verica mktg 06092010summary

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  • 1. Verica Sightline Marketing PlanSummaryThis document is excerpted from a business plan written for theUniversity of Washington Medical Product CommercializationProgram. The business plan was written with a team of three peopleincluding myself as one of the team leaders. The marketing sectionfollowing this was written by me as my primary contribution to theproject. It lays out the product marketing position and part of thebusiness case for investment. It includes a single page marketingstory intended as a hand-out at meetings and trade shows. It is theemotional link in the marketing story and is intended to draw poten-tial investors and customers into the products mission and brand. Ialso created the graphic design and industrial design contentcontained in the plan.Domenic Stephen Michael 992 3712
  • 2. VERICA SIGHTLINE 3D Guided NeedleBiopsy SystemMarketing Strategy for Incorporation into the Verica Business PlanJune 2010University of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli -1-
  • 3. SummaryIn 2009 the close friend of a Verica founder went through a routine recommendedscreening for breast cancer. The mammogram showed suspect lesions, and a tissuebiopsy was prescribed to narrow down the possible diagnosis. She waited anxiously forthe biopsy appointment. The procedure was a core needle tissue biopsy that requiredmultiple insertions resulting in pain, discomfort and minor bleeding at the biopsy tracts.The diagnosis for breast cancer was negative to the great relief of the patient. Theanxiety, waiting and hoping was exhausting for her.There is a significant likelihood that an American woman will undergo a breast biopsyprocedure during her lifetime. When considering the emotional and physical costs to thepatient, we believe it is important to improve the reliability and safety of this minimallyinvasive diagnostic procedure.The MissionVerica will provide healthcare with the safest and most accuratediagnostic solutions.Verica is committed to creating affordable products for the safe, accurate and efficientdiagnosis of organ and soft tissue disease. The brand will embody the highest concernfor the health and welfare of the patient, effectiveness and ease of use for clinicians andthe efficient use of health care resources.University of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli -2-
  • 4. The Business CaseOver 3 million needle biopsies are performed in the US each year, and many require extrainsertions, multiple visits, or complications due to inaccurate placement of the biopsyneedle. The result is unnecessary pain and discomfort, tissue damage, wasted time,stress, and unnecessary cost.Ultrasound guided needle placement has become common, though it is typicallyperformed with the limited view of a 2D ultrasound image. The ultrasound probe andneedle are held in two different hands. The user makes a reasonable estimate of theneedle insertion path, inserts the needle, and then adjusts the needle position based onthe ultrasound image visual feedback. Repositioning after insertion may cause tissuedamage or complications.The problem is partially addressed by existing products. 3D ultrasound imaging isemerging as a method for accurate needle guidance, but is not yet widely used. Fixedneedle guides are available as third-party accessories for ultrasound probes. There is nocomplete and integrated solution.The Sightline system enables highly accurate positioning with fewer procedure steps andreduced rate of complications. This is contrasted to ultrasound systems that are unable todisplay the needle path prior to insertion.Verica expects this new technology to become a standard tool for biopsy procedures,providing revenue growth to $70M by the year 2015, with additional growth potentialthrough increased penetration of its target markets, and expansion of medical indicationsto additional target organs for needle biopsies.In addition to biopsy procedures, the technology can potentially be applied to any guidedinsertion (such as needle injections and catheterization), providing opportunity for futureproduct line expansion using the Sightline platform technology.University of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli -3-
  • 5. Strengths Weaknesses Unique product niche Time to market Low risk technology Low technology bar to entry Low risk regulatory path No established sales network Substantial market potential Long clinical adoption curveOpportunities Threats Patent fence Competitive interest from Recruit existing sales majors in sector channels Recruit clinical thought leaders Joint agreements with a major player Sightline Platform Technology OutlookUniversity of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli -4-
  • 6. Market AnalysisWhat medical problem does Verica Sightline technology solve ?Needle tissue biopsies are a required procedure for the diagnosis of disease in manypatient conditions. Needle biopsies expose both the patient and practitioner to healthrisks. The procedure may produce complications that outweigh the benefit to the patient.Though many needle biopsy procedures are ultrasound-guided, accurate positioningremains challenging. Inaccurate needle positioning may resulting in increased incidenceof bleeding and tissue damage. Additional insertions are sometimes required. Trauma toadjacent organs and tissue structures is a potential complication. The product will improvepatient outcomes and reduce treatment costs by facilitating an expediant procedure withlower risk of complications.Over 3 million needle biopsy procedures are performed annually in the USA. At least 2million of these will benefit from the use of the companys product. The product isintended for use on soft tissue where the probe can be placed on the skin surface directlyover the targeted tissue (kidney, liver, breast, pancreas).University of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli -5-
  • 7. Ultrasound guided needle biopsy, Ultrasound guided needle biopsy, surgeon with assisting clinician. surgeon with assisting clinician. Fine needle breast biopsy without Fine needle breast biopsy without imaging. imaging.Complications of Needle Biopsy ProceduresNeedle biopsy is a frequently used procedure to diagnose diseases in soft tissues andorgans. It is considered a minimally invasive surgical procedure. As with any form ofsurgery there are risks involved for the patient and sometimes risks to health carepractitioners (e.g. transmission of disease from needle sticks).University of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli -6-
  • 8. Complications of Needle Biopsy Procedures1 1. Pain and discomfort 2. Hemorrhage (bleeding and fluid discharge) 3. Hematoma (blood blister near skin surface) 4. Biopsy induced pneumothorax (Introduction of air into thoracic structure e.g. from lung, kidney, or liver core needle biopsies) 5. Puncture of adjacent organs and tissues 6. Infection 7. Needle tract implantation, seeding of tumor cells along needle biopsy path. 1 Needle tract implantation after percutaneous interventional procedures in hepatocellular carcinomas: lessons learned from a 10-year experience.; Chang S, Kim SH, Lim HK, Kim SH, Lee WJ, Choi D, Kim YS, Rhim H.; Department of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. Korean Journal of Radiology. 2008 May-Jun;9 (3) :268-74 University of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli -7-
  • 9. Proposal for an integrated needle and ultrasound imaging probe.The Sightline System Solution The Sightline system is designed to reduce complications from tissue biopsy. The Sightline guide can be used to introduce a cauterization probe to the biopsy tract. Cauterization techniques will sterilize the biopsy tract and minimize bleeding. The Sightline system has proven to improve the efficiency of biopsy procedures. Single