Quality: everybody’s business at KA Imaging

Did you know KA Imaging has a Quality Policy?

At KA Imaging, we are committed to the design and development of X-ray systems that meet the needs of our customers. Through the implementation of our quality processes, we will comply with all applicable regulatory requirements and maintain the effectiveness of
the Quality Management System. We build quality in all we do.

Therefore, at KA Imaging, quality is everybody’s business! It is a journey of continuous improvement. The question is: how do you achieve quality?

Quality is defined as Conformance to Requirements. That is, any product, service, or process that conforms to its requirements is a Quality Product, Service, or Process.

At KA Imaging, ‘Quality’ is based upon Process Management and Improvement Methodology (PM&I). It focuses upon processes and their efficiencies that produce their outcomes in a consistent and a repeatable manner. The process outcomes must meet their agreed upon requirements. The pictorial view below represents KA Imaging’s PM&I model.

Pictorial view of KA Imaging Process Management and Improvement Methodology

 

For KA Imaging to function effectively, it has identified and has linked all business processes.  The application of a system of processes within an organization, together with the identification and interactions of these processes and their management to produce the desired outcome, can be referred to as the “process approach”.  The linking of the processes to produce outcomes is also known as inter-related processes.

KA Imaging deploys a RASUI concept in its approach towards designing and developing products. RASUI is an acronym that stands for ‘Reliability, Availability, Serviceability, Usability, and Installability’.

KA Imaging being in the business of Development and Manufacturing of medical devices such as high-end Dual-Energy X-Ray Detectors, it is crucial that it consistently meets the ISO 13485:2016 Standard and Regulatory requirements. To this end, KA Imaging engages in training all its employees in the Process based Quality Management System including Management.

Read more

2020: a year of change for KA Imaging

2020 heralds a year of change for KA Imaging.

For starters, the office in Kitchener (Ontario, Canada) became restrictive as the team expanded at an unprecedented rate—with three times more jobs created in 2019 than the year before. As a result, KA Imaging moved to a new location, a spacious 9,000 square-foot newly-renovated facility in Waterloo.

The office, however, is the smallest of the changes expected. “After almost five years of extensive development, we are starting to commercialize our line of products,” Amol Karnick, president and CEO at KA Imaging says. “Our focus is on our customers; what they need and how we can help.”

With an ambitious product and technology roadmap, the company is now developing strategic partnerships across the world. One example is the exclusive distribution agreement for KAI’s inline benchtop micro-CT system inCiTe™ with Angstrom Scientific Inc. (USA).  InCiTe™ offers revolutionary phase contrast micro-CT imaging and is ideal for use on biomaterials, polymer composites and other low-density materials.

On the medical imaging side, KAI’s dual-energy single exposure X-ray detector Reveal must be submitted for FDA clearance this year.

KA Imaging is a University of Waterloo spin-off and has scaled rapidly since inception. The company aims to establish itself as a major player in the X-ray detector industry. “It’s been a long journey for us. Our team has worked hard to strengthen our patent portfolio. We now have over 50 patents worldwide and plan to continue developing disruptive X-ray tech. over the next year,” concludes Dr. Karim S Karim, CTO at KA Imaging.

Read more

2019 at a glance

“We set a number of very ambitious stretch goals for 2019 and incredibly, accomplished most of them,” said Dr. Karim S Karim, CTO at KA Imaging.  “I’m very happy and proud of the entire KA family and how well they work with and support each other,” he continued.

A family that has continuously grown

In 2019, 10 new people joined KA Imaging, sharing their expertise in different areas, such as Engineering, Finance and Business Development. The number of employees is now 58% higher than in 2016. “We have a great team of dedicated people who are interested in learn and developing good products,” explained Amol Karnick, CEO at KAI. “The team has grown this year to included additional skill set including hardware and software design,” he said.

A year to celebrate

2019 was full of highlights. The company exhibited at six conferences and visited several others, having traveled more than 10,000 km around the globe.

KA Imaging’s inCiTe™ micro CT had its commercialization started and the first unit was delivered at the National Research Council Canada. At MRS, the technology was introduced to researchers, along with BrillianSe™, the world’s highest spatial resolution direct conversion X-ray detector for hard X-ray. Christopher Scott, an engineer leading the inCiTe™ and BrillianSe™ product development, had a poster presentation to talk about the technology.

The dual-energy single exposure flat panel detector Reveal™ was launched at RSNA and has sparked interest in the industry. Engineer Sebastian Maurino had a talk during the conference and gave more details about the technology. Representing KA Imaging, his abstract received the Roadie Award from AuntMinnie.  “Our clinical trial with patient data has been excellent as well, as it shows tangibly the benefits of KA Imaging’s efforts,” celebrated Dr. Karim.

Read more
Amol Karnick, CEO (M.Eng, BASc)
Amol is a seasoned executive in the medical device industry. His experience covers the whole spectrum; from start-ups (Ultrasonix, Sentinelle Medical, Ventripoint) to large OEMs (GE Healthcare). Entering into the profession with a Bachelors in Engineering from UW and a Masters in Electrical Engineering from McGill, Amol spent 20 years in the medical imaging space to become a leader of multidisciplinary teams (sales, engineering and operations). Amol is now poised to steer KA Imaging into a position of global leadership.
Do you want more traffic?
Dignissim enim porta aliquam nisi pellentesque. Pulvinar rhoncus magnis turpis sit odio pid pulvinar mattis integer aliquam!
  • Goblinus globalus fantumo tubus dia montes
  • Scelerisque cursus dignissim lopatico vutario
  • Montes vutario lacus quis preambul den lacus
  • Leftomato denitro oculus softam lorum quis
  • Spiratio dodenus christmas gulleria tix digit
  • Dualo fitemus lacus quis preambul pat turtulis
  • Scelerisque cursus dignissim lopatico vutario
  • Montes vutario lacus quis preambul den lacus
SUBSCRIBE TO OUR NEWSLETTER AND START INCREASING YOUR PROFITS NOW!
* we never share your e-mail with third parties.
Karim S. Karim, CTO
(PhD, PEng, MBA)
A professor of Electrical and Computer Engineering at the University of Waterloo, Dr.Karim is a distinguished academician known for pioneering and commercializing large area current mode active pixel sensor technology that is now used in bio-metric fingerprint readers for mobile phones. With 20 years of experience in designing and prototyping large area digital imagers, Dr.Karim has been instrumental in raising over $12 million in research funding. A full member of the American Association of Physicists in Medicine (AAPM), Dr.Karim is also an IEEE distinguished lecturer.
Sina Ghanbarzadeh, Co-Founder
(MSc, PhD*)
Sina is the co-founder and the lead of the design team at KA Imaging Inc. He brings over 7 years of experience in design and characterization of imaging detectors to the KA Imaging Inc. He has designed the state of the art imaging detector prototype and currently leading the design team at both device and system level. Sina holds a Masters in Science degree in Electrical Engineering from the University of Waterloo and is also working towards his PhD at University of Waterloo.
Joan Medley, Quality Regulatory Expert (ISO 13485)
Joan began her career as a Medical Radiation Technologist at Sunnybrook Health Sciences, specializing in general and trauma radiography, CT scanning, angiography, heart catheterizations and fulfilled the role of clinical instructor. She has co-authored a Quality & Regulatory college course providing outline, course content and learning objectives. With over 2 decades of experience as a Quality Assurance (QA) Manager and Director, Joan has led medical device manufacturers through ISO registration and managing Quality Management systems. Certified as an ISO 13485 Lead Auditor, Joan currently provides contract services for a certification body.
Jill Zappitelli, Human Resources Consultant (CHRL)
An experienced and accredited Human Resource Professional and Program/Project Manager, Jill’s rich expertise and national and international experience in every facet of Human Resources affords her the distinction of being one of the most sought-after HR professionals in the region. As a member of the HRPA Board of Directors, her CHRL designation combined with a Business Administration Management Diploma from Conestoga College – Jill brings a genuine level of confidence to any organization that finds itself without some HR guidance. Creating and implementing authentic and effective HR solutions to solve an array of employee challenges have been Jill’s signature for several years with companies ranging from SunLife Financial to Blackberry, to non-profits such as Trellis Mental Health. Now, as a consultant to Waterloo’s emerging businesses and tech community, Jill has been delivering relevant and meaningful solutions to scale – be it program level or simply getting the right advice.
Ako S. Williams, Vice President
Ako Williams is Vice President, General Counsel and Corporate Secretary of Ushio America, Inc., which is a U.S. subsidiary of Ushio Inc. in Tokyo, Japan. Ushio is a leading provider of light sources and solutions for a wide variety of applications, including medical imaging and illumination, scientific, semiconductor, entertainment, horticulture, and architectural applications. A seasoned global enterprise executive with a strategic problem solving approach, Ako oversees Ushio America’s legal, regulatory compliance, risk management, and corporate governance matters. Previously, she was an Assistant General Counsel and Compliance Officer of Christie Digital Systems USA, Inc. (an Ushio group company) and an Assistant General Counsel of a leading home healthcare provider in the U.S. She holds a B.S. (highest distinction) from Northwestern University and a J.D. from Loyola University Chicago School of Law.
(B.S, J.D)
Ian Cunningham (BSc, MSc, PhD)
Dr. Ian Cunningham is a professor and scientist at the Robarts Research Institute at The University of Western Ontario and physicist at London Health Sciences Centre. He directs a research team of graduate students and post-doctoral fellows that are investigating new ways of acquiring and displaying medical images using digital radiography and computed tomography for improved health care.
Susan Horton (BA, MA, PhD)
Working for the World Bank got Susan interested in health and economics. Dr. Horton then proceeded to work at the International Centre for Diarrheal Disease Research in Bangladesh while writing her thesis. She has worked or taught in about 25 low and middle income countries, on topics ranging from labour markets, women's participation, benefits and costs of micronutrient interventions, and currently costs and benefits of breastfeeding, cost and cost-effectiveness of cancer interventions, and disease control priorities in low and middle income countries. Currently, Dr.Horton is working on the Disease Control Priorities project and in the past, worked on research projects with the World Bank, FAO, WHO, UNICEF, Copenhagen Consensus, etc.
Ruben Romero (CPA, CMA)
Ruben has a strong background in finance, accounting and strategic business operations from several years of work experience in various industries. Prior to joining KA Imaging's team, Ruben gained valuable experience working for Canadian and Global firms such as Class 1 Inc. and Bimbo Bakeries. Ruben has been a Chartered Professional Accountant and Certified Management Accountant for over ten years.
David Bell (PhD)
David Bell is a clinical and public health physician with a PhD in population health and background in internal medicine, modelling and epidemiology of infectious disease. Previously, he was Director of the Global Health Technologies at Intellectual Ventures Global Good Fund in the USA, Programme Head for Malaria and Acute Febrile Disease at FIND in Geneva, and coordinating malaria diagnostics introduction and scale-up with the World Health Organization in Manila and Geneva. David specializes in point of care technology development and introduction in low-resource health systems.
Evan Lee (BA, MD, MBA)
Evan Lee is a Geneva-based global health consultant. He has a BA from Harvard, an MD from New York University, and an MBA from MIT. He has worked with Médecins Sans Frontières in Kenya and Uganda and for Foundation for Innovative New Diagnostics and Management Sciences for Health. Most recently, he led Eli Lilly’s global health programs working on MDR-TB and NCDs, and founded Lilly’s 30x30 initiative to reach 30 million people by 2030.
David Koff (MD FRCPC)
David Koff (MD FRCPC) is a Professor of Radiology at McMaster University, former Chair and Chief of the department. He is founder and director of MIIRCAM, the Medical Imaging Informatics Research Centre at McMaster, and Chair and co-founder of Canada Safe Imaging. He has been a co-founder of IHE Canada (Integrating the Healthcare Enterprise) and is a member of the IHE section of the Medical Informatics Committee and RSNA. He is also a past co-Chair of the IHE International Radiology Planning Committee. Dr. Koff is fellowship trained in chest and body imaging.
Sandy Pironaggi-Trocchi (BSc)
Experienced regulatory affairs and quality assurance professional with a demonstrated history of developing and executing strategic regulatory submissions across global markets as well as implementing and maintaining quality management systems focusing on Health Canada, US FDA, MDR, MDSAP and ISO compliance.
Robert Moccia (BS, MS)
Bob brings 20+ years of management experience in the medical device industry to KA Imaging. Prior to joining KAI, Bob held various executive commercial roles with GE Healthcare in the areas of ultrasound and mammography, where most recently was the GM of Enterprise Sales. Prior to that Bob held various general management positions in Cardiovascular Ultrasound. Bob’s commercial experience at GE ranges from building and integrating startup business to rebuilding existing commercial teams. While at GE, Bob developed indirect and direct distribution models to serve customers across all market segments. Bob received his BS and MS degrees in Management from Lesley University.