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MedTech Resource Library

Resources Available

Supplier Quality as Competitive Advantage: Perspectives from PwC, Cardinal Health, and Veeva

Supplier Quality as Competitive Advantage: Perspectives from PwC, Cardinal Health, and Veeva

Sponsored By Veeva Medtech

To address today’s supply chain challenges and ensure quality products it’s critical to have a robust quality management system. Download this article featuring PwC and Cardinal Health for insights on building a business case and supporting digital transformation goals.

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AI Medical Device Software Under the MDR

AI Medical Device Software Under the MDR

Sponsored By DNV

This paper reviews some key aspects of safety and performance assessments of AI medical device software according to the existing regulation (EU) 2017/745 (MDR) ahead of the upcoming regulatory updates and standards publication. It also provides a review of requirements to be addressed in order to bring an SaMD to market.

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Symmetry Surgical Uses ETQ Reliance Out-of-the-Box to Streamline, Enhance Quality

Symmetry Surgical Uses ETQ Reliance Out-of-the-Box to Streamline Enhance Quality

Sponsored By etq part of Hexagon

Symmetry Surgical® is a leading healthcare technology and solutions provider of high-quality surgical instrumentation, a full-line electrosurgery portfolio, and minimally invasive surgical devices. The company needed to adhere to changing FDA and other regulations while simultaneously protecting its brand value.

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Predictive Quality for Medical Devices

Predictive Quality for Medical Devices

Sponsored By Critical Manufacturing

Wouldn’t it be great to know and be able to automatically release products when every process stayed within the specified envelope? And to sample or test only as much as a particular process requires, no more or less? Those are the promises of predictive quality. Get to know what executives from Medtronic, B Braun, Jabil and Ultradent have to say about it.

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Increase agility and innovation with PLM for medical devices

Increase agility and innovation with PLM for medical devices

Sponsored By Siemens

Siemens PLM for medical devices is an integrated end-to-end product development system that tackles complexity and regulation through re-use, content capture and collaboration.

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The Impact of Covid-19 on the Medical Device Supply Chain

The Impact of Covid-19 on the Medical Device Supply Chain

Sponsored By Loftware, Inc.

It’s no secret, the medical device supply chain was significantly impacted by the COVID-19 pandemic. Discover how leading medical device manufacturing companies adapted to meet the changing demands with labeling to ensure uptime.

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Drive Healthcare Transformation with Enterprise-Level Infrastructure

Drive Healthcare Transformation with Enterprise-Level Infrastructure

Sponsored By Arrow and Dell Technologies

Learn the key considerations and best-fit solutions for healthcare transformation that optimize operations for providers and ensure better outcomes for patients. Discover how the Arrow Electronics and Dell Technologies OEM Solutions portfolio can match any healthcare need.

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Adapting to COVID-19 with simulation in the medical device industry

Adapting to COVID-19 with simulation in the medical device industry

Sponsored By Siemens

Learn how medical device manufacturers are using simulation to enhance their design process to help fight COVID-19 and continuously innovate.

Read More

Preparing for Europe’s New Medical Device Regulation: The Essential Guide to EU MDR Compliance

Preparing for Europe’s New Medical Device Regulation: The Essential Guide to EU MDR Compliance

Sponsored By PTC Arena

Download our whitepaper today as we provide the key steps to making a successful MDR transition, as well as some insights on how an enterprise quality management system (eQMS) solution can help simplify compliance.

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6 Requirements for Medical Device Manufacturers in 2022

6 Requirements for Medical Device Manufacturers in 2022

Sponsored By Rootstock Cloud ERP

Discover the 6 key requirements to consider when executing your digital transformation strategy and learn how to turn uncertainty and disruption into a model for sustainable growth.

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Data Curation: Enabling your Digital Strategy with a Comprehensive Data Strategy

Data Curation: Enabling your Digital Strategy with a Comprehensive Data Strategy

Sponsored By Innovaccer

With the changing market landscape, heightened patient expectations, pricing pressures, and healthcare reforms, life sciences companies need to quickly adapt to enable high-quality care by embracing digital transformation. Through this whitepaper look under the hood to see how Innovaccer can help life-science companies address these challenges and move towards the digital disease management ecosystem.

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7 Principles of Product-Centric Quality Management: A Guide for Medical Device Innovators

7 Principles of Product-Centric Quality Management: A Guide for Medical Device Innovators

Sponsored By PTC Arena

Read this eBook to learn how to overcome process delays, compliance risks, and barriers that impede innovation.

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Launching your medical device: A strategy & execution cross-functional guide

Launching your medical device: A strategy & execution cross-functional guide

Sponsored By Definitive Healthcare

Learn how the experts launch their medical devices. Definitive Healthcare’s eBook cowritten by Carl Zeiss Meditec Inc. is packed with checklists and descriptions of all major pre-launch action items each team in your org needs to complete to successfully launch your device.

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Unified Medical Imaging Solutions: The Next Evolution in Imaging

Unified Medical Imaging Solutions: The Next Evolution in Imaging

Sponsored By Arrow and Dell Technologies

Move from disconnected PACS and VNA instances to a unified architecture that enables data analysis in real-time and seamlessly shares data with all the stakeholders. Learn about the Arrow Electronics and Dell Technologies OEM Solutions portfolio for unified medical imaging solutions.

Read More

The Rise of Implantable Devices

The Rise of Implantable Devices

Sponsored By AMETEK-COINING

In this whitepaper, we'll take a closer look into the state of the medical device industry, in general, and the rise of implantable devices, specifically. We'll touch on how those devices are changing people's lives for the better and what to consider when choosing the right materials that go into making these devices.

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Medical device design control with Siemens Digital Industries Software

Medical device design control with Siemens Digital Industries Software

Sponsored By Siemens

The goal of this paper is to dive into the nuanced topics of a requirements management and tracking solution. We will explore the broader use of our PLM tool for concept management throughout their lifecycle.

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The Post-Market Gambit: After EU MDR and IVDR: A Systematic Compliance Framework for Driving MedTech Innovation

The Post-Market Gambit: After EU MDR and IVDR: A Systematic Compliance Framework for Driving MedTech Innovation

Sponsored By Huma.AI

Based on extensive research and expert interviews, this 60-page ebook explores the challenges, costs, and opportunities that EU MDR and IVDR have created. Moreover, it offers a solution and vision for a New Era of Post-Market Intelligence.

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Connected Health Consumer Report (2nd ed.): Trust in a new era of health

Connected Health Consumer Report – Trust in a new era of health

Sponsored By Salesforce

58% of consumers say interactions with medical technology companies feel transactional. Read this report and see what 12,000 global health consumers say they would like from medtech organizations when it comes to building relationships centered on trust and communication.

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How to Address the Top Four Labeling Challenges Facing Medical Device Manufacturers

How to Address the Top Four Labeling Challenges Facing Medical Device Manufacturers

Sponsored By Loftware, Inc.

Discover the four key challenges facing medical device manufacturers and learn how modern, cloud-based label management helps companies tackle these challenges and optimize their operations for the global marketplace.

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The Ultimate Guide to Next-Generation Supplier Management

The Ultimate Guide to Next-Generation Supplier Management

Sponsored By ComplianceQuest

Technology is not only an enabler of supply chain management but is fast disrupting trends and practices. Think IoT, industrial robotics, other embedded systems on the shop floor, data-driven inventory optimization, digital transformation, automation and more.

Read More

Think You Know Everything About CRM for Medtech? Think Again.

Think You Know Everything About CRM for Medtech? Think Again.

Sponsored By Salesforce

Learn how a purpose-built platform for the medtech industry can be your system of engagement to drive commercial excellence by connecting teams, surfacing commercial planning insights, and deepening patient connections.

Read More

Operational Excellence: Charting a path to operational excellence with a focus on manufacturing

Operational Excellence: Charting a path to operational excellence with a focus on manufacturing

Sponsored By Siemens

Download this white paper today and find out how operational excellence for medical devices helps enterprises go beyond the complex modern requirements of medical device manufacturing. Learn how eliminating manual DHR activities will improve resource utilization and remove errors.

Read More

Beyond Inspection: Rethinking the role of video in manual assembly

Beyond Inspection: Rethinking the role of video in manual assembly

Sponsored By Drishti Technologies, Inc.

What if “inspection” meant more than identifying faulty or suspect units before they escape the factory? Thinking beyond inspection means infusing quality practices into every step of the assembly process.

Read More

Empowering emerging medical device manufacturers

Empowering emerging medical device manufacturers

Sponsored By Siemens

This eBook reviews the industry trends in MDD and the unique challenges facing SMB. The requirements for a digital infrastructure that addresses those challenges are detailed, and the Siemens solution developed according to those requirements is explained.

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Accelerating growth for emerging medical device and diagnostic industry SMB manufacturers

Accelerating growth for emerging medical device and diagnostic industry SMB manufacturers

Sponsored By Siemens

This is an infographic focusing on Small-to-Medium sized businesses (SMB), which are the emerging manufacturers in the medical devices market.

Read More

Top 6 uses for video on medical device assembly lines

Top 6 uses for video on medical device assembly lines

Sponsored By Drishti Technologies, Inc.

The video revolution has come to medical device assembly. Here are the top six ways leading Class II/III device manufacturers are using video to transform the effectiveness of everyone on and around the line — including the line operators themselves.

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Reduce Your Medical Device Time-to-Market with CPQ Software

Reduce Your Medical Device Time-to-Market with CPQ Software

Sponsored By Experlogix, LLC

Specifically designed for the Medical and Mobility industry’s complex and custom products, discover how CPQ (configure, price, quote) software can help your company save money, increase customer satisfaction, and generate real ROI. Download our latest datasheet to learn more about how CPQ software can help your business.

Read More

Deliver Accurate Medical Device Configurations and Quotes with CPQ

Deliver Accurate Medical Device Configurations and Quotes with CPQ

Sponsored By Experlogix, LLC

CPQ (configure, price, quote) software is designed to help medical device and mobility manufacturers accelerate the quoting and proposal generation process, eliminate mistakes, and easily guide users through the most complex pricing and quoting.

Read More

How medical device companies can create end-to-end connectivity for in-hospital equipment

How medical device companies can create end-to-end connectivity for in-hospital equipment

Sponsored By S3 Connected Health

Data insights collected on connected medical devices can bring many benefits for vendors, healthcare providers, and patients; from improving healthcare outcomes to reducing the cost of care and device maintenance. This whitepaper details the key steps to consider when creating a secure, scalable connectivity ecosystem based around medical equipment in the hospital environment.

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The Business Value of Cybersecurity in MedTech

The Business Value of Cybersecurity in MedTech

Sponsored By Irdeto

Build a secure line of defense for your devices against a growing range of cyberattacks. Irdeto's report in collaboration with Censuswide has identified clear ways for Health companies to improve customer and patient outcomes, make better data-driven decisions, increase trust, and generate more revenue.

Read More

BSI - MDR Documentation Submissions: Best Practices Guidelines

MDR Documentation Submissions: Best Practices Guidelines

Sponsored By bsi

The two most frequent reasons for delays to technical documentation reviews are: 1) BSI has not been provided with all of the information needed for the review; 2) The information is present within the technical documentation, but is difficult to locate.

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Explaining IVD Classification Issues

Explaining IVD Classification Issues

Sponsored By bsi

To comply with the Regulation on in vitro diagnostic medical devices (2017/746) (IVDR) manufacturers must classify their in vitro diagnostic (IVD) devices in accordance with the rules set out in Annex VIII of the Regulation. There are some significant differences between the classification systems for medical devices and IVD medical devices under the new regulations.

Read More

Telemedicine Cybersecurity Report: Android Patient-Facing Mobile Apps

Telemedicine Cybersecurity Report: Android Patient-Facing Mobile Apps

Sponsored By Irdeto

In this new whitepaper, Irdeto identified five B2C patient-facing Android telemedicine mobile apps that offer both synchronous and asynchronous virtual visit experiences to US consumers and are downloadable via Google Play and performed an extensive cybersecurity threat risk analysis of these apps.

Read More

Unlocking Medtech’s Future Potential with Connected Devices and Services

Unlocking Medtech’s Future Potential with Connected Devices and Services

Sponsored By S3 Connected Health

With the global market for connected medical devices expected to reach $188 billion by 2024, connectivity is top of mind for leading medtech companies. Meanwhile, a surge in demand for remote care and the urgent need for hospitals to operate at peak efficiency is driving demand for services based around connected devices.

Read More

How to optimize coatings and substrates for compatible medical devices

How to optimize coatings and substrates for compatible medical devices

Sponsored By KRÜSS

Taking a close look at coatings, substrates, and surface preparation helps not only develop ground-breaking materials, but also enhances how well existing liquids and solids work together.

Read More

Telemedicine Mobile App Cybersecurity Infographic

Securing devices so that clinicians and patients connect without fear.

Sponsored By Irdeto

If mobile medical app cybersecurity is not well implemented, there can be several negative consequences. How can you protect your mobile medical application from hackers? Download the infographic to learn more.

Read More

Irdeto Telemedicine Cybersecurity Report: iOS Patient-Facing Mobile Apps

Telemedicine Cybersecurity Report: iOS Patient-Facing Mobile Apps

Sponsored By Irdeto

In this white paper, Irdeto identified five popular patient-facing iOS telemedicine mobile apps that offer on-demand virtual visits direct to customers through the App Store and performed an extensive cybersecurity threat risk analysis of these apps.

Read More

The engineer’s guide to wearables: Lessons learned from design mishaps

The engineer’s guide to wearables

Sponsored By 3M

“Doctor’s orders” used to be the be-all, end-all. Today, it’s common for patients to seek multiple opinions, highly-tailored treatment options and ways to monitor their health themselves. Wearable medical devices have been game-changers – especially for people with chronic illnesses. Wearables enable patients to have constant access to health data that allows them to make critical health decisions from the comfort of their own homes or on-the-go.

Read More

Evidera - Trends in Medical Device Purchasing

Trends in Medical Device Purchasing, Evaluation of Value, and Advice for Manufacturers

Sponsored By Evidera

Gone are the days of selling med tech products to surgeons and physicians based on relationships alone. Today, surgeons must convince hospitals that a new product provides clinical and economic value, and manufacturers must arm surgeons with evidence to facilitate successful discussions with hospital value-analysis teams (VAT).

Read More

The Growing Need for Real-World Evidence in Medical Devices

The Growing Need for Real-World Evidence in Medical Devices

Sponsored By Evidera

Derived from a wide range of data sources, real-world evidence (RWE) is used to complement clinical trial data to create a robust evidence base showing both safety and efficacy in defined populations (clinical trials), as well as outcomes in the general populations.

Read More





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Unified Medical Imaging Solutions: The Next Evolution in ImagingUnified Medical Imaging Solutions:

The Next Evolution in Imaging

Move from disconnected PACS and VNA instances to a unified architecture that enables data analysis in real-time and seamlessly shares data with all the stakeholders. Learn about the Arrow Electronics and Dell Technologies OEM Solutions portfolio for unified medical imaging solutions.

Learn More
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Tony Blank, Barton & BlankTony Blank is president of Infinity Biomedical Group. He is formerly the cofounder of Barton & Blank, a regulatory consulting firm specializing in providing strategic and tactical regulatory support for medical devices and combination products. Immediately prior to forming Barton & Blank, Blank spent 12 years at Boston Scientific Corp. in both corporate and business regulatory leadership roles. Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and combination products—among these being worldwide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization. Blank has likewise been an active representative for Boston Scientific, the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups—including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired). He is very involved in developing and delivering meaningful educational programs in the field of regulatory affairs and has been a regular speaker at educational events. In addition to his time at Boston Scientific, Blank has worked with cardiopulmonary, surgical, ophthalmic, vascular access and critical care medical devices.

Pat BairdPat Baird works at Philips as the head of global software standards. Baird likes to think of his job as “policy engineering”— understanding the unmet needs (and frustrations) of regulators and developers, and working to develop standards, whitepapers and training to meet those needs. Past roles have included software developer, engineering manager, project manager, lead engineer, and most recently he was the director of risk management at Baxter Healthcare. Drawing on 20 years’ experience in product development, he has published and presented more than 50 papers regarding product development. Baird has an MBA and a Masters in healthcare quality and patient safety from Northwestern University.

Roberta Goode, Altrec
Roberta Goode, Principal Trainer, Altrec

Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created more than 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for the world’s largest medical device manufacturers, Goode turned her attention to sharing that wealth of accumulated knowledge. Look for her in 2018 in a technical training and mentoring role as the head of Altrec, LLC.

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    Susan Alpert, SFA Consulting, Global Regulatory StrategySusan Alpert, M.D. is president of SFA Consulting, LLC. She previously served as senior vice president, chief regulatory officer at Medtronic and was responsible for all of the company’s global regulatory efforts. Prior to joining Medtronic, Alpert served as vice president of regulatory sciences for C.R. Bard, Inc. She also previously worked at FDA where she held a variety of positions in the Centers dealing with drugs, devices and radiological health, and foods, including six years as the director of the Office of Device Evaluation.

    Alpert is a microbiologist and a pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials. She serves on the board of advisors for the Medical Technology Leadership Forum and the board of the Women Business Leaders, or organization of women leaders in the health care sector. She also serves on the Executive Committee of the Clinical Trials Transformation Initiative, one of the public/private partnerships working with FDA to streamline the development of medical products.

    Dr. Christopher Joseph Devine, President, Devine Guidance InternationalDr. Christopher Joseph Devine is the president of Devine Guidance International, a consulting firm specializing in providing solutions for regulatory compliance, quality, supplier management, and supply-chain issues facing the device industry. Devine has 32 years of experience in quality assurance, regulatory compliance and program management. He is a senior member of the American Society for Quality (ASQ), a member of the Regulatory Affairs Professionals Society (RAPS), and a member of the Project Management Institute, and resides on several technical advisory boards. Devine received his doctorate from Northcentral University, with his doctoral dissertation titled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study.” Devine holds a graduate degree in organizational management (MAOM) and an undergraduate degree in business management (BSBM).

    Mark Leimbeck, ULMark Leimbeck is the principal of UL Solutions Risk Management Practice. He has served as a subject matter expert and advisor in a number of functional areas, including risk management, quality management, project management, software application development, and engineering. During his career, Leimbeck has led and supported the implementation of various corporate improvement and development programs including quality system and regulatory compliance programs, new product development, IT systems and enterprise resource planning (ERP) implementation, and quality/lean Six Sigma process improvement projects. Leimbeck continues in a subject matter and advisory role, and participates in international, national and industry-based standards and guidance development committees. He holds a B.S. E.E.T. from Southern Illinois University and an M.B.A from the University of Chicago.

    Steve Wilcox, Design ScienceStephen Wilcox, Ph.D., FIDSA is a principal and the founder of Design Science (Philadelphia), a 30+ person firm that specializes in optimizing the usability of products, particularly medical devices for clients including many major multinational corporations. Wilcox is a member of the Industrial Designers Society of America’s (IDSA) Academy of Fellows. He also served for several years as Chair of the IDSA Human Factors Professional Interest Section.

    Wilcox also serves on the Advisory Boards of the Industrial Design Department of Philadelphia University and the School of Design of Carnegie Mellon University, on the Human Factors Engineering Committee of AAMI, and on the ISO/IEC committee (“Working Group 4”) that wrote the standard, IEC/ISO 62366. He holds a BS in psychology and anthropology from Tulane University, a Ph.D. in experimental psychology from Penn State, and a Certificate in Business Administration from the Wharton School of the University of Pennsylvania. He has won a number of design awards, has guest edited the journal Innovation several times and has served as a judge for a number of product design award competitions.

    Wilcox has given hundreds of invited addresses to various organizations, has published more than 70 articles in professional journals, and is the current Editor in Chief of the Human Factors and Ergonomics Society journal, Ergonomics in Design. His book, Designing Usability into Medical Products (CRC/Taylor & Francis), co-authored with Michael Wiklund, was published in 2005.

    Alberto VelezAlberto Velez is a consultant for Chimera Consulting North America, LLC. Velez is a recognized expert in organization development for combination products with more than 12 years of experience in applying CGMP concepts to more than 35 combination products in new product development, manufacturing and quality systems. He is a frequent speaker on combination products topics at industry meetings and has more than 30 years of varied experience in medical device and combination product quality assurance, FDA readiness, product development and organizational effectiveness in the pharmaceutical and medical device industries. Velez has applied the CGMP’s/QSR’s to several different divisions in the Johnson & Johnson family of companies as well as other smaller medical device companies. He has also led R&D teams to develop and launch new technologies in endoscopic surgery and enteral feeding. His educational background is in chemical engineering, industrial engineering and quality engineering.

    John Pracyk, J&JJohn Pracyk, is a rare Neurological Surgeon with an uncommon blend of business and medical expertise. This sophisticated futurist is recognized as a national thought leader in the design, development, and management of collaborative care delivery based on his history of healthcare program build-outs and medical administration successes. An accomplished writer and platform speaker, he is a frequently requested keynote speaker at prestigious organizations such as the Congress of Neurological Surgeons, The Barrow Neurological Institute, and Stryker Performance Solutions.

    Having completed a healthcare-focused MBA from the nation’s preeminent physician-only degree program, with a Master’s thesis on competitive strategy and service-line development, Dr. Pracyk is a proactive innovator who inspires teams to surpass organizational goals, exceed patient care metrics, and enable transformational change. Healthgrades acknowledged him with their honor roll distinction.

    His career to date has been characterized by three key elements: First, his ability to foster multidisciplinary consensus and collaborative care; second, his grasp of competitive strategy as a program architect; and third, his ethics-driven approach to medicine. While recognizing that revenue generation drives business, Dr. Pracyk balances business necessities with patient care and market realities. In 2016, Johnson & Johnson Medical Devices appointed him Franchise (Worldwide) Medical Director for Spine.

    Patric Caines, BaxterPatrick Caines is director, quality & post-market surveillance at Baxter Healthcare where he is responsible for the company’s global post-market surveillance and associated quality systems. Caines has 20 years’ experience in quality systems and compliance for both medical devices and clinical diagnostics and served as director, corporate post-market surveillance at General Electric Healthcare and Boston Scientific, and director of worldwide customer quality at Johnson and Johnson. Caines began his career as a hospital-based clinical laboratory scientist and held faculty appointments at the University of Windsor and Wayne State University. He holds a Ph.D. in clinical biochemistry from the University of Windsor, Ontario, Canada as well as an MBA from St. John Fisher College, Rochester, New York.

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