Applying a Structured Innovation Process to Interventional Radiology: A Single-Center ExperienceMaterials and MethodsStep 1: Clinical Observation PhaseStep 2: Creation of Need StatementObservationProblemStep 3: Needs ScreeningStep 4: BrainstormingResultsStep 1: Clinical Observations PhaseStep 2: Creation of Need StatementStep 3: Needs ScreeningObservationProblem(a) Disease State Fundamentals(b) Existing Technologies(c) Stakeholder AnalysisPhysiciansNursesHospitals, nursing homes, and payers (Medicare or private insurance)(d) Market Analysis(e) Reimbursement(f) Regulatory ConsiderationsNeed Specification DocumentNeed CriteriaStep 4: BrainstormingDiscussionReferencesCLINICAL STUDYApplying a Structured Innovation Process toInterventional Radiology: A Single-CenterExperienceAkhilesh 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, andLawrence V. Hofmann, MDABSTRACTPurpose: To determine the feasibility and efficacy of applying an established innovation process to an active academic interventionalradiology (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 intoneed statements. One particular need relating to gastrostomy tubes was diligently screened and was the subject of a single formalbrainstorming session.Results: Investigators collected 82 observations, 34 by faculty and 48 by fellows. The categories that generated the mostobservations were enteral feeding (n ! 9, 11%), biopsy (n ! 8, 10%), chest tubes (n ! 6, 7%), chemoembolization andradioembolization (n ! 6, 7%), and biliary interventions (n ! 5, 6%). The output from the screening on the gastrostomy tube needwas a specification sheet that served as a guidance document for the subsequent brainstorming session. The brainstorming sessionproduced 10 concepts under three separate categories.Conclusions: This formalized innovation process generated numerous observations and ultimately 10 concepts to potentially tosolve a significant clinical need, suggesting that a structured process can help guide an IR practice interested in medical innovation.ABBREVIATIONSFDA ! Food and Drug Administration, PEG ! percutaneous endoscopic gastrostomy, PRG ! percutaneous radiologicgastrostomyDespite being a small subspecialty, interventional radiology(IR) has attracted some of the most illustrious inventors;their novel ideas have advanced medicine and benefitedmillions of patients. The successes of these individuals arefounded in the creativity and unpredictability of the field; aprocedure may take an unexpected turn, or a patient’sanatomy or disease may present challenges that previousimaging or clinical history could not foresee. These diffi-culties are compounded by the mandate to use minimallyinvasive techniques to reach areas of the body far removedfrom the operator’s hands. There is no shortage of unmetneeds encountered by interventional radiologists, but mostdo not have the time, resources, or training to address anyor all of them in a systematic fashion.The purpose of this study was to apply the principles ofthe Stanford Biodesign medical technology innovation pro-cess (1,2) to an academic IR practice to assess its efficacyFrom Interventional Radiology (A.K.S.), Weill Cornell Medical College, 525East 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.), StanfordHospital and Clinics, Stanford, California; Interventional Radiology (K.Y.), Em-ory 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: [email protected] of the authors have identified a conflict of interest.© SIR, 2012J Vasc Interv Radiol 2012; 23:488 – 494DOI: 10.1016/j.jvir.2011.12.029in driving innovation in the IR suite. This article describesour experience with four initial steps of the Stanford Biode-sign process— clinical observation, creation of a need state-ment, need screening, and brainstorming.MATERIALS AND METHODSThe project was led by the primary author (A.K.S.), whocompleted the Stanford Biodesign 1-year fellowship in med-ical device innovation. The study took place within the divi-sion of interventional radiology at a tertiary care academicmedical center that performs arterial, oncologic, venous, gas-trointestinal, genitourinary, and biliary procedures. Institu-tional review board approval was not required. An explanationof the four steps employed during the study follows.Step 1: Clinical Observation PhaseAn observation is defined as a clinical occurrence with asuboptimal outcome (ie, pain, death, anxiety, uncertainty,high cost, or inefficiency). It may be patient-centered orprocedure-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 recordclinical observations, which were placed in a shared spread-sheet. The observation, the context or category of the ob-servation, the name of the observer, and the date of theobservation were included in the spreadsheet.Step 2: Creation of Need StatementThe next step involves transforming the observation into ageneralized problem statement, as follows:Observation. The tip of an implanted port flipped intothe azygos vein 3 months after placement, requiring trans-venous access and repositioning with a snare.Problem. Ports for vascular access are not readily accessi-ble after placement, and solving a problem with a malfunc-tioning port often requires an invasive and complex procedure.The problem statement lays the foundation for the needstatement, which transforms the problem into an actionablesentence or group of sentences. It begins generically with “abetter way to”; more specific variations include “a safermethod of” or “a faster way to.”Working with the problem statement, a correspond-ing need statement may read: Abetterwaytopreventport catheter tip migration that eliminates
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