Enabling MedTech Translation in Academia: Redefining Value Proposition with Updated Regulations

Letourneur, Didier; Joyce, Kieran; Chauvierre, Cédric; Bayon, Yves; Pandit, Abhay

doi:10.1002/adhm.202001237

Cited by 17 publications

(20 citation statements)

References 38 publications

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“…At the same time, it is SMEs rather than large companies that are vulnerable to changes in device development regulation due to the limited possibilities of co-financing additional administrative costs. Letourneur et al 56 and Vasiljeva et al 57 also comment on the effectiveness of the new EU regulation on medical devices. Vasiljeva et al 57 draw attention to the increasing strictness of the regulatory framework, represented by the new MDR legislation, in the field of medical devices on the common EU market.…”

Section: Search Results On Regulation Innovation Economic Impact and Medical Devicementioning

confidence: 99%

“…In terms of economic impact, Vasiljeva et al 57 note that there is no certainty as to the change in compliance costs resulting from the MDR legislation. Letourner et al 56 perform a SWOT analysis and conclude, among other findings, that the tightening regulatory demands are resource-intensive (eg the increased time-to-market for the originator). However, the authors believe that the new legislation brings new opportunities for spin-off and start-up companies collaborating with academic institutions.…”

Section: Search Results On Regulation Innovation Economic Impact and Medical Devicementioning

confidence: 99%

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Critical Factors and Economic Methods for Regulatory Impact Assessment in the Medical Device Industry

Mačí¹

2022

RMHP

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Introduction The regulatory area is one that restricts human behaviour and opportunities, but it also allows the prevention of loss of property, health, or even life in various fields. Regulations provide the market with public confidence, which is extremely important in the field of innovative medical devices. The aim of this article is to analyse critical factors and economic methods for regulatory impact assessment in the medical device industry, to focus on the finances, processes, or innovation activity of organisations operating in the medical device sector. Methods The paper consists of a scoping review according to the PRISMA methodology of the available literature in Web of Science and Scopus database, whereby combing the keywords “regulation” AND “innovation” AND “medical device” AND “economic impact,” we obtained a set of 156 results in the form of English-written articles. The output was then limited to the period between 2011 and 2020. Finally, 23 papers were used based on the exclusion and inclusion criteria. Results The resulting challenges of the identified problems in particular are the amount of high-quality data available at an appropriate cost and the availability of a flexible notified body. There are also challenges specific to the situation, such as demands on the safety of medical devices for children. From a public expectations point of view, there is a continuing need to maintain the urgency of the balance between available innovation and safety. Discussion As for the methods of economic assessment in general, or methods for assessing the economic impact of regulations in particular, cost-effectiveness analysis is the most commonly used method for research and development, while internal rate of return is frequently used for the producers, and budget impact analysis is typically used for healthcare service providers. A non-financial indicator that is often discussed is the time demands associated with meeting compliance requirements. The time-to-market indicator is also often mentioned. Economic and financial topics are not discussed in depth, as the reviewed articles simply mention the generally high costs attendant on complying with regulations and obtaining certificates.

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Section: Search Results On Regulation Innovation Economic Impact and Medical Devicementioning

confidence: 99%

Section: Search Results On Regulation Innovation Economic Impact and Medical Devicementioning

confidence: 99%

Critical Factors and Economic Methods for Regulatory Impact Assessment in the Medical Device Industry

Mačí¹

2022

RMHP

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“…One of the only practical, short-term pathways to translate a new technology into medicine is to have it advanced by a company. 36,37…”

Section: B3 Academic-industry Partnershipsmentioning

confidence: 99%

A roadmap for research in medical physics via academic medical centers: The DIVERT Model

2021

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The field of medical physics has struggled with the role of research in recent years, as professional interests have dominated its growth toward clinical service. This article focuses on the subset of medical physics programs within academic medical centers and how a refocused academic mission within these centers should drive and support Discovery and Invention with Ventures and Engineering for Research Translation (DIVERT). A roadmap to a DIVERT‐based scholarly research program is discussed here around the core building blocks of: (a) creativity in research and team building, (b) improved quality metrics to assess activity, (c) strategic partnerships and spinoff directions that extend capabilities, and (d) future directions driven by faculty‐led initiatives. Within academia, it is the unique discoveries and inventions of faculty that lead to their recognition as scholars, and leads to financial support for their research programs and reconition of their intellectual contributions. Innovation must also be coupled to translation to demonstrate outcome successes. These ingredients are critical for research funding, and the two‐decade growth in biomedical engineering research funding is an illustration of this, where technology invention has been the goal. This record can be contrasted with flat funding within radiation oncology and radiology, where a growing fraction of research is more procedure‐based. However, some centers are leading the change of the definition of medical physics, by the inclusion or assimilation of researchers in fields such as biomedical engineering, machine learning, or data science, thereby widening the scope for new discoveries and inventions. New approaches to the assessment of research quality can help realize this model, revisiting the measures of success and impact. While research partnerships with large industry are productive, newer efforts that foster enterprise startups are changing how institutions see the benefits of the connection between academic innovation and affiliated startup company formation. This innovation‐to‐enterprise focus can help to cultivate a broader bandwidth of donor‐to‐investor networks. There are many predictions on future directions in medical physics, yet the actual inventive and discovery steps come from individual research faculty creativity. All success through a DIVERT model requires that faculty‐led initiatives span the gap from invention to translation, with support from institutional leadership at all steps in the process. Institutional investment in faculty through endowments or clinical revenues will likely need to increase in the coming years due to the relative decreasing size of grants. Yet, radiology and radiation oncology are both high‐revenue, translational fields, with the capacity to synergistically support clinical and research operations through large infrastructures that are mutually beneficial. These roadmap principles can provide a pathway for committed academic medical physics programs in scholarly leadership that will preserve medic...

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“…The selection of the tissue source for the extraction of the collagen raw material has increasingly been identified as a key aspect to ensure reproducibility, scalable development, and clinical translation of new medical device prototypes. This is dictated by (i) the animal-induced variation in the chemical composition of collagen; (ii) the recent implementation of the new medical device regulation in the EU [15,16]; and (iii) the increasing efforts of academic institutions worldwide to pursue technology innovation and bridge the gap between the bench and bedside [17].…”

Section: Introductionmentioning

confidence: 99%

Effect of Mammalian Tissue Source on the Molecular and Macroscopic Characteristics of UV-Cured Type I Collagen Hydrogel Networks

Brooker

Tronci

2022

Prosthesis

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The tissue source of type I collagen is critical to ensure scalability and regulation-friendly clinical translation of new medical device prototypes. However, the selection of a commercial source of collagen that fulfils both aforementioned requirements and is compliant with new manufacturing routes is challenging. This study investigates the effect that type I collagen extracted from three different mammalian tissues has on the molecular and macroscopic characteristics of a new UV-cured collagen hydrogel. Pepsin-solubilised bovine atelocollagen (BA) and pepsin-solubilised porcine atelocollagen (PA) were selected as commercially available raw materials associated with varying safety risks and compared with in-house acid-extracted type I collagen from rat tails (CRT). All raw materials displayed the typical dichroic and electrophoretic characteristics of type I collagen, while significantly decreased lysine content was measured on samples of PA. Following covalent functionalisation with 4-vinylbenzyl chloride (4VBC), BA and CRT products generated comparable UV-cured hydrogels with significantly increased averaged gel content (G ≥ 97 wt.%), while the porcine variants revealed the highest swelling ratio (SR = 2224 ± 242 wt.%) and an order of magnitude reduction in compression modulus (Ec = 6 ± 2 kPa). Collectively, these results support the use of bovine tissues as a chemically viable source of type I collagen for the realisation of UV-cured hydrogels with competitive mechanical properties and covalent network architectures.

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Enabling MedTech Translation in Academia: Redefining Value Proposition with Updated Regulations

Cited by 17 publications

References 38 publications

Critical Factors and Economic Methods for Regulatory Impact Assessment in the Medical Device Industry

Critical Factors and Economic Methods for Regulatory Impact Assessment in the Medical Device Industry

A roadmap for research in medical physics via academic medical centers: The DIVERT Model

Effect of Mammalian Tissue Source on the Molecular and Macroscopic Characteristics of UV-Cured Type I Collagen Hydrogel Networks

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