This article was originally published by Business Barbados.

Lenstec Inc. is a wholly owned subsidiary of Lenstec Corporation, a Florida-based medical device company serving the global ophthalmic surgical market. In 1995 the company established its sole global manufacturing and production facility in Barbados, starting with just four employees. Today, with over 200 people on staff, Lenstec Barbados designs, manufactures and distributes a wide range of intraocular lens (IOL) implants and lens injection systems to more than 60 countries around the world.

Lenstec Barbados has elevated itself from originally being a ‘me-too’ manufacturer to one that is now internationally renowned for innovation and the design of leading-edge medical device technologies. This advancement from being solely a manufacturing company to one where design and development are central to future sales growth required the recruitment of a cadre of highly qualified people. Today, Lenstec’s team of scientists and engineers, who are all graduates from the Barbados Cave Hill campus of the University of the West Indies (UWI) or the Samuel Jackman Prescod Polytechnic, are responsible for all the design testing, product validation and regulatory documentation of the company’s products.

Lenstec’s in-house Microbiology Department, initially launched as a summer student internship in conjunction with the university, today employs three Masters and Bachelors qualified Microbiologists, who constantly monitor production and run programmes aimed at further honing the cleanliness of the products. This has resulted in Lenstec setting new, higher global standards for the cleanliness of medical devices, as required by the United States Food and Drug Administration.

Kirk Douglas – Senior Microbiologist, Lenstec Barbados

I was born and raised in Barbados and, other than the final year of my BSc Microbiology at University of Toronto via an international student study programme, all of my education has taken place at home. I graduated with a Bachelors of Science (B.Sc) in Microbiology from UWI Cave Hill in 2001, with honours, and then successfully completed a Masters of Philosophy (MPhil.) in Microbiology in 2007. I am currently in the final year of study for PhD degree in Medical Microbiology, also at Cave Hill.

After graduating from university I was eager to put my studies to use in the real world, so I was delighted to join Lenstec in October 2002. My time with the company has been very rewarding as it has permitted me the opportunity to gather valuable work experience, further my academic studies and implement what I have learnt to help place Lenstec in a strategic position within the medical device market.

My main role as Senior Microbiologist is to oversee all the functions of our QA/Micro-Laboratory, researching and sourcing relevant laboratory testing equipment and methodologies, and to manage all Microbiology related regulatory audits, including US Food & Drug Administration (US FDA), and British Standards Institute (BSI) audits. I also supervise two other microbiologists who perform routine microbiological testing for the support of manufacturing.

A big part of Lenstec’s directive is continuous improvement that seeks to avoid resting on our laurels while constantly striving for excellence. This has overflowed into my approach to quality and laboratory testing of our medical devices. Of the number of routine tests performed by the QA/Micro-Laboratory, the endotoxin test is the most crucial. From the time I started in 2002, my intention has been to drive down the microbial levels within our manufacturing process. Whilst the endotoxin levels on our medical devices were consistently meeting the acceptable limit of 20 Endotoxin Units (EU)/Device, we took the initiative to review and profile our process to assess the levels at each manufacturing stage, thus allowing us to target specific areas for reduction. At that time it was not mandatory but we had enough foresight to strive for excellence. We set about initiating the action plan and achieving significant process improvements. In 2008 we successfully applied for acceptance of our medical device into the US market through the US FDA. One key portion of our success was the preparatory work we had initiated on mapping our IOL manufacturing process and acquiring detailed knowledge of endotoxin levels at each stage.

Through our own initiatives, we were able to quantify the efficiency of our cleaning processes to show the quality assurance levels of safety for each lens product produced. This was well received by the US FDA as they had previously reduced the endotoxin limit from 20 EU/Device to 2 EU/Device. The endotoxin limit was then further reduced from 2 EU/Device to 0.2 EU/device. Yet, even with these reductions, we were consistently meeting all endotoxin limits quite easily. Our standards assisted the FDA in their drive to reduce endotoxin levels for the industry, as our results were so much lower than the endotoxin limit of 0.2 EU/device. Our current endotoxin limit for IOLs, as set by the US FDA, is 0.12 EU/device, which is likely the lowest among all IOL manufacturers worldwide. This means Lenstec has the cleanest IOLs currently on the market. Yet we still set about improving our production process even further, but this required an improvement in the endotoxin testing method to increase both the accuracy and level of detection. We acquired arguably the most sensitive and accurate testing equipment on the market, with the ability to detect endotoxin levels as low as 0.001 EU/mL. This required a review of our endotoxin testing methods and validation to achieve consistent endotoxin testing results, which we have now successfully completed.

As a direct result of the stringent standards we have set for ourselves, the FDA’s current regulatory endotoxin limit is no longer 0.2 EU/device. The FDA now requires all manufacturers, anywhere in the world, to set their endotoxin limits to these new lower limits based on what we have achieved here in Barbados.

Obviously it feels very rewarding to know that with our vision and hard work we have attained a noteworthy milestone, but we will still continue to improve our quality to consistently produce the cleanest lenses in the world.

www.lenstec.com

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