This report represents DiCE’s deliverable 3.2 ‘Demonstration of refurbishment process and technologies for refurbishment of the ePaper labels, not subject to EU MDR’ and is linked to
task 3.3 ‘Development and Demonstration of refurbishment technologies for digital health devices not subject to EU MDR’.
The overall goal of the refurbishment tests is to provide evidence for the feasibility of a refurbishment process for a digital health device, not subject to EU MDR. The ePaper label, also known as digital display label (DDL), is used a representative device. A method for refurbishment and reuse of DDLs was developed and tested, with a target refurbishing rate of 80% of devices for up to five cycles of reuse. The report covers overall testing strategy, execution, and results of the refurbishment test. The refurbishment test protocol consists of two parts, with each part being carried out by a packaging partner at their respective manufacturing facilities. A total of 100 DDLs are used in the test, 50 DDLs with a fixed battery and 50 DDLs with a replaceable battery. The DDLs used in the test have been purchased from ECCT B.V.
The first part of the test protocol comprises a refurbishment cycle, which consists of five main steps: (1) diagnostic tests on returned DDLs, (2) a repair stage including potential battery replacement, (3) re-assembly of DDLs in new packaging materials, (4) quality control, and (5) clinical packaging. The second part of the test protocol comprises a return phase, which covers the separation of the DDL from the old packaging materials, and a data reset.
The results of executing the test protocol include direct feedback from a Johnson & Johnson clinical packaging site and healthcare professionals from a clinical site on the refurbishment and reuse process steps, which were simulated in the packaging partner’s facilities.
An overall refurbishment rate of 91.0% after five cycles was demonstrated, exceeding the expected target of at least 80.0%. Out of 100 DDLs, 91 units reached the end of the fifth refurbishment cycle. On a total of 9 failures, most occurred in the battery replacement process (5/9), with material allocation (3/9) and undetermined (1/9) as other failure categories. DDLs with a replaceable battery were more sensitive to failures (6/9) than the DDLs with fixed battery, with 5/9 failures directly linked to the process of battery replacement itself. Most failures occurred early in the test cycles (cycle 1: 5 failures, cycle 3: 4 failures, none in cycles 2, 4 and 5). None of the failure categories poses a fundamental barrier to circularity as design and process improvements have been proposed. These improvements are expected to reduce the failure rate significantly if further developed.
Key success factors in the refurbishment of DDLs are modularity in design to simplify the refurbishment process significantly, and a willingness for stakeholders to engage in a close collaboration across all stages of the supply chain. Collaboration with stakeholders was vital in the process design and setup, even for the areas outside their individual control. The partnership of DiCE’s consortium with industry throughout this deliverable leveraged relevant packaging and electronics experience in the setup and execution of the tests. Furthermore, the collaboration with industrial partners demonstrates industry’s interest in the concept of circularity and has contributed to the awareness of refurbishment processes in the DDL ecosystem. Key challenges remain the maturity of the processes and added complexity of aligning a wide range of requirements across many stakeholders.
In conclusion, the report shows evidence for the technical feasibility of a refurbishment process for the DDL as a representative digital health device not subject to EU MDR. Additionally, the report demonstrates that a fully circular product introduction requires dedicated and focused effort with circularity as a central theme throughout the development cycle. A strong business Deliverable 3.2 | circulardigitalhealth.eu | 8 case for all stakeholders is a necessary condition to justify the effort to adopt circularity and to enable its success.