Introduction of Medical Device Development through Industry–Academia Collaboration by the Hamamatsu Method

IF 0.8 Q4 ENGINEERING, BIOMEDICAL
Yuko Amano-Ito
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引用次数: 0

Abstract

To develop medical devices, collaborations are necessary between universities and hospitals that have technological problems and companies with the appropriate technological facilities to solve these problems. Large companies do not generally compete in niche markets, where large sales and profits are not expect-ed, which then become the target for small and medium enterprises (SMEs). In this study, the “ Mono-Dzukuri region ” was considered because of its dense concentration of universities or hospitals and SMEs. However, interventions by industry–academia collaboration coordinators (CDs) are required to ensure smooth collaborations between academia and SMEs that are unfamiliar with medical device development as well as companies that lack market presence in the medical device field. In this study, the Hamamatsu area, a locality that is actively engaged in medical device development through collaborations, was evaluated for different hypotheses. The CDs are integral to forming an appropriate ecosystem for the development team to educate doctors, medical workers, SMEs, and venture companies. Specifically, seminars on medical and clinical research methods are used to educate stakeholders on the importance of collaboration. These seminars provide collaborative op-portunities, R&D expenses, and technology transfer and sales promotion support from commercialization to sales. Local governments and banks also support these efforts. CDs from different institutions also actively col-laborate with each other; they use co-working spaces and the Coordinator Support System to share information and consult on problems. Through these efforts, CDs have successfully assisted the continuous development of medical devices. Both successful and failed commercialization cases are reported herein. After examining the causes of failure, it was found that collaborations often failed when the needs of the marketing authorization holders could not be met and when the medical and technical needs were not fully understood. To gradually increase the number of successful cases of medical devices developed in Japan, it is necessary to build a development model, expand it to other geographical areas, such as Shinshu, Oita, and Tottori, and support the development of CDs. Additionally, it is important to develop a knowledge base while utilizing the advantages of the local characteristics of these areas.
采用滨松方法通过产学研合作开发医疗器械
为了开发医疗设备,有技术问题的大学和医院与具有解决这些问题的适当技术设施的公司之间必须进行合作。大公司通常不会在利基市场竞争,因为利基市场的销售额和利润不高,因此成为中小型企业(SMEs)的目标。在这项研究中,由于大学或医院和中小企业的密集集中,因此考虑了“Mono-Dzukuri地区”。然而,需要产学研协作协调员(cd)的干预,以确保学术界与不熟悉医疗器械开发的中小企业以及在医疗器械领域缺乏市场份额的公司之间的顺利合作。在本研究中,滨松地区,一个地方,是积极从事医疗器械的发展,通过合作,评估了不同的假设。这些cd是为开发团队形成一个适当的生态系统以教育医生、医务工作者、中小企业和风险公司所必需的。具体而言,利用关于医学和临床研究方法的研讨会,教育利益攸关方了解合作的重要性。这些研讨会提供合作机会、研发费用、技术转移和从商业化到销售的销售促进支持。地方政府和银行也支持这些努力。来自不同机构的cd也积极地相互合作;他们使用联合办公空间和协调员支持系统来共享信息和咨询问题。通过这些努力,光盘成功地协助了医疗器械的不断发展。本文报告了成功和失败的商业化案例。在审查了失败的原因后,发现在不能满足销售许可持有人的需求和不能充分了解医疗和技术需求时,合作往往会失败。为了逐步增加日本医疗器械开发的成功案例,有必要建立一个发展模式,将其扩展到其他地理区域,如信州、大分、鸟取,并支持cd的发展。此外,在利用这些地区的地方特色优势的同时,建立一个知识库是很重要的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Advanced Biomedical Engineering
Advanced Biomedical Engineering ENGINEERING, BIOMEDICAL-
CiteScore
1.40
自引率
10.00%
发文量
15
审稿时长
15 weeks
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