D. Cebon, Granta Design Ltd., Cambridge, United Kingdom; M. Helmus, Advance Nanotech Incorporated, New York, NY; D. F. Gibbons, 3M Company, North Oaks, MN
Designing devices for implanting in the human body requires handling a host of complex inter-related issues: biocompatibility, mechanical characteristics, material processing, coatings, drug delivery mechanisms, the performance of existing devices for similar applications, as well as the medical device regulatory process. The information that designers need to deal with these issues is scattered across a wide range of sources. These may be in-house; such as design guidelines, data references and previous experience; or they may come from published sources such as academic literature, handbooks, manufacturer’s data sheets, FDA documents, ASTM Standards, etc. Finding the necessary information is difficult, error-prone and time-consuming. Once it has been found the information has to be organized, correlated, checked and qualified and its traceability needs to be documented. Until recently there have not been any information resources available to support designers with these diverse information requirements.
This paper will present a software system developed to support the information needs of medical device designers. The first data module provides comprehensive information concerning materials for implantable cardiovascular devices. This encyclopedic resource helps medical device designers to search for information about existing implantable cardiovascular devices; to select and optimise materials, including compatible combinations of materials, coatings and elutable drugs; and to find engineering information about materials and export it to analysis programs. Further data modules are currently under development.
The underlying materials data management software can also be used to capture, manage and deploy in-house materials information, enterprise wide, so as to maximise its quality, reliability and utility. In combination with extensive peer reviewed data modules, the system thus provides a complete materials information resource for medical device manufactures, that can be integrated with companies’ existing design and simulation systems.
Summary: Designing devices for implanting in the human body requires handling a host of complex inter-related issues: biocompatibility, mechanical characteristics, material processing, coatings, drug delivery mechanisms, the performance of existing devices for similar applications, as well as the medical device regulatory process. The information that designers need to deal with these issues is scattered across a wide range of sources. These may be in-house; such as design guidelines, data references and previous experience; or they may come from published sources such as academic literature, handbooks, manufacturer’s data sheets, FDA documents, ASTM Standards, etc. Finding the necessary information is difficult, error-prone and time-consuming. Once it has been found the information has to be organized, correlated, checked and qualified and its traceability needs to be documented. Until recently there have not been any information resources available to support designers with these diverse information requirements.
This paper will present a software system developed to support the information needs of medical device designers. The purpose-built data structure supports a rich collection of information about the engineering and medical properties of materials, coatings, drugs, processes, approved medical devices and manufacturer’s data. The first data module provides comprehensive information concerning materials for implantable cardiovascular devices. This encyclopaedic resource helps medical device designers to search for information about existing implantable cardiovascular devices; to select and optimise materials, including compatible combinations of materials, coatings and elutable drugs; and to find engineering information about materials and export it to analysis programs. Further data modules are currently under development.
The underlying materials data management software can also be used to capture, manage and deploy in-house materials information, so as to maximise its quality and reliability and deploy it enterprise-wide. In combination with the extensive peer reviewed data modules, the system thus provides a complete materials information resource for medical device manufactures, that can be integrated with companies’ existing design and simulation systems.
