Who is Lenstec, Inc.?
Lenstec, Inc. is a privately held Florida-based medical device corporation serving the global ophthalmic surgical market, with products currently marketed in more than 50 countries around the world. The company was founded by John Clough in 1992 and has its head office in St. Petersburg, Florida.
Lenstec specializes in designing, manufacturing and distributing a wide range of intraocular lens (IOL) implants and lens injection systems, which are used in cataract surgery. The company has established a reputation for rapid prototype design and development, and high quality/low cost manufacturing.
Lenstec was originally set up to commercialize lens manufacturing technologies developed by Mr Clough, and in 1995 made a strategic decision to set up its own lens manufacturing operation. An international search led Lenstec to choose Barbados as the centre for its manufacturing operations, which started here in early 1996.
In the first five years of operation, Lenstec more than doubled its sales each year and expanded its manufacturing facility from the initial 5000 sq ft; in 1998 expanding to 10,000 sq ft, and then again in 2000 to 15,000 sq ft. From 2002, the company was looking for a suitable site to further expand. It took two years of planning and building for the new state-of-the-art manufacturing facility to be built at Airport Commercial Centre, Pilgrim Road, Christ Church and this opened in July 2008. This new building is double the size of their previous premises at Newton Industrial Estate, so it has enabled them to expand and increase their production and distribution to meet growing market demand.
Why Choose Barbados? What made Barbados attractive?
Barbados’ international business environment is essentially what attracted Lenstec to set up here.Â As an International Business Corporation, Lenstec was initially attracted by favorable tax rates in Barbados but this was a minor part of the mix of factors that have contributed to the company’s decision to keep its manufacturing base in Barbados for the long term.
Ian Hickling, (President – Manufacturing), stated that the company was very impressed with the professionalism of the BIDC team, which was led by Henderson Holmes (now BIBA’s CEO), that handled the initial approaches from Lenstec.Â Other important factors considered were the high level of transparency in the Barbados corporate environment, the long history of political and economic stability, the high level of adult literacy and universal education. Since 1996, Lenstec has also noted other benefits of operating in Barbados, including excellent transport links to major markets in Europe and being on the same time zone as corporate headquarters in Florida. Â Initially concerned how the medical community would react to the “Made in Barbados” tag, Lenstec was pleasantly surprised to find their products well received, and not being viewed asÂ “Third World” produced. Mr Hickling believe that Barbados’ unique combination of geographical, economic and labour assets makes it ideal for the development and production of high value, small volume products such as medical devices, pharmaceuticals and other biotechnologies.
Lenstec differentiates itself through innovation of new medical device products and through superb customer service, providing speedy delivery via DHL and FEDEX. International enquiries are increasingly being handled from the Barbados branch as the US headquarters will shortly be starting distribution of its Barbados-made products into the US market. The company also operates a UK subsidiary of the Barbados branch in Yorkshire, selling directly to the National Health Service (NHS) and private surgeons.
Lenstec began its operations in Barbados with just four staff members. Today, it employs 125 people. Out of that total, only two staff members are non-nationals who are here with a work permit.
Due to the highly specialized nature of the manufacturing processes, Lenstec offers detailed on-the-job training. The company has a core manufacturing staff of secondary school leavers, supplemented by a group of mechanical engineering graduates from the Samuel Prescod Polytechnic who run high precision lathe and mill technology. Additionally, because research and development is a large part of the business, Lenstec has employed a growing number of university graduates specialized in subject areas such as Information Technology and the Sciences.
Lenstec manufactures approximately 20 different models of intraocular lenses, each of which can have up to 15 different dioptres. When first established, Lenstec produced general cataract lenses but its ongoing emphasis on product development has resulted in its lens technologies being at the forefront of medical science. It’s Tetraflex lens is one such example, being widely used in Europe for reducing the need for reading glasses after surgery.
International Product Approvals
The medical device industry is heavily regulated by international healthcare authorities, and for Lenstec to sell in a country it must receive regulatory approval. In December 1997 the Lenstec Barbados facility received ISO 9001 and CE Mark certification from British Standards Institution, enabling it to sell in the European Union. In 1999 Lenstec received approval from the Japanese government. Australian approval was received in 2005 and Canadian approval in 2007. Currently Lenstec sells direct from Barbados to more than 50 countries, and has sales of more than 250,000 lenses a year.
Lenstec’s most recent regulatory application has been through the United States Food & Drug Administration. This is certainly one of the more difficult certifications to achieve as it involved year-long clinical trials in the US for two of its IOL designs (The TetraflexTM presbyopia correcting IOL & the Softec HDTM aberration-neutral IOL). These trials are highly expensive and have cost Lenstec at least US $2million per year to develop. Once the trials were successfully completed, a team from the US FDA in Washington travelled to Barbados during the first week of December 2009 to conduct a five day compliance audit of the Lenstec factory.
Lenstec is now awaiting a formal response from the US FDA on its submission for approval of its first lens model, and assuming there are no holdups in the approval process, Lenstec could be selling lenses in the US market as soon as March 2010. Lenstec is now confident that annual global demand for its lenses will exceed 500,000 after FDA approval.
How does Lenstec plan to stay on top of its game?
Staying close to the industry is one of Lenstec’s key strategies. Maintaining a partnership with opinion leaders in ophthalmology to monitor surgical advances and respond with product developments. More and more cataract surgery is moving towards smaller incisions, use of disposable instruments to reduce the possibility for infection. Lenstec latest advance which should be released in March 2010 is a pre-loaded injector which responds to surgeons’ demands for “no-touch surgery” by delivering the lens directly into the eye without the need for any handling by surgical staff.
This unremitting focus on research and development and the development of a pipeline of products that meets surgical advances is what has given rise to Lenstec’s rapid growth over the past decade and a half. It’s manufacturing base in Barbados is a critical part of this success.
President – Manufacturing
Airport Commercial Centre