Forming effective relationships between academia and the medical devices industry with a focus on launching a smart heart valve prosthesis for pediatric patients

Translational Medicine Communications - Tập 4 Số 1 - 2019
Albert Ryszard Liberski1, Jonathan T. Butcher2, Zbigniew Nawrat3, Tal Golesworthy4, Dena A. Al Thani5
1Division of Sustainable Development, College of Science & Engineering, Hamad Bin Khalifa University, P.O. Box 34110, Education City, Doha, Qatar
2Nancy E. and Peter C. Meinig School of Biomedical Engineering, Cornell University, Weill Hall, Ithaca, NY, 14853, USA
3Foundation of Cardiac Surgery Development, Wolnosci 345a, 41-800, Zabrze, Poland
4Exstent Limited, Theocsbury House, 18 – 20 Barton Street, Tewkesbury, Gloucestershire, GL20 5PP, UK
5Information & Computing Technology, College of Science and Engineering, Hamad Bin Khalifa University, P.O. Box 34110, Education City, Doha, Qatar

Tóm tắt

AbstractBackgroundThis article presents examples of how to utilize the research output, to initiate academia-industry interaction, with the ultimate task of launching a new product: a smart heart valve prosthesis for pediatric patients. The article summarizes our efforts in a way that may also be informative to researchers working in fields other than medical devices development. Our task is not to provide a step-by-step guide, but rather to create inspiration, also by describing differences in expectations of business and academic entities.MethodsWe analyzed market reports, surveyed the scientific literature and conducted interviews with the key players in the field of medical devices. We also obtained a feedback from clinicians, academia and industry-related researchers, technology transfer centres, representatives of public organization and the creators of legislation.ResultsWe have obtained and reported the definitive answers that together constitute a critical review of strategies that should be used by researchers who seek to commercialize the outputs of their research.ConclusionAs a result of our investigation, we discovered that the commercialization of research is a complex process, which in some critical aspects does not depend solely on the researcher himself. The most promising ideas, supported by strong experimental evidence, can simply be overlooked by industry representatives, without the proper support of institutions such as a technology transfer centre. Besides, the involvement of scientists in a business project takes them, at least temporarily, outside the regular academic environment, which may cause discomfort and pose a risk to the career path. The limitation to be addressed is the reluctance to report the unsuccessful attempts, which should be considered a legitimate educational experience that ultimately leads to improvement.

Từ khóa


Tài liệu tham khảo

Gottland: Mostly True Stories from Half of Czechoslovakia - Mariusz Szczygiel - Google Książki [Internet]. [cited 2019 Sep 4]. Available from: https://books.google.com.qa/books/about/Gottland.html?id=CcMPAgAAQBAJ&redir_esc=y

Wojciechowska D, Liberski AR, Wilczek P, Butcher J, Scharfschwerdt M, Hijazi Z, et al. The optimal shape of an aortic heart valve replacement – on the road to the consensus. QScience Connect. 2017;2017(3):1.

Liberski A, Latif N, Raynaud C, Bollensdorff C, Yacoub M. Alginate for cardiac regeneration: From seaweed to clinical trials, Global Cardiology Science and Practice. 2016;4. https://doi.org/10.21542/gcsp.2016.4 .

Liberski A, Ayad N, Wojciechowska D, Zielińska D, Struszczyk MH, Latif N, Yacoub M. Knitting for heart valve tissue engineering, Global Cardiology Science and Practice. 2016;31. https://doi.org/10.21542/gcsp.2016.31 .

Liberski AR. Three-dimensional printing of alginate: from seaweeds to heart valve scaffolds. QScience Connect. 2016;2016(2):3.

Liberski AR, Raynaud CM, Ayad N, Wojciechowska D, Sathappan A. Valve tissue engineering with living absorbable threads. Macromol Biosci. 2017;17(5). https://doi.org/10.1002/mabi.201600196 .

Liberski A, Ayad N, Wojciechowska D, Kot R, Vo DMP, Aibibu D, et al. Weaving for heart valve tissue engineering. Biotechnol Adv. 2017;35(6):633–56.

Intelligent materials for in-situ heart valve tissue engineering | projects | FP7-NMP | CORDIS | European Commission [internet]. [cited 2019 Feb 6]. Available from: https://cordis.europa.eu/project/rcn/110963/factsheet/en .

Kluin J, Talacua H, Smits AIPM, Emmert MY, Brugmans MCP, Fioretta ES, et al. In situ heart valve tissue engineering using a bioresorbable elastomeric implant – from material design to 12 months follow-up in sheep. Biomaterials. 2017;125:101–17.

Bouten CVC, Smits AIPM, Baaijens FPT. Can we grow valves inside the heart? Perspective on material-based in situ heart valve tissue engineering. Front Cardiovasc Med. 2018;5:1–10.

Reynolds MR, Lei Y, Wang K, Chinnakondepalli K, Vilain KA, Magnuson EA, et al. Cost-effectiveness of Transcatheter aortic valve replacement with a self-expanding prosthesis versus surgical aortic valve replacement. J Am Coll Cardiol. 2016;67(1):29–38.

Beresniak A, Sabatier B, Achouh P, Menasché P, Fabiani J-N. Cost-effectiveness of mitral valve repair versus replacement by biologic or mechanical prosthesis. Ann Thorac Surg. 2013;95(1):98–104.

McCarthy Fenton H, McDermott Katherine M, Saif A, Jay G, Hoedt Ashley C, Dale K, et al. Cost of Transcatheter aortic valve replacement in Medicare patients. Circ Cardiovasc Qual Outcomes. 2015;8(suppl_2):A22.

Tam DY, Hughes A, Fremes SE, Youn S, Hancock-Howard RL, Coyte PC, et al. A cost-utility analysis of transcatheter versus surgical aortic valve replacement for the treatment of aortic stenosis in the population with intermediate surgical risk. J Thorac Cardiovasc Surg. 2018;155(5):1978–1988.e1.

Huygens SA, Goossens LMA, van EJA, Takkenberg JJM, Mölken MPMHR. How much does a heart valve implantation cost and what are the health care costs afterwards? Open Heart. 2018;5(1):e000672.

Manolis AS. Transcatheter aortic valve implantation economics: a grisly reality. Ann Cardiothorac Surg. 2017;6(5):516–23.

Mabin TA, Candolfi P. An analysis of real-world cost-effectiveness of TAVI in South Africa. Cardiovasc J Afr. 2014;25(1):21–6.

Kuwata S, Maisano F. Looking to the future of mitral valve replacement. Eur Heart J. 2017;38(9):622–4.

Fioretta ES, Dijkman PE, Emmert MY, Hoerstrup SP. The future of heart valve replacement: recent developments and translational challenges for heart valve tissue engineering. J Tissue Eng Regen Med. 2018;12(1):e323–35.

Kheradvar A, Groves EM, Goergen CJ, Alavi SH, Tranquillo R, Simmons CA, et al. Emerging trends in heart valve engineering: part II. Novel and standard technologies for aortic valve replacement. Ann Biomed Eng. 2015;43(4):844–57.

ltd R and M. Aortic Valve Replacement Devices Market Size, Share And Trends Analysis Report By Surgery (Open, Minimally Invasive), By Product (Transcatheter Aortic Valve, Sutureless Valve), By End-user, And Segment Forecasts, 2018–2025 [Internet]. [cited 2019 Feb 6]. Available from: https://www.researchandmarkets.com/reports/4582056/aortic-valve-replacement-devices-market-size

Intelligence AA&. Heart Valve Repair and Replacement Devices Market - Global Outlook and Forecast 2018-2023 [Internet]. Arizton Advisory & Intelligence. [cited 2019 Feb 6]. Available from: https://www.arizton.com/market-reports/heart-valve-repair-and-replacement-devices-market

Heart Valves Structural Heart and Endograft Technologies [Internet]. [cited 2019 Feb 6]. Available from: https://www.vizientinc.com/-/media/Documents/SitecorePublishingDocuments/Public/2017_Heart_Valves_Structural_Heart_and_Endograft_Technologies_Vol1.pdf

Prosthetic Heart Valve Market by Type & Region - Global Forecast 2022 | MarketsandMarkets [Internet]. [cited 2019 Feb 6]. Available from: https://www.marketsandmarkets.com/Market-Reports/prosthetic-heart-valve-market-245407958.html?gclid=CjwKCAiAqOriBRAfEiwAEb9oXXIMpQBsG9lh4s3yiRV6a5EzxmjmZe62DryIYgaQE8JTBXrF7_f2FhoCwLYQAvD_BwE

ltd R and M. Prosthetic Heart Valves - Global Strategic Business Report [Internet]. [cited 2019 Feb 6]. Available from: https://www.researchandmarkets.com/reports/1824155/prosthetic_heart_valves_global_strategic

Knowledge HW. New medical devices get to patients too slowly [Internet]. Forbes. [cited 2019 Feb 6]. Available from: https://www.forbes.com/sites/hbsworkingknowledge/2015/08/11/new-medical-devices-get-to-patients-too-slowly/

ltd R and M. Transcatheter Aortic valve Replacement Market: Global Industry Analysis, Trends, Market Size and Forecasts up to 2023 [Internet]. [cited 2019 Feb 6]. Available from: https://www.researchandmarkets.com/reports/4520809/transcatheter-aortic-valve-replacement-market

Rome BN, Kramer DB, Kesselheim AS. Approval of high-risk medical devices in the US: implications for clinical cardiology. Curr Cardiol Rep. 2014;16(6):489.

Demanding Financial Value In Valve Programs [Internet]. Cardiovascular Business. [cited 2019 Feb 6]. Available from: https://www.cardiovascularbusiness.com/topics/structural-congenital-heart-disease/demanding-financial-value-valve-programs

Report on HV prosthesis usage in Poland [Internet]. Available from: http://albert-liberski.eu/wp-content/uploads/2019/02/Copy-of-Copy-of-NFZ_Skan.pdf .

Kopczak L, Lee H. Hewlett-Packard Company DeskJet printer supply chain (A). Case GS-3A. Stanford, CA: Stanford Graduate School of Business. 2001.

Liberski A. Example of the survey e-mail [internet]. [cited 2019 Feb 7]. Available from: http://albert-liberski.eu/wp-content/uploads/2019/02/Example-Invitation.docx .

Narodowy Fundusz Zdrowia [Internet]. Narodowy Fundusz Zdrowia. [cited 2019 Feb 6]. Available from: http://www.nfz.gov.pl/ .

Medtroneic. Medtronic Patient Services [Internet]. [cited 2019 Feb 6]. Available from: https://www.medtronic.com/us-en/patients/patient-services.html

Patient voice | Edwards Lifesciences [Internet]. [cited 2019 Feb 6]. Available from: https://www.edwards.com/aboutus/patientvoice

Z-MED™ & Z-MED II™ | B. Braun Interventional Systems [Internet]. [cited 2019 Feb 7]. Available from: http://www.bisusa.org/products/pta-ptv-balloons/z-med

Hijazi ZM, Homoud M, Aronovitz MJ, Smith JJ, Faller GT. A new platinum balloon-expandable stent (Angiostent) mounted on a high pressure balloon: acute and late results in an atherogenic swine model. J Invasive Cardiol. 1995;7(5):127–34.

Hijazi ZM, Geggel RL, Aronovitz MJ, Marx GR, Rhodes J, Fulton DR. A new low profile balloon atrial septostomy catheter: initial animal and clinical experience. J Invasive Cardiol. 1994;6(6):209–12.

Du ZD, Hijazi ZM, Kleinman CS, Silverman NH, Larntz K, Amplatzer Investigators. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol. 2002;39(11):1836–44.

Patel H, Holzer R, Cao Q-L, Hijazi ZM. Transcatheter Closure of Atrial-Septal Defects Using the Amplatzer Devices. In: Herrmann HC, editor. Interventional Cardiology: Percutaneous Noncoronary Intervention. Totowa: Humana Press; 2005. p. 161–78. (Contemporary Cardiology).

Suradi HS, Hijazi ZM. Percutaneous pulmonary valve implantation. Glob Cardiol Sci Pract. 2015;2015(2):23.

Holoshitz N, Kavinsky CJ, Hijazi ZM. The Edwards SAPIEN Transcatheter heart valve for calcific aortic stenosis: a review of the valve, procedure, and current literature. Cardiol Ther. 2012;1(1):6.

PICS Symposium [Internet]. [cited 2019 Feb 7]. Available from: http://www.picsymposium.com/ .

Al Jazeera English. Qatar uses gene mapping in bid to improve national health [internet]. [cited 2019 Feb 7]. Available from: https://www.youtube.com/watch?v=xTP1J3sHLYw

By MASSDEVICE staff. Bankrupt NMT Medical sells intellectual property to W.L. Gore [Internet]. MassDevice. 2011. Available from: https://www.massdevice.com/bankrupt-nmt-medical-sells-intellectual-property-wl-gore/ . [Cited 2019 Feb 7].

Cheung DY, Duan B, Butcher JT. Current progress in tissue engineering of heart valves: multiscale problems, multiscale solutions. Expert Opin Biol Ther. 2015;15(8):1155–72.

No donor required: 5 body parts you can make with 3-D printers [Internet]. [cited 2019 Feb 7]. Available from: https://www.forbes.com/sites/robertszczerba/2015/06/17/no-donor-required-5-body-parts-you-can-make-with-3-d-printers-2/#1d78c5fc7d55

Frendl CM, Butcher JT. Biomedical implant for use in fluid shear stress environments [Internet]. US20140350671A1, 2014 [cited 2019 Feb 7]. Available from: https://patents.google.com/patent/US20140350671A1/en?inventor=Jonathan+T.+Butcher

Butcher J, Gould R. Method and device for evaluation of local Tissue’s biological or biomechanical character [Internet]. 20130190597, 2013 [cited 2019 Feb 7]. Available from: http://www.freepatentsonline.com/y2013/0190597.html

Butcher JT, Kang KH, Yeh K, Cheung PY, Hockaday LA. Method for specifying and fabricating an object, associated apparatus, and applications [Internet]. US20140052285A1, 2014 [cited 2019 Feb 7]. Available from: https://patents.google.com/patent/US20140052285/en?oq=Jonathan+T.+Butcher

Foundation of Cardiac Surgery Development - publications [Internet]. [cited 2019 Feb 11]. Available from: https://frk.pl/publikacje-biocybernetyki.html

Zbigniew Nawrat - Director of the Heart Prosthesis Institute - PUBLICATIONS [Internet]. Zbigniew Nawrat. [cited 2019 Feb 11]. Available from: http://e-nawrat.eu/publications/ .

The history of a picture that changed the world [Internet]. [cited 2019 Feb 7]. Available from: https://www.zmescience.com/other/great-pics/zbigniew-religa-picture/ .

Religa G, Jasińska M, Czyżewski Ł, Torba K, Różański J. The effect of the sequential therapy in end-stage heart failure (ESHF) - from ECMO, through the use of implantable pump for a Pneumatic heart assist system, Religa heart EXT, as a bridge for Orthotopic heart transplant (OHT). Case study. Ann Transplant. 2014;19:537–40.

Kuśmierczyk M, Kuć M, Szymański J, Juraszek A, Kołsut P, Kuśmierski K, et al. Pulsatile-flow mechanical circulatory support (MCS) as a bridge to transplantation or recovery. Single-Centre experience with the POLCAS system in 2014. Kardiochirurgia Torakochirurgia Pol J Thorac Cardiovasc Surg. 2015;12(3):228–32.

Foundation of Cardiac Surgery Development patents list [Internet]. [cited 2019 Feb 7]. Available from: https://frk.pl/patenty-pracowni-sztucznego-serca.html

Litwiński P, Woźniewicz B, Religa G, Pastuszek M, Parulski A, Jasińska M, et al. Polish ventricular assist device (POLVAD) support for the treatment of cardiogenic shock in patients with myocarditis. Kardiochirurgia Torakochirurgia Pol J Thorac Cardiovasc Surg. 2006;2(4):33–40.

FRK Homograft [Internet]. [cited 2019 Feb 7]. Available from: https://homograft.frk.pl/ .

Nawrat Z. State of the art in medical robotics in Poland: development of the Robin heart and other robots. Expert Rev Med Devices. 2012;9(4):353–9.

Nawrat Z, Kostka P. Polish cardio-robot ‘Robin heart’. System description and technical evaluation. Int J Med Robot Comput Assist Surg MRCAS. 2006;2(1):36–44.

Nawrat Z. Robot chirurgiczny Robin Heart: projekty, prototypy, badania, perspektywy. Śląski Uniwersytet Medyczny; 2011. 290 p.

Nawrat Z. The Robin heart story. Med Robot Rep. 2012;1:19–21.

Lis K, Lehrich K, Mucha Ł, Nawrat Z. Concept of application of the light-weight robot Robin heart (‘Pelikan’) in veterinary medicine: a feasibility study. Med Weter. 2017;73:88–91.

Mucha Ł, Lis K. Force Feedback Sleeve Using Pneumatic and Micro Vibration Actuators. In: Soft and Stiffness-controllable Robotics Solutions for Minimally Invasive Surgery: The STIFF-FLOP Approach. Denmark: River Publishers; 2018. p. 251–62. (River Publishers Series in Automation, Control and Robotics).

Nawrat Z. Zbigniew Religa: an unfinished story. Int J Artif Organs. 2009;32(6):315–7.

Nadziakiewicz P, Szyguła-Jurkiewicz B, Pacholewicz J, Zakliczyński M, Przybyłowski P, Krauchuk A, et al. Predictive value of models for end-stage liver disease score in patients with pulsatile flow POLVAD MEV left ventricular assist device support. Transplant Proc. 2018;50(7):2075–9.

Nadziakiewicz P, Borkowski J, Szygula-Jurkiewicz B, Niklewski T, Pacholewicz J, Zakliczynski M, et al. Right ventricular function in patients with left ventricular assist device support by pulsatile Polvad MEV and continuous-flow pumps Heartware and heartmate II. Transplant Proc. 2016;48(5):1786–90.

Nadziakiewicz P, Szygula-Jurkiewicz B, Niklewski T, Pacholewicz J, Zakliczynski M, Borkowski J, et al. Effects of left ventricular assist device support on end-organ function in patients with heart failure: comparison of pulsatile- and continuous-flow support in a single-center experience. Transplant Proc. 2016;48(5):1775–80.

Rohr K, Fürjes P, Mucha L, Lis K, Radó J, Dücső C, et al. Robin heart force feedback/control system based on INCITE sensors: preliminary study. Med Robot Rep. 2015;4:10–7.

Małota Z, Nawrat Z, Sadowski W. Benchmarking for Surgery Simulators. In: River Publishers Series in Automation, Control and Robotics. Denmark: River Publishers; 2018. p. 309–23. (River Publishers Series in Automation, Control and Robotics).

Łukasz M, Lis K, Krawczyk D, Nawrat Z. The Design of a Functional STIFF-FLOP Robot Operator’s Console. In: Soft and Stiffness-controllable Robotics Solutions for Minimally Invasive Surgery: The STIFF-FLOP Approach. Denmark: River Publishers; 2018. p. 221–8. (River Publishers Series in Automation, Control and Robotics).

Arezzo A, Mintz Y, Allaix ME, Arolfo S, Bonino M, Gerboni G, et al. Total mesorectal excision using a soft and flexible robotic arm: a feasibility study in cadaver models. Surg Endosc. 2017;31(1):264–73.

Lis K, Mucha Ł, Lehrich K, Nawrat Z. RobinHand Haptic Device. In: Soft and Stiffness-controllable Robotics Solutions for Minimally Invasive Surgery: The STIFF-FLOP Approach. Denmark: River Publishers. p. 289–305. (River Publishers Series in Automation, Control and Robotics).

Golesworthy T. How I repaired my own heart [Internet]. [cited 2019 Feb 7]. Available from: https://www.ted.com/talks/tal_golesworthy_how_i_repaired_my_own_heart

Liquid Crystals for Windows | Merck Global [Internet]. [cited 2019 Feb 19]. Available from: http://www.merckgroup.com/en/expertise/architecture/solutions/liquid-crystal-windows.html

Endumax® | Teijin Aramid [Internet]. [cited 2019 Feb 19]. Available from: https://www.teijinaramid.com/en/products/endumax/ .

DPI Contact weebsite [Internet]. [cited 2019 Feb 7]. Available from: https://www.polymers.nl/contact .

Qatar National Research Strategy (QNRS) [Internet]. [cited 2019 Feb 7]. Available from: http://www.qnrf.org/en-us/About-Us/QNRS .

Qatar National research Fund ‘NATIONAL PRIORITIES RESEARCH PROGRAM - STANDARD’, Request for proposals 12th cycle [internet]. [cited 2019 Feb 7]. Available from: https://www.qnrf.org/Portals/0/RFP-NPRP-S-12-Final_1.pdf .

Intellectual Property and Technology Transfer [Internet]. [cited 2019 Feb 11]. Available from: http://www.qfrdi.org/iptt .

Descoutures F, Himbert D, Radu C, Iung B, Cueff C, Messika-Zeitoun D, et al. Transarterial Medtronic CoreValve system implantation for degenerated surgically implanted aortic prostheses. Circ Cardiovasc Interv. 2011;4(5):488–94.

Geisbüsch S, Bleiziffer S, Mazzitelli D, Ruge H, Bauernschmitt R, Lange R. Incidence and management of CoreValve dislocation during transcatheter aortic valve implantation. Circ Cardiovasc Interv. 2010;3(6):531–6.

Webb JG, Wood DA. Current status of Transcatheter aortic valve replacement. J Am Coll Cardiol. 2012;60(6):483–92.

D’Ancona G, Dissmann M, Heinze H, Zohlnhöfer-Momm D, Ince H, Kische S. Transcatheter aortic valve replacement with the 34 mm Medtronic Evolut valve. Neth Heart J. 2018;26(7-8):401–8.

Hellhammer K, Piayda K, Afzal S, Kleinebrecht L, Makosch M, Hennig I, et al. The latest evolution of the Medtronic CoreValve system in the era of Transcatheter aortic valve replacement: Matched Comparison of the Evolut PRO and Evolut R. JACC Cardiovasc Interv. 2018;11(22):2314–22.

Shivaraju A, Michel J, Frangieh AH, Ott I, Thilo C, Schunkert H, et al. Transcatheter Aortic and Mitral Valve-in-Valve Implantation Using the Edwards Sapien 3 Heart Valve. J Am Heart Assoc Cardiovasc Cerebrovasc Dis. 2018;7

(14) [cited 2019 Feb 7]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6064864/ .

Thông tin
Thông tin xuất bản

Translational Medicine Communications

Tập 4 Số 1

Thông tin tác giả