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Small Clinics: Next Frontier for Sterilization Bioindicators

Ander Gentry - Gamma Biolabs
Director and Co-Founder


Jan Hogewoning By Jan Hogewoning | Journalist and Industry Analyst - Tue, 09/29/2020 - 11:33

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Q: How far are you with the launch of your two new products?

A: We have a new bioindicator that is in the last phase of development. We sent a prototype to several clients who are testing it. We hope to launch it commercially in the coming months. It is suitable for a type of sterilization process; besides the four sterilization processes we already cover. Our biological indicators check sterilization effectiveness by being placed in the sterilization machine before tests are sent to incubation and analysis. This type of sterilization is a process that uses low temperature and moist heat. Many sterilization processes use heat to kill germs and bacteria. However, there are some items that you cannot expose to elevated temperatures because they degrade, melt or simply cease to work. Low heat sterilization is commonly used for culture media or liquids with nutrients. This process could be used in the food and pharmaceutical sectors.

Another service we recently launched is smaller batch biological indicator boxes for small medical and dental clinics. These clinics are often forced to throw away bioindicators because they can only order large batches. We decided to make it possible to order a smaller batch that suits their lower usage. These clinics also lack the infrastructure to perform their own incubation of the biological indicator after having placed it in the sterilization equipment. So, we now provide a service where they can send the bioindicators to us and we perform the incubation and analysis. We then provide a report that demonstrates if their sterilization process is working. By law, these clinics have to test their sterilization process at least every two months. We think this service has a great deal of potential. We have not seen any other company that can do this on such a large scale.

Q: How much did the company grow in 2019 and what are your expectations for 2020?

A: In 2019, we saw a great deal of growth in dry heat sterilization strips. There are many medical and dental clinics that sterilize using dry heat. We improved our products through 2019 to make the packaging easier to open and handle. This was received very well by our clients. Overall, our sales increased by 35 percent in 2019, compared to 2018. This year, due to the pandemic, we saw a small drop in demand, particularly from dental clinics. However, steady demand from pharmaceutical companies has kept our sales constant. By the end of the year, I am expecting between 10 and 20 percent growth in sales against 2019.

Q: What is your strategy to reach new clients?

A: Our growth has been primarily due to word of mouth recommendations but also efforts including Google, Facebook and LinkedIn ads.  We are building an online platform where clients, especially dental clinics can hire our services. As we launch this in the coming months, we will continue to reach out to potential clients through more online marketing. We believe the smaller medical and dental clinics will be the primary growth drivers for us this year. We have not really dug into the hospital or food sector, but we do have some clients in those areas.

Q: How are you improving production capacity to keep up with demand?

A: At the beginning of 2020, we finished constructing a new laboratory. This increased our production capacity five-fold and will allow us to meet demand in the coming years. We now have a laboratory in Guadalajara and a distribution center in Mexico City, which pretty much covers those areas. One of the challenges is to be able to deliver our biological indicators to every area of the country where there is a concentration of clinics. Our plan for now is to use carrier services to reach these communities. One very interesting market for us is Tijuana. There is significant medical and dental tourism from the US and patients are expecting their clinics to comply with safe sterilization measures.

Q: What has been the progress in expanding into the EU market?

A: We are targeting the Dutch and the German markets. However, this is still in the early stages. We now have a few clients in the Netherlands and have developed some strong relationships with companies there. The German market is more challenging. Every country in the EU has its own legislation, which means we have to adapt our products and services. For example, the regulations for sterilization in dental clinics can vary a lot depending on the country. With respect to practices and protocols in the pharmaceutical industry, there is much more similarity between countries. We are an attractive supplier because we use an efficient production process, which means lower production costs and lower product prices. We have reduced the use of raw materials needed to make the final product. This process is not patented but it is a company secret. 

Q: What are your main priorities for this year?

A: We have been working for a long time to become ISO certified, and we expect to complete this process shortly. Another process we are working on is to be registered with the FDA. We started this process this year and hope to have it complete by the end of the year. Both of these recognitions would help us to grow internationally and to access bigger multinationals and pharmaceuticals.


Gamma Biolabs produces and distributes biological indicators used to test the effectiveness of sterilization processes. The company is active in the Mexican and Dutch markets and is seeking to expand to other countries

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