Safety and Effectiveness of Medical Device Therapy

Author(s):  
Robbert Zusterzeel
2016 ◽  
Vol 25 (5) ◽  
pp. 428-430 ◽  
Author(s):  
Robbert Zusterzeel ◽  
Kathryn M. O'Callaghan ◽  
Daniel A. Caños ◽  
William E. Sanders ◽  
Danica Marinac-Dabic ◽  
...  

2021 ◽  
pp. bmjinnov-2020-000427
Author(s):  
Faisal Sharif ◽  
Ian Quinn

AimMedical devices (medtech) is a strong driver of innovation and new treatments in healthcare. Straddling the fields of engineering and healthcare, successful medtech development demands critical needs assessment, highly skilled medical engineering professionals, and the successful collaboration between medical and other experts. Optimal development and testing need an efficient dialogue with third parties, including regulators and payers. BioInnovate Ireland was established in 2011 as a multidisciplinary, structured programme to shape the future of medical device therapy based on innovation and interdisciplinary cross-fertilisation.Methods and results107 fellows have completed the programme covering 20 clinical areas. Fellows have funded companies at a rate of more than 1.5 companies per year which have attracted Irish and international seed funding in excess of €40 million, excluding undisclosed investments.ConclusionsA multidisciplinary programme targeting mature, experienced professionals can drive a highly successful medtech start-up culture in the right ecosystem.


1989 ◽  
Vol 53 (3) ◽  
pp. 149-156 ◽  
Author(s):  
Don M. Long ◽  
Sumio Uematsu ◽  
Richard B. Kouba

2020 ◽  
Vol 15 ◽  
Author(s):  
Leonardo Guimaraes ◽  
David del Val ◽  
Sebastien Bergeron ◽  
Kim O’Connor ◽  
Mathieu Bernier ◽  
...  

The creation of an interatrial shunt has emerged as a new therapy to decompress the left atrium in patients with acute and chronic left heart failure (HF). Current data support the safety of this therapy, and promising preliminary efficacy results have been reported in patients who are refractory to optimal medical/device therapy. This article aims to provide an updated overview and clinical perspective on interatrial shunting for treating different HF conditions, and highlights the potential challenges and future directions of this therapy.


2004 ◽  
Author(s):  
Ibraheem S. Al-Tarawneh ◽  
Walter J. Stevens ◽  
Steven R. Arndt

2017 ◽  
Vol 65 (S 01) ◽  
pp. S1-S110
Author(s):  
C. Gestrich ◽  
J.E. Klein ◽  
B. Toctam ◽  
G.D. Dürr ◽  
J.M. Sinning ◽  
...  

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

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.


2020 ◽  
Vol 64 (1-4) ◽  
pp. 1253-1259
Author(s):  
Minghui Wang ◽  
Hongliu Yu

Clamping devices with constant force or pressure are desired in medical device, such as hemostatic forceps and the artificial sphincter, to prevent soft tissues from injures due to overloading. It is easily obtained by stretching an SMA wire. However, studies with SMA bending round bar have seldom been reported before. This paper studied constant force characteristic of C-shaped round bar with shape memory alloys. Optimization designs of the components were carried out with computational simulation. Numerical results show that the phenomenon of constant force strongly depends on contour curve shape and geometric dimensions of the C-shaped round bar of SMA component.


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