Pacemakers manage heart rhythm in cardiovascular patients. Hylomate – a biosynthetic material forming a protective envelope – minimizes the foreign body reaction against these devices, thus improving their integration. Hylomate is designed to be coupled to the pacemaker by the surgeon immediately before implantation, in a process which shall be aseptic and time efficient.
3FOLD employed the user centered design approach and rapid prototyping to create a foldable applicator tool enabling a safe, comfortable and expedite surgical process in which Hylomate is applied to the pacemaker.
Pacemakers are widely applied and safe electronic devices which improve the quality of life in cardiovascular patients. As for all soft tissue implants, comprised of synthetic materials, a major risk is introduced by the foreign body reaction, generating fibrotic tissue and causing pain, device failure, and complicating the revision surgeries. These adverse events necessitate medical attention and hospitalization with significant healthcare costs and increased mortality. The avoidance of post-operative complications in implantable medical devices is an unmet clinical need.
Hylomate – a biosynthetic natural envelope developed by the company Hylomorph AG – establishes a durable protective layer around the pacemaker, and minimizes fibrosis, thus supporting implant integration and facilitating its revisions (Robotti et al. Biomaterials 2020). The Hylomate envelope is mounted around the target device immediately before implantation. The safety, comfort, and promptness of this process, performed by the surgeon, are key to its success.
The research project 3FOLD improves the surgical protocol with a parametric medical applicator tool that enables a touchless and fast application of protective envelopes on target implants. Following the user-centered design approach, each phase of the process relates to the user and includes the design-thinking phases Define, Develop, and Deliver:
Define – The medical procedure was observed and the potential for improvement of each phase was defined. Unexpected or unknown processes or habits from practice, which often differ from theory, were incorporated into the assignment of the applicator tool. Different concepts were outlined and graphically illustrated.
Develop – Multiple solutions to the defined problem were proposed. The concept ideas were discussed, analysed, and tested for feasibility with experts from various fields in a cross-field approach. Three concepts based on different folding and expanding principles and materials were selected and developed to be implemented in the next phase.
Deliver – Iterative fabrication, testing and selection of alternative solutions. The infrastructure of ZHdK with its labs, software and workshops enabled fast and realistic prototyping in a wide variety of materials and production concepts. Various prototypes were produced to optimally enable a parametric design. Iterative user testing and validation of the prototypes were performed in clinical settings by the end users. A final selection was based on the end-user feedback and on the quantitative measurement of the application time, number of touches and failures. Furthermore, an innovative protocol for remote usability testing in the design of physical medical products was developed, validated and presented in form of a research paper.
The project is based on a three-pillar value concept with the ambitious goal of improving the health situation of the patient, increasing the quality of life, and having a positive social impact while creating economic value in Switzerland. Due to its versatile potential, the collaboration between Hylomorph and ZHdK was funded by Innosuisse.