant that can help you with your current needs — but then what?

They’ve spent time getting to know your company and device. What other skills do they bring to the table that could be utilized to help you take your device further and grow your company even more?

You May Need More Than Consulting

Bringing a device to market successfully involves more than just conquering FDA hurdles. You have to encourage consumer confidence and build your brand around quality.

Consumers are excited but wary. They’ve heard stories, read about lawsuits, and will be hesitant to trust that your product will work, especially if their life could quite literally depend on it.

All it takes is one slip-up in your process to ruin everything you’ve built.

Quality has to be at the core of your company if you’re going to truly rise above your competitors and claim your market share. With the right eQMS software and team in place, you can put quality first and get to market faster.

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Published by Robert Fenton January 7, 2020
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