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    Verica mktg 06092010summary Verica mktg 06092010summary Document Transcript

    • 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 product’s mission and brand. Ialso created the graphic design and industrial design contentcontained in the plan.Domenic Stephen Michael Giuntolidsmg.connect@gmail.comwww.linkedin.com/in/domenicgiuntoli206 992 3712
    • 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-
    • 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-
    • 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-
    • 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-
    • 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 company’s 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-
    • 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-
    • 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-
    • 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 procedure, fewer “sticks”, less procedure time, higher patient throughput.• The use of Sightline technology will improve the reliability of biopsy results. Guided imagery confirms the location of the biopsy site.• The Sightline system will efficiently and accurately acquire high quality tissue samples for biopsy. Fewer insertions will be required to extract the required samples.University of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli -8-
    • Marketing ObjectivesThe Verica Sightline products will deliver these brand promises:• The health care practitioner will associate Verica Sightline products with confidence and ease of use.• The patient will be familiar with the technology through her clinician and associate it with safety and accuracy.• The healthcare system will associate Verica Sightline with high quality products and services.Market SizeTissue biopsies are a routine step in the screening process for several conditions and it isthe standard for diagnosis for cancer. Biopsy procedures range in cost from $550 to $800.There are about 1 million breast biopsy procedures per year in the United States. Thisfigure is produced from the following statistics: • There are around 20 million mammograms ordered or provided at physician office visits and hospital outpatient department visits in the United States per year. National Ambulatory Medical Care Survey: 2006 Summary • Less than 5% of mammograms are called back for a biopsy procedure. [Jemal A, Murray T, Ward E, et al. “Cancer Statistics, 2005.” CA Cancer J Clin 55(1) (2005):10-30]The total value of breast biopsy procedures per year in the US is $550M, based on 1million biopsies at the $550 per procedure.The estimated size of the liver, kidney and pancreas biopsy markets in the US on anannual basis is $250M. ( This is derived using the same cancer case/biopsy ratio from theabove case for breast biopsy: 4/1. )The total procedure cost for breast, kidney, liver and pancreas biopsy procedures per yearin the US is approximately $800M.Market RelationshipsUniversity of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli -9-
    • • The target users are pathologists, radiologists, surgeons, oncologists, general practitioners, medical physicists, urologic oncologists. < http://www.cancer.org > • The influencers for purchasing and specification are clinicians involved in the diagnosis of breast health issues such as nurses, gynecologists and general physicians. Equipment technicians and lab technicians may also be included in this category. • The decision makers for purchasing capital equipment such as the Verica system are purchasing agents, hospital value review boards, clinic and hospital administrations.Sources of RevenueRevenue will be derived from a combination of special-purpose guided-needle ultrasoundsystems, probe-related proprietary disposables, and software upgrades. Training fees,extended warrantees and services contracts will provide additional revenue. The probeand software may be licensed as an OEM subsystem for integration with general-purposeultrasound diagnostic imaging systems.University of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli - 10 -
    • CompetitionThe competition for Verica are the global players in the medical application of ultrasoundtechnology. The major players in the US and Europe include Siemens Medical, Philips,and GE Healthcare. Toshiba and Chongqing are major players in Asia. The majority ofactivity is in screening and diagnosis.The global market for diagnostic imaging is large and growing. Verica is addressing arelatively small segment of that total market that is underserved by the major players. Theglobal diagnostic imaging market is forecast to reach $24.6 billion in 2015 (reference:Diagnostic Imaging Market to Grow 7 Percent by 2015 , Imaging Technology Newshttp://www.itnonline.net).Our strategy includes forming a strategic partnership with one of the potential competitors.This relationship could take the form of a joint development agreement, and is a potentialpath for acquisition by the investing partner.University of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli - 11 -
    • Verica is targeting a segment of the tissue biopsy market thatcurrently represents expenditures of over $800M per year onprocedures performed in the United States.“More than 550,000 ultrasound guided core needle biopsy procedures are performedannually, primarily with spring loaded core devices. The number of diagnostic breastbiopsies is increasing every year. A report in the September 2006 issue of the Journal ofthe American College of Radiology indicates a 61 percent increase in biopsy proceduresand procedure volumes going up by 101 percent among radiologists compared tosurgeons. "With 80 percent of those biopsies resulting in a negative diagnosis,"Pearson says, "there is no reason why women should undergo procedures that arepainful or traumatic." SEPT 2006 Journal of American College of Radiology • Substantial market potential • Low risk regulatory path through 510(K) submission • Established, low risk technologyUniversity of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli - 12 -
    • Research Notes1)Pain (0.056-22%) o Pleuritic o Peritoneal o DiaphragmaticHemorrhage o Intraperitoneal (0.03-0.7%) o Intrahepatic and / or subcapsular (0.059-23%) o Hemobilia (0.059-0.2%)Bile peritonitis (0.03-0.22%)BacteremiaSepsis (0.088%) and abscess formationPneumothorax and/or pleural effusion (0.08-0.28%)Hemothorax (0.18-0.49%)Arteriovenous fistula (5.4%)Subcutaneous emphysema (0.014%)Anesthetic reaction (0.029%)Needle break (0.02-0.059%)Biopsy of other organs o Lung (0.001-0.014%) o Gallbladder (0.034-0.117%) o Kidney (0.096-0.029%)Colon (0.0038-0.044%)Mortality (0.0088-0.3%)Complications of Percutaneous Liver Biopsyhttp://emedicine.medscape.com/article/1819437-treatment2)Percutaneous interventional procedures under image guidance, such as biopsy, ethanolinjection therapy, and radiofrequency ablation play important roles in the management ofhepatocellular carcinomas. Although uncommon, the procedures may result in tumorimplantation along the needle tract, which is a major delayed complication. ImplantedUniversity of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli - 13 -
    • tumors usually appear as one or a few, round or oval-shaped, enhancing nodules alongthe needle tract on CT, from the intraperitoneum through the intercostal or abdominalmuscles to the subcutaneous or cutaneous tissues. Radiologists should understand themechanisms and risk factors of needle tract implantation, minimize this complication, andalso pay attention to the presence of implanted tumors along the needle tract duringfollow-up.Needle tract implantation after percutaneous interventional procedures in hepatocellularcarcinomas: lessons learned from a 10-year experience. Chang S, Kim SH, Lim HK, KimSH, 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 ofRadiology.2008 May-Jun;9(3):268-74)3)To determine whether the increasing use of percutaneous fine-needle biopsy ofabdominal lesions is associated with an increase in serious complications, the authorupdated a literature search and evaluated a questionnaire (distributed among selectedhospitals in the United States in 1986 and 1987) that followed up a questionnairedistributed in 1983. The updated literature review revealed a total of 24 deaths and 20needle tract seedings. The updated questionnaire revealed five deaths after 16,381biopsies (0.031%), whereas the previous questionnaire had shown four deaths after63,108 biopsies (0.006%). Two similar European questionnaires revealed mortality ratesof 0.008% and 0.018%, respectively. Of the total of 33 deaths, 21 involved biopsies ofliver lesions; six involved pancreatic biopsies. Seventeen of the 21 deaths after liverbiopsies were secondary to hemorrhage; five of the six deaths after pancreatic biopsieswere due to pancreatitis. Of the 23 instances of needle tract seeding, 10 occurred afterbiopsies of pancreatic malignancies. The frequencies of needle tract seeding in the fourquestionnaires were 0.005%, 0.006%, 0.003%, and 0.009%, respectively. Althoughinfrequent, serious complications may be associated with this procedure. The authormakes suggestions that may help minimize them.Complications of Percutaneous Abdominal Fine-needle Biopsyhttp://www.ncbi.nlm.nih.gov/pubmed/1984314Smith EH. Department of Radiology, University of Massachusetts Medical Center,Worcester 01655.University of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli - 14 -
    • 4)Animal trial bleeding liver biopsy: http://www.youtube.com/watch?v=fWDetY1lVWU5)Biopsy trauma http://www.youtube.com/watch?v=ZfW6XLpdMWk&feature=related6)Breast cancer is the most common cancer among women and the second leading causeof cancer deaths in women in the United States. The American Cancer Society estimatesthat a woman in the United States has a 1 in 7 chance of developing invasive breastcancer during her lifetime [1]. Currently, finding breast cancer early and treating it are themost important strategies to fight this disease. The earlier the cancer is diagnosed, thegreater the chance for successful treatment [2], since more treatment options areavailable and a complete recovery is more likely.Mammography is commonly used to look for breast disease, which is a specific type ofimaging that uses a low-dose X-ray system to detect tumors or other abnormalities in thebreast. It can be used either for screening or for diagnostic purposes in evaluating abreast lesion. Mammography plays a key role in early detection of breast cancers, as itcan show changes in the breast up to two years before a patient or physician can feelthem. However mammographic images are not always enough to determine the existenceof a benign or malignant disease with certainty. If a finding or spot on the image seemssuspicious, patients are usually recommended for a breast biopsy procedure.A breast biopsy is the removal of a sample of breast tissue for examination and is the onlydefinitive way to determine if an abnormality detected on breast examination ormammogram is benign or malignant. Open surgical biopsy and needle biopsy are twocommonly used biopsy procedures for the diagnosis of breast lesions. Open surgicalbiopsy has traditionally been used for breast cancer diagnosis. This procedure isperformed in the operating room, and requires general anesthesia. The surgeon makes anincision in the breast and removes a tissue lump from the suspicious region. Needlebiopsy is a minimally invasive biopsy procedure for obtaining a sample from the breastlesion. The physician makes a small skin incision through which a needle is placed intothe lesion to obtain tissue samples for analysis.1M per year US breast needle biopsies.…the sampling accuracy of needle biopsy is limited because only a few small pieces oftissue are sampled in the suspicious mass, and it is very difficult to verify that the samplesare removed from the cancerous tissue site because two-dimensional imaging is used toUniversity of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli - 15 -
    • guide the needle into a three-dimensional mass. This results in a 1 – 7 % false negativerate [4] and 9 – 18% of patients having to endure repeat biopsies [5,6]. In addition, about80% of all biopsies done in the U.S. are benign (not cancerous), according to theAmerican Cancer Society, which means a large number of benign tissues areunnecessarily removed.Optically Guided Breast Biopsy
1R01CA100559, Ramanujam (PI); 1R21EB002742nimmi.bme.duke.edu/cancer.html7)There were almost 27,000 post-training professionally active diagnostic radiologists in theUS in 2003. In addition, there were 4000 residents, 1000 in fellowship training, and 6000retirees. In the same year, there were 3500 post-training professionally active radiationoncologists, 500 physicians in training, and 500 retirees.www.acr.org American College of Radiologists8)“More than 550,000 ultrasound guided core needle biopsy procedures are performedannually, primarily with spring loaded core devices. The number of diagnostic breastbiopsies is increasing every year. A report in the September 2006 issue of the Journal ofthe American College of Radiology indicates a 61 percent increase in biopsy proceduresand procedure volumes going up by 101 percent among radiologists compared tosurgeons. "With 80 percent of those biopsies resulting in a negative diagnosis," Pearsonsays, "there is no reason why women should undergo procedures that are painful ortraumatic."SEPT 2006 Journal of American College of Radiology.9)“There were almost 27,000 post-training professionally active diagnostic radiologists inthe US in 2003. In addition, there were 4000 residents, 1000 in fellowship training, and6000 retirees. In the same year, there were 3500 post-training professionally activeradiation oncologists, 500 physicians in training, and 500 retirees.”www.acr.org American College of RadiologistsUniversity of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli - 16 -
    • 10)Needle aspiration of breast cysts is a relatively benign procedure that provides great reliefto the patient, and is typically performed by obstetricians and gynecologists (Ob-Gyn),interventional radiologists, family physicians, and breast surgeons [1–16]. Although needleaspiration of the breast is generally considered safe, complications and injuries to thepatient do occur and range from 0.1 to 3% and include vasovagal reactions, anxiety,procedural pain, ecchymosis at the puncture site, hematoma, hemothorax, infection,abscess, pneumothorax, respiratory compromise, ischemic necrosis, and tumorseeding.[17–27]. Similarly, needlesticks are one of the greatest hazards to healthcareworkers (HCW) including Ob-Gyn who perform needle breast aspiration procedures, andthe consequences of a needlestick can be career-ending [28–32]. Moreover, injuries topatients and needlestick injuries to HCW have become intense areas for lawsuits, medicalmalpractice claims, and workman compensation actions [33–39].Arch Gynecol Obstet DOI 10.1007/s00404-008-0710-8Integration of new safety technologies for needle aspiration of breast cystsRandy R. Sibbitt Æ Dennis J. Palmer Æ Arthur D. Bankhurst Æ Wilmer L. Sibbitt JrUniversity of Washington Bioengineering 534, Medical Device Commercialization, Created by D Giuntoli - 17 -