Case Study:
Providing System Maintenance and Support for a U.S. Medical Device Manufacturer

Case Study:
Providing System Maintenance and Support for a U.S. Medical Device Manufacturer

The Client

The Client

The client is a Fortune 500 medical technologies firm based in the United States. They manufacture medical devices and medical equipment, which are exported to more than 120 countries.

The Team

Richard Yang Business Analyst

Richard has over 10 years' experience in software development. He also worked as the BA for this project. He provided great help with team building and acted as the clients advocate ensuring all business requirements were met on-time.

Ted Song Lead Developer

Ted is a core member of the team, he participated in several projects for the client in the past four years and helped deliver all projects successfully under a tight schedule.

Justin Tian Developer

Justin is a technical generalist that can quickly resolve all kinds of issues in projects. He always pays attention to detail and is a champion for accuracy and quality of work.

Kevin Wang Developer

Kevin is very easy to work with, and he is always willing to take any tasks assigned and can finish them quickly with excellent quality.

The Challenge

The client was managing product registrations, inventory and labeling at their Asia Pacific regional headquarters in Hong Kong using three separate systems, all of which were built years ago on outdated .NET 2005 technology. In the meantime, a new U.S. Food and Drug Administration (FDA) rule required healthcare manufacturers to label their products with unique device identifiers (UDIs) to increase patient safety and help optimize patient care. In order to meet these new requirements, the client had to transform their legacy systems. At the same time, they wanted to take the opportunity to combine their three systems into one, upgrade the technology, and add new functions. Before working with Shinetech, the client had been outsourcing to a company specializing in ERP development, but the delivery quality had become unsatisfactory. The client turned to Shinetech to discuss how to improve and bring the project back on schedule.

The Challenge

The client was managing product registrations, inventory and labeling at their Asia Pacific regional headquarters in Hong Kong using three separate systems, all of which were built years ago on outdated .NET 2005 technology. In the meantime, a new U.S. Food and Drug Administration (FDA) rule required healthcare manufacturers to label their products with unique device identifiers (UDIs) to increase patient safety and help optimize patient care. In order to meet these new requirements, the client had to transform their legacy systems. At the same time, they wanted to take the opportunity to combine their three systems into one, upgrade the technology, and add new functions. Before working with Shinetech, the client had been outsourcing to a company specializing in ERP development, but the delivery quality had become unsatisfactory. The client turned to Shinetech to discuss how to improve and bring the project back on schedule.

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The Solution

The client initially planned to transfer the entire project to Shinetech for ongoing development. However, considering the critical schedule for development, and the time needed to properly transition the project over to us, we suggested working together with the existing vendor, with Shinetech assuming responsibility for code review and testing to ensure the quality. This arrangement worked out well, and after phase one was completed, Shinetech took over the entire project. The client has gradually grown the team from three developers to eight, including a leader, five developers, a tester, and a Level 1 help desk support person. The three core technical people have remained part of the team. Since our collaboration began two years ago, the Shinetech team has often travelled to Hong Kong to work onsite with the client’s internal team for one or two weeks at a time. We shared & discussed project plans, business requirements, maintained development efficiency and ensured high-quality deliveries. Our teams are always ready to put in the extra effort to ensure critical milestones are met.

The Solution

The client initially planned to transfer the entire project to Shinetech for ongoing development. However, considering the critical schedule for development, and the time needed to properly transition the project over to us, we suggested working together with the existing vendor, with Shinetech assuming responsibility for code review and testing to ensure the quality. This arrangement worked out well, and after phase one was completed, Shinetech took over the entire project. The client has gradually grown the team from three developers to eight, including a leader, five developers, a tester, and a Level 1 help desk support person. The three core technical people have remained part of the team. Since our collaboration began two years ago, the Shinetech team has often travelled to Hong Kong to work onsite with the client’s internal team for one or two weeks at a time. We shared & discussed project plans, business requirements, maintained development efficiency and ensured high-quality deliveries. Our teams are always ready to put in the extra effort to ensure critical milestones are met.

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The Technology

The system we worked on for two years was developed in Microsoft .NET. EDI and SSIS are used for data communication with external systems. The main functions include: registration management for markets in different countries; inventory management module, connected with partners’ systems and clients’ ERP; and label generation and labeling for all products.
The system we worked on for two years was developed in Microsoft .NET. EDI and SSIS are used for data communication with external systems. The main functions include: registration management for markets in different countries; inventory management module, connected with partners’ systems and clients’ ERP; and label generation and labeling for all products.

The Result

The Shinetech team has successfully completed the integration of the three systems as well as the transformation required to meet the new FDA standards. In addition, we added new functions including a system admin module; and an approval management module which greatly increases the client’s efficiency through an automated approval process. We have a deep understanding of the system and our client’s related business logic, allowing us to deal with requirements and tasks quickly and efficiently.
First group meeting
The client flew to meet the whole team in our Beijing office for a 1 week product workshop.

The Team

Business Analyst: Richard Yang
Richard has over 10 years' experience in software development. He also worked as the BA for this project. He provided great help with team building and acted as the clients advocate ensuring all business requirements were met on-time.
Lead Developer: Ted Song
Ted is a core member of the team, he participated in several projects for the client in the past four years and helped deliver all projects successfully under a tight schedule.
Developer: Justin Tian
Justin is a technical generalist that can quickly resolve all kinds of issues in projects. He always pays attention to detail and is a champion for accuracy and quality of work.
Developer: Kevin Wang
Kevin is very easy to work with, and he is always willing to take any tasks assigned and can finish them quickly with excellent quality.

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