- ViewRay’s Cobalt-based radiation technology is a breakthrough that integrates high quality intensity modulated radiation therapy (IMRT) with simultaneous magnetic resonance imaging (MRI) of soft tissues to provide optimal alignment, adaptation, and tracking. However, Linear Accelerator (linac) systems are perceived to have several advantages.
- Linear Accelerator technology obviates the need for the inspection, replacement, and disposal of Cobalt-60, and oversight from the Nuclear Regulatory Commission (or national agency in foreign countries). Additionally, Linear Accelerators are [more] familiar to the market.
- Linac-based radiation therapy delivery systems allow for higher dose, faster electronic variation of dose and electronic beam activation and deactivation.
- ViewRay solved two major long-standing problems to compactly integrate a linac beam with an MRI system: 1) linac radiofrequency interference with the operation of the MRI and 2) MRI magnetic interference with the operation of the linac.
- Linacs utilize high-powered microwave generators similar to equipment used in radar at airports. These “radar stations” inside the linac create noise that can corrupt the delicate signals measured from the patient’s body to generate MR images. ViewRay solved this problem by introducing technology similar to that used in stealth aircraft. Stealth aircraft can hide from radar by using a coating that reflects and absorbs microwaves, thus preventing radar beams that strike the aircraft from bouncing back to the radar station. In a similar manner, we reflect and absorb the output of the linac “radar station” to hide it from the MRI, producing images as noise-free as MRI images with no integrated linac.
- MRIs utilize high-powered superconducting magnets that are required to image the patient’s tissues. Many linac components will not operate properly when placed close to or inside these strong magnetic fields, and such placement is necessary to produce a compact system like the MRIdian linac. ViewRay overcame this challenge by creating magnetic shielding shells that create voids in the magnetic field without significantly disturbing the magnetic field used for imaging. This allows the linac to operate on the MRIdian gantry as if there were no magnetic field present.
MRIdian with cobalt radiation is available for sale and delivery in: USA, EU, Japan, China, Taiwan, United Arab Emirates, and Korea.
American Stock Transfer & Trust Company, LLC
6201 15th Avenue
Brooklyn, NY 11219
(800) 937-5449
Website: www.amstock.com
Email: info@amstock.com
Manufacturing and Supply Chain Management Statement
We strive to conduct our activities in a manner that reflects our mission and Code of Business Conduct and Ethics – which includes being a good corporate citizen, dealing fairly in business, behaving ethically, supporting a safe and healthy workplace, doing business in an environmentally responsible manner, and complying with applicable law. We are committed to ensuring that our supply chain reflects our values and beliefs, including adherence to principles of responsible sourcing materials for our products. We monitor our supply chain against these principles for potential opportunities of continual improvement.
We manufacture our products at our manufacturing facility located in Mountain View, California. We purchase finished subsystems from qualified suppliers for incorporation into the final system assembly and installation at the specified location at the customer’s facility. We purchase raw materials and finished subsystems from numerous suppliers in various countries. For quality assurance, sole source availability or cost effectiveness purposes, we may procure certain components and raw materials from a sole supplier. We work closely with our suppliers to ensure continuity of supply while maintaining high levels of quality and reliability. We use quality systems in the design, production, warehousing, distribution, installation, servicing, and disposal of our products to ensure our products are safe and effective.
- ViewRay’s quality management system is structured to meet the requirements below including other applicable local regulatory requirements for geographies into which ViewRay products are installed: The FDA’s Quality System Regulation under section 520 of the federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Part 820, 803, 806 and 7;
- The International Standards Organization – EN ISO 13485:2016, Medical devices – Quality management systems; and 14971 Application of risk management to medical devices
- The European Council Directives 93/42/EEC and (and current Amendment(s)) [Regulation (EU) 2017/745 (effective May 2021)] which relates to medical devices.
- Canadian Medical Device Regulations (CMDR) SOR/98-282
- Australian Regulatory Guidelines for Medical Devices (ARGMD)
- Japan’s Ministry of Health, Labor and Welfare (MHLW) Ministerial Ordinance 136 QA Procedures for Devices & 169 QMS Compliance
- Other applicable & equivalent worldwide regulations: China, Korea, Taiwan, Brazil, etc.
BSI Group America Inc., an independent certification body for both CE Mark and MDSAP, acts as our Notified Body to ensure that our manufacturing quality systems comply with ISO 13485:2016 and MDSAP regulations. MedPass International acts as our Authorized Representative to maintain a legal presence in the EU and fulfill and to act as a focal point for communication with EU Competent Authorities on safety issues.
In addition, we utilize environmental management systems and safety programs to protect the environment and our teammates.
Some of the regulations and governmental agencies with which we comply are as follows:
- The U.S. EPA;
- The Occupational Health and Safety Assessment System;
- The European Union Registration, Evaluation, Authorization and Restriction of Chemicals;
- The U.K. DEFRA;
- Italian regulations under the IEA.
Energy, Water and Waste
Topic | Metric | 2020 | 2021 |
---|---|---|---|
Energy |
Total Energy Consumption
|
907,997 kwh (CA)
1,614 Metric Tons
|
1,049,719 kwh (CA)
1,074 Metric Tons
|
Renewable Sources of Energy (%) | 32.35% (CA) 20.00% (OH) Unknown (CO)* |
23.52% (CA) 18.76% (OH) Unknown (CO)* |
|
Water | Water Consumption (Units) * | Unknown* | Unknown* |
Wastewater Discharge (gallons) ** | N/A^ | N/A^ | |
Safe disposal of wastewater ** | N/A^ | N/A^ | |
Waste | Hazardous Waste | N/A^ | N/A^ |
Safe disposal of waste | N/A^ | N/A^ | |
* We are unable to track water consumption due to buildings being tied to multiple meters, or being included in base rent. ** All of our sites generate zero wastewater and zero hazardous waste. |
Environmental Goals
2021-2023 GOALS
- Reduce absolute emissions by 10%
- Reduce water consumption by 5%
ViewRay has set a five-year goal of reducing CO2 emissions by 10 percent compared with the benchmark year of 2020. This goal is based on the climate goal of the United Nations to reduce global warming to significantly below 2 degrees Celsius. According to scientific studies, it will be necessary to cut back net emissions of global greenhouse gases to zero by 2060. This calculates to a reduction of 2.2 percent per year on average from 2015 onward. ViewRay is committed to this goal and would like to make an appropriate contribution.
Attract, Retain & Develop
At ViewRay, we believe our shared values and a culture where we truly care for and about one another is instrumental to our growth and success. We are passionate about attracting, retaining, and developing the best talent on the planet – it is essential to our success.
We are engaged in an ongoing effort to attract, retain, and develop a diverse team ready for the challenge a growth company presents. We believe diversity and inclusion are more than just words – they are fundamental to ViewRay’s shared values, which put Teammates at the center of all we do. We believe that we successfully attract and retain a qualified team in a highly competitive market due, in large part, to our strong culture, rewarding work environment, competitive compensation and benefits, and by encouraging continuous professional development.
We attract and retain our teammates through globally competitive compensation and benefits programs. We actively identify top talent and high potential teammates and provide engaging, challenging work and commensurate remuneration. To ensure alignment with the fair pay standards, we benchmark our payment policies and practices, ensuring that ViewRay continues to be an equitable and diverse employer, free from discrimination.
At ViewRay, each teammate owns their development by creating a professional development plan and regularly updating that plan with the help of other teammates and leaders across the organization. ViewRay also provides necessary training and coaching in technical skill development, leadership ability, and strategic thinking to support these plans. Our senior leaders play an active part in developing the team by participating in various high potential development activities, succession planning, and mentoring.
Our High-Performance Management System (HPMS) unites the team around our vision, shared values, and commitment to quality. The HPMS process provides a blueprint of how we achieve success and guides what we deliver. This platform creates a stronger connection between our company beliefs and our business goals, ultimately generating stronger teammate engagement and future success.
Workplace Safety
We take great pride in creating and maintain a safe working environment for our teammates. ViewRay provides training to all teammates on our comprehensive safety policy and, all teammates are empowered and encouraged to raise any safety concerns or suggestions. ViewRay has never experienced any teammate fatalities and, we recorded no worker’s compensation claims in 2020. We continually monitor our safety standards and review our practices to ensure a healthy environment for all teammates.
Political Advocacy
In 2020, ViewRay did not make any donations to political parties, political candidates nor did we engage in any lobbying activities.
ViewRay maintains memberships with trade associations relevant to our business, including AdvaMed and MDMA.