Abbreviations:CMS (Centers for Medicare & Medicaid Services), CPT® (Current Procedural Terminology), FDA (Food and Drug Administration), HRS (Heart Rhythm Society), ICD (implantable cardioverter-defibrillator), IDE (investigational device exemption), LCD (local coverage determination), NCD (national coverage determination), PMA (premarket approval)
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California Healthcare Institute, The Boston Consulting Group. Competitiveness and regulation: The FDA and the future of America's biomedical industry. 2011. https://www.bcg.com/documents/file72060.pdf. Published 2011. Accessed December 31, 2015.
The Pew Charitable Trusts. Medical device innovation. http://www.pewtrusts.org/en/research-and-analysis/collections/2014/07/medical-device-innovation. Accessed December 31, 2015.
The Fogarty Institute. http://www.fogartyinstitute.org/. Accessed December 31, 2015.
U.S. Food and Drug Administration. CDRH innovation initiative. Published 2011. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/UCM242528.pdf. Published February, 2011. Accessed December 31, 2015.
- You have an idea, now what?.Semin Pediatr Surg. 2006; 15: 302-308
- Physician-entrepreneurship: a user’s manual, part 1: critical questions for early-stage medical ventures.J Am Coll Radiol. 2005; 2: 607-612
- Users as innovators: a review, critique, and future research directions.J Manage. 2010; 36: 857-875
- How much do physician-entrepreneurs contribute to new medical devices?.Med Care. 2013; 51: 461-467
- The dominant role of users in the scientific instrument innovation process.Res Policy. 1976; 5: 212-239
- Postmarketing trials and pediatric device approvals.Pediatrics. 2014; 133: e1197-e1202
- Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring.Am J Med. 2014; 127: e11-e17
- FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.JAMA. 2014; 311: 385-391
- The short life of a medical device.Health Forum J. 2002; 45: 34-38
- The role of human factors in the design and development of an insulin pump.J Diabetes Sci Technol. 2012; 6: 260-264
- Human factors and ergonomics as a patient safety practice.BMJ Qual Saf. 2014; 23: 196-205
Association for the Advancement of Medical Instrumentation. Collection of human factors standards. http://www.aami.org/productspublications/ProductDetail.aspx?ItemNumber=926. Published March, 2014. Accessed December 31, 2015.
U.S. Food And Drug Administration. Draft Guidance: Applying human factors and usability engineering to optimize medical device design. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259760.pdf. Published June 22, 2011. Accessed December 31, 2015.
- Conditions for Patentability; Novelty, 35 USC §102a (2011).
Blair A. Google’s new moonshot project: the human body: baseline study to try to create picture from the project’s findings. Wall Street Journal. July 25, 2014:B1.
Walker J. Next in Tech: Funding dries up for medical startups. Wall Street Journal. November 5, 2013:B1.
- The decline of venture capital investment in early-stage life sciences poses a challenge to continued innovation.Health Aff (Millwood). 2015; 34: 271-276
- PET imaging of atherosclerosis.Future Cardiol. 2015; 11: 115-131
- Kaiser Permanente’s performance improvement system, part 1: from benchmarking to executing on strategic priorities.Jt Comm J Qual Patient Saf. 2010; 36: 484-498
- Kaiser Permanente’s performance improvement system, part 2: developing a value framework.Jt Comm J Qual Patient Saf. 2010; 36: 552-560
- Evolving reimbursement and pricing policies for devices in Europe and the United States should encourage greater value.Health Aff (Millwood). 2013; 32: 788-796
Health eHeart. https://www.health-eheartstudy.org/. Accessed December 31, 2015.
U.S. Food and Drug Administration Notification of substantial equivalence of the LARIAT(R) III Suture Delivery Device. http://www.accessdata.fda.gov/cdrh_docs/pdf14/K142241.pdf. Published 2014. Accessed December 31, 2015.
- Safety and procedural success of left atrial appendage exclusion with the Lariat device: a systematic review of published reports and analytic review of the FDA MAUDE database.JAMA Intern Med. 2015; 175: 1104-1109
- Lariat—small step or giant leap?.JAMA Intern Med. 2015; 175: 1110-1111
- ACC/HRS/SCAI Left Atrial Appendage Occlusion Device Societal Overview: a professional societal overview from the American College of Cardiology, Heart Rhythm Society, and Society for Cardiovascular Angiography and Interventions.J Am Coll Cardiol. 2015; 2015: 791-807
U.S. Food and Drug Administration. Use of LARIAT Suture Delivery Device for left atrial appendage closure: FDA safety communication. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454501.htm. Issued July 13, 2015. Accessed December 31, 2015.
U.S. Food and Drug Administration. Significant risk and Nonsignificant risk medical device studies. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf. Published January 2006. Accessed December 31, 2015.
U.S. Food and Drug Administration. Draft Guidance: Factors to consider when making benefit-risk determinations for medical device investigational device exemptions (IDEs) http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm451440.pdf. Published June 18, 2015. Accessed December 31, 2015.
U.S. Food and Drug Administration. Draft Guidance: Acceptance of medical device clinical data from studies conducted outside the United States: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm443133.pdf. Published April 22, 2015. Accessed December 31, 2015.
U.S. Food and Drug Administration Draft Guidance: Humanitarian device Exemption (HDE): Questions and answers. March 18, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM389275.pdf. Published March 18, 2014. Accessed December 31, 2015.
U.S. Food and Drug Administration. Information for physicians and patients on the withdrawal of two humanitarian Device Exemptions (HDEs) for Patent Foramen Ovale (PFO) occluders. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/ucm135747.htm. Updated May 20, 2015. Accessed December 31, 2015.
- Berlin Heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children.Circulation. 2013; 127: 1702-1711
- The Watchman saga—closure at last?.N Engl J Med. 2015; 372: 994-995
U.S. Food And Drug Administration Summary of safety and effectiveness: WATCHMAN(R) LAA closure technology. http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130013b.pdf. Published March 13, 2015. Accessed December 31, 2015.
The Boston Consulting Group. Regulation and access to innovative medical technologies: A comparison of the FDA and EU approval processes and their impact on patients and industry. http://www.eucomed.org/uploads/ModuleXtender/Newsroom/97/2012_bcg_report_regulation_and_access_to_innovative_medical_technologies.pdf. Published June, 2012. Accessed December 31, 2015.
- Innovation at the Food and Drug Administration’s device center.JACC Cardiovasc Interv. 2012; 5: 797-798
U.S. Food and Drug Administration. Expedited access for premarket approval and de novo medical devices intended for unmet medical need for life threatening or irreversibly debilitating diseases or conditions. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM393978.pdf. Published April 23, 2014. Accessed December 31, 2015.
U.S. Food and Drug Administration. Investigational Device Exemptions (IDEs) for early feasibility medical device clinical studies, Including certain First in Human (FIH) studies. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103.pdf. Published November 10, 2011. Accessed December 31, 2015.
U.S. Food and Drug Administration. Requests for feedback on medical device submissions: The Pre-submission program and meetings with Food and Drug Administration staff. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103.pdf. Published February 18, 2014. Accessed December 31, 2015.
U.S. Food and Drug Administration Balancing premarket and postmarket data collection for devices subject to premarket approval. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm393994.pdf. Published April 13, 2015. Accessed December 31, 2015.
U.S. Food and Drug Administration. Guidance for the use of Bayesian statistics in medical device clinical trials. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071121.pdf. Published February 5, 2010. Accessed December 31, 2015.
- U.S. Food and Drug Administration. Adaptive designs for medical device clinical studies: Draft Guidance. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm446729.pdf. Published May 18, 2015. Accessed December 31, 2015.
- HR 6 - 21st Century Cures Act (2015).
- Outlook for medical technology innovation: Will patients get the care they need?.Health Industry Manufacturers Association, Washington, DC2001
- Experience with Medicare’s new technology add-on payment program.Health Aff (Millwood). 2008; 27: 1632-1641
- Medicare Program; Revised process for making national coverage determination.Federal Regist. 2013; 78: 48164-48169
- From medical invention to clinical practice: the reimbursement challenge facing new device procedures and technology—part 2: coverage.J Am Coll Radiol. 2006; 3: 772-777
Centers for Medicare & Medicaid Services. Medicare national coverage determination: Implantable cardioverter defibrillators. http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R29NCD.pdf. Issued March 4, 2005. Accessed December 31, 2015.
- Response to the Center for Medicare & Medicaid Services coverage with evidence development request for primary prevention implantable cardioverter-defibrillators: data from the OMNI study.Heart Rhythm. 2012; 9: 1058-1066
Centers for Medicare & Medicaid Services. Decision Memo for Transcatheter Aortic Valve Replacements (TAVR). http://www.cms.gov//medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=257. Issued May 1, 2012. Accessed December 31, 2015.
Tunis SR, Berenson RA, Phurrough SE, Mohr PE. Improving the quality and efficiency of the Medicare program through coverage policy. http://www.urban.org/sites/default/files/alfresco/publication-pdfs/412392-Improving-the-Quality-and-Efficiency-of-the-Medicare-Program-Through-Coverage-Policy.PDF. Published August 2011. Accessed December 31, 2015.
U.S. General Accounting Office. Divided authority for policies on coverage of procedures and devices results in inequities. http://www.gao.gov/assets/240/237841.pdf. Published April 2003. Accessed December 31, 2015.
- Medical device development: from prototype to regulatory approval.Circulation. 2004; 109: 3068-3072
- Forecast for the Physician Payment Sunshine Act: partly to mostly cloudy?.Ann Intern Med. 2014; 161: 915-916
- Medical device market in China.Artif Organs. 2015; 39: 520-525
- Diffusion of medical technology: medical devices in India.Expert Rev Med Devices. 2009; 6: 197-205
- Multiregional medical device development: regulatory perspective.Clin J Gastroenterol. 2014; 7: 108-116
- Global cardiovascular device innovation: Japan-USA synergies: Harmonization by Doing (HBD) program, a consortium of regulatory agencies, medical device industry, and academic institutions.Circ J. 2013; 77: 1714-1718
- Innovation and implementation in cardiovascular medicine: challenges in the face of opportunity.JAMA. 2015; 313: 1007-1008
- Improving cardiovascular health: a balance between discovery and delivery.JAMA. 2013; 309: 1117-1118
- Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women).Am Heart J. 2013; 166: 421-428
- Outcomes following transcatheter aortic valve replacement in the United States.JAMA. 2013; 310: 2069-2077
- A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) Trial.JACC Cardiovasc Interv. 2014; 7: 857-867
- Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective.JACC Cardiovasc Interv. 2012; 5: 790-796
- A historical perspective on clinical trials innovation and leadership: where have the academics gone?.JAMA. 2011; 305: 713-714
House Energy and Commerce Committee. 21st century cures White Paper responses. http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/analysis/21stCenturyCures/20140707PCASTWhitePaperResponses.pdf. Accessed December 31, 2015.
- The current status of local Medicare payment policy: how specialty societies can influence local coverage determinations.J Am Coll Radiol. 2008; 5: 727-736
Developed in partnership with and endorsed by the Heart Rhythm Society