As of 2018, the medical device industry was valued at $425.5 billion. Thanks to a compound annual growth rate of 5.4%, it’s expected to be worth $625.7 billion by 2025. This sector is one of the most lucrative industries and has been attracting significant investments in recent years. And a medical device consultant can help with the investment process.
Even though the medical device industry is lucrative, it is also one of the most competitive and has a high failure rate. This is why companies strive to come up with innovations first, to gain a competitive advantage. For medical device manufacturers, the COVID-19 pandemic has presented a unique opportunity. To safeguard staff, students, and customers’ safety, institutions are in dire need of solutions that help disinfect people to prevent the spread of the virus.
As normalcy resumes, businesses are welcoming employees and customers, students are going back to school, and hotels are now reopening. For such institutions with high traffic, manual disinfection processes are inefficient. This is why there is a great need for solutions that can help institutions sanitize many people at a go and quickly.
One such solution that is ideal for schools and hotels is the use of ultraviolet disinfecting lights. With the US Food and Drug Administration (FDA) validating ultraviolet radiation as an effective method of disinfection of the COVID-19 virus, institutions are investing heavily in the technology.
As plans to reopen schools continue, there is great urgency to speed up your ultraviolet disinfecting light design and development. One of the best ways to ensure your product is designed, developed, and ready for the market is by working with a medical device consultant.
Do you want to get your products to the market on time? Read on to find out how a medical device partner can assist you.
What Does a Medical Device Consultant Do?
Medical device consultants are individuals or firms that work with manufacturers to simplify and speed up the process of bringing devices to market. Some of the services they offer include:
- Enhancing device design and development
- Advice on suitable regulatory options based on classification and therapeutic area
- Comprehensive research on relevant literature
- Prepare necessary submissions for regulatory approval
- Craft grant proposals for funding
- Analysis of clinical trial data and crafting protocols for clinical trials
- Handles communication with stakeholders via whitepapers, blog articles, website content, etc.
How Can a Medical Device Partner Assist You?
The demand for UV disinfecting lights in schools and hotels is soaring. However, the window to fully capitalize on the demand while it’s at its peak is limited. Therefore, your ultraviolet lighting solutions must be ready for the market as soon as possible. Here’s how a medical device consultant will benefit you:
1. Speedy Approval
The medical device industry is one of the most regulated sectors and with good reason. Before devices are released to the market and branded as solutions to particular medical needs, their capacity to do so must be demonstrated and backed by data from clinical trials. Conducting such trials and demonstrating that a device meets all the regulatory requirements can be long and tedious.
Any delays with getting your UV lighting solutions approved can translate to losing ground to your competitors. With the right consulting partner by your side, you will get crucial support with software and validation testing, quality requirements, validate device research, and support you with policy and procedural controls.
Along with such support, you will also get experience, tried and tested processes of navigating regulatory requirements, and much more. This will expedite the approval process, allowing your UV disinfecting lights for schools and hotels to be available to customers on time.
2. Objectivity
One of the biggest risks of only involving your team in product design and development is that they may develop a bias of achieving something in a particular way. As a result, they will lose objectivity, which is crucial in medical device manufacturing.
When this happens, there are high risks for design and product flaws to go unnoticed. Such flaws can come up during the clinical trial phase, sending you back to the design table. This will translate into wasted time and resources.
With the eyes of a medical device consultant, you’ll not only have someone interested in the success of the device but also one who is not invested in particular design ideas. Their experience may also help identify areas that could present challenges when seeking approval.
3. Experience and Innovation
However talented your team may be, there is no substitute for experience. This is especially so when it comes to medical device manufacturing. It’s not just about designing and developing a device that’s effective but also one that will be approved.
Though getting a medical device approved is a rigorous process, it is often so because of minor issues that are not easy to spot early on. Medical device consultants have years of experience under their belt from which they picked up unique solutions to common challenges. Having one on your team will allow you to capitalize on invaluable experience.
4. Product Communication
Getting approval is challenging. However, it’s after getting approved that the most important work begins. You need to organize a product launch to showcase your UV light disinfectants to buyers and stakeholders. This is where you need to make a compelling case for your products.
To achieve this, you will need several documents that will help back your claims. These include a literature review, case studies, and research reports, among others. A medical device consultant will prepare all these documents for you. This way, you can rest assured that they will contain the necessary data, and your team will be free to focus on other matters.
Are Medical Device Consultants Worth It?
For medical device manufacturers, getting to the market first or second can translate to a difference of millions of dollars in revenues. Considering that the demand for UV light disinfectants is at its highest, there is a great need to have your products ready for schools.
Do you want to speed up your medical device design, development, and approval process? C3 Medical Device Consulting offers a wide range of services to help you get products to market faster. Schedule a free consultation to find out more about our services.
