I recently took a two week vacation to South Africa traveling to Cape Town, Prince Albert and various parts of the northern Western Cape. It was an absolutely amazing trip with many memories of time spent with my family. Traveling to a foreign country has shown me a lot of new things about the world and the various cultures and lifestyles that people experience from the food, music, and climate to politics, religion and available healthcare.

This trip has caused me to think more about the globalization of the medical device industry and the impact RQS wants to make on a global level. Looking at it, the need for medical device technology is different in countries depending on economic status. Device companies target first world countries by marketing their products as “sexy”, sleek and cutting edge. However the appeal might not be the same in third world countries that are much more restricted because of cost. These third world countries are more focused on technologies that are affordable, easy to use and get the job done.

So how can companies bridge the gap between the two markets that have different needs and uses for the medical device technology?

One thing I have seen more and more with the various clients I have worked with is a cheaper and simpler version/revision of the device. Companies initially target those countries that can afford the technology with the most advanced features and after that has been successful, the company will create a more "bare bones" device with fewer advanced options which costs less. Cutting costs by changing the type of material used is also an option. Reimbursement policies vary depending on the country. It is important to understand how a device is coded in each country and what type of documentation/testing is necessary depending on the specific policy. Planning out a reimbursement strategy and aligning certain countries can really cut down on future costs.

One thing that is extremely important across all countries is to have a solid intended use statement. Changing the intended use from country to country increases the cost of the device because separate documentation, claims and submissions are required. However creating a clear and consistent statement that is relevant for every country across the board is extremely helpful in cutting down costs.

Understanding that there are different markets for medical device technologies (location being one of them) is important for countries to understand when developing a technology. Understanding the end goal and the need for the device will open more doors to revenue streams.

-- Jillian F. Walker

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