TY - JOUR A1 - Singh, Max Diamond A1 - Russ, Jochen A1 - Terzidis, Orestis T1 - The Impact of the ObamaCare Excise Tax on Innovation and Entrepreneurship – Early Empirical Findings JF - International Journal of Innovation Science N2 - This study addresses aspects of governmental influence on innovation by analyzing the impact of the ObamaCare excise tax on the medical device industry. We initially give an overview of common approaches to measuring innovativeness and entrepreneurship, empirically assess whether existing metrics are suitable for investigating the innovation performance of the U.S. medical device industry, and define a new measure (firm innovation activity) for entrepreneurship. Then we perform a quantitative analysis to explore the impact of the tax. We analyze more than 60,000 product clearances from 1996 to 2013, using the FDA database. We find a significant relationship between product counts and revenues for one segment. Contrary to the present criticism of the excise tax, we find hardly any noteworthy response in either firm innovation activity or number of products launched in the year after the tax was introduced. The 2013 reduction of new product submissions is well within the limits of typical annual fluctuations observed in previous years. This provides a first indication that the excise tax act did not have a strong impact on innovative activities through the present. Y1 - 2015 U6 - https://doi.org/10.1260/1757-2223.7.2.75 VL - 7 IS - 2 SP - 75 EP - 90 PB - Emerald ER - TY - GEN A1 - Singh, Max Diamond T1 - Zusätzliche Anforderungen an Produktdaten und technische Dokumentation durch die MDR T2 - Medizintechnik Kongress 2018: Effizienz in der Medizinprodukteentwicklung vor dem Hintergrund von MDR und IVDR ; Frankfurt am Main, 08.11.2018, [Veranstalter: Velten Consulting & ILC Consulting] Y1 - 2018 ER - TY - GEN A1 - Singh, Max Diamond T1 - MDR Implementation Status and Lessons Learned from the Past Months: A Notified Body Perspective T2 - Cambridge Healthtech Institute's 2nd Annual Medical Device Clinical Trial Design and Operations: Trial Design and Technology to Optimize Medical Device Trials, Orlando, Florida + Virtual, 02.-03.03.2021 Y1 - PB - Cambridge Innovation Institute ER - TY - GEN A1 - Singh, Max Diamond T1 - MDR implementation status & lessons learned BT - MDR-Audtis – Best Practive & Learning, Tuttlingen, 10.02.2021 Y1 - 2021 ER - TY - JOUR A1 - Singh, Max Diamond T1 - Orthopedic Medical Devices Under The Scope of The EU MDR JF - MedTech Outlook Y1 - 2019 UR - https://embedded-solutions.medicaltechoutlook.com/cxoinsight/orthopedic-medical-devices-under-the-scope-of-the-eu-mdr-nwid-921.html ER - TY - GEN A1 - Singh, Max Diamond T1 - Stakeholder view on Post Market Surveillance under the EU MDR: Timelines, Compliance and Requirements ; Post Market Surveillance & Vigilance BT - [Vortrag gehalten am: 23.6.2020] T2 - MedTech summit 2020: EU MDR & IVDR: the end ist in sight, 22.-26.06.2020, Dublin/virtual Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - Quality in Medical Device Innovation for Start-ups, SME, and large enterprises through the new Medical Device Regulation T2 - 3rd European QA Conference, Dublin, 06. - 08.11.2019 Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - Notified body feedback: PSUR Forms. Post Market Surveillance & Vigilance BT - [Vortrag gehalten am 24.06.2020] T2 - MedTech Summit 2020: EU MDR & IVDR: the end is in sight, Dublin/virtual, 20.-26.06.2020 Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - Technical Documentation MDR / IVDR, including the Declaration of Conformity BT - [Vortrag gehalten am 24.02.2020] T2 - MDR Training: Person Responsible for Regulatory Compliance, 24.-25.02.2020, Tel Aviv, Obelis Academy Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - Notified Body Viewpoint : Preparing for MDR/IVDR T2 - MDR/IVDR - Status Report from Stakeholders. Where are we now in November 2018? - Bern, 22.11.2018 - [Veranstalter: RAPS : Regulatory Affairs Professionals Society] Y1 - 2018 ER -