With implementation of TVT in its quality assurance department, New World Medical is achieving significant time savings. It now also plans to roll out the automated proofreading solution from Schlafender Hase across other parts of the company.
Kejdi Tafili, Senior Regulatory Affairs Specialist at New World Medical, manages regulatory aspects of medical device registration and approvals. This includes proofreading labels and other approval documentation, as well as proofreading or verifying changes to SOPs and a wide range of quality-related documents. “The medical devices industry deals with patients who depend on the products we design and build,” he explains. “If an error finds its way into labeling and documentation, it can lead to a product recall – and this is obviously something any company wishes to avoid.”
Until very recently, proofreading was performed using an “old fashioned” approach based on manually proofreading documents item by item, explains Kejdi Tafili. This was time-consuming. Manual proofreading is also fraught with the uncertainty that a mistake may find its way into a document and be overlooked due to human error. “The “old fashioned” proofreading takes many, many hours, and that extends into days when it comes to instructions for use (IFUs) for some of our products,” explains Kejdi Tafili. Invariably, time is also wasted by backtracking and re-checking sections of documents whenever a proofreader takes a necessary break or resumes work on a large document the following day.
Choosing TVT, Text Verification Tool from Schlafender Hase
In late 2022 Kejdi Tafili and his line manager, Senior Global Regulatory Affairs Manager Victor Arellano, began seriously considering alternatives to manual proofreading. Kejdi Tafili contacted Schlafender Hase and after speaking to the Schlafender Hase team, a demo version of TVT was provided to New World Medical. At the same time, New World Medical was also aware of competitor solutions. At least one member of the Regulatory Affairs team had already had experience with a competitor solution. Clearly, automated proofreading offered many advantages over manual approaches. Now, the only question was which software to choose.
A New World Medical team of eight users put TVT through its paces over a two-month period, rigorously weighing up the advantages against competitors. Regulatory Affairs at New World Medical was especially interested in a solution that could be installed on a user’s desktop, as it didn’t want to be reliant on the cloud. During this trial period, users found that, in addition to its powerful capabilities to verify text, TVT had the edge over competitors in terms of verifying images and artwork. Another factor that made TVT very attractive for New World Medical was the validation package offered by Schlafender Hase. This supported the company with its overriding priority: compliance and quality assurance.
By the end of the trial, the team was convinced that TVT was the best solution, and New World Medical took the decision to go ahead with implementation . “Our intention had been to really find the perfect automated proofreading solution for our company, and once we did, we wanted to move forward as quickly as possible so we can really save resources and improve time management for our proofreaders,” Kejdi Tafili says. “Schlafender Hase was very thorough in explaining how TVT works, including any technical aspects, and worked closely with our technical staff.”
Kejdi Tafili and Victor Arellano also had the opportunity to meet the Schlafender Hase team in person at a Regulatory Affairs Professionals Society (RAPS) event. Kejdi Tafili got to know the team better, and developed a feel for the people behind TVT and the tool itself.
Implementation and expansion into new countries and regions
New World Medical is currently implementing TVT, including TVT Artwork and TVT Spelling modules. As part of the implementation, users of TVT benefit from online training, and experts at Schlafender Hase are on-hand to individually guide users whenever they wish to follow up personally.
Initial rollout is in the quality assurance department. In the coming months, New World Medical plans to extend the use case to regulatory affairs and translations in order to maximize the benefits of TVT. The fact that TVT can compare any two documents, regardless of the respective document formats or size, was a further reason for choosing the solution from Schlafender Hase. Just one of the many ways in which New World Medical intends to use TVT, explains Kejdi Tafili, is to verify SOPs and other large quality documentation. But he also anticipates TVT being very useful for comparing updated company-external documents in order to identify all changes, such as updated regulatory documents issued by health authorities.
Given New World Medical’s presence in 88 countries, verifying documents in different languages will be a very high priority, and TVT’s ability to detect deviations regardless of language or characters – including right to left reading languages – is expected to bring new efficiencies.
“TVT will really help us in our current expansion into more countries and regions, especially for verifying IFUs in multiple languages.” Kejdi Tafili explains
By automating proofreading in quality assurance, Kejdi Tafili expects the team to save days proofreading, and he and his department will be able to devote more time to medical device registrations and company expansion in markets. That means better health services, while allowing developing countries in particular to benefit more from products designed and manufactured by New World Medical.
About New World Medical
Founded over 30 years ago, New World Medical is a medical devices provider with headquarters in Rancho Cucamonga, USA. It specializes in the design and manufacture of innovative surgical devices to alleviate the suffering of glaucoma patients. Its products are distributed worldwide. New World Medical has a strong commitment to improving health globally. It donates 10% of annual profits to promote screening and surgical skills transfer in the developing world. As with all medical device manufacturers, regulatory compliance is crucial to its profitability, market presence and reputation for quality products.