Innovating in the medical device industry – challenges &amp; opportunities ESB 2015 translational research symposium

Bayon, Yves; Bohner, Marc; Eglin, David; Procter, Philip; Richards, R. Geoff; Weber, Jayne Dixon; Zeugolis, Dimitrios I.

doi:10.1007/s10856-016-5759-5

Cited by 21 publications

(22 citation statements)

References 10 publications

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“…PLA-based nanofibrous fibers have large surface areas, allowing them to interact with large volumes of other substances in their environment. This is a distinguishing feature of this material (Bayon et al, 2016;Toniatto et al, 2017;Salles et al, 2018). The fiber surfaces have several characteristics that make them similar to the extracellular matrices (ECMs) used in biomedical applications.…”

Section: Introductionmentioning

confidence: 99%

“…Due to their inherent material properties, these mats not only provide a three-dimensional structure but are also biocompatible, bioabsorbable, and have antibacterial properties, making them extremely desirable for use in scaffolds and medical devices (Roux et al, 2013;Stocco et al, 2018). PLA/TiO 2 -nanofibrous fibers produced by electrospinning are being studied in order to evaluate their potential in dressing and wound healing applications (Bayon et al, 2016;Toniatto et al, 2017;Ghosal et al, 2018;Salles et al, 2018).…”

Section: Introductionmentioning

confidence: 99%

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Electrospun Nanofibrous Poly (Lactic Acid)/Titanium Dioxide Nanocomposite Membranes for Cutaneous Scar Minimization

Marsi

Ricci

Toniato

et al. 2019

Front. Bioeng. Biotechnol.

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Poly (lactic acid) (PLA) has been increasingly used in cutaneous tissue engineering due to its low cost, ease of handling, biodegradability, and biocompatibility, as well as its ability to form composites. However, these polymers possess a structure with nanoporous that mimic the cellular environment. In this study, nanocomposites are prepared using PLA and titanium dioxide (TiO 2) (10 and 35%-w/w) nanoparticles that also function as an active anti-scarring agent. The nanocomposites were prepared using an electrospinning technique. Three different solutions were prepared as follows: PLA, 10% PLA/TiO 2 , and 35% PLA/TiO 2 (w/w%). Electrospun PLA and PLA/TiO 2 nanocomposites were characterized morphologically, structurally, and chemically using electron scanning microscopy, transmission electron microscopy, goniometry, and X-ray diffraction. L929 fibroblast cells were used for in vitro tests. The cytotoxic effect was evaluated using 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assays. Versicam (VCAN), biglicam (BIG), interleukin-6 (IL6), interleukin-10 (IL-10), and type-1 collagen (COL1A1) genes were evaluated by RT-qPCR. In vivo tests using Wistar rats were conducted for up to 15 days. Nanofibrous fibers were obtained for all groups that did not contain residual solvents. No cytotoxic effects were observed for up to 168 h. The genes expressed showed the highest values of versican and collagen-1 (p < 0.05) for PLA/TiO 2 nanocomposite scaffolds when compared to the control group (cells). Histological images showed that PLA at 10 and 35% w/w led to a discrete inflammatory infiltration and expression of many newly formed vessels, indicating increased metabolic activity of this tissue. To summarize, this study supported the potential of PLA/TiO 2 nanocomposites ability to reduce cutaneous scarring in scaffolds.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Electrospun Nanofibrous Poly (Lactic Acid)/Titanium Dioxide Nanocomposite Membranes for Cutaneous Scar Minimization

Marsi

Ricci

Toniato

et al. 2019

Front. Bioeng. Biotechnol.

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“…Adding to the challenge, inventors also need to go through the process in an evolving health economics climate where the trend is away from introducing innovations that bring large costs but only have an incremental improvement in health. 70,71 Performing the process correctly is important; regardless of the market size, it can take 5 to 10 years to bring a medical device to market in a biophotonics industry.…”

Section: Developing a Business Strategymentioning

confidence: 99%

Biomedical device innovation methodology: applications in biophotonics

et al. 2017

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Abstract. The process of medical device innovation involves an iterative method that focuses on designing innovative, device-oriented solutions that address unmet clinical needs. This process has been applied to the field of biophotonics with many notable successes. Device innovation begins with identifying an unmet clinical need and evaluating this need through a variety of lenses, including currently existing solutions for the need, stakeholders who are interested in the need, and the market that will support an innovative solution. Only once the clinical need is understood in detail can the invention process begin. The ideation phase often involves multiple levels of brainstorming and prototyping with the aim of addressing technical and clinical questions early and in a cost-efficient manner. Once potential solutions are found, they are tested against a number of known translational factors, including intellectual property, regulatory, and reimbursement landscapes. Only when the solution matches the clinical need, the next phase of building a "to market" strategy should begin. Most aspects of the innovation process can be conducted relatively quickly and without significant capital expense. This white paper focuses on key points of the medical device innovation method and how the field of biophotonics has been applied within this framework to generate clinical and commercial success.

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“…In other words, we are currently in a position where we have to smoothly amalgamate two counterparts that were not necessarily made to co-exist. On the one hand, the MD industry serves its pivotal role by introducing sophisticated new technologies while trying to maintain its revenues amid alarming cases of vigilance data cover-up and lack of sufficient pre-and post-authorization controls [9][10][11][22][23][24]. On the other hand, the physician grapples with the expanding technical demands of medical practice, thus complicating his everyday tasks and increasing medical errors [25][26][27].…”

Section: Introductionmentioning

confidence: 99%

Impact of Design on Medical Device Safety

Miclăuş

Valla

Koukoura

et al. 2019

Ther Innov Regul Sci

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The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre-and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.

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Innovating in the medical device industry – challenges & opportunities ESB 2015 translational research symposium

Cited by 21 publications

References 10 publications

Electrospun Nanofibrous Poly (Lactic Acid)/Titanium Dioxide Nanocomposite Membranes for Cutaneous Scar Minimization

Electrospun Nanofibrous Poly (Lactic Acid)/Titanium Dioxide Nanocomposite Membranes for Cutaneous Scar Minimization

Biomedical device innovation methodology: applications in biophotonics

Impact of Design on Medical Device Safety

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