Sweeping revisions to Costa Rica's medical-products registration process are receiving one last in-house review before the final recommendations are delivered to officials at the Ministry of Health.

The project, initiated at the request of Costa Rican President Laura Chinchilla, is one of three major initiatives on the docket at Georgia Tech's Costa Rica Trade, Innovation, and Productivity Center (TIP). The other projects involve development of a food traceability system and a proposal to create a methodology for prioritizing future infrastructure projects in terms of their value to the country's trade chain.

In Costa Rica as in most countries, certain medical products — primarily pharmaceuticals, either produced in-country or imported — must undergo a registration process before they can be sold there. The problem is that the procedure takes 12 months, strong evidence that it's riddled with inefficiencies. The cumbersome registration process not only results in higher costs, but the long delay prevents patients from receiving the most up-to-date treatments in a timely manner.

Industrial engineers at the TIP Center modeled the registration procedure in detail. "We determined there was a lot of duplication and unnecessary steps in the process," said Emmanuel Hess, general manager at the center.

Using software developed by Amar Ramudhin, director of Supply Chain Management & Technology at Georgia Tech's Supply Chain & Logistics Institute (SCL), the routine was re-engineered and a series of recommendations for its implementation was drawn up. When fully operational, the newly streamlined process will "lead to savings in time and cost not only for the Ministry of Health, but also for the private producers and private distributors that are registering medicines here in Costa Rica," Hess explained.

The effort will open the door for additional TIP Center projects with other government agencies, said Jaymie Forrest, managing director of SCL.

"President Chinchilla has a Competitiveness Council that's using this project as a base study to show how other internal processes need to be improved, and how they can be more efficient in other matters," she said.

Food Traceability

A product tracing requirement that documents Costa Rican agricultural exports each step of the way, from local farm to retailer in the U.S., will help ensure a safe and wholesome food supply, and could serve as a model for other Latin American countries.

Started four years ago, the TIP Center's food traceability project presaged the Food Safety Modernization Act of 2011, a U.S. law passed in the wake of several high-profile cases of food contamination. The law mandates a number of health and safety measures for food imports, including a product tracing system requirement. The Act gives the U.S. Food and Drug Administration (FDA) authority to unilaterally block any import or importer of fruits and vegetables even if there is only the suspicion of contaminated product in the food chain. Before, a problem had to be specifically identified — a painstaking process that could take months.

Regulations detailing the law's requirements and implementation are still unfolding, with the FDA requesting industry feedback on the latest set of food safety standards it issued in January 2013.

"Currently we are working with local authorities in giving back comments and making remarks with regard to these rules," said Hess. "We're also trying to create a sense of urgency among small- and medium-size producers around the country as to the need to adapt and abide by the law's provisions."

Tightening import rules will have a significant impact on countries that rely heavily on agricultural exports, by spurring them to deploy a formalized, country-level structure so their governments can ensure that their products are traceable to point of origin, as required by the Food Modernization Act, and all the necessary documentation is readily available if something goes wrong.

"Being able to know exactly where contaminated products came from is important to a developing country because it would be devastating to their economy if all of their U.S. exports of a particular product were shut off," Forrest said, noting that more than 60 percent of the produce Americans consume is imported. "The only way you can trace an international food chain in two days is if you have a well-defined, automated system where participants are talking to each other. It really has to be an integrated supply chain.”

She added, "We've probably done more in this area than anybody else right now. We want Costa Rica to be the first country in the world to be able to say that their exports are traceable with a country-level strategy."

Optimizing Infrastructure Planning

The Costa Rica TIP Center has completed the necessary groundwork to conduct a structured value-chain analysis that will inform the country's decision making regarding current and future infrastructure investments. The next step is to secure funding to implement the proposal, but to date, an appropriation has not been forthcoming. Hess, however, remains optimistic.

"We're hopeful to get funding through the Costa Rican government and the Interamerican Development Bank in the next few months," he said. "We feel this is going to happen, but we're not sure if this is going to be done under this administration, which has about a year left in its term."

The proposal, developed at the request of Vice President Luis Lieberman, calls for Georgia Tech engineers to examine selected infrastructure projects already built, under construction or on the drawing board, in terms of their overall value to the national trade chain.

"After analyzing the cost-benefit opportunities of these particular investments, we'll create a methodology of how to make better decisions in the future," said Forrest.

Worldwide Outreach 

The Costa Rica TIP Center is one of six international logistics research centers operated under the auspices of the Supply Chain and Logistics Institute and the Stewart School of Industrial & Systems Engineering at Georgia Tech in Atlanta.

Centers are located in Atlanta, Singapore, Shanghai, Panama, and Mexico. Their common purpose is to develop insights, strategies, and methodologies to improve the productivity of existing trade chains while promoting innovation for identifying and enabling new trade-chain opportunities. In addition, the centers support a range of educational activities related to trade-chain infrastructure, innovation, and productivity.

Written by: Gary Goettling