CLINICAL STUDY Applying a Structured Innovation Process to Interventional Radiology A Single Center Experience Akhilesh K Sista MD Gloria L Hwang MD David M Hovsepian MD Daniel Y Sze MD PhD William T Kuo MD Nishita Kothary MD John D Louie MD Kei Yamada MD Richard Hong MD Riaz Dhanani MD Todd J Brinton MD Thomas M Krummel MD Joshua Makower MD MBA Paul G Yock MD and Lawrence V Hofmann MD ABSTRACT Purpose To determine the feasibility and efficacy of applying an established innovation process to an active academic interventional radiology IR practice Materials and Methods 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 Results 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 Conclusions 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 ABBREVIATIONS FDA Food and Drug Administration PEG percutaneous endoscopic gastrostomy PRG percutaneous radiologic gastrostomy Despite being a small subspecialty interventional radiology IR has attracted some of the most illustrious inventors From Interventional Radiology A K S Weill Cornell Medical College 525 East 68th Street P 514 New York NY 10065 Interventional Radiology G L H D M H D Y S W T K N K J D L R H R D L V H Stanford Hospital and Clinics Stanford California Interventional Radiology K Y Emory University Atlanta Georgia and Stanford Biodesign T J B T M K J M P G Y Stanford University Stanford California Received November 1 2011 final revision received December 17 2011 accepted December 24 2011 Address correspondence to A K S E mail aks9010 med cornell edu None of the authors have identified a conflict of interest SIR 2012 J Vasc Interv Radiol 2012 23 488 494 DOI 10 1016 j jvir 2011 12 029 their novel ideas have advanced medicine and benefited millions of patients The successes of these individuals are founded in the creativity and unpredictability of the field a procedure may take an unexpected turn or a patient s anatomy or disease may present challenges that previous imaging or clinical history could not foresee These difficulties are compounded by the mandate to use minimally invasive techniques to reach areas of the body far removed from the operator s hands There is no shortage of unmet needs encountered by interventional radiologists but most do not have the time resources or training to address any or all of them in a systematic fashion The purpose of this study was to apply the principles of the Stanford Biodesign medical technology innovation process 1 2 to an academic IR practice to assess its efficacy Volume 23 Number 4 April 2012 in driving innovation in the IR suite This article describes our experience with four initial steps of the Stanford Biodesign process clinical observation creation of a need statement need screening and brainstorming MATERIALS AND METHODS The project was led by the primary author A K S who completed the Stanford Biodesign 1 year fellowship in medical device innovation The study took place within the division of interventional radiology at a tertiary care academic medical center that performs arterial oncologic venous gastrointestinal genitourinary and biliary procedures Institutional review board approval was not required An explanation of the four steps employed during the study follows Step 1 Clinical Observation Phase An observation is defined as a clinical occurrence with a suboptimal outcome ie pain death anxiety uncertainty high cost or inefficiency It may be patient centered or procedure related All physicians including fellows n 4 and faculty n 7 performing clinical procedures from August 1 2010 through November 30 2010 were asked to record clinical observations which were placed in a shared spreadsheet The observation the context or category of the observation the name of the observer and the date of the observation were included in the spreadsheet Step 2 Creation of Need Statement The next step involves transforming the observation into a generalized problem statement as follows Observation The tip of an implanted port flipped into the azygos vein 3 months after placement requiring transvenous access and repositioning with a snare Problem Ports for vascular access are not readily accessible after placement and solving a problem with a malfunctioning port often requires an invasive and complex procedure The problem statement lays the foundation for the need statement which transforms the problem into an actionable sentence or group of sentences It begins generically with a better way to more specific variations include a safer method of or a faster way to Working with the problem statement a corresponding need statement may read A better way to prevent port catheter tip migration that eliminates the need for reintervention In the example the problem is port catheter tip migration and the clinical need is a better way to prevent port catheter tip migration This phrase calls attention to the fact that existing methods fall short of solving the clinical need The need statement tacitly includes a desired outcome There should be a 0 reintervention rate One subtle aspect to this need statement is that solutions are confined to the design of the port or catheter itself 489 and its initial placement In other words there is no allowance for solutions that more easily revise an already implanted port with a malpositioned catheter To address this shortcoming a separate need statement could be created A better way to revise a malpositioned port catheter tip that reduces patient discomfort As this example shows a single problem can lead to
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