You can fill out the questionnaire below. This should take about 20 minutes. Name Your e-mail * Your name * General questions Was the research in academic or private setting? * Academic Private Was the preclinical research industry driven? * Yes No Was the preclinical research in collaboration with industry? * Yes No Were clinicians involved in the preclinical research? * Yes No At what moment was first contact with clinicians? * Was guidance or expertise available for helping with the translation course that had to be followed? (eg. Technology transfer office) * Yes No Were the results of the research successful? * Yes No General issues for further research Further translation into clinical practice was not performed due to: Lack of clinical interest (clinical needs versus potential benefit) * Yes No Lack of industry interest * Yes No Lack of motivation of researcher for further translation * Yes No Lack of experience with translation of preclinical research * Yes No What moment was the first contact with regulatory authorities (eg. FDA,EMA, NMPA,…)? Please specify. * Was a market search performed? * Yes No Patent issues Was there freedom to operate? Yes No Was intellectual protection (patents) for the coating secured? * Yes No Technical issues regarding coating for clinical use Were there technological issues regarding the coating process? * Yes No Was the coating process performed by the company or by the researcher? Please explain. * Were there technological issues regarding upscaling (drug manufacturing) * Yes No Was a contract with a company available to define how to proceed with upscaling? * Yes No Were there toxicity or safety issues? * Yes No Were there dose issues or administration route issues? * Yes No Was the preclinical set-up comparable to the use in clinical practice? * Yes No Were negative outcome results present or published? * Yes No Was an optimal industrial benchmark available? * Yes No Did translation from one animal model to another animal model cause problems? * Yes No Was the studied technology compared with competing similar (already available) technologies? * Yes No Financial issues Whick kind of funding was available? * Investments Industry Grant Did the phase of preclinical set-up influence the possibility for funding? (e.g. funding for proof of concept versus funding for clinical translatability) * Yes No Was there a business model set-up to define collaboration with companies? * Yes No Was there an application for funding performed? * Yes No Was there a funding for fundamental research available (incubation funding)? * Yes No Was there a funding for translational research available (seed/starting funding)? * Yes No Was there a post-incorporation funding available? * Yes No Was the funding sufficient to perform the research? * Yes No Was there assistance available for the funding application? * Yes No Was a collaboration with a company established? * Yes No Regulatory issues What was the official regulatory organ? FDA/EMA/NMPA (national medical products administration (China)). Please specify. * At which moment was the first contact with regulatory authorities? Please specify. * Was the contact before or after the new regulation for medical devices (MDR), EU 2017/745? Please specify. * Did early contact/dialogue with regulatory authorities bring-up issues that discouraged/inhibited further translation? * Yes No Were regulatory requirements clear enough for the researchers? * Yes No Did interaction with regulatory authorities influence the research set-up? * Yes No Was there a lack of resources to achieve regulatory compliance? * Yes No Specification of issues: Was an additional animal requested? * Yes No Were additional data requested because of insufficient reporting of experimental condition? * Yes No Were there concerns about the choice of animal (age, strain, gender)? * Yes No Were there issues regarding study length? * Yes No Did the statistical design lack power? * Yes No Was duplication of the study in another lab performed? (cfr 50% failure rate) * Yes No Were additional tests needed to meet Iso standards/medical device regulations (MDR)? * Yes No If clinical application was performed: At which stage did it end? Please specify. Was clinical testing stopped earlier than expected? Yes No Was clinical investigation performed according to MDR? (eg. Focus on safety/performance of device, not efficacy) Yes No Which phase? Phase 0: pharmacokinetic testing Phase 1: dose ranging testing Phase 2: efficacy/side effect testing Phase 3: efficacy testing, safety testing Phase 4: post marketing surveillance Were there any difficulties for inclusion of patients? Yes No Were real world data available? Yes No Which problems were encountered when going from one phase to another? Please specify.
