scholarly journals Health Software Product or Software as Medical Device

2021 ◽  
Vol 7 (2) ◽  
pp. 644-647
Author(s):  
Tabea Lukas ◽  
Keywan Sohrabi ◽  
Volker Gross ◽  
Michael Scholtes
Keyword(s):  
Medical Device ◽  
Early Stage ◽  
Medical Product ◽  
Physiological Data ◽  
Software Products ◽  
Regulatory Affairs ◽  
The Right ◽  
Start Ups ◽  
Medical Device Regulation ◽  
Young Entrepreneurs

Abstract The number of software products in the field of health and medicine increases excessively. Self-tracking, fitness, health advice, dose calculation, and analysis of physiological data - apps are popular and commonly used. Some of the products are affected by the medical device regulation, consciously or unconsciously. For young entrepreneurs, it is difficult to recognize and understand the distinction between software as medical product and health software products. A product-related orientation guide could help start-ups to understand the difference and to find the right strategy for placing their product on the market. All relevant information were collected and analyzed. Input came from a systematic literature research, an evaluation of the CHARISMHA study and a consideration of the medical device regulation as well as the relevant standards (e.g. IEC 62304 and IEC 82304). The guide was adapted to the particular situation of start-ups and microenterprises, inter alia having regard to missing regulatory affairs competences. A product-related orientation guide for young entrepreneurs was developed, which helps to identify whether products are affected by the medical device regulation or not. The guide uses a few simple questions, and it allows the entrepreneurs to estimate the related effort. Furthermore, it provides an overview of relevant standards and needed competences for the chosen path. The guide brings certainty and can help young entrepreneurs to identify the upcoming workload at an early stage. Due to the decision tree concept, it is easy to adapt the product-related strategy and see the consequences. This might help entrepreneurs to find the right strategy for placing their product on the market. Nevertheless, field testing with the guide is necessary to validate its benefit.

Early stage and seed financing for biotechnology start-ups: A UK perspective

10.5912/jcb33 ◽  
1969 ◽  
Vol 9 (3) ◽  
Author(s):  
George Whitehead
Keyword(s):  
Final Section ◽  
Early Stage ◽  
Investment Opportunity ◽  
Biotechnology Companies ◽  
The Right ◽  
Start Ups

It is a tough climate in which to be raising early stage investment but there is funding available for the very best of British biotechnology. This report outlines several sources of funding that the author has found most relevant to early stage biotechnology companies. The competition for the limited funds is harsh so it is vital that biotechnology entrepreneurs choose the right sources of funding and approach them in the right way. The final section briefly outlines how companies can 'tilt the balance' in their favour and learn to move from just being scientifically convincing to becoming a commercially convincing investment opportunity.

scholarly journals Measurements in the Early Stage Software Start-ups: A Multiple Case Study in a Nascent Ecosystem

2018 ◽  
Vol 43 (4) ◽  
pp. 251-280 ◽  
Author(s):  
Grace Kamulegeya ◽  
Raymond Mugwanya ◽  
Regina Hebig
Keyword(s):  
East Africa ◽  
Early Stage ◽  
Multiple Case Study ◽  
Developed Countries ◽  
Structured Interviews ◽  
Software Products ◽  
Analysis Technique ◽  
Multiple Case ◽  
Start Ups

Abstract Context: Software measurement is crucial to stay competitive and deliver quality software products. Problem: While much research has been done on measurement in large companies in developed countries, there is limited research on measurement in start-ups. So far there are no studies on whether these results apply to nascent ecosystems, such as those in East Africa. Goal: The aim of this study is to understand the use and perceived benefits of measurement in software start-ups in East Africa. Method: We performed a multi-case study on 19 software start-ups in hubs in Uganda and Kenya, through conducting semi-structured interviews. We transcribed and analyzed them using the content analysis technique. Results: We identified that start-ups are using a number of business and product-oriented metrics. Furthermore, we found no evidence on the use of design-oriented metrics. Nonetheless, start-ups have considerable expectations on the benefits of measuring. Finally, metrics found in this study partially differ from metrics used in start-ups in developed countries. Conclusion: There is a need to create a more inclusive characterization for measurement as early start-ups in East Africa cannot yet be represented with known models.

Europäischer Medizinproduktemarkt: Wie sich Einkauf und Logistik auf die europäische MDR vorbereiten müssen

2019 ◽  
Vol 01 (04) ◽  
pp. 74-77
Author(s):  
Thomas Gallmann
Keyword(s):  
Medical Device ◽  
Medical Device Regulation

Nicht lieferbare Medizinprodukte sind für Kliniken ein Albtraum – mitunter müssen sogar geplante OPs abgesagt werden. Die Folge: Die mit den Kostenträgern vereinbarten Leistungszahlen sind schwieriger zu erfüllen und es könnte zu schwer kompensierbaren Erlöseinbußen für die Leistungserbringer kommen. Die Medical Device Regulation (MDR) wird die Liefersituation von Medizinprodukten ab 2020 wahrscheinlich noch weiter verschärfen.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

2021 ◽  
Vol 10 (1) ◽  
pp. 64-88
Author(s):  
James I. J. Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Transition Period ◽  
Eu Directive ◽  
Custom Made ◽  
Dental Setting ◽  
The Uk ◽  
Dental Professionals ◽  
The Eu ◽  
Medical Device Regulation

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.

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