Quality risk management is critical for identifying and mitigating risks in the drug and medical device manufacturing process. In the life sciences industry, this process is typically done using paper reports and spreadsheets, a practice that is prone to errors and can make information that is critical for patient safety and regulatory audits inaccessible.
CINCO Engineering‘s solution to this problem is a web-based software that effectively assesses, organizes, analyzes and traces information critical to the quality of a drug or medical device. The company developed the software based on risk management from the ground up and not just as a tool for risk management.
CINCO’s Capabilities and Benefits
The CINCO software focuses on manufacturing equipment, facilities and utilities instead of research and development. Its target customers are technical services directors and quality directors in the life sciences industry.
The software offers the following capabilities and benefits:
- Provides on-demand access to information that is critical for product quality and patient safety.
- Features standardized templates, risk assessment tools and globally proven libraries.
- Promotes sustainable compliance throughout the products’ lifecycle.
- Keeps products’ institutional memory at the customer’s site.
- Facilitates training of the critical aspects of a manufacturing operation.
- Enables users to automate the traceability of critical aspects.
- Supports daily decision-making.
- Complies with global regulatory expectations.
CINCO Engineering’s scaling strategy involves increasing data usage in multinational companies with presence in Puerto Rico, such as Amgen, Baxter and Johnson & Johnson. A global implementation of the software in one of these companies would produce nearly $1 million in annual revenue.
The company is forecasting $500,000 in contracts by the end of 2020 and about $1.5 million by the end of 2021. Its key traction metrics are demos performed, purchase orders and risk documents.
Biggest Challenge: Reaching the Right People
Developing the software in Puerto Rico has made finding the right talent to develop the software challenging because the app has requirements that are uncommon in the startup eco-system.
Obtaining access to decision makers in the life sciences industry also has turned out to be a challenge. Piloting in Puerto Rico has been successful because there’s considerable drug and medical device manufacturing on the island, but purchase decisions for enterprise software are usually made at the corporate level, which is rarely local.
Rising Entrepreneurs Program Experience
The Bravo Family Foundation’s Rising Entrepreneurs Program guided CINCO Engineering to focus on profitable growth, improved pricing models and return on investment. As a result, the company is working on optimizing its development processes, reducing administrative costs and becoming profitable as soon as possible.
“The program has given us the tools we need to run a business successfully,” said founder and CEO Ruben Morales. The company is also counting on its team extensive experience in the life sciences industry and its founders’ proven leadership skills.
After the program, CINCO Engineering’s hopes to obtain an enterprise license subscription on a top 20 life science multinational company with which it already has a paid pilot deal. Such an opportunity would allow the company to achieve sustainability as well as product market fit. Following that step, the company will seek a Series A funding round to pursue international growth and scalability.
“Much of my life I’ve worked solving problems that were selected by someone else. As an entrepreneur, I get the opportunity of choosing problems that I want to solve. Such a freedom and power is important for the life I want to lead.”Ruben Morales, CINCO founder and CEO