About

John Linehan is a Clinical Professor of Biomedical Engineering at Northwestern University. His research interests include medical device innovation processes, health technology assessment, and FDA regulation of medical devices. He has contributed to the understanding of the development and regulation of medical devices through various publications, including reviews of U.S. medical device regulation, stage-gate processes for medical device development, and studies on physician interaction in the medical device design process. His work emphasizes the importance of regulatory pathways and economic analysis in advancing medical technology and improving healthcare outcomes.

Research topics

• Chemistry
• Medicine
• Internal medicine
• Cardiology
• Anatomy

Selected publications

• Core Competencies for Undergraduates in Bioengineering and Biomedical Engineering: Findings, Consequences, and Recommendations

  Annals of Biomedical Engineering · 2020-02-05 · 71 citations

  editorialOpen access

  This paper provides a synopsis of discussions related to biomedical engineering core curricula that occurred at the Fourth BME Education Summit held at Case Western Reserve University in Cleveland, Ohio in May 2019. This summit was organized by the Council of Chairs of Bioengineering and Biomedical Engineering, and participants included over 300 faculty members from 100+ accredited undergraduate programs. This discussion focused on six key questions: QI: Is there a core curriculum, and if so, what are its components? QII: How does our purported core curriculum prepare students for careers, particularly in industry? QIII: How does design distinguish BME/BIOE graduates from other engineers? QIV: What is the state of engineering analysis and systems-level modeling in BME/BIOE curricula? QV: What is the role of data science in BME/BIOE undergraduate education? QVI: What core experimental skills are required for BME/BIOE undergrads? s. Indeed, BME/BIOI core curricula exists and has matured to emphasize interdisciplinary topics such as physiology, instrumentation, mechanics, computer programming, and mathematical modeling. Departments demonstrate their own identities by highlighting discipline-specific sub-specialties. In addition to technical competence, Industry partners most highly value our students' capacity for problem solving and communication. As such, BME/BIOE curricula includes open-ended projects that address unmet patient and clinician needs as primary methods to prepare graduates for careers in industry. Culminating senior design experiences distinguish BME/BIOE graduates through their development of client-centered engineering solutions to healthcare problems. Finally, the overall BME/BIOE curriculum is not stagnant-it is clear that data science will become an ever-important element of our students' training and that new methods to enhance student engagement will be of pedagogical importance as we embark on the next decade.

  PublisherOA PDFDOI

• Elucidation of the Reaction Mechanisms of Autooxidative Processes in Complex Condensed-Phase Mixtures

  2020-11-01 · 1 citations

  reportOpen access

  In this report, we discuss the oxidative processes of gasoline surrogate fuels comprised of a neat olefin, such as 1-hexene.Oxidative reactions are thought to involve the peroxyl radical and peroxide chemistry with initial hydrogen abstraction by O2, followed by addition of O2 or HOO to the hydrocarbon to form unstable peroxy radicals and peroxides that result in a chain reaction.In the condensed phase environment (liquid), we also consider polymeric-forming chain reactions, such as hydrocarbon radical-radical carbon chain growth.We present our experimental results showing the reaction products resulting from 1-hexene oxidation, along with chemical kinetic modeling of the system showing product ratios as a function of time.Applicability of our observations to oxidation-promoted fouling in hydrocarbon fuels (i.e., formation of gum) and radical-promoted polymerizations will also be discussed.

  PublisherOA PDFDOI

• Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience—Part 2: Medical Device Ecosystem and Policy

  Journal of Medical Devices · 2013-06-01 · 3 citations

  articleSenior author

  The FDA 510(k) clearance process is the most common regulatory pathway for medical devices. Since 2010, it has been at the forefront of regulatory policy discussion, with a multitude of stakeholders involved in a substantive exchange of ideas about the need and opportunities for improving the process and its implementation. This article is the second in a two-part series reporting the findings of a questionnaire-based assessment of recent industry experience with the 510(k) process. While the first article focused on findings directly relating to the medical device innovation process, this article reports more broadly on the findings and implications of interest to the medical community and policymakers. We discuss results in five key areas, ranging from the current performance of the 510(k) regulatory process to proposed changes and suggested performance metrics, and place identified challenges in perspective with ongoing and forthcoming FDA actions. Through the survey we also report on current trends in the amount of clinical evidence required by FDA for 510(k) devices and on the interactions between sponsors and the agency during various phases of clinical testing. The results suggest that significant opportunities exist for both industry and FDA to further improve the 510(k) process and the effectiveness of its implementation. Continued collection of process performance data can contribute to prioritizing suggested policy changes, and gauging their effects in a timely manner.

  PublisherDOI

• BioInnovate Ireland—Fostering Entrepreneurial Activity Through Medical Device Innovation Training

  Annals of Biomedical Engineering · 2013-03-13 · 12 citations

  articleSenior author
  PublisherDOI

• Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience

  Journal of Medical Devices · 2012-05-24 · 13 citations

  articleSenior authorCorresponding

  Medical device regulation plays a significant role in promoting and protecting the public health. But the regulatory process and its requirements also exercise substantial influence over the design, development, and commercialization of new medical technologies. In recent months, FDA’s premarket notification (510(k)) process, through which the majority of medical devices are cleared to the market, has been at the forefront of policy discussions, and efforts are continuing to further analyze and strengthen the process. In this paper, we report findings from our recently completed, comprehensive, industry-wide survey to provide input and perspective for the current discussions about changes to the 510(k) process. The findings reported here focus on five aspects of the 510(k) process with principal relevance to medical technology developers and innovators: predictability of the process, impact of regulatory requirements, role of guidance documents, interaction with FDA, and international comparisons. The results confirm the substantial influence of regulatory requirements on investment decisions and development priorities. The data suggest that improvement of regulatory process predictability needs to be a top priority for all stakeholders – especially FDA. Increasing the number of guidance documents available to industry, and ensuring that their content is timely updated to reflect current FDA thinking, could be one way to achieve this goal. Consistent implementation of the regulatory process and enhanced communications between sponsors and the agency could further contribute to improvements, along with efforts to provide additional training opportunities for reviewers and industry personnel. The survey data suggest that small companies, when compared to large companies, are particularly challenged by the current process, and should therefore receive particular attention in any reform and improvement efforts.

  PublisherDOI

• An Integrated Health-Economic Analysis of Diagnostic and Therapeutic Strategies in the Treatment of Moderate-to-Severe Obstructive Sleep Apnea

  SLEEP · 2011-05-31 · 151 citations

  articleOpen accessSenior author

  STUDY OBJECTIVES: Obstructive sleep apnea (OSA) is a common disorder associated with substantially increased cardiovascular risks, reduced quality of life, and increased risk of motor vehicle collisions due to daytime sleepiness. This study evaluates the cost-effectiveness of three commonly used diagnostic strategies (full-night polysomnography, split-night polysomnography, unattended portable home-monitoring) in conjunction with continuous positive airway pressure (CPAP) therapy in patients with moderate-to-severe OSA. DESIGN: A Markov model was created to compare costs and effectiveness of different diagnostic and therapeutic strategies over a 10-year interval and the expected lifetime of the patient. The primary measure of cost-effectiveness was incremental cost per quality-adjusted life year (QALY) gained. PATIENTS OR PARTICIPANTS: Baseline computations were performed for a hypothetical average cohort of 50-year-old males with a 50% pretest probability of having moderate-to-severe OSA (apnea-hypopnea index [AHI] ≥ 15 events per hour). MEASUREMENTS AND RESULTS: For a patient with moderate-to-severe OSA, CPAP therapy has an incremental cost-effectiveness ratio (ICER) of $15,915 per QALY gained for the lifetime horizon. Over the lifetime horizon in a population with 50% prevalence of OSA, full-night polysomnography in conjunction with CPAP therapy is the most economically efficient strategy at any willingness-to-pay greater than $17,131 per-QALY gained because it dominates all other strategies in comparative analysis. CONCLUSIONS: Full-night polysomnography (PSG) is cost-effective and is the preferred diagnostic strategy for adults suspected to have moderate-to-severe OSA when all diagnostic options are available. Split-night PSG and unattended home monitoring can be considered cost-effective alternatives when full-night PSG is not available.

  PublisherOA PDFDOI

• Academic/Industry Challenges for Medical Device Development

  Science Translational Medicine · 2010-12-22 · 16 citations

  article1st authorCorresponding

  A Clinical and Translational Science Awards Industry Forum titled "Promoting Efficient and Effective Collaborations Among Academia, Government, and Industry" was held in February 2010. A workshop at this forum was organized to discuss ways to promote medical device innovation. Specific challenges to the device development process were identified, as well as practical ways to address some of these issues.

  PublisherDOI

• A Case Study of Physician Interaction in the Medical Device Development Process

  Journal of Medical Devices · 2010-06-01

  articleOpen access

  A multiphase empirical field study is being conducted at Stanford University to examine the process of physician interaction during medical device development. The initial component of this study involved creating an analytic framework for case-based research that provided a conceptual guide for the pilot case study documented in this paper. The pilot case study examined the process of engaging physicians in medical device development within the context of an entrepreneurial device company. The methods used in this study included a combination of interviews with cross-functional team members, a quantitative survey, and the collection of archival data. Data analysis first involved documenting physician-developer interaction practices that had been used within the company, from needs finding to post-market surveillance, across multiple product generations. Leading development factors involving physicians that had influenced the company’s clinical and financial outcomes were next identified. The case study illustrated the importance of working with and understanding the user experiences of a wide range of physicians when developing new products. The case also captured how physician interaction influences risk perceptions toward medical device performance for both surgeons and developers. The case likewise highlighted the benefits of a systems-based design approach, as opposed to designing products for a single technical end point. From a methodological perspective, the case study revealed the importance of examining user interaction within a contextual framework, as opposed to an isolated examination of input and output variables. The study presented in this paper has provided a foundation for future case-based analyses regarding the process of physician interaction in medical device development.

  PublisherOA PDFDOI

• NOVEL TRUNCATION MUTATION OF PRNP CAUSES CHRONIC DIARRHOEA, SENSORY NEUROPATHY AND AUTONOMIC FAILURE ASSOCIATED WITH PRION PROTEIN DEPOSITION IN THE CEREBRAL BLOOD VESSELS AND SMALL BOWEL

  UCL Discovery (University College London) · 2010-07-01

  article
  Publisher

• The Iterative Nature of Medical Device Design

  2009-12-01 · 3 citations

  articleSenior author

  A one-year study, sponsored by The Institute for Health Technology Studies, was conducted by a team of Stanford University researchers to develop a linear model of the medical device development process, from concept to commercialization. The empirical field study involved interviewing and surveying individuals who had been involved with various stages of the development process, ranging from concept definition to post-market surveillance. Six medical device case studies were conducted to exemplify the device development process and its variations for different types of technologies. The focus of this paper is to examine variations to the linear device development model, specifically iterations that occur across development phases. Development variations for drug/device combination medical products and variations influenced by financial constraints are likewise explored. The data presented in this paper is intended to provide a foundation for creating new development models and guidelines which reflect the highly complex and iterative nature of medical device design.

  Publisher

Recent grants

• NIH Grant R01HL024349

  NIH · $4.1M · 2012

Frequent coauthors

• C. A. Dawson

  228 shared

• D. A. Rickaby

  Medical College of Wisconsin

  73 shared

• T. A. Bronikowski

  65 shared

• Said H. Audi

  Marquette University

  48 shared

• Christopher C. Hanger

  Medical College of Wisconsin

  42 shared

• Wiltz W. Wagner

  University of South Alabama

  33 shared

• Robert G. Presson

  Indiana University School of Medicine

  33 shared

• David L. Roerig

  Medical College of Wisconsin

  32 shared

Labs

• Biomedical EngineeringPI