@misc{Singh, author = {Singh, Max Diamond}, title = {Reclassification of Orthopedic Devices per the Medical Device Regulation}, series = {OSMA Winter Educational Program, St. Petersburg/USA, 2019. - [Veranstalter: Orthopedic Surgical Manufacturers Association (OSMA)]}, journal = {OSMA Winter Educational Program, St. Petersburg/USA, 2019. - [Veranstalter: Orthopedic Surgical Manufacturers Association (OSMA)]}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {European Union MDRs impact on device manufacturers: Reprocessing of surgical invasive devices, critical timeliness and technical documentation requirements under MDR}, series = {The validation of sterile medical devices: sterilization, packaging, biocompatibility, toxicology and reprocessing, Amsterdam, 26.03. - 28.03.2019 [Veranstalter: Nelson Labs ; Sterigenics]}, journal = {The validation of sterile medical devices: sterilization, packaging, biocompatibility, toxicology and reprocessing, Amsterdam, 26.03. - 28.03.2019 [Veranstalter: Nelson Labs ; Sterigenics]}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Challenges to innovate in the medical device industry under the light of the new EU MDR : a notified body perspective}, series = {Intelligent medical devices - the next disruptor in healthcare ; challenges and oppoertunieties: technical, clinical, regulatory and health economics/market access}, journal = {Intelligent medical devices - the next disruptor in healthcare ; challenges and oppoertunieties: technical, clinical, regulatory and health economics/market access}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Innovation challenges for orthopedic device manufacturers under the new EU MDR}, series = {ORS (Orthopaedic Research Society) Annual Meeting. - Phoenix, Arizona, 08. - 11.02.2020}, journal = {ORS (Orthopaedic Research Society) Annual Meeting. - Phoenix, Arizona, 08. - 11.02.2020}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {EU-MDR from a Notified Body Perspective - aktuelle Situation hinsichtlich der Anforderungen zum Lieferantenmanagement}, language = {de} } @misc{Singh, author = {Singh, Max Diamond}, title = {EU Medical Device Regulation: Top Challenges of Orthopedic Manufacturers}, series = {OMTEC 2019 : 15th Annual Orthopedic Manufacturing \& Technology Exposition and Conference, Chicago, 11.6.2019}, journal = {OMTEC 2019 : 15th Annual Orthopedic Manufacturing \& Technology Exposition and Conference, Chicago, 11.6.2019}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {KARL STORZ Navigation Panel Unit - Navigation for ENT surgery}, series = {FESS 2010 : International Workshop on FESS ; Lectures \& Live Surgery. - Royal Pearl Hospital, Tiruchirappalli (Indien), 10.-11.04.2010}, journal = {FESS 2010 : International Workshop on FESS ; Lectures \& Live Surgery. - Royal Pearl Hospital, Tiruchirappalli (Indien), 10.-11.04.2010}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Conformity Assessment Procedure MDR}, series = {MDR Training: Person Responsible for Regulatory Compliance Course, 24.-25.02.2020, Tel Aviv, Obelis Academy}, journal = {MDR Training: Person Responsible for Regulatory Compliance Course, 24.-25.02.2020, Tel Aviv, Obelis Academy}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Innovationsmanagement}, language = {de} } @misc{Singh, author = {Singh, Max Diamond}, title = {General Overview of the Medical Device Regulation}, series = {MDR-Roadshow - T{\"U}V S{\"U}D MHS, India}, journal = {MDR-Roadshow - T{\"U}V S{\"U}D MHS, India}, language = {en} } @incollection{SinghCapanni, author = {Singh, Max Diamond and Capanni, Felix}, title = {Medizintechnik-Spin-offs aus der Hochschule - Ein Prozessbeispiel}, series = {Entrepreneurship im Gesundheitswesen II}, booktitle = {Entrepreneurship im Gesundheitswesen II}, editor = {Pfannstiel Mario A., and Da-Cruz, Patrick and Rasche, Christoph}, publisher = {Springer Gabler}, address = {Wiesbaden}, isbn = {978-3-658-14781-5}, abstract = {Die Aufmerksamkeit f{\"u}r Unternehmensgr{\"u}ndungen hat in den letzten Jahren extrem zugenommen. Grunds{\"a}tzlich muss ein Start-up in einem kompetitiven Umfeld erfolgreich sein, um bestehen zu k{\"o}nnen. Der Weg dorthin wird maßgeblich beeinflusst durch Planung und finanzielle Ressourcen, die die Gr{\"u}nder bereitstellen m{\"u}ssen. In der Medizinprodukteindustrie kommen zus{\"a}tzlich große H{\"u}rden hinzu, die u. a. einen kurzen Produktlebenszyklus, lange Projektlaufzeiten, aufwendige klinische Studien und aktuell neue gesetzliche Verordnungen betreffen. Dieser Beitrag konzentriert sich zun{\"a}chst auf m{\"o}gliche F{\"o}rdermittel und Beratung von Start-up-Projekten aus dem Hochschulbereich. Aus einer Analyse derzeit existierender Gr{\"u}nderwettbewerbe im Hinblick auf das Gesundheitswesen werden dem Leser entsprechende Adressen zum Einwerben von F{\"o}rdermitteln geliefert. Dar{\"u}ber hinaus wird ein Pilot-Prozess vorgestellt, wie eine Ausgr{\"u}ndungsberatung an der Hochschule Ulm im Studiengang Medizintechnik derzeit verl{\"a}uft. Dies kann m{\"o}glicherweise ein Ankn{\"u}pfungspunkt f{\"u}r eine zuk{\"u}nftige Institutionalisierung von Spin-off-Vorhaben aus dem Hochschulbereich sein.}, language = {de} } @incollection{Singh, author = {Singh, Max Diamond}, title = {Produktmanagement in der Medizintechnik}, series = {Medizinprodukte Management}, booktitle = {Medizinprodukte Management}, editor = {Schwegel, Philipp and Da-Cruz, Patrick and Hemel, Ulrich and Oberender, Peter}, publisher = {PCO-Verlag}, address = {Bayreuth}, isbn = {978-3-941678-47-7}, pages = {148 -- 161}, abstract = {Das Management in der Medizinprodukteindustrie steht vor vielf{\"a}ltigen Herausforderungen. So sinken einerseits die Produktpreise, anderseits wird auch f{\"u}r die kommenden Jahre in vielen Segmenten ein Mengenwachstum erwartet. Dies stellt die internen Prozesse, vom Customer Service bis hin zur Forschung \& Entwicklung, auf den Pr{\"u}fstand. Die Entscheidungstr{\"a}ger auf Kundenseite ver{\"a}ndern sich, weg vom Produktanwender hin zu professionellen Einkaufsgemeinschaften mit immer gr{\"o}ßerer Verhandlungsmacht. Der hohe Internationalisierungsgrad der Unternehmen f{\"u}hrt zu einer steigenden Komplexit{\"a}t bei der Implementierung von Marketing-, Vertriebs- und Produktentwicklungsstrategien auf L{\"a}nderebene. Dar{\"u}ber hinaus werden zunehmend neue Gesch{\"a}ftsmodelle mit hohem Dienstleistungsanteil entwickelt, die mit der traditionellen Lieferantenrolle wenig zu tun haben und von Managern eine neue F{\"a}higkeiten f{\"u}r die Umsetzung erfordern. Die Autoren des Sammelbands greifen die genannten Herausforderungen auf und bieten mit ihren Beitr{\"a}gen L{\"o}sungsans{\"a}tze, die sowohl f{\"u}r Manager im Medizinprodukteunternehmen als auch f{\"u}r Wissenschaftler und Studierende relevant sind.}, language = {de} } @misc{Singh, author = {Singh, Max Diamond}, title = {Managing Innovation from the Notified Body Perspective - Understanding the 3 C's of EU Regulations to Ensure Product Compliance: Changes, Challenges and Contributions}, series = {3rd annual european medical device and diagnostic product development and management meeting, 12-13 February 2019, Brussels}, journal = {3rd annual european medical device and diagnostic product development and management meeting, 12-13 February 2019, Brussels}, language = {en} } @misc{SinghSchlagintweitReischle2020, author = {Singh, Max Diamond and Schlagintweit, S. and Reischle, G.}, title = {Additive-Manufactured Orthopedic Implants Under MDR}, number = {08.11.20}, year = {2020}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Joint NB-Position Paper on Spinal Classification per the MDR}, language = {en} } @phdthesis{Singh, author = {Singh, Max Diamond}, title = {Aspects of the Dynamics of Spine Surgery Technologies: Assessing the Reality of Innovation and Entrepreneurship in the U.S. Medical Device Industry}, publisher = {Karlsruhe Institute of Technology}, address = {Karlsruhe}, pages = {xix, 254 S.}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {MDR - Die neuen rechtlichen Bedingungen f{\"u}r H{\"a}ndler und Hersteller: aus der Sicht einer benannten Stelle}, series = {MEGRA Jahrestagung. - Wien, 18.05.2020 [Veranstalter: Mitteleurop{\"a}ische Gesellschaft f{\"u}r Regulatory Affairs]}, journal = {MEGRA Jahrestagung. - Wien, 18.05.2020 [Veranstalter: Mitteleurop{\"a}ische Gesellschaft f{\"u}r Regulatory Affairs]}, language = {de} } @misc{Singh, author = {Singh, Max Diamond}, title = {Medical Device Regulation}, series = {Forum MedTech Pharma: Start-ups in der Medizintechnik: Besonderheiten und Fallbeispiele, M{\"u}nchen, 17.7.2019}, journal = {Forum MedTech Pharma: Start-ups in der Medizintechnik: Besonderheiten und Fallbeispiele, M{\"u}nchen, 17.7.2019}, language = {de} } @misc{Singh, author = {Singh, Max Diamond}, title = {Market Access for Devices under MDD and MDR: Obligations for Manufacturers}, series = {OSMA - Orthopedic Surgical Manufacturers Association, Winter Educational Program - virtual}, journal = {OSMA - Orthopedic Surgical Manufacturers Association, Winter Educational Program - virtual}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Herausforderungen der Medizinprodukteindustrie bei der Internationalisierung}, series = {Studienwoche an der HNU (Hochschule Neu-Ulm) 2020}, journal = {Studienwoche an der HNU (Hochschule Neu-Ulm) 2020}, language = {de} } @article{SinghRussTerzidis, author = {Singh, Max Diamond and Russ, Jochen and Terzidis, Orestis}, title = {The Impact of the ObamaCare Excise Tax on Innovation and Entrepreneurship - Early Empirical Findings}, series = {International Journal of Innovation Science}, volume = {7}, journal = {International Journal of Innovation Science}, number = {2}, publisher = {Emerald}, doi = {10.1260/1757-2223.7.2.75}, pages = {75 -- 90}, abstract = {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.}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Zus{\"a}tzliche Anforderungen an Produktdaten und technische Dokumentation durch die MDR}, series = {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]}, journal = {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]}, language = {de} } @misc{Singh, author = {Singh, Max Diamond}, title = {MDR Implementation Status and Lessons Learned from the Past Months: A Notified Body Perspective}, series = {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}, journal = {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}, publisher = {Cambridge Innovation Institute}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {MDR implementation status \& lessons learned}, language = {en} } @article{Singh, author = {Singh, Max Diamond}, title = {Orthopedic Medical Devices Under The Scope of The EU MDR}, series = {MedTech Outlook}, journal = {MedTech Outlook}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Stakeholder view on Post Market Surveillance under the EU MDR: Timelines, Compliance and Requirements ; Post Market Surveillance \& Vigilance}, series = {MedTech summit 2020: EU MDR \& IVDR: the end ist in sight, 22.-26.06.2020, Dublin/virtual}, journal = {MedTech summit 2020: EU MDR \& IVDR: the end ist in sight, 22.-26.06.2020, Dublin/virtual}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Quality in Medical Device Innovation for Start-ups, SME, and large enterprises through the new Medical Device Regulation}, series = {3rd European QA Conference, Dublin, 06. - 08.11.2019}, journal = {3rd European QA Conference, Dublin, 06. - 08.11.2019}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Notified body feedback: PSUR Forms. Post Market Surveillance \& Vigilance}, series = {MedTech Summit 2020: EU MDR \& IVDR: the end is in sight, Dublin/virtual, 20.-26.06.2020}, journal = {MedTech Summit 2020: EU MDR \& IVDR: the end is in sight, Dublin/virtual, 20.-26.06.2020}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Technical Documentation MDR / IVDR, including the Declaration of Conformity}, series = {MDR Training: Person Responsible for Regulatory Compliance, 24.-25.02.2020, Tel Aviv, Obelis Academy}, journal = {MDR Training: Person Responsible for Regulatory Compliance, 24.-25.02.2020, Tel Aviv, Obelis Academy}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Notified Body Viewpoint : Preparing for MDR/IVDR}, series = {MDR/IVDR - Status Report from Stakeholders. Where are we now in November 2018? - Bern, 22.11.2018 - [Veranstalter: RAPS : Regulatory Affairs Professionals Society]}, journal = {MDR/IVDR - Status Report from Stakeholders. Where are we now in November 2018? - Bern, 22.11.2018 - [Veranstalter: RAPS : Regulatory Affairs Professionals Society]}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Strategies to Navigate to the EU MDR and Clinical Requirements}, series = {Regulatory Affairs Professionals Society (RAPS): Session 1 - Tampa, Florida 2019}, journal = {Regulatory Affairs Professionals Society (RAPS): Session 1 - Tampa, Florida 2019}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Technical Aspects for Navigated Sinus Surgery}, series = {4th Workshop on Endoscopic Surgery of the Maxillary Sinus and Navigation, T{\"u}bingen University Hospital, 2009}, journal = {4th Workshop on Endoscopic Surgery of the Maxillary Sinus and Navigation, T{\"u}bingen University Hospital, 2009}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Overview of the Medical Device Regulation (MDR)}, language = {en} } @article{SinghTerzidis, author = {Singh, Max Diamond and Terzidis, O.}, title = {Introducing Innovation Phase Transition}, series = {International Journal of Innovation Science}, volume = {7}, journal = {International Journal of Innovation Science}, number = {4}, publisher = {Emerald}, issn = {1757-2223}, doi = {10.1108/IJIS-07-04-2015-B003}, pages = {249 -- 262}, abstract = {Innovation diffusion points toward how innovations spread into the market after launch. This paper investigates diffusion dynamics at market entry time and proposes a new evolution pattern at the intersection between inventions and innovations. With this in mind, we initially prove that patent filings correlate with new product introductions in the U.S. spine market. Then we test our new theory supposing that certain patent filing threshold numbers accelerate strong economic returns in terms of innovations. We find that firms hitting certain patent filing thresholds significantly increase their product launches in the mentioned market. Moreover, the results seem to indicate that economic returns of inventions may be measured substantially. Thus, this paper suggests a new research area by utilizing our proposed concept about an Innovation Outcome Trigger Value (IOTV). Furthermore, the implications may also be interesting for practitioners, since we empirically prove that inventive activities turn out to be worthwhile, indeed.}, language = {en} }