SERVICE AND SUPPORT
provide worldwide maintenance and support services to our customers for our integrated products directly or with the assistance
of outsourced product and service representatives. By utilizing these relationships, we provide direct, on-site technical support
activities, including call center, customer support engineers and service parts logistics and delivery. In certain situations,
we use these third parties as a single point of contact for the customer, which allows us to focus on providing installation,
training, and back-up technical support.
back-up technical support includes a combination of on-line, telephone and on-site technical assistance services 24 hours a day,
seven days a week. We employ service and support engineers with networking and medical equipment expertise, and outsource a portion
of our installation and support services. We offer different levels of support to our customers, including basic hardware and
software maintenance, extended product maintenance, and rapid response capability for both parts and service.
have established a call center in our St. Louis facilities, which provides real-time clinical and technical support to our customers
Odyssey, and Vdrive Systems
manufacturing strategy for our Niobe system and Odyssey Solution is to sub-contract the manufacture of major subassemblies
of our systems to maximize manufacturing flexibility and lower fixed costs. Our current manufacturing strategy for the Vdrive
system is to build all subassemblies in-house using sub-contract manufactured components. We maintain quality control for
all of our systems by completing final system assembly and inspection in-house.
purchase both custom and off-the-shelf components from a large number of suppliers and subject them to quality specifications
and processes. Some of the components necessary for the assembly of our products are currently provided to us by sole-sourced
suppliers (the only recognized supply source available to us) or single-sourced suppliers (the only approved supply source for
us among other sources). We purchase the majority of our components and major assemblies through purchase orders rather than long-term
supply agreements and generally do not maintain large volumes of finished goods.
manufacturing strategy for disposable interventional devices is to outsource their manufacture through subcontracting and to expand
partnerships for other interventional devices. We work closely with our contract manufacturers and have strong relationships with
component suppliers. We have entered into manufacturing agreements to provide high volume capability for devices other than catheters.
software components of the robotic magnetic system, the Vdrive system and Odyssey Solution, including control and
application software, are developed both internally and with integrated modules we purchase or license. We perform final testing
of software products in-house prior to their commercial release.
manufacturing facility operates under processes that meet the FDA’s requirements under the Quality System Regulation (QSR).
Our ISO registrar and European notified British Standard Institution (BSI) has audited our facility annually since 2001 and found
the facility to be in compliance with relevant requirements. The initial ISO 9001 certification was issued in January 2002 and
the most recent ISO 13485 certificate was issued in 2016.
market our products in the U.S and internationally through a direct sales force of senior sales specialists, distributors and
sales agents, supported by account managers and clinical specialists who provide training, clinical support, and other services
to our customers. In addition, Biosense Webster distributes magnetically-enabled electrophysiology mapping and ablation catheters,
co-developed pursuant to our agreement with them.
sales and marketing efforts include two important elements: (1) selling robotic magnetic systems, Odyssey Solutions,
and Vdrive systems directly and through distributors; and (2) leveraging our installed base of systems to drive recurring
sales of disposable interventional devices, software and service.
believe that substantially all of the procedures, whether commercial or in clinical trials, conducted in the U.S. with the Niobe
system or Vdrive system have been reimbursed to date. We expect that third-party payors will reimburse, under existing
billing codes, procedures in which compatible ablation catheters are used. We expect healthcare facilities in the U.S. to bill
various third-party payors, such as Medicare, Medicaid, other government programs and private insurers, for services performed
with our products. We believe that procedures performed using our products, or targeted for use by products that do not yet have
regulatory clearance or approval, are generally already reimbursable under government programs and most private plans. Accordingly,
we believe providers in the U.S. will generally not be required to obtain new billing authorizations or codes in order to be compensated
for performing medically necessary procedures using our products on insured patients. We cannot guarantee that reimbursement policies
of third-party payors will not change in the future with respect to some or all of the procedures using the robotic magnetic system.
countries outside the United States, reimbursement is obtained from various sources, including governmental authorities, private
health insurance plans, and labor unions. In most foreign countries, private insurance systems may also offer payments for some
therapies. Additionally, health maintenance organizations are emerging in certain European countries. In Europe, we believe that
substantially all of the procedures, whether commercial or in clinical trials, conducted with the Niobe system or Vdrive
system have been reimbursed to date. In Japan, the Ministry of Health, Labor and Welfare (MHLW) has classified the Niobe
system as a C2 medical device (the highest reimbursement category), and has established a “technical fee” of Japanese
Yen 50,000 per procedure. In other foreign countries, we may need to seek international reimbursement approvals, and we do not
know if these required approvals will be obtained in a timely manner or at all.
“Item 1A—Risk Factors” for a discussion of various risks associated with reimbursement from third-party payors.