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    3FOLD

    A 3D foldable applicator for the insertion of implantable medical devices in protective envelopes

    Institut für Designforschung (IDE)

    3FOLD ZHdK Industrial Design

    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.

    Details

    • Forschungsschwerpunkt
      • FRID Industrial Design
    • Projektleitung
      • Aldo Ferrari (Hylomorph AG)
    • Gesuchsteller/in
      • Nicole Kind (FRID)
    • Team
      • Salome Grand (FRID)
      • Benjamin Josi (FRID)
      • Nicole Kind (FRID)
      • Lisa Ochsenbein (FRID)
      • Hansruedi Rohrer (FRID)
      • Laurin Schaffner (FRID)
      • Mirjam Schnedl (FRID)
    • Kooperationen
      • Hylomorph AG
    • Laufzeit

      01.07.2021 – 01.06.2023

    • Finanzierung
      • Innosuisse - Schweizerische Agentur für Innovationsförderung (01.07.2021 – 01.06.2023)
    • Forschungszugänge
      • Angewandte Forschung
      • Künstlerisch-wissenschaftliche Forschung
    • Disziplinen

      Design

    • Schlagworte

      Health, Pacermaker, Cardiology, Surgery, Hylomate, Hylomorph, Usability, Medical Design, 3Fold, Surgical Applicator, Medtech

    Output

    • Aufsätze in Tagungsakten (Vortrag, Keynote)

      Schaffner, Laurin / Josi, Benjamin / Robotti, Francesco / Bottan, Simone / Ferrari, Aldo / Ochsenbein, Lisa & Kind, Nicole (2023): «Remote Synchronous Usability Testing Yields Reliable Data for User-Centered Design Development of Physical Medical Devices». In: Chakrabarti, Amaresh & Singh, Vishal (Hg.): Design in the Era of Industry 4.0. Volume 2. Springer, 249–259. Online unter: https://doi.org/10.1007/978-981-99-0264-4_22.

    • Ausstellungen, Konzerte, Aufführungen, Filmpräsentationen etc.

      Schaffner, Laurin & Josi, Benjamin (2024): «SF Design Week Studio Crawl: Circular Design Showcase». 3FOLD. 11.06.2024. Swissnex, San Francisco. Online unter: https://swissnex.org/sanfrancisco/event/sf-design-week-studio-crawl-circular-design-showcase/.

    • Ausstellungen, Konzerte, Aufführungen, Filmpräsentationen etc.

      Schaffner, Laurin & Josi, Benjamin (2024): «Swiss Design Awards». 3FOLD. 11.06.2024–16.06.2024. Messe Basel, Halle 1.1, Basel. Online unter: https://swissdesignawards.ch/.

    • Ausstellungen, Konzerte, Aufführungen, Filmpräsentationen etc.

      Thies, Maike (2023): «REFRESH #5». 3FOLD. 09.11.2023–12.11.2023. Zürcher Hochschule der Künste, Zürich. Online unter: https://refresh.zhdk.ch/refresh-5/exhibition/3fold/.

    • Öffentliche Präsentationen

      Thies, Maike (2023): «Die Industrie Designer Benjamin Josi & Laurin Schaffner geben Einblicke in den Arbeits- und Forschungsprozess des Projekts 3FOLD». ZHdK, Toni Areal, Kino Toni (3.G02), Zürich. Online unter: https://design.zhdk.ch/projekte/interdisziplinaere-vorlesungsreihe-kein-kino/.

    • Teilnahmen auf Einladung

      Schaffner, Laurin / Josi, Benjamin / Ferrari, Aldo / Bottan, Simone / Robotti, Francesco / Ochsenbein, Lisa & Kind, Nicole (2023): «Research Protocol for Remote Synchronous Usability Testings». 9th International Conference on Research Into Design - Design in the Era of Industry 4.0. Paper Presentation. 09.01.2023–11.01.2023. Indian Institute of Science, Bangalore, Indien. Online unter: https://cpdm.iisc.ac.in/icord23/.

    • Webseiten

      Oppliger, Cedric / Grand, Salome / Helfer, Lukas / Weinlein, Daniel / Skal, Mirjam / Josi, Benjamin & Schaffner, Laurin (2023): «3FOLD X ROLI Deluxe». ROLI Deluxe. Online unter: https://www.roli-deluxe.ch/projects/threefold.

    • Webseiten

      Schaffner, Laurin & Josi, Benjamin (2023): «3FOLD. Faltbares, chirurgisches Applikationsinstrument». Industrial Design Zürcher Hochschule der Künste (ZHdK). Online unter: https://industrialdesign.zhdk.ch/forschung/projekte/3fold/.

    • Preise

      Schaffner, Laurin & Josi, Benjamin (2023): Product Design 2023. Für: «3Fold». Design Preis Schweiz. 03.11.2023. Langenthal. Online unter: https://designpreis.ch/project/3fold/.

    • Medienresonanz

      GREATER ZURICH AREA (2023): «Researchers from ZHdK develop tool for heart surgery.». In: GREATER ZURICH AREA (Hg.): 27.11.2023. Besprechung von: 3FOLD. Schaffner, Laurin /Josi, Benjamin. Online unter: https://www.greaterzuricharea.com/en/news/researchers-zhdk-develop-tool-heart-surgery.

    • Medienresonanz

      Hagmann, Lea (2023): «Beim Design Preis Schweiz wurden sieben Projekte prämiert. Neu dabei: «Food Design»». In: NZZ Bellevue (Hg.): 03.11.2023. Besprechung von: 3FOLD. Schaffner, Laurin /Josi, Benjamin. Online unter: https://bellevue.nzz.ch/design-wohnen/design-preis-schweiz-das-sind-die-gewinner-im-jahr-2023-ld.1762162.

    • Medienresonanz

      Janik Schmid (2023): «Winterthurer holt Design-Preis. Das Operationsinstrument 3Fold ermöglicht eine schnelle und schonende Implantation von Herzschrittmachern». In: Winterthurer Zeitung (Hg.): 07.12.2023. Besprechung von: 3FOLD. Schaffner, Laurin /Josi, Benjamin. Online unter: https://www.winterthurer-zeitung.ch/winterthur/detail/winterthurer-holt-design-preis.

    • Medienresonanz

      Lukacs, Lilla / Schaffner, Laurin & Josi, Benjamin (2023): «Design für den OP». Hochparterre, 03.03.2023. Besprechung von: 3FOLD. Schaffner, Laurin & Josi, Benjamin. Online unter: https://www.hochparterre.ch/campus/design-fuer-den-op?tx_hochparterreblog_pi1%5Btitle%5D=20306&cHash=9a8ee8510b6673e65c9b01eda9a25816.

    • Medienresonanz

      punkt4 (2023): «Forschende der Hochschule der Künste entwickeln Instrument für Herzoperationen». Limmatstadt. Raum für mehr., 27.11.2023. Besprechung von: 3FOLD. Schaffner, Laurin /Josi, Benjamin. Online unter: https://www.limmatstadt.ch/news/forschende-der-hochschule-der-kunste-entwickeln-instrument-fur-herzoperationen-30607/.

    • Medienresonanz

      Raderschad, Kristina (2023): «Allumfassend». Meter Magazin, 15.09.2023. Besprechung von: 3FOLD. Schaffner, Laurin /Josi, Benjamin. Online unter: https://meter-magazin.ch/ch/design/19690-allumfassend.

    • Medienresonanz

      swisstrade (2023): «Researchers from ZHdK develop tool for heart surgery». In: swisstrade (Hg.): 27.11.2023. Besprechung von: 3FOLD. Schaffner, Laurin /Josi, Benjamin. Online unter: https://swisstrade.com/news/detail/news/forschende-der-hochschule-der-kuenste-entwickeln-instrument-fuer-herzoperationen/.

    • Medienresonanz

      Thomas Schaffner (2023): ««Gute Arbeit! Ihr Produkt ist idiotensicher». Design-Forschende haben mit Origami-Falttechnik die Implantation von Herzschrittmachern massiv vereinfacht. Mit dabei: der Winterthurer Laurin Schaffner.». Der Landbote, 21.12.2023. Besprechung von: 3FOLD. Schaffner, Laurin & Josi, Benjamin. Online unter: https://www.landbote.ch/junger-forscher-aus-winterthur-gute-arbeit-ihr-produkt-ist-idiotensicher-969164406408.