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Digital Health

Featured Articles

January 22, 2023
Rama Chellappa

Instilling Trust in AI

By MedTech Intelligence Staff

Rama Chellappa, PhD, John Hopkins University Bloomberg Distinguished Professor in electrical, computer, and biomedical engineering, and co-author of "Can We Trust AI?" looks at the promise of AI in health care and how we can best utilize this extraordinary tool to save lives and improve health equity.

January 9, 2023
Dr. Abtin Rad

New Cybersecurity Standards for Medical Applications

By Dr. Abtin Rad

Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.

January 4, 2023
Andrew Mackinnon

Connecting More Patients to Clinical Trials

By Andrew Mackinnon

Connected sensors are a key component to improving patient access to and patient retention in clinical trials. Following are considerations for developers and sponsors when designing and selecting sensors for use in trials.

December 21, 2022
Emily Newton, Revolutionized Magazine

How MedTech Is Helping the Hearing Impaired

Advances in medical devices and technology have had a profound effect on those with mild, moderate and severe hearing loss. Here, we take a closer look at how these technologies have evolved and what the future may hold.

December 6, 2022
Stuart Long

Moving the Needle on Virtual and Connected Care

By MedTech Intelligence Staff

There are several challenges and opportunities on the road to a truly connected, hospital to home healthcare system. Stuart Long, CEO of InfoBionics, discusses new innovations as well as what’s needed to move connected care and remote patient monitoring to the next level of adoption.

December 5, 2022
Vijay Parmar

Microbattery Advancements Will Unlock a New Wave of MedTech Innovation

By Vijay Parmar

Microbatteries are on the cusp of a new era as solid-state lithium technology arrives to pack more energy into smaller form factors. These batteries will enable the products they power to be offered in smaller sizes and more comfortable shapes, with enormous implications for future medtech product designs and capabilities, from the convergence of hearables and OTC hearing aids to wearable devices that are used for remote health monitoring and fitness tracking.

November 21, 2022
Anthony Fernando

From Art to Science:  How Machine Learning Is Changing the Surgical Landscape

By MedTech Intelligence Staff

Anthony Fernando, CEO and president of Asensus Surgical, discusses the potential benefits of augmented intelligence in robotic surgery for both patients and physicians.

November 14, 2022
AMA Logo

AMA Releases Blueprint for Optimizing Digitally Enabled Care

By MedTech Intelligence Staff

The blueprint includes opportunities for various healthcare stakeholders to contribute to the full optimization of digitally enabled care and includes case examples featuring organizations with care models that leverage the blueprint’s six pillars. 

August 24, 2022
Gustavo De Moraes, MD

Technology’s Role in Improving Clinical Trial Equity

By Gustavo De Moraes, MD, PhD, MPH

Improving clinical trial equity can help close the gap between the challenges to enroll and retain patients in clinical trials and the growing burden of diseases. All in all, there are immense benefits to creating and providing remote technologies for clinical trial participants.

July 25, 2022
NIST Graphic

NIST Seeks Feedback on New Guidance for Healthcare Cybersecurity

By MedTech Intelligence Staff

The revised cybersecurity draft publication is not intended to be a checklist for healthcare organizations to follow, but rather a guide to help them comply with the HIPAA Security Rule.

View More Digital Health Articles »

Columns

January 25, 2023
From The Editor's Desk

Connected Care: Overcoming Roadblocks and Identifying Opportunities

By MedTech Intelligence Staff
CCEast logo

Leaders in digital health development and regulation look at best practices, pitfalls and what’s next for connected medical devices and technologies.

January 10, 2023
Ask the Engineer

Best Practices and Pitfalls When Going from Concept to Commercialization

By Danny Wilson
Danny Wilson

MedTech IoT start-ups and early-stage innovators often launch with a minimum viable product, or MVP, a version with just enough features and stability to be used in clinical or field-testing. With the right MVP, companies can prove technical feasibility and position themselves for success with investors. Here is how to get there.

December 21, 2022
From The Editor's Desk

MedTech Intelligence Announces 2023 Conference Series

Conference Photos

MedTech Intelligence will host four vertical in-person events in 2023 covering connected care, regulatory compliance, advanced manufacturing and supply chain. The Washington, DC-based conferences bring together MedTech professionals for education, networking and discussion on the key challenges and opportunities facing the MedTech industry.

November 22, 2022
Soapbox

How Health Tech Can Combat the High Cost of Lifestyle Choices

By Trenholm Ninestein
Trenholm Ninestein

We’ve all dabbled with apps that affect various parts of our health and wellness, but never in a holistic way. This is an opportunity for the tech sector to help patients drive better health outcomes and reduce overall healthcare costs by showing them how to embark on a path of wellness. It’s just a matter of pulling it together into the right user experience.

October 23, 2022
Soapbox

Nudging Towards Safer Decision Making

By Laís Junqueira
Laís Junqueira

There is an increased need to foster effective and improved dynamics between people, processes, knowledge and technology to generate an output of safety. “Nudges,” which can help optimize choices by encouraging safer and healthier behaviors, are a promising option.

September 13, 2022
Soapbox

Prognosis: Medical Device Security Needs Improvement

By Emily Newton
Emily Newton, Revolutionized Magazine

Connected medical devices have many advantages but require a higher level of security. If the medical industry doesn’t improve its cybersecurity posture, it could endanger patient privacy and lives.

September 6, 2022
Soapbox

AI Applications

By Calum Cunningham
Calum Cunningham

Artificial intelligence has numerous practical applications in diagnostic imaging; the key to making them work for clinicians and patients lies in developing and embracing integrated workflow networks.

August 23, 2022
Soapbox

Empowering Patients Through RPM

By Jennifer Kent, Ph.D.
Jennifer Kent

Remote care in the home relies both on the quality of patient monitoring and on the insights provided to the care team. There is a real danger that data overload and alert fatigue will undermine otherwise well-designed remote patient monitoring (RPM) and Hospital at Home programs. The software platform and algorithms tasked with integrating and evaluating data must identify the data that matters, when it matters.

Upcoming Events & Webinars

February 22, 2023 – 11:00 am – 11:45 am
Quality Management and Regulatory Compliance for Medical Devices – What’s in for 2023?
March 14, 2023 – 8:45 am – March 15, 2023 – 3:00 pm
ConnectedCare Summit East


On Demand Events & Webinars

January 18, 2023
MedTech Regulatory Intelligence: Post-Market Surveillance
December 16, 2022
The Benefit and Risk of AI Software in Medical Devices
November 18, 2022
Literature Reviews Strategies & Best Practices While Establishing State of the Art for EU MDR Compliance
November 17, 2022
The Med Tech Supply Chain – Challenges and Strategies
November 17, 2022
Moving Beyond ASL with Design Controls and Supplier Management
October 27, 2022
Transforming Medical Device Sales for the Digital World
October 6, 2022
Why a Product-Centric Approach to Quality Matters
September 29, 2022
How AI is Powering the Next Generation of Cloud Quality Management Systems
August 30, 2022
Getting Your Regulatory Ducks in a Row – Why a Regulatory Information Strategy is Critical for Successful MDR/IVDR Transitions
July 19, 2022
How Symmetry Surgical Increased Efficiency, Reduced Compliance Risk & Increased Awareness thru Quality Process Automation
June 16, 2022
Rethinking the Medical Device Supply Chain
June 15, 2022
End-to-end Data Integration, Health Records through Medical Devices (Connected Care: Digital Health, Wearables & Connectivity)
May 25, 2022
Supply Chain Quality Management

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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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