Biomaterials data: where to find it and difficulties in its interpretation

Regulatory data

The final goal of an engineered biomaterial is to become part of a medical product that will pass the approval procedures of regulatory agencies. To achieve the approval of medical products, regulatory documentation containing evidence of their intended clinical use is required and needs to be presented to regulatory agencies (i.e., Food and Drug Administration for the U.S. and European Medicines Agency for Europe). The content of this kind of approval documents depends on the type of product and the extent of its differences to similar approved products. In addition, one fundamental aspect about approved biomaterials is that their long-term performance and adverse effects must be monitored and reported. For that, regulatory agencies ask manufacturers to submit post-market surveillance reports for their products.

In the case of medical devices approved by the FDA, the different kinds of documentation are registered among several databases that can be found at Medical Device Databases | FDA. Similarly, medical devices on the European market are being registered in the EUDAMED database (Devices/SPPs – EUDAMED). Although these tools help to manage the regulatory documentation of medical products, similarly to what can be observed with clinical trial repositories, the specific biomaterial composition is not well determined, which makes it difficult to correlate the biocompatibility results of medical devices with the biomaterials they are composed of.

Product data

Relevant data about biomaterial-related products can be found in commercial product datasheets, both for the final medical product and for suppliers of raw materials. However, in the case of raw material suppliers, the information about this kind of commercial product is not well centralised and compiled in specific tools covering the biomaterials field. Biomaterial suppliers are mostly found among material marketplaces that cover a large amount of industrial material applications, with the lack of specialization making it difficult to find relevant information. One exception is knowde – The marketplace for ingredients, polymers and chemistry, which offers a separate section for materials employed for medical applications. However, the main limitation of knowde is that the marketplace mostly focuses on polymers, and it does not collect key aspects of the materials such as detailed information about the sterilisation process or about which characteristics qualify them as medical grade biomaterials. In addition, following the same trend as clinical and regulatory data, the connection of medical products and their biomaterials composition is not well defined due to confidentiality issues.

Biomaterial databases

To facilitate the understanding of biomaterial data and, subsequently,their development, the construction of specialized databases in this field is required. As these specialized databases reduce the amount of raw data, they can be used to provide advanced search systems or even visualization tools that help to interpret the information. In the biomaterials field, specialized databases are still limited, and only a few open access tools can be found (Table 4).