Joshua Makower

All Publications

• Time From Authorization by the US Food and Drug Administration to Medicare Coverage for Novel Technologies. JAMA health forum Sexton, Z. A., Perl, J. R., Saul, H. R., Trotsyuk, A. A., Pietzsch, J. B., Ruggles, S. W., Nikolov, M. C., Schulman, K. A., Makower, J. 2023; 4 (8): e232260

  Abstract

  A wide variety of novel medical diagnostics and devices are determined safe and effective by the US Food and Drug Administration (FDA) each year, but to our knowledge the literature lacks evidence documenting how long it takes to establish new Medicare coverage for these technologies.To measure time from FDA authorization to at least nominal Medicare coverage for technologies requiring a new reimbursement pathway.In this cross-sectional study, public databases were used to associate each technology to billing codes, determine the effective date of each code and Medicare coverage decisions, and stratify by the maturity of the Medicare coverage. At least nominal coverage was defined as achievement of explicit coverage milestones through a national coverage determination, local coverage determinations by Medicare administrative contractors, or by implicit coverage aligned to a new billing code. Characterization by product type (acute treatment, chronic or ongoing treatment, diagnostic assay, and diagnostic device), manufacturer size, and evidence level were assessed for association with coverage achievement. The study included new product applications authorized by the FDA through the premarket approval pathway, the de novo pathway, or with breakthrough designation in the 510(k) pathway from January 1, 2016, to December 31, 2019. Data analysis took place between May 1, 2022, and December 31, 2022.Time from FDA authorization to the first coverage milestone.Among 281 identified technologies in the total sample, 64 (23%) were deemed novel technologies based on the absence of coverage determinations and/or the use of temporary or miscellaneous billing codes. Twenty-eight of 64 technologies (44%) successfully achieved explicit or implicit coverage following FDA authorization. The median time to at least nominal coverage for the analysis cohort was 5.7 years (90% CI, 4.4-NA years). Analysis of time-to-coverage data highlighted company size (log-rank P<.001) and product type (log-rank P = .01) as significant covariates associated with coverage achievement. No association was observed for technologies with level 1 evidence at FDA authorization and subsequent coverage milestone achievement (log-rank P = .40).In this cross-sectional study of 64 novel technologies, only 28 (44%) achieved coverage milestones over the study timeline. The several-year period observed to establish at least nominal coverage suggests existing coverage processes may affect timely reimbursement of new technologies.

  View details for DOI 10.1001/jamahealthforum.2023.2260

  View details for PubMedID 37540524

• Need Statements in Healthcare Innovation. Annals of biomedical engineering Mokarram, N., Denend, L., Lyon, J., Rait, D., Brinton, T., Makower, J., Yock, P. 2021

  View details for DOI 10.1007/s10439-021-02782-3

  View details for PubMedID 34100147

• Inspiration, Perspiration, and Perseverance: An Innovator's Perspective MEDICAL INNOVATION: CONCEPT TO COMMERCIALIZATION Makower, J., Denend, L., Behrns, K. E., Gingles, B., Sarr, M. G. 2018: 251–60

  View details for DOI 10.1016/B978-0-12-814926-3.00026-7

  View details for Web of Science ID 000488302600027

• Needs-Based Innovation in Interventional Radiology: The Biodesign Process TECHNIQUES IN VASCULAR AND INTERVENTIONAL RADIOLOGY Steinberger, J. D., Denend, L., Azagury, D. E., Brinton, T. J., Makower, J., Yock, P. G. 2017; 20 (2): 84–89

  Abstract

  There are many possible mechanisms for innovation and bringing new technology into the marketplace. The Stanford Biodesign innovation process is based in a deep understanding of clinical unmet needs as the basis for focused ideation and development. By identifying and vetting a compelling unmet need, the aspiring innovator can "derisk" a project and maximize chances for successful development in an increasingly challenging regulatory and economic environment. As a specialty founded by tinkerers, with a history of disruptive innovation that has yielded countless new ways of delivering care with minimal invasiveness, lower morbidity, and lower cost, interventional radiologists are uniquely well positioned to identify unmet needs and develop novel solutions free of dogmatic convention.

  View details for PubMedID 28673651

• Inspiration, perspiration, and execution: An innovator's perspective SURGERY Makower, J. 2017; 161 (5): 1187-1190

  Abstract

  Josh Makower, MD, is a General Partner at New Enterprise Associates, Consulting Professor of Medicine at Stanford University Medical School, Co-Founder of Stanford's Biodesign Innovation Program, and Founder and Executive Chairman of the medical device incubator, ExploraMed Development, LLC.

  View details for DOI 10.1016/j.surg.2016.06.060

  View details for Web of Science ID 000400318000003

  View details for PubMedID 28438272

• Biodesign: The Process of Innovating Medical Technologies Zenios, S., Makower, J., Yock, P., et al Cambridge University Press. 2015
• Outcomes from a Postgraduate Biomedical Technology Innovation Training Program: The First 12 Years of Stanford Biodesign ANNALS OF BIOMEDICAL ENGINEERING Brinton, T. J., Kurihara, C. Q., Camarillo, D. B., Pietzsch, J. B., Gorodsky, J., Zenios, S. A., Doshi, R., Shen, C., Kumar, U. N., Mairal, A., Watkins, J., Popp, R. L., Wang, P. J., Makower, J., Krummel, T. M., Yock, P. G. 2013; 41 (9): 1803-1810

  Abstract

  The Stanford Biodesign Program began in 2001 with a mission of helping to train leaders in biomedical technology innovation. A key feature of the program is a full-time postgraduate fellowship where multidisciplinary teams undergo a process of sourcing clinical needs, inventing solutions and planning for implementation of a business strategy. The program places a priority on needs identification, a formal process of selecting, researching and characterizing needs before beginning the process of inventing. Fellows and students from the program have gone on to careers that emphasize technology innovation across industry and academia. Biodesign trainees have started 26 companies within the program that have raised over $200 million and led to the creation of over 500 new jobs. More importantly, although most of these technologies are still at a very early stage, several projects have received regulatory approval and so far more than 150,000 patients have been treated by technologies invented by our trainees. This paper reviews the initial outcomes of the program and discusses lessons learned and future directions in terms of training priorities.

  View details for DOI 10.1007/s10439-013-0761-2

  View details for Web of Science ID 000323736800002

  View details for PubMedID 23404074

• A Role for Entrepreneurs An Observation on Lowering Healthcare Costs via Technology Innovation AMERICAN JOURNAL OF PREVENTIVE MEDICINE Gottlieb, S., Makower, J. 2013; 44 (1): S43-S47

  View details for DOI 10.1016/j.amepre.2012.09.006

  View details for Web of Science ID 000311636100011

  View details for PubMedID 23195166

• Applying a Structured Innovation Process to Interventional Radiology: A Single-Center Experience JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY Sista, A. K., Hwang, G. L., Hovsepian, D. M., Sze, D. Y., Kuo, W. T., Kothary, N., Louie, J. D., Yamada, K., Hong, R., Dhanani, R., Brinton, T. J., Krummel, T. M., Makower, J., Yock, P. G., Hofmann, L. V. 2012; 23 (4): 488-494

  Abstract

  To determine the feasibility and efficacy of applying an established innovation process to an active academic interventional radiology (IR) practice.The Stanford Biodesign Medical Technology Innovation Process was used as the innovation template. Over a 4-month period, seven IR faculty and four IR fellow physicians recorded observations. These observations were converted into need statements. One particular need relating to gastrostomy tubes was diligently screened and was the subject of a single formal brainstorming session.Investigators collected 82 observations, 34 by faculty and 48 by fellows. The categories that generated the most observations were enteral feeding (n = 9, 11%), biopsy (n = 8, 10%), chest tubes (n = 6, 7%), chemoembolization and radioembolization (n = 6, 7%), and biliary interventions (n = 5, 6%). The output from the screening on the gastrostomy tube need was a specification sheet that served as a guidance document for the subsequent brainstorming session. The brainstorming session produced 10 concepts under three separate categories.This formalized innovation process generated numerous observations and ultimately 10 concepts to potentially to solve a significant clinical need, suggesting that a structured process can help guide an IR practice interested in medical innovation.

  View details for DOI 10.1016/j.jvir.2011.12.029

  View details for Web of Science ID 000302396300009

  View details for PubMedID 22464713

• FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies. Makower, J., Meer, A., Denend, L. AdvaMed and the National Venture Capital Association. 2010
• Biodesign: The Process of Innovating Medical Technologies Yock, P., Zenios, S., Makower, J., et al Cambridge. 2009
• Inventing our future: training the next generation of surgeon innovators. Seminars in pediatric surgery Krummel, T. M., Gertner, M., Makower, J., Milroy, C., Gurtner, G., Woo, R., Riskin, D. J., Binyamin, G., Connor, J. A., Mery, C. M., Shafi, B. M., Yock, P. G. 2006; 15 (4): 309-318

  Abstract

  Current surgical care and technology has evolved over the centuries from the interplay between creative surgeons and new technologies. As both fields become more specialized, that interplay is threatened. A 2-year educational fellowship is described which teaches both the process and the discipline of medical/surgical device innovation. Multi-disciplinary teams (surgeons, engineers, business grads) are assembled to educate a generation of translators, who can bridge the gap between scientific and technologic advances and the needs of the physician and the patient.

  View details for PubMedID 17055962

• Principles of Innovation Interventional Cardiology Makower, J., Nayak, A., 2006; Chapter 71
• Percutaneous transvenous cellular cardiomyoplasty - A novel nonsurgical approach for myocardial cell transplantation JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Thompson, C. A., Nasseri, B. A., Makower, J., Houser, S., McGarry, M., Lamson, T., Pomerantseva, I., Chang, J. Y., Gold, H. K., Vacanti, J. P., Oesterle, S. N. 2003; 41 (11): 1964-1971

  Abstract

  The study evaluated a nonsurgical means of intramyocardial cell introduction using the coronary venous system for direct myocardial access and cell delivery.Direct myocardial cell repopulation has been proposed as a potential method to treat heart failure.We harvested bone marrow from Yorkshire swine (n = 6; 50 to 60 kg), selected culture-flask adherent cells, labeled them with the gene for green fluorescence protein, expanded them in culture, and resuspended them in a collagen hydrogel. Working through the coronary sinus, a specialized catheter system was easily delivered to the anterior interventricular coronary vein. The composite catheter system (TransAccess) incorporates a phased-array ultrasound tip for guidance and a sheathed, extendable nitinol needle for transvascular myocardial access. A microinfusion (IntraLume) catheter was advanced through the needle, deep into remote myocardium, and the autologous cell-hydrogel suspension was injected into normal heart. Animals were sacrificed at days 0 (n = 2), 14 (n = 1, + 1 control/collagen biogel only), and 28 (n = 2), and the hearts were excised and examined.We gained widespread intramyocardial access to the anterior, lateral, septal, apical, and inferior walls from the anterior interventicular coronary vein. No death, cardiac tamponade, ventricular arrhythmia, or other procedural complications occurred. Gross inspection demonstrated no evidence of myocardial perforation, and biogel/black tissue dye was well localized to sites corresponding to fluoroscopic landmarks for delivery. Histologic analysis demonstrated needle and microcatheter tracts and accurate cell-biogel delivery.Percutaneous intramyocardial access is safe and feasible by a transvenous approach through the coronary venous system. The swine offers an opportunity to refine approaches used for cellular cardiomyoplasty.

  View details for DOI 10.1016/S0735-1097(03)00397-8

  View details for Web of Science ID 000183219100010

  View details for PubMedID 12798567

• Percutaneous in-situ coronary venous arterialization (PICVA) improves survival in response to acute ischemia in the porcine model Oesterle, S. N., Yeung, A. C., Lo, S., Virmani, R., Van Bibber, R., Flaherty, J. C., Lamson, T. C., Kim, S. W., Garibotto, J. T., Tumas, M. W., Makower, J. ELSEVIER SCIENCE INC. 2000: 61A–61A

  View details for Web of Science ID 000085209700235

• New Approaches and Conduits: In Situ Venous Arterialization and Coronary Artery Bypass. Current interventional cardiology reports Fitzgerald, Hayase, Yeung, Virmani, Robbins, Burkhoff, Makower, Yock, OESTERLE 1999; 1 (2): 127-137

  View details for PubMedID 11096617

• The Characterization of the Dexterous Hand Master Index Finger in Flexion and Extension The Association for the Advancement of Medical Instrumentation Makower, J.,, Parnianpour, M., Nordin, M. 1990; May: 61
• The Validity Assessment of the Dexterous Hand Master: A Linkage System for the Measurement of Joints in the Hand The Annals of Biomedical Engineering and Biomedical Instrumentation and Technology Makower, J.,, Parnianpour, M., Nordin, M. 1990; August