GENERAL SCIENTIFIC SESSION 4 GENERAL SCIENTIFIC SESSION 4
Investing in Neurosurgery Innovations: An Editorial Chandan Krishna, MD*‡ Sabareesh K. Natarajan, MD, MS*‡ L. Nelson Hopkins, MD*‡§¶ *Department of Neurosurgery and Toshiba Stroke and Vascular Research Center and §Department of Radiology, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York; ‡Department of Neurosurgery, Gates Vascular Institute, Kaleida Health, Buffalo, New York; ¶Jacobs Institute, Buffalo, New York Correspondence: L. Nelson Hopkins, MD, Jacobs Institute, 875 Ellicott St, 5th Floor, Buffalo, NY 14203. E-mail: [email protected] Copyright © 2014 by the Congress of Neurological Surgeons.
The 2013 CNS Annual Meeting presentation on which this article is based is available at http://bit.ly/ 1eIqa4G.
CLINICAL NEUROSURGERY
T
he key to the betterment of our society lies in innovation, be it in medicine, technology, or otherwise. Innovation has led to many tools, devices, and medicines that have led us to become more productive and healthy. Specifically in medicine, it has afforded us the privilege to tackle disease processes that were previously deemed unconquerable. Society usually does not stand to gain much from stagnation. Innovation is progression. “If you always do what you always did, you will always get what you always got.” This quote has been attributed to many individuals, including Albert Einstein, Henry Ford, and even Mark Twain. Regardless of its origin, it conveys a very important message. As the famed 1937 Noble Laureate in Medicine, Albert von Szent-Gyorgyi, once stated, “Discovery consists of seeing what everybody has seen and thinking what nobody has thought.” Innovation can be evolutionary or revolutionary. However, it must be relevant. Inspiration can often be drawn from outside one’s skill set or specialty. It is of the utmost importance to remain flexible and to realize that sometimes the best ideas are the simplest of ideas. Seldom does an object remain unchanged over years, and room for improvement on previously designed concepts may exist. Contrary to the generally accepted notion, Thomas Edison did not invent the light bulb. He did, however, after thousands of attempts and just as many failures, innovate an affordable and effective light bulb.1 Neurosurgeons are natural physician leaders and are well poised to implement innovations. Clinical practice provides a fertile foundation for research and development. Identifying a unique medical concept begins with defining a specific problem to address, along with the novelty and
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.neurosurgery-online.com).
pros and cons of the proposed solution. The next step should be to protect the invention or intellectual property. Here, it is highly advisable to seek professional counseling. Prototype and product development require a large capital infusion and can often be prohibitively expensive. Therefore, one must cultivate financial support from venture capitalists and academicians, as well as industry, within an ethically defined framework2,3 because partnership with industry is a must in the context of financial support, research and development, and market analysis. However, for obvious reasons, this often leads to more regulations and scrutiny and arouses general suspicion in society as a whole. The physician and industry partnership should always be conducted with the highest degree of transparency and disclosure.4 The United States remains a global leader in healthcare research and development, including medical device development.5 According to some estimates, US healthcare research and development expenditure amounted to $181.1 billion in 2012 and was expected to rise to $189.3 billion in 2013.6,7 Therefore, ample opportunity exists for securing financial backing, which often begins with a “pitch meeting” with interested parties. Pitch meeting preparation involves examining and thoroughly understanding the proposal, along with the involved competition, audience, and expected public health impact. Once again, protecting the intellectual property rights should remain first and foremost, and all such meetings should be preceded with a nondisclosure pact (sample available at http://www.hbs. edu/entrepreneurship/pdf/Sample_NDA.pdf). Dr Hopkins is often asked if government regulations have made innovation difficult. It is true that there is an abundance of red tape requiring a successful launch of a medical device. This is due partially to the fact that governmentaffiliated regulatory institutions such as the US Food and Drug Administration are inherently inefficient and slow and partially to some widely publicized and spectacular product failures such as the Depuy ASR hip replacement devices.8,9
VOLUME 61 | NUMBER 1 | AUGUST 2014 | 135
Copyright © Congress of Neurological Surgeons. Unauthorized reproduction of this article is prohibited
KRISHNA ET AL
There have been numerous suggestions that the current Food and Drug Administration medical device approval process is impeding innovation. It is a daunting process, to say the least, and the entire Food and Drug Administration medical device approval pathway is long overdue for a much-needed overhaul.10,11 However, this process must be dealt with for the time being. The recently enacted Affordable Health Care Law may levy yet an additional burden on the device companies in its form of excise tax on medical devices.12 Both opponents and proponents of the bill are busy defending or criticizing the newly imposed financial burden on the device companies. Finally, failures of new medical devices are often intertwined with success. Amid temporary setbacks, one should never lose sight of the end point. It may require multiple iterations of a prototype before gaining some traction with the device companies. The quintessential traits of an innovator are foresight and perseverance. Disclosures Dr Hopkins receives grant/research support from Toshiba; serves as a consultant to Abbott, Boston Scientific, Cordis, Micrus, and Silk Road; holds financial interests in AccessClosure, Augmenix, Boston Scientific, Claret Medical, Endomation, Micrus, and Valor Medical; holds a board/trustee/ officer position with Access Closure and Claret Medical; serves on the speakers’ bureau for Abbott Vascular; and has received honoraria from Bard, Boston Scientific, Cleveland Clinic, Complete Conference Management, Cordis, Memorial Health Care System, and the Society for Cardiovascular Angiography and Interventions. Drs Krishna and Natarajan report no financial relationships.
REFERENCES 1. Bredhoff S. American Originals. Seattle, WA: The University of Washington Press; 2001:62-63.
136 | VOLUME 61 | NUMBER 1 | AUGUST 2014
2. Congress of Neurological Surgeons. Guidelines for Interaction With Commercial Enterprises and Medical Industry for the Congress of Neurological Surgeons (CNS), CNS Members, and CNS Publications. 2008. Available at: http://w3.cns.org/education/ toolkit/CNSGuidelinesforInteractionwithCommercialEnterprisesandMedicalIndustry. pdf. Accessed March 4, 2014. 3. American Association of Neurological Surgeons. Position Statement: 2008 May 05: Guidelines on Neurosurgeon-Industry Conflicts of Interest (Statement Approved by the AANS Board of Directors on 04/25/08). Available at: http://www.aans.org//link. aspx?_id=360DCEF0D6464BA3A086EF32819B1DD6&_z=z. Accessed March 4, 2014. 4. Robertson JH. Neurosurgery and industry. J Neurosurg. 2008;109(6):979-988. 5. National Institutes of Health. Turning Discovery into Health. Global Competitiveness: The Importance of U.S. Leadership in Science and Innovation for the Future of Our Economy and Our Health. Available at: http://www.nih. gov/about/impact/impact_global.pdf. Accessed March 4, 2014. 6. Battelle R&D. 2013 Global R & D Funding Forecast: Congressional R & D Caucus Briefing. Available at: http://www.battelle.org/docs/default-document-library/ 2013-R-and-D-Funding-Forecast.pdf?sfvrsn=4. Accessed March 4, 2014. 7. Pogoreic D. Healthcare R & D in 2013: Globalization & collaboration will rule. Available at: http://medcitynews.com/2012/12/analysis-healthcare-will-spendmore-on-r-globalization-collaboration-will-rule/#ixzz2q0XioiPB. Accessed March 4, 2014. 8. Hug KT, Watters TS, Vail TP, Bolognesi MP. The withdrawn ASR THA and hip resurfacing systems: how have our patients fared over 1 to 6 years? Clin Orthop Relat Res. 2013;471(2):430-438. 9. Reito A, Puolakka T, Elo P, Pajamaki J, Eskelinen A. High prevalence of adverse reactions to metal debris in small-headed ASR hips. Clin Orthop Relat Res. 2013; 471(9):2954-2961. 10. Fargen KM, Frei D, Fiorella D, et al. The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation? J Neurointerv Surg. 2013;5(4):269-275. 11. Welle C, Krauthamer V. FDA regulation of invasive neural recording electrodes: a daunting task for medical innovators. IEEE Pulse. 2012;3(2):37-41. 12. Nexon D, Ubl SJ. Implications of health reform for the medical technology industry. Health Aff (Millwood). 2010;29(7):1325-1329.
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.neurosurgery-online.com).
www.neurosurgery-online.com
Copyright © Congress of Neurological Surgeons. Unauthorized reproduction of this article is prohibited
Investing in Neurosurgery Innovations: An Editorial Chandan Krishna, MD*‡ Sabareesh K. Natarajan, MD, MS*‡ L. Nelson Hopkins, MD*‡§¶ *Department of Neurosurgery and Toshiba Stroke and Vascular Research Center and §Department of Radiology, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York; ‡Department of Neurosurgery, Gates Vascular Institute, Kaleida Health, Buffalo, New York; ¶Jacobs Institute, Buffalo, New York Correspondence: L. Nelson Hopkins, MD, Jacobs Institute, 875 Ellicott St, 5th Floor, Buffalo, NY 14203. E-mail: [email protected] Copyright © 2014 by the Congress of Neurological Surgeons.
The 2013 CNS Annual Meeting presentation on which this article is based is available at http://bit.ly/ 1eIqa4G.
CLINICAL NEUROSURGERY
T
he key to the betterment of our society lies in innovation, be it in medicine, technology, or otherwise. Innovation has led to many tools, devices, and medicines that have led us to become more productive and healthy. Specifically in medicine, it has afforded us the privilege to tackle disease processes that were previously deemed unconquerable. Society usually does not stand to gain much from stagnation. Innovation is progression. “If you always do what you always did, you will always get what you always got.” This quote has been attributed to many individuals, including Albert Einstein, Henry Ford, and even Mark Twain. Regardless of its origin, it conveys a very important message. As the famed 1937 Noble Laureate in Medicine, Albert von Szent-Gyorgyi, once stated, “Discovery consists of seeing what everybody has seen and thinking what nobody has thought.” Innovation can be evolutionary or revolutionary. However, it must be relevant. Inspiration can often be drawn from outside one’s skill set or specialty. It is of the utmost importance to remain flexible and to realize that sometimes the best ideas are the simplest of ideas. Seldom does an object remain unchanged over years, and room for improvement on previously designed concepts may exist. Contrary to the generally accepted notion, Thomas Edison did not invent the light bulb. He did, however, after thousands of attempts and just as many failures, innovate an affordable and effective light bulb.1 Neurosurgeons are natural physician leaders and are well poised to implement innovations. Clinical practice provides a fertile foundation for research and development. Identifying a unique medical concept begins with defining a specific problem to address, along with the novelty and
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.neurosurgery-online.com).
pros and cons of the proposed solution. The next step should be to protect the invention or intellectual property. Here, it is highly advisable to seek professional counseling. Prototype and product development require a large capital infusion and can often be prohibitively expensive. Therefore, one must cultivate financial support from venture capitalists and academicians, as well as industry, within an ethically defined framework2,3 because partnership with industry is a must in the context of financial support, research and development, and market analysis. However, for obvious reasons, this often leads to more regulations and scrutiny and arouses general suspicion in society as a whole. The physician and industry partnership should always be conducted with the highest degree of transparency and disclosure.4 The United States remains a global leader in healthcare research and development, including medical device development.5 According to some estimates, US healthcare research and development expenditure amounted to $181.1 billion in 2012 and was expected to rise to $189.3 billion in 2013.6,7 Therefore, ample opportunity exists for securing financial backing, which often begins with a “pitch meeting” with interested parties. Pitch meeting preparation involves examining and thoroughly understanding the proposal, along with the involved competition, audience, and expected public health impact. Once again, protecting the intellectual property rights should remain first and foremost, and all such meetings should be preceded with a nondisclosure pact (sample available at http://www.hbs. edu/entrepreneurship/pdf/Sample_NDA.pdf). Dr Hopkins is often asked if government regulations have made innovation difficult. It is true that there is an abundance of red tape requiring a successful launch of a medical device. This is due partially to the fact that governmentaffiliated regulatory institutions such as the US Food and Drug Administration are inherently inefficient and slow and partially to some widely publicized and spectacular product failures such as the Depuy ASR hip replacement devices.8,9
VOLUME 61 | NUMBER 1 | AUGUST 2014 | 135
Copyright © Congress of Neurological Surgeons. Unauthorized reproduction of this article is prohibited
KRISHNA ET AL
There have been numerous suggestions that the current Food and Drug Administration medical device approval process is impeding innovation. It is a daunting process, to say the least, and the entire Food and Drug Administration medical device approval pathway is long overdue for a much-needed overhaul.10,11 However, this process must be dealt with for the time being. The recently enacted Affordable Health Care Law may levy yet an additional burden on the device companies in its form of excise tax on medical devices.12 Both opponents and proponents of the bill are busy defending or criticizing the newly imposed financial burden on the device companies. Finally, failures of new medical devices are often intertwined with success. Amid temporary setbacks, one should never lose sight of the end point. It may require multiple iterations of a prototype before gaining some traction with the device companies. The quintessential traits of an innovator are foresight and perseverance. Disclosures Dr Hopkins receives grant/research support from Toshiba; serves as a consultant to Abbott, Boston Scientific, Cordis, Micrus, and Silk Road; holds financial interests in AccessClosure, Augmenix, Boston Scientific, Claret Medical, Endomation, Micrus, and Valor Medical; holds a board/trustee/ officer position with Access Closure and Claret Medical; serves on the speakers’ bureau for Abbott Vascular; and has received honoraria from Bard, Boston Scientific, Cleveland Clinic, Complete Conference Management, Cordis, Memorial Health Care System, and the Society for Cardiovascular Angiography and Interventions. Drs Krishna and Natarajan report no financial relationships.
REFERENCES 1. Bredhoff S. American Originals. Seattle, WA: The University of Washington Press; 2001:62-63.
136 | VOLUME 61 | NUMBER 1 | AUGUST 2014
2. Congress of Neurological Surgeons. Guidelines for Interaction With Commercial Enterprises and Medical Industry for the Congress of Neurological Surgeons (CNS), CNS Members, and CNS Publications. 2008. Available at: http://w3.cns.org/education/ toolkit/CNSGuidelinesforInteractionwithCommercialEnterprisesandMedicalIndustry. pdf. Accessed March 4, 2014. 3. American Association of Neurological Surgeons. Position Statement: 2008 May 05: Guidelines on Neurosurgeon-Industry Conflicts of Interest (Statement Approved by the AANS Board of Directors on 04/25/08). Available at: http://www.aans.org//link. aspx?_id=360DCEF0D6464BA3A086EF32819B1DD6&_z=z. Accessed March 4, 2014. 4. Robertson JH. Neurosurgery and industry. J Neurosurg. 2008;109(6):979-988. 5. National Institutes of Health. Turning Discovery into Health. Global Competitiveness: The Importance of U.S. Leadership in Science and Innovation for the Future of Our Economy and Our Health. Available at: http://www.nih. gov/about/impact/impact_global.pdf. Accessed March 4, 2014. 6. Battelle R&D. 2013 Global R & D Funding Forecast: Congressional R & D Caucus Briefing. Available at: http://www.battelle.org/docs/default-document-library/ 2013-R-and-D-Funding-Forecast.pdf?sfvrsn=4. Accessed March 4, 2014. 7. Pogoreic D. Healthcare R & D in 2013: Globalization & collaboration will rule. Available at: http://medcitynews.com/2012/12/analysis-healthcare-will-spendmore-on-r-globalization-collaboration-will-rule/#ixzz2q0XioiPB. Accessed March 4, 2014. 8. Hug KT, Watters TS, Vail TP, Bolognesi MP. The withdrawn ASR THA and hip resurfacing systems: how have our patients fared over 1 to 6 years? Clin Orthop Relat Res. 2013;471(2):430-438. 9. Reito A, Puolakka T, Elo P, Pajamaki J, Eskelinen A. High prevalence of adverse reactions to metal debris in small-headed ASR hips. Clin Orthop Relat Res. 2013; 471(9):2954-2961. 10. Fargen KM, Frei D, Fiorella D, et al. The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation? J Neurointerv Surg. 2013;5(4):269-275. 11. Welle C, Krauthamer V. FDA regulation of invasive neural recording electrodes: a daunting task for medical innovators. IEEE Pulse. 2012;3(2):37-41. 12. Nexon D, Ubl SJ. Implications of health reform for the medical technology industry. Health Aff (Millwood). 2010;29(7):1325-1329.
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.neurosurgery-online.com).
www.neurosurgery-online.com
Copyright © Congress of Neurological Surgeons. Unauthorized reproduction of this article is prohibited
