1. Verica Sightline Marketing Plan
Summary
This document is excerpted from a business plan written for the
University of Washington Medical Product Commercialization
Program. The business plan was written with a team of three people
including myself as one of the team leaders. The marketing section
following this was written by me as my primary contribution to the
project. It lays out the product marketing position and part of the
business case for investment. It includes a single page marketing
story intended as a hand-out at meetings and trade shows. It is the
emotional link in the marketing story and is intended to draw poten-
tial investors and customers into the product’s mission and brand. I
also created the graphic design and industrial design content
contained in the plan.
Domenic Stephen Michael Giuntoli
dsmg.connect@gmail.com
www.linkedin.com/in/domenicgiuntoli
206 992 3712

2. VERICA SIGHTLINE® 3D Guided Needle
Biopsy System
Marketing Strategy for Incorporation into the Verica Business Plan
June 2010
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3. Summary
In 2009 the close friend of a Verica founder went through a routine recommended
screening for breast cancer. The mammogram showed suspect lesions, and a tissue
biopsy was prescribed to narrow down the possible diagnosis. She waited anxiously for
the biopsy appointment. The procedure was a core needle tissue biopsy that required
multiple 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. The
anxiety, waiting and hoping was exhausting for her.
There is a significant likelihood that an American woman will undergo a breast biopsy
procedure during her lifetime. When considering the emotional and physical costs to the
patient, we believe it is important to improve the reliability and safety of this minimally
invasive diagnostic procedure.
The Mission
Verica will provide healthcare with the safest and most accurate
diagnostic solutions.
Verica is committed to creating affordable products for the safe, accurate and efficient
diagnosis of organ and soft tissue disease. The brand will embody the highest concern
for the health and welfare of the patient, effectiveness and ease of use for clinicians and
the efficient use of health care resources.
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4. The Business Case
Over 3 million needle biopsies are performed in the US each year, and many require extra
insertions, multiple visits, or complications due to inaccurate placement of the biopsy
needle. 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 typically
performed with the limited view of a 2D ultrasound image. The ultrasound probe and
needle are held in two different hands. The user makes a reasonable estimate of the
needle insertion path, inserts the needle, and then adjusts the needle position based on
the ultrasound image visual feedback. Repositioning after insertion may cause tissue
damage or complications.
The problem is partially addressed by existing products. 3D ultrasound imaging is
emerging as a method for accurate needle guidance, but is not yet widely used. Fixed
needle guides are available as third-party accessories for ultrasound probes. There is no
complete and integrated solution.
The Sightline system enables highly accurate positioning with fewer procedure steps and
reduced rate of complications. This is contrasted to ultrasound systems that are unable to
display 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 potential
through increased penetration of its target markets, and expansion of medical indications
to additional target organs for needle biopsies.
In addition to biopsy procedures, the technology can potentially be applied to any guided
insertion (such as needle injections and catheterization), providing opportunity for future
product line expansion using the Sightline platform technology.
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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 curve
Opportunities 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 Outlook
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6. Market Analysis
What medical problem does Verica Sightline technology solve ?
Needle tissue biopsies are a required procedure for the diagnosis of disease in many
patient conditions. Needle biopsies expose both the patient and practitioner to health
risks. The procedure may produce complications that outweigh the benefit to the patient.
Though many needle biopsy procedures are ultrasound-guided, accurate positioning
remains challenging. Inaccurate needle positioning may resulting in increased incidence
of bleeding and tissue damage. Additional insertions are sometimes required. Trauma to
adjacent organs and tissue structures is a potential complication. The product will improve
patient outcomes and reduce treatment costs by facilitating an expediant procedure with
lower risk of complications.
Over 3 million needle biopsy procedures are performed annually in the USA. At least 2
million of these will benefit from the use of the company’s product. The product is
intended for use on soft tissue where the probe can be placed on the skin surface directly
over the targeted tissue (kidney, liver, breast, pancreas).
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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 Procedures
Needle biopsy is a frequently used procedure to diagnose diseases in soft tissues and
organs. It is considered a “minimally invasive” surgical procedure. As with any form of
surgery there are risks involved for the patient and sometimes risks to health care
practitioners (e.g. transmission of disease from needle sticks).
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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
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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 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.
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10. Marketing Objectives
The 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 Size
Tissue biopsies are a routine step in the screening process for several conditions and it is
the 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. This
figure 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 1
million biopsies at the $550 per procedure.
The estimated size of the liver, kidney and pancreas biopsy markets in the US on an
annual basis is $250M. ( This is derived using the same cancer case/biopsy ratio from the
above case for breast biopsy: 4/1. )
The total procedure cost for breast, kidney, liver and pancreas biopsy procedures per year
in the US is approximately $800M.
Market Relationships
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11. • 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 Revenue
Revenue will be derived from a combination of special-purpose guided-needle ultrasound
systems, probe-related proprietary disposables, and software upgrades. Training fees,
extended warrantees and services contracts will provide additional revenue. The probe
and software may be licensed as an OEM subsystem for integration with general-purpose
ultrasound diagnostic imaging systems.
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12. Competition
The competition for Verica are the global players in the medical application of ultrasound
technology. 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 of
activity is in screening and diagnosis.
The global market for diagnostic imaging is large and growing. Verica is addressing a
relatively small segment of that total market that is underserved by the major players. The
global diagnostic imaging market is forecast to reach $24.6 billion in 2015 (reference:
Diagnostic Imaging Market to Grow 7 Percent by 2015 , Imaging Technology News
http://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 potential
path for acquisition by the investing partner.
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13. Verica is targeting a segment of the tissue biopsy market that
currently represents expenditures of over $800M per year on
procedures performed in the United States.
“More than 550,000 ultrasound guided core needle biopsy procedures are performed
annually, primarily with spring loaded core devices. The number of diagnostic breast
biopsies is increasing every year. A report in the September 2006 issue of the Journal of
the American College of Radiology indicates a 61 percent increase in biopsy procedures
and procedure volumes going up by 101 percent among radiologists compared to
surgeons. "With 80 percent of those biopsies resulting in a negative diagnosis,"
Pearson says, "there is no reason why women should undergo procedures that are
painful or traumatic." SEPT 2006 Journal of American College of Radiology
• Substantial market potential
• Low risk regulatory path through 510(K) submission
• Established, low risk technology
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14. Research Notes
1)
Pain (0.056-22%)
o Pleuritic
o Peritoneal
o Diaphragmatic
Hemorrhage
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%)
Bacteremia
Sepsis (0.088%) and abscess formation
Pneumothorax 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 Biopsy
http://emedicine.medscape.com/article/1819437-treatment
2)
Percutaneous interventional procedures under image guidance, such as biopsy, ethanol
injection therapy, and radiofrequency ablation play important roles in the management of
hepatocellular carcinomas. Although uncommon, the procedures may result in tumor
implantation along the needle tract, which is a major delayed complication. Implanted
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15. tumors usually appear as one or a few, round or oval-shaped, enhancing nodules along
the needle tract on CT, from the intraperitoneum through the intercostal or abdominal
muscles to the subcutaneous or cutaneous tissues. Radiologists should understand the
mechanisms and risk factors of needle tract implantation, minimize this complication, and
also pay attention to the presence of implanted tumors along the needle tract during
follow-up.
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)
3)
To determine whether the increasing use of percutaneous fine-needle biopsy of
abdominal lesions is associated with an increase in serious complications, the author
updated a literature search and evaluated a questionnaire (distributed among selected
hospitals in the United States in 1986 and 1987) that followed up a questionnaire
distributed in 1983. The updated literature review revealed a total of 24 deaths and 20
needle tract seedings. The updated questionnaire revealed five deaths after 16,381
biopsies (0.031%), whereas the previous questionnaire had shown four deaths after
63,108 biopsies (0.006%). Two similar European questionnaires revealed mortality rates
of 0.008% and 0.018%, respectively. Of the total of 33 deaths, 21 involved biopsies of
liver lesions; six involved pancreatic biopsies. Seventeen of the 21 deaths after liver
biopsies were secondary to hemorrhage; five of the six deaths after pancreatic biopsies
were due to pancreatitis. Of the 23 instances of needle tract seeding, 10 occurred after
biopsies of pancreatic malignancies. The frequencies of needle tract seeding in the four
questionnaires were 0.005%, 0.006%, 0.003%, and 0.009%, respectively. Although
infrequent, serious complications may be associated with this procedure. The author
makes suggestions that may help minimize them.
Complications of Percutaneous Abdominal Fine-needle Biopsy
http://www.ncbi.nlm.nih.gov/pubmed/1984314
Smith EH. Department of Radiology, University of Massachusetts Medical Center,
Worcester 01655.
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16. 4)
Animal trial bleeding liver biopsy: http://www.youtube.com/watch?v=fWDetY1lVWU
5)
Biopsy trauma http://www.youtube.com/watch?v=ZfW6XLpdMWk&feature=related
6)
Breast cancer is the most common cancer among women and the second leading cause
of cancer deaths in women in the United States. The American Cancer Society estimates
that a woman in the United States has a 1 in 7 chance of developing invasive breast
cancer during her lifetime [1]. Currently, finding breast cancer early and treating it are the
most important strategies to fight this disease. The earlier the cancer is diagnosed, the
greater the chance for successful treatment [2], since more treatment options are
available and a complete recovery is more likely.
Mammography is commonly used to look for breast disease, which is a specific type of
imaging that uses a low-dose X-ray system to detect tumors or other abnormalities in the
breast. It can be used either for screening or for diagnostic purposes in evaluating a
breast lesion. Mammography plays a key role in early detection of breast cancers, as it
can show changes in the breast up to two years before a patient or physician can feel
them. However mammographic images are not always enough to determine the existence
of a benign or malignant disease with certainty. If a finding or spot on the image seems
suspicious, 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 only
definitive way to determine if an abnormality detected on breast examination or
mammogram is benign or malignant. Open surgical biopsy and needle biopsy are two
commonly used biopsy procedures for the diagnosis of breast lesions. Open surgical
biopsy has traditionally been used for breast cancer diagnosis. This procedure is
performed in the operating room, and requires general anesthesia. The surgeon makes an
incision in the breast and removes a tissue lump from the suspicious region. Needle
biopsy is a minimally invasive biopsy procedure for obtaining a sample from the breast
lesion. The physician makes a small skin incision through which a needle is placed into
the 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 of
tissue are sampled in the suspicious mass, and it is very difficult to verify that the samples
are removed from the cancerous tissue site because two-dimensional imaging is used to
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17. guide the needle into a three-dimensional mass. This results in a 1 – 7 % false negative
rate [4] and 9 – 18% of patients having to endure repeat biopsies [5,6]. In addition, about
80% of all biopsies done in the U.S. are benign (not cancerous), according to the
American Cancer Society, which means a large number of benign tissues are
unnecessarily removed.
Optically Guided Breast Biopsy 1R01CA100559, Ramanujam (PI); 1R21EB002742
nimmi.bme.duke.edu/cancer.html
7)
There were almost 27,000 post-training professionally active diagnostic radiologists in the
US in 2003. In addition, there were 4000 residents, 1000 in fellowship training, and 6000
retirees. In the same year, there were 3500 post-training professionally active radiation
oncologists, 500 physicians in training, and 500 retirees.
www.acr.org American College of Radiologists
8)
“More than 550,000 ultrasound guided core needle biopsy procedures are performed
annually, primarily with spring loaded core devices. The number of diagnostic breast
biopsies is increasing every year. A report in the September 2006 issue of the Journal of
the American College of Radiology indicates a 61 percent increase in biopsy procedures
and procedure volumes going up by 101 percent among radiologists compared to
surgeons. "With 80 percent of those biopsies resulting in a negative diagnosis," Pearson
says, "there is no reason why women should undergo procedures that are painful or
traumatic."
SEPT 2006 Journal of American College of Radiology.
9)
“There were almost 27,000 post-training professionally active diagnostic radiologists in
the US in 2003. In addition, there were 4000 residents, 1000 in fellowship training, and
6000 retirees. In the same year, there were 3500 post-training professionally active
radiation oncologists, 500 physicians in training, and 500 retirees.”
www.acr.org American College of Radiologists
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18. 10)
Needle aspiration of breast cysts is a relatively benign procedure that provides great relief
to the patient, and is typically performed by obstetricians and gynecologists (Ob-Gyn),
interventional radiologists, family physicians, and breast surgeons [1–16]. Although needle
aspiration of the breast is generally considered safe, complications and injuries to the
patient 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 tumor
seeding.[17–27]. Similarly, needlesticks are one of the greatest hazards to healthcare
workers (HCW) including Ob-Gyn who perform needle breast aspiration procedures, and
the consequences of a needlestick can be career-ending [28–32]. Moreover, injuries to
patients and needlestick injuries to HCW have become intense areas for lawsuits, medical
malpractice claims, and workman compensation actions [33–39].
Arch Gynecol Obstet DOI 10.1007/s00404-008-0710-8
Integration of new safety technologies for needle aspiration of breast cysts
Randy R. Sibbitt Æ Dennis J. Palmer Æ Arthur D. Bankhurst Æ Wilmer L. Sibbitt Jr
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