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Lisa Barker Trip Report

Medtech Conference 2011


November 1, Chapel Hill, North Carolina

On Tuesday November 1st, I attended the 2011 Medtech Conference at the


Sheraton in Chapel Hill, North Carolina with, and at the invitation of, Mica
Welsh, Research Assistant with the North Carolina Biotech Workforce and
Forsyth Technical Community College.
This conference was set up similar to many of the various industry trade
shows I have attended or participated in over the past several years. The
exhibitors were a mix of medical device designer/developers and
manufacturers, as well as suppliers of various support services relating to the
medical device/technology industry. Most exhibitors had a booth/table, with
many of them showcasing their latest new products, concepts, or prototypes,
and marketing materials. There were also poster exhibitors, who had
informational posters in designated display areas, with representatives
available to discuss their work and provide additional information.
The following represents the types of exhibitors and their services:

Design, Engineering, and Development Services from concept to


commercialization, including intellectual property value development
and claim substantiation and regulatory support
Production and Assembly/Packaging/Fulfillment companies (including
rapid prototyping, tooling, and contract manufacturing, as well as
operations and logistics services ) especially useful for
entrepreneurs/start-ups or low volume runs for mid-large
manufacturers
Tissue Banking cryogenic storage and transport management of
biomaterials and biological specimens
Marketing/Promotional Communication and Business Development
firms- to assist companies with identifying most effective
promotional/positioning strategies, best distribution channels, and
potentially advantageous strategic alliances, as well as finance and
accounting support for assistance with developing growth capital
Contract Research Organizations - for in vivo and human cadaveric
models for proof of concept, R&D, safety and efficacy, regulatory

evaluation of drugs, medical devices, biologics and combination


products
Intellectual Property Services including litigation and prosecution of
patent claims, trademarks, etc., domestic and worldwide, including
licensing and strategic patent leveraging
Software Builders - for medical device, process, clinical trial design
and control
Export and Trade Assistance - providing Federal guidance in doing
business overseas (including industry-specific and country-specific
market access, trade leads, market research and statistics, finance,
insurance, licenses and grant assistance
Specialized Product Brokers - assisting with global procurement and
logistics/distribution
Real Estate Management and Advisory firms, including facility
management

Throughout the day there were breakout sessions with panels of industry
experts discussing topics that are currently key concerns within the industry
as a whole. This was an interactive forum where audience members could
email questions or comments as the discussion was taking place. During
the lunch break, presentations were made by a few select companies
introducing a new product or technology, and discussing where they are in
terms of product launch - ie., development, clinical testing, venture capital
development, FDA approval, etc. Below are a few notes about the industry
panel discussions and company product presentations:
LUNCHEON - Company Presentations
Company: Smart Perfusion, LLC
Product: VasoWave System
Presenter:
Smart Perfusion has invented a system to extend organ life, keeping them
fully alive and functional outside the human body. This will revolutionize
organ transplantation by minimizing organ damage from the point of harvest
until transplantation in the recipient. It will reduce incidents of rejection by
removing all residual donor blood, and allows for significant improvement in
management of tissue oxygenation, ion concentration, fluid exchange,
antigen matching, and measurement of organ health before it is implanted.
This system is expected to reduce organ transplantation costs and deliver

greater success in transplantation of the heart, kidney, lung and liver, with
success in additional organs expected as clinical trials continue.
Company: Entericon, Inc.
Product: Suction Endoscope for the Small Intestine
Presenter: Stephen J. Kennedy, PhD
Entericon, Inc.s Suction Endoscope for the Small Intestine was developed at
the University of Florida by Mihir Wagh, MD and Stephen J. Kennedy, PhD.
The device is still in the development stage, but holds significant promise for
success in identifying and treating endoscopically those diseases or
conditions deep within the small intestine that have traditionally been very
difficult to diagnose - with treatment usually being major invasive surgical
procedures. The product which is an attachment that accompanies an
endoscope, is in the end stages of prototyping and is ready to move toward
production. The company is currently in the process of seeking first round
investors to finance production and clinical trials, with the expectation of FDA
approval within ~1 from initial financing.
Company: WellDoc, Inc.
Product: WellDoc Mobile Diabetes Management RCT
Presenter: Jon Brilliant, CFO/Ryan Sysko, Founder & CEO
WellDoc is a medical virtual office system designed to truly personalize
medicine by allowing diabetes patients to monitor and manage their own
medical care by participating in personal solution management. This personcentric care is accomplished by cellphone based software which captures
real-time data entered by patients and sends it to servers with analytical
programs created by endocrinologists and diabetes educators. The
programs contain therapy optimized tools that analyze the data and
interactively suggest treatment steps the patient can take, and or suggests
alternates if the patient is unable to act on the first response. It can assist
with issues as simple as medication adherence, or as complex as multiple
disease management. The program contains information on medication
regimens and treatment algorithms to coincide with them. The WellDoc
Mobile Diabetes Management RCT is the first of potentially many platforms
for diseases and conditions to be managed with this app. Thus far it shows
considerable success, some of which can be attributed to patients
establishing and realizing a connection between their own actions and the
outcome which empowers and encourages them to self-manage. The

program also sends a virtual logbook to the patients physician every 6


weeks so that the physician understands ahead of a patient office visit just
how the patient is doing rather than relying on the patient to remember to
carry their manual logbook in for the visit. WellDoc is currently working to
adapt the software and program to other diseases such as heart disease,
asthma and cancer.
Company: Medivo, Inc.
Product: Medivo Platform
Presenter: Sundeep Bhan, Co-founder and CEO
Medivo has developed a data mining platform which is geared to assist
companies in developing plans for their product marketing efforts, as well as
assisting consumers in managing their health care and selecting the services
that are available and best address their health needs. It allows patients
access to national MD networks and laboratories, testing and monitoring
services that may assist them with better understanding their health issues.
They will also be better able to select where they receive their care, and
potentially even what the costs associated with it may be. The Medivo
Platform also allows companies to access information about patients and
patient populations. This is service is geared toward Wellness Companies,
Managed Care Companies, Pharmaceutical and Life Science Companies,
Pharmacy Benefit Managers, and Consumer-Driven Testing Companies. It
allows access to ~ 80% of US outpatient lab tests at 4000+ patient service
centers. Use of this data would allow companies to identify practices which
have a high volume of patients that could benefit from their product, and can
assist in identifying and engaging undiagnosed and undertreated patients.
Doctors would be better able to access gaps in patient treatment and focus
on more appropriate testing.
PANEL DISCUSSIONS
A New Generation of Health Metrics: Unlocking Information and
Transforming the Healthcare Landscape
Panelists Included:
Sundeep Bhan, CEO and Co-founder of Medsite and Medivo
Fred Goldwater, Fmr. SVP of Strategic Development and Operations BCBSNC

Mark Phelps, PhD, Sr. Program Director, Subcutaneous Diagnostics and


Monitoring, Medtronic
Holt Anderson, Executive Director of NCHICA
The panel discussed several topics including the following:
Necessity of transparency in healthcare costs and the disparity of
provider charges
Impending shortage of Primary Healthcare Providers in the US
Urgency of developing one universal system in US for managing
patient records
Benefits of a Medication Management Module (universal)
Benefits of a Patient Care Management Program (universal)
Necessity of patient counseling related to sensitive medical information
(due to giving the patient access to all their medical information so
they may act on it owning their test results which brings up the
liability & responsibility issue, and necessitating interpretation
management)
Resistance of general population to having all their health data
centralized and available to any/all medical personnel (citing privacy
and discrimination issues)
Home Health Monitoring more effective than traditional Dr. visits, and
will necessarily increase in the near future due to short supply of
Primary Care Providers
Quality Costs Less improving the quality and effectiveness of
preventive care reduces the overall cost of individual lifetime care
Health Integration Networks collection of uncoordinated services vs
true health care system

Working Smarter: Making Medical Devices More Intelligent to


Address Looming Healthcare Challenges
Panelists Included:
David Hendelsman, Sr. Mgr., Center for Health Analytics and Insights, SAS
Institute
Al Lauritano, MSc, CLP, Director, Business Development, BD Technologies
Bryant Moore, PhD, VP External Partnerships and Technology Assessment,
Medtronic
Mark Phelps, PhD., Sr. Program Director, Cardiac Diagnostics & Monitoring,
Medtronic

Daniel Winfield, Sr. Director, Technology Applications, RTI International


This panel addressed many concerns and issues facing companies who
provide medical devices/equipment or technology to the medical community,
and the hurdles they face along the path to product launch. Discussions
included:

Necessity to develop devices that interact with devices made by other


companies
Necessity of real time feedback is critical when conducting clinical
trials which can be lengthy and may not net meaningful data until
trial is over (need to be able to make assessments of data during the
process)
Smart Devices will increasingly continue to improve Home Health
Care
Major concerns when developing products/processes/therapies for
medical industry
New innovation - Will insurance companies code/reimburse
for it?
How much will they reimburse for it?
What conditions will it be reimbursable for?
Improvement on existing product or therapy will the cost
savings or improvement in clinical outcome be enough to
get coding/reimbursement for it?
If insurance wont code/reimburse for it, will patients be
willing to pay out of pocket?
If its medical equipment, and insurance companies wont
code/reimburse for use of it, will physicians still purchase
the equipment?
The true innovators in this field are clinicians, engineers, development
scientists
Clinical practice will continue to change in response to current and
upcoming changes in healthcare system - with nurse practitioners
seeing more patients with increasing levels of healthcare needs,
leaving physicians to address the most serious or most difficult cases
SAS Institute offers a broad scope of analytics at their Center for
Health Analytics and Health Insights a cross disciplinary health
industry think tank to foster best practices and innovation in medical
care

NC is first in healthcare innovation and healthcare technology (RTP,


medical research in hospitals and universities, biotech industry)
Use of patient coordinators and patient advocates reduces overall
healthcare costs

Additional Panel Discussions on Nov. 1 & 2 (Did not attend)


Are They Boomers or Busters? The Impact of the Aging Population on the
MedTech Industry
Southeast Investment Trends in the Medical/Technology Industry
Can the Rest of the World Save the US Medical Industry?
Can You Still Get Early-Stage Funding for Your MedTech Company in the
Southeast?
________________________
There was considerable knowledge and information to be gained at this
conference, along with the energy and excitement of being on the cutting
edge of technology. I enjoyed meeting representatives from many of the
companies present, and learning about their roles within that specific
company. I collected information on companies, agencies, and programs
that I hope to use in the future as I get more involved in the health/med/tech
industry and learn more about the type of role I would like to take on.
It was also quite a learning experience to hear about the many hurdles and
roadblocks that companies face when trying to bring a new
product/drug/therapy to market. The upfront costs can be tremendous, and
until the company can be assured of getting coded by insurance or getting
approval from the FDA, those costs can end up bearing no fruit or at least
not for a long time.
I was pleased to see so many experts with a vast diversity of experience
coming together to make significant contributions to the industry. It is clear
that there are many ways to be a part of and contribute to this industry (and
addressing its challenges), and that makes me even more excited about
becoming a part of it through nursing and additional roles that I would
ultimately like to pursue.

Also, one big takeaway from this conference was seeing how necessary it is
to work together as members of the industry to improve various aspects of
it, or learn how to best handle issues as they arise. I believe this type of
event is valuable for students of all levels so that they can begin to
understand a little about an industry while they are preparing and
developing the skills needed to get into it. It is important to understand what
one is becoming a part of, where one fits into it, and why the work is
important.
I am very grateful to have had the opportunity to attend this conference,
especially at this point in my studies.
Lisa Barker