A medical device consultant can provide research, regulatory, communication and product development services, so that you can launch your product in the market with confidence.
[Cover photo credit: Chaotic Moon]
Recent advances in technology and research has accelerated the growth of the medical device industry, which is growing at an unprecedented rate. It is predicted that medical device market will achieve a compound annual growth rate of 4.9% over the coming years, leading to its value to top $200 billion in 2023, according to Fitch Solutions. However, medical devices are heavily regulated. It’s a long and painstaking process to convert a potential idea for a product into a viable medical device that can be launched in the market.
However, as the world also turns to remote working and freelancing, many of the steps involved in the medical device development process are being outsourced to specialist freelancers. According to a recent FlexJobs report, the industry with the maximum number of remote workers is Health & Medicine. And this is not surprising, as many small businesses and startups do not have the resources to hire full-time specialists. Biostatisticians, medical device consultants, freelance medical writers — all of them play a big role in shaping the success of a medtech product.
Here are 3 ways a medical device consultant can help you accelerate time to market.
1. Regulatory writing
Launching a medical product involves meeting several regulatory requirements and getting all the licenses and certifications required to prove the safety and efficacy of your device. Irrespective of which country you live in, you will need to get approval from your local regulatory body such as the FDA or MHRA. Putting together an FDA submission can be a daunting process, especially for someone doing it for the first time.
However, there are experts who specialize in just that, and are able to take on the task of putting together all the documentation in the required format to increase your chances of approval.
A recent paper by Dörr et al., published in Medical Devices, European Medical Writers’ Association, states that:
“Smaller medical device companies such as start-up companies typically have less than 20 employees and may not possess individuals with the skills to clean, analyse, and present data in the required format for regulatory approval or scientific publications, so that this task may fall to the medical writer.
Furthermore, because patient numbers are generally smaller than in drug trials, another interesting aspect of working with devices is that the experienced writer may have the opportunity to dig deeper into the data, look beyond the endpoints and seek out potential interactions.”
Patient anonymization also needs to be upheld across documentation, which is especially tricky in the age of wearable trackers and other devices which can help you easily identify a patient. An article by Raquel Billiones in the journal Medical Writing urges medical writers to take extra measures to make sure that there is no de-anonymisation of patient data. Hiring an expert medical writer can help you ensure patient privacy and safety.
2. Clinical trials and statistical analyses
If you’re conducting a pre-clinical study or a clinical trial, you need to make sure that your data is accurate at all times and is being interpreted correctly. Before submitting the results of your research for approval, or for publication in a journal, you might want to get your data verified and validated. Consulting a medical statistician can help you establish whether the methodology used was correct, and whether your research study was robust enough to give you a reliable outcome.
Take for example, Alandra Medical, a Mexico-based medical device company. They had just finished a preclinical trial to measure the efficacy of their device and were looking for someone to help them verify their results and prepare a report for publication. They hired a Netherlands-based biostatistician on Kolabtree, who conducted a statistical analysis and helped make their data publication-ready. It only took about a week, helping the organization cut across borders and access the expertise they needed at short notice.
3. Product communication
One of the most important things required for the successful launch of a medical device is to have all the documents and communication required for you to make a compelling case to all buyers and stakeholders.
This may involve putting together a set of case studies, a literature review, research reports, and more. Here’s when the skills of a scientific writer or medical writer can help you save time and effort.
For example, Jon Mendelsson, the COO of Chemo Mouthpiece, a medical device company, was looking for an expert to prepare all the documentation he needed for launching his product in the market. He hired an India-based scientific writer, who helped him put together a summary of outcomes, a literature review and a research report that was required for the launch of his product. Jon used the report to effectively position and sell his product in the market.
As highly-qualified scientists and PhDs turn to consulting and freelancing, companies have a growing pool of on-demand talent now available to them. Small businesses can hire experts from anywhere in the world, at a budget of their choice.
From verifying your research results to increasing your chances of getting FDA approval, a medical device consultant can help you accelerate time to market. Need to hire a medical device consultant? Simply post your project on Kolabtree and get quotes from qualified experts.