In this tabel, five elements can be found for each initiative. The title, the type of initiative (development resource, development practice, modeling and simulation tool, initiatives, regulatory tools, funding and others), the kind of development activity it belongs to, and the stage of the medical device lifecycle.
The kind of development activities are divided into: 1) pre-clinical development, 2) clinical development, 3) business development, 4) technology development, 5) regulatory development and 6) other.
The stages of medical device lifecycle are divided into: 1) concept, 2) prototype, 3) pre-clinical, 4) clinical, 5) manufacturing, 6) marketing, 7) commercial use and 8) reimbursement.
| Name | Type | Development Activity | Medical device lifecycle stage | Link |
|---|---|---|---|---|
| Adaptive designs medical device clinical trials | Development practice | 1, 2, 5 | 3, 4 | https://www.fda.gov/regulatory-information/search-fda-guidance-documents/adaptive-designs-medical-device-clinical-studies |
| AI development in software as a medical device | Development resource | 1, 2, 4 | 1, 2, 3, 4, 5, 6 | https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-software-medical-device |
| Alternative designs for Small Population Clinical Trials | 2 | 2 | 4 | https://sit.bmj.com/content/3/1/e000066 |
| Assessment framework for digital health frameworks – EDIHTA | Regulatory tool | 4, 5 | 4 | https://edihta-project.eu |
| CEPS, OpenCARP, Propag | Modelling and simulation tool | 1 | https://www.sciencedirect.com/science/article/abs/pii/S0169260721002972 | |
| Computer models of heart for paediatrics population at different ages | 1 | 1, 2, 3, 4, 5 | 2, 3, 4 | https://www.erasmusmc.nl/en/sophia/research/projects/3d-geometric-models-of-paediatric-cardiac-shape |
| Crowd funding | Funding | 1, 2, 3, 4, 5 | 1, 2, 3, 4, 5 | https://www.gofundme.com/, https://www.kickstarter.com, https://www.crowdfunding.com and others |
| Custom-made device guidance | Regulatory tool | 4, 5 | 1, 2, 3, 4 | https://health.ec.europa.eu/system/files/2021-03/mdcg_2021-3_en_0.pdf |
| Development and use of Patient-Centered Outcome Measures | Development practice | 2, 5 | 3, 4 | https://erica-rd.eu/work-packages/patient-centred-research/proms-repository/ |
| EMA pilot to support orphan devices | Regulatory tool | 2, 5 | 3, 4 | https://www.ema.europa.eu/en/news/new-pilot-programme-support-orphan-medical-devices |
| ERAMET | Modelling and simulation tool | 1, 2, 3, 4, 5 | https://www.erametproject.eu | |
| EU Expert Panels | Development resource | 2, 5 | 3, 4 | https://health.ec.europa.eu/medical-devices-expert-panels/experts/expert-panels_en |
| EU Medical Device Regulation | Regulatory tool | 5 | 3, 4, 5, 6 | https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng |
| European Commission funded programs and resources | Development resource | 1, 2, 3, 4 | 1, 2, 3, 4, 5 | https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes_en |
| European Patients’ Academy (EUPATI) toolbox | Development resource | 1, 2 | 3, 4 | https://toolbox.eupati.eu |
| European Strategy Forum on Research Infrastructures | Development resource | 4 | 2 | https://www.esfri.eu |
| Extrapolation of efficacy and safety in device development | Development practice | 1, 2, 5 | 3, 4 | https://www.ncbi.nlm.nih.gov/books/NBK225517/ |
| FAIR principle for data use | Development practice | 1, 2, 3, 4, 5 | 2, 3, 4, 5, 6, 7, 8 | https://www.go-fair.org/fair-principles/ |
| FDA Catalogue: medical device development tools | Development resource | 1, 2, 3, 4 | 1, 2, 3, 4 | https://www.fda.gov/medical-devices/medical-device-development-tools-mddt |
| Guidance document for summary of safety and performance | Regulatory tool | 2, 5 | 4 | https://health.ec.europa.eu/document/download/5f082b2f-8d51-495c-9ab9-985a9f39ece4_en |
| Guidance Legacy to MDR transition | Regulatory tool | 3, 5 | 4, 5, 6 | https://health.ec.europa.eu/document/download/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en |
| Guidance of classification of device types | Regulatory tool | 5 | 3, 5 | https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf |
| Guidance of early feasibility studies | Regulatory tool | 1, 2 | 3, 4 | https://pubmed.ncbi.nlm.nih.gov/35579009/ |
| Guidance on developing interventions to improve health and health care | Development resource | 2 | 1, 4 | https://pubmed.ncbi.nlm.nih.gov/31420394/ |
| Guidance on the clinical evaluation of orphan medical devices | Regulatory tool | 2, 5 | 4 | https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf |
| Horizon Scanning: Landscape analysis/ Stakeholder identification and engagement | Development practice | 1, 3, 4 | 1, 2, 6, 7 | https://visualping.io/blog/what-is-horizon-scanning |
| IMDRF Guidance personalized devices | Regulatory tool | 4, 5 | 1, 2, 3, 4 | https://www.imdrf.org/working-groups/personalized-medical-devices |
| InSilicoTesting | Development practice | 1, 2, 4 | 2, 3 | https://insilico.com |
| Interest group HTA rare diseases | Development practice | 3, 5, 6 | 6, 7, 8 | https://htai.org/interest-group/rare-diseases/#:~:text=This%20Interest%20Group%20is%20dedicated,patients%20and%20society%20when%20determining |
| Joint HTA+SA advice for devices | Regulatory tool | 2, 3, 5 | 6, 8 | https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-clinical-assessments_en |
| LeanEntries | Development resource | 1, 2, 5 | 4 | https://www.leanentries.com |
| Machine Learning Support Initiative | Initiative | 1, 2, 4 | 2, 4, 5 | https://www.medical-device-regulation.eu/wp-content/uploads/2020/09/machine_learning_ai_in_medical_devices.pdf |
| MDCG guidance on clinical evaluation of orphan devices (to improve predictability of CE marking process) Presubmission meetings to provide (academic and commercial) trial sponsors with advice for conducting pre-market clinical investigations | Initiative | 1, 2, 5 | 3, 4 | https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf |
| Natural History Studies (NHS) | Development practice | 1, 2, 5 | 3, 4 | https://pubmed.ncbi.nlm.nih.gov/38522179/ |
| NICE Guidance | Regulatory tool | 6 | 4, 6, 7 | https://www.nice.org.uk/guidance |
| Orphan and paediatric medical devices in Europe: recommendations to support their availability for on-label and off-label clinical indications | Development practice | 2 | 4 | https://pubmed.ncbi.nlm.nih.gov/39302881/ |
| Orphanet database | Development resource | 1, 2, 5 | 3, 4 | https://www.orpha.net |
| PARADIGM Patient Engagement Toolbox | Other | 1, 2, 4, 5 | 1, 3, 6, 7 | https://imi-paradigm.eu/ https://www.eucapa.eu/ |
| Patent framework | Development practice | 3, 4 | 1, 2, 6, 7 | https://www.epo.org/en/applying/european/unitary/unitary-patent/legal-framework |
| Patient engagement in device trial design and feasibility | Development practice | 1, 2 | 1, 2, 3, 4 | https://heuefs.eu |
| Patient organisations | Development resource | 1, 2 | 3, 4 | https://www.rarediseasesinternational.org and https://www.eurordis.org |
| Patient surveys / Patient Preferences studies / Ethnographic research | Development practice | 1, 2 | 3, 4 | https://www.ema.europa.eu/en/documents/presentation/presentation-patient-preference-research-k-morgan-mpe_en.pdf |
| post-market surveillance studies | Development practice | 2, 5 | 4, 7 | https://www.who.int/publications/i/item/9789240015319 |
| Private funding | Development resource | 2, 3, 4, 5 | 1, 2, 3, 4, 5, 6, 7, 8 | https://ide.group/2024/11/top-funding-opportunities-for-medtech-startups-in-the-netherlands-and-europe/ |
| PyPeCT2S pipeline – Pythonic Paediatric Computed Tomography to Strength | Modelling and simulation tool | Paediatrice Device | 4 | Github for PyPeCT2S: https://github.com/INSIGNEO/PyPeCT2S Previous publication: https://doi.org/10.1016/j.crad.2019.08.026 |
| Rare diseases clinical outcome assessment | Development resource | 1, 2 | 4 | https://c-path.org/program/rare-disease-clinical-outcome-assessment-consortium/#rare-disease-coa-resource |
| Registries for Rare Diseases | Development practice | 1, 2, 4, 5 | 3, 4, 7, 8 | https://eu-rd-platform.jrc.ec.europa.eu/_en |
| SPARK | Development resource | 1, 2, 3, 4 | 1, 2, 3, 4, 6 | https://www.thesparkinitiative.com/ |
| Specific material for advanced medical simulation | Development practice | 4 | https://www.ipss.org/ | |
| Target Patient Value Profile | Development practice | 1, 2, 5 | 1, 2, 3 | https://patientengagementopenforum.org/docs/Workshop-1-PE-in-early-development.pdf |
| Technology transfer offices | Development resource | 3, 4 | 2, 3, 6 | https://www.wipo.int/en/web/technology-transfer/organizations |
| Template EUDAMED submission | Regulatory tool | 5 | 5 | https://webgate.ec.europa.eu/eudamed-help/en/documentation/user-guides-and-templates.html |
| The IDEAL Framework, in particular IDEAL-D. | Development resource | 1, 2, 3, 4, 5 | 1, 2, 3, 4, 5, 7 | https://journals.lww.com/annalsofsurgery/fulltext/2022/01000/ideal_d_framework_for_device_innovation__a.13.aspx https://www.ideal-collaboration.net/ |
| The Virtual Family: A set of anatomically correct whole-body computational models | Modelling and simulation tool | 1, 2, 5 | 1, 2, 3, 4 | https://cdrh-rst.fda.gov/virtual-family-set-anatomically-correct-whole-body-computational-models |
| Workflow for Assessing the Credibility of Patient-Specific Modeling in Medical Device Software | Modelling and simulation tool | 1, 2, 5 | 1, 2, 3, 4 | https://cdrh-rst.fda.gov/workflow-assessing-credibility-patient-specific-modeling-medical-device-software |