The Rewarding Benefits of Medical Device Consulting

Author: Trinity M Consulting, LLC. |

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In light of COVID-19, the global medical device outsourcing market reached $99.9 billion in 2020. The healthcare and medical device manufacturing industries are constantly growing to meet new demands. Unfortunately, healthcare reform, digital transformation, and other issues can affect medical device sales. Are you struggling through the device design, manufacturing, and sales process? You don't have to navigate the complexities of this process alone. Instead, consider medical device consulting. Consulting with a professional company can help you find the advice and expertise you need. You can address compliance issues and streamline the process with help from an expert. Still on the fence? Here are six rewarding benefits of medical device consulting. By exploring these benefits, you can make a better choice for your business. Read on to learn more!

1. Minimize Potential Risks

As a medical device manufacturing company, you need to prepare for any potential crises ahead. Otherwise, you'll have to deal with:

  • Product recalls
  • FDA warning letters
  • Client complaints

These issues could impact your company's reputation and bottom line. You might struggle to retain clients and grow your business.

Instead, consider hiring a medical device consulting firm. They can help you prepare for a wide range of potential crises. With their help, you'll learn how to respond to any crisis effectively and calmly. Developing a plan will help you avoid:

  • Criminal or civil actions
  • Substantial fines
  • Financial penalties

Otherwise, these issues could lead you to shut down your business. Do you know how to respond after learning your device could cause injuries? Should you inform the FDA? What options do you have? What corrective actions should you take? An experienced medical consultant will help you respond to an FDA audit or warning letter.

You can even take a proactive approach. They'll help you prepare for any potential issues before they happen. Having a plan in place will give you peace of mind.

2. FDA Regulatory Approval

The medical device manufacturing process is full of complications. You'll need to anticipate potential and often costly delays.

Each person who reviews your product is looking for something different. Meanwhile, submission deliverable requirements change constantly. Over 60% of medical devices that entered the market within five years were exempt from FDA approval. About 31% underwent the 510(k) process. Only 1% went through premarketing approval before reaching the market. The cost of submitting for premarket approval is sometimes 10 times higher than the expense of submitting to a 510(k) notification for new devices. Meanwhile, the FDA can order product recalls for devices that pose a health risk. About 2,900 products were recalled in a single year. About 4% of these devices posed a serious health risk. Instead of handling this process alone, consider hiring the best medical device consultant firm. With their help, you'll gain a better understanding of the FDA submission process. They'll help you through 510(k)s or premarket approvals. They'll even develop a regulatory strategy based on your unique needs. With their help, you can save time, money, and minimize stress. Their process could help you develop a faster approval process, too. Your medical device consulting firm can help you with:

  • Software and validation testing
  • Policy and procedural controls
  • Quality agreements
  • Predictive device research

These steps can help you achieve approvals faster. Your consultant will already have the experience and process you need to develop a strategy. They'll help you navigate regulatory meetings, submissions, and the registration process. Look for a medical consultant who has years of experience in the industry. You can learn from their prior experience. They'll help you find a holistic approach. With their help, you can avoid risks, unnecessary costs, and wasting time. Otherwise, a mistake could cost you delays. Meanwhile, you'll need to learn how to navigate learning curves on your own.  You don't have to start from scratch! Instead, you can leverage their existing experience and expertise. They'll streamline the process, improving your bottom line. With their help, you can identify potential mistakes with your process before they occur. Then, you can avoid obstacles and potential downtime. You can set your business up for growth and success. 

3. Expand Your Market

In order to remain competitive, you might want to consider expanding globally this year. Do you want to start reaching businesses in Europe? You'll need to meet your European Community requirements. Only then can you receive the CE Mark before you start selling medical devices in Europe. Hire a medical device consultant who has experience with global markets. They can help you with device classification and ensure you meet the proper requirements. With their help, you can avoid costly mistakes and delays. They'll ensure you expand your market and start reaching new customers.

4. Stay Up-to-Date

Remember, the industry is changing costly. You're busy enough running your business and building your medical devices. Remaining up-to-date with the latest FDA and ISO regulations can add unnecessary stress to your plate. Instead, consider hiring a medical consulting firm. They'll remain up-to-date with the latest regulations for you. You won't have to learn these new rules on your own. Instead, you can rely on your consultant. With their services, you can meet the latest requirements without wasting valuable time.

5. Product Communication

How do you plan on making a case in front of buyers and stakeholders? Do you have the proper documents in hand? Your medical device consultant can help. For example, they can help you gather research reports, case studies, and literature reviews. You can outsource these tasks to save time in your schedule. Meanwhile, you'll have peace of mind knowing the content is error-free. With help from an expert, you can attract new buyers and sell your device in the market!

6. Statistical Analyses

Are you conducting a pre-clinical study or trial? You'll need to make sure your data is accurate and properly interpreted. Then, you can submit your search to a publication. Your consultant can review the data for you. They'll ensure it's verified and validated. Otherwise, you might make a mistake that will impact your company's reputation and credibility.

Eager to get started? We're here to help. Contact us today for a free consultation!



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