Department of Next Generation Endoscopic Intervention (Project ENGINE), Osaka University Graduate School of Medicine, Osaka, Japan.
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Surg Endosc. 2023 Dec;37(12):9633-9642. doi: 10.1007/s00464-023-10474-3. Epub 2023 Oct 27.
Training next-generation personnel from small/medium enterprises (SMEs) is an urgent issue in promoting medical device research and development (R&D). Since 2014 we have engaged in governmentally funded human resource development program for medical/non-medical SMEs, and have assessed its effectiveness by analyzing self-evaluation of achievement level (SEAL) data obtained before and after the training course.
Human resource development experts interviewed 34 key opinion leaders with deep knowledge of medical device R&D from industry, government, and academia. The skills required for R&D personnel were written down, and a set of skills was created by making a greatest common measure in the list of common elements among them. Using that skill sets, skill evaluations were conducted on trainees at "Osaka University Training Course," twice before participation and after completion of the entire program using SEAL assessment.
There were 97 men and 25 women, with one-third in the'30 s. Among them, 61 participants (50%) were from R&D divisions, and 32 (26%) were from business/sales divisions. 94 (77%) were from medical SMEs, and 28 (23%) were from non-medical SMEs (new entry). After completing the training course, significant growth was observed in every item of both Soft and Hard skill sets. Especially in new entry SME members, a striking improvement was observed in practical medical knowledge to enhance communication with medical doctors (p < 0.0001).
Our training course, though 7-day-short in total, showed that both Soft and Hard skills could be improved in young medical/non-medical SME members. Further assessment is needed to establish the necessary skill sets for our future partners from industries, to foster the creation of innovative medical devices through med-tech collaboration.
培养来自中小企业（SMEs）的下一代人才是推动医疗器械研发（R&D）的当务之急。自 2014 年以来，我们一直参与政府资助的医疗/非医疗中小企业人力资源开发计划，并通过分析培训课程前后获得的自我评估成就水平（SEAL）数据来评估其效果。
人力资源开发专家采访了来自行业、政府和学术界的 34 位对医疗器械研发有深入了解的主要意见领袖。将研发人员所需的技能写下来，并通过对他们的共同要素列表进行最大公因数运算，创建一套技能。使用该技能集，在参与大阪大学培训课程之前和整个课程完成后两次对学员进行技能评估，使用 SEAL 评估。
共有 97 名男性和 25 名女性，其中三分之一在 30 多岁。其中，61 名参与者（50%）来自研发部门，32 名（26%）来自业务/销售部门。94 名（77%）来自医疗中小企业，28 名（23%）来自非医疗中小企业（新进入者）。完成培训课程后，软技能和硬技能的每个项目都有显著增长。特别是在新进入的 SME 成员中，观察到与医生沟通的实用医学知识显著提高（p < 0.0001）。
我们的培训课程虽然总共只有 7 天，但表明年轻的医疗/非医疗中小企业成员的软技能和硬技能都可以得到提高。需要进一步评估，以确定未来与工业界合作伙伴合作所需的技能集，通过医疗技术合作促进创新医疗器械的开发。
