After 6 months of extensive research and interviews, 3DHEALS team is finally ready to publish this anticipated white paper explaining the complex world of biocompatible materials for 3D printing/ 3D printed medical devices. 

   While many have recognized and advocated the vast potential of 3D printing technology in healthcare, based on recent survey results, hesitance is palpable within the ecosystem, ranging from 3D printing entrepreneurs, device makers, healthcare organizations, to other corporations in the healthcare field. Part of this uncertainty comes from the fact that 3D printing is a relatively new and different manufacturing process from traditional ones and the existing biocompatible materials used for traditional manufacturing processes may not demonstrate similar behaviors if translated for use in 3D printing. For example, in the 3D printing manufacturing process of metal powders, there is partial re-melting and solidification of the initial powder that may change the material physical and/or chemical properties of the printed object. Also, because of the added structural complexity (often an advantage of 3D printing), the behaviors of the final device are also not well known and need to be validated for both “safety” and “effectiveness”. Another example is the 3D printing of objects with non-solid fill (e.g., a honeycomb fill) has been used to decrease their weight and create structures that more closely mimic biological materials (e.g., the internal structure of bone). The cleaning of these complex geometries and the gas or liquid within these structures needs to be evaluated for safety during the regulatory process of a medical device.

   The objectives of this white paper are to provide clarification and in-depth discussion of the topics below, which are critical elements to the additive manufacturing industry in healthcare:

  • Definition of biocompatibility.
  • Discussion on how biocompatibility is assessed within the current regulations of materials and medical devices by major regulatory agencies.
  • Summary of how different regulatory agencies are managing the introduction of 3D printing into the healthcare space to date.
  • List of major available biocompatibility materials and those in development.

We are open to feedback and suggestions for a future edition. We are very honored and excited to be part of this innovative journey.