January 20, 2021
At some point, medical device companies will have to handle customer complaints. The countless numbers of forms and requirements in the medical device industry can overwhelm even the most talented Quality Assurance teams. It is far too common for complaint forms to be returned by the FDA or CAPA as incomplete due to improper documentation of evidence and use-case formatting.
In today’s digital age your company can be receiving complaints from several different sources, even social media (3%). In fact, in a survey conducted by Compliance Alliance, some of the most common complaints were the inability to capture sufficient information about the event that led to the complaint, as well as obtaining details from the user or customer.
Even contacting to create a complaint can go in numerous directions: only 40% of people contact a designated number, 32% contact a field service representative, and 25% contact the main number of the medical device firm. We can now see how many different obstacles can exist in ensuring that information can be captured in a fruitful way.
Using Natural Language Processing (NLP) can help streamline these processes and eliminate the many sources of human-error that can exist when capturing information and completing the appropriate formats and studies needed to have a successful complaint report.
The digitization of information is here and is commonly used; even government agencies require reports to be sent electronically. It is estimated that the complaint management industry will have a bigger role in the years to come, as more medical devices become digital and the standards for submitting mandatory FDA/CAPA reports increase. In fact, a study in 2019 projected that the industry is set to grow 7.6% annually in the next 5 years – and that priority has likely only grown with the COVID-19 pandemic.
There has not been a more critical time to have a streamlined format to capture, retrieve, complete, and quantify information. NLP solutions such as Tali allow for your team to do just that. Using an NLP solution can allow your team to have an assistant that knows exactly what form and evidence to capture in order to have a successful complaint report. This means that your Quality Assurance team can complete complaints in a timely manner, be notified of similar complaints over time, avoid product recalls or further device errors that can cost a medical device company millions of dollars in lawsuits. Using an NLP solution for your complaint handling department can also become a management analytics oversight tool that can streamline complaints across different legislations such as EU, FDA, Health Canada, and more. Harnessing the ability to have a mass of manuals and forms easily accessed is as simple as asking: “Tali, what is the proper form and evidence I need to file a complaint about my product #83450 in Canada? Please help me complete the form with the complaint from my email”