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Jennifer Geetter

Successful Development, Approval and Deployment of Digital Health Solutions

By Jennifer Geetter

For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists, turns and roadblocks. This article examines some of the major challenges to bringing digital health products to market and explores potential opportunities to ease the journey.  

Featured Articles

September 26, 2023
FDA Logo

FDA Issues Final Guidance on Cybersecurity in Medical Devices

By MedTech Intelligence Staff

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions provides recommendations on what information to include in premarket submissions and emphasizes that cybersecurity is a component of quality system regulation.

September 20, 2023
Renée Bailey

Instructional Materials: The Basis for Safety Between Users and Medical Devices

By Renée Bailey

Instructional materials help users grasp how to use a device safely. Renée Bailey, Certified Instructional Technologist (CIT), explains how effective instructional materials are vital for the medtech design process, and shares necessary considerations to produce instructions that are coherent, easy to understand and aligned with the human factors engineering process.

September 20, 2023
FDA Logo

FDA Updates Breakthrough Devices Program Guidance

By MedTech Intelligence Staff

The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria.

September 13, 2023
FDA Logo

FDA Updates Guidance on ISO 10993-1 for Evaluation of Biocompatibility  

By MedTech Intelligence Staff

The FDA has updated its guidance, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,” to provide further clarification and updated information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” in pre-market applications.

September 13, 2023
Jennifer Geetter

Successful Development, Approval and Deployment of Digital Health Solutions

By Jennifer Geetter

For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists, turns and roadblocks. This article examines some of the major challenges to bringing digital health products to market and explores potential opportunities to ease the journey.

September 6, 2023
FDA Logo

FDA Issues Three New Draft Guidances on the 510(k) Program

By MedTech Intelligence Staff

The FDA has issued three new draft guidances related to the 510(k) submissions program, including Best Practices for Selecting a Predicate Device, Use of Clinical Data in Premarket Notification and Evidentiary Expectations for Implant Devices. The agency is accepting comments and will host a webinar for stakeholders on October 26, 2023, to provide more information on the guidances.

September 5, 2023
Louis Lehot and Eric CHow

Reshaping of the Biotech M&A Landscape

By Eric Chow, Louis Lehot

While the road ahead might be unpredictable, the core dynamics of the life sciences sector and the coming expiry of patents worth over $100 billion are poised to drive a renaissance in biotech mergers and acquisitions. 

September 5, 2023
HiRO and Courante logos

HiRO Enters U.S. with Acquisition of CRO Courante Oncology

“This acquisition allows us to leverage Courante’s extensive experience in oncology trials and enhance our capabilities in managing global studies.”

September 1, 2023
Christian Götz and Dr. Jara Brenke

EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose

By Christian Götz, Dr. Jara Brenke

Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with the regulation. However, responsibility for proactively pursuing the EU certificate of conformity for the products rests with the manufacturers.

August 30, 2023
GetWell Logo

Get Well Achieves FedRAMP Authorized Designation

By MedTech Intelligence Staff

The Get Well platform is used at more than 70 Veteran Affairs Medical Centers (VAMCs). Now that it is listed on the FedRAMP Marketplace, the Get Well digital patient engagement platform can be contracted by any government agency without additional security vetting required. 

Columns

September 26, 2023
Soapbox

Precision Medicine Meets AI: Advances in Cough Monitoring

By Carlos Chaccour, M.D., Ph.D.
Carlos Chaccour, M.D., Ph.D.

Recent developments, specifically artificial intelligence and the ubiquity of smart devices, enable us to monitor cough unobtrusively and continuously for periods of time. Objective cough quantification can be combined with patients’ perceptions to better determine diagnosis, treatment response and prognosis.

September 20, 2023
Soapbox

The Power of AI to Enhance Clinical Trials

By John Schwope
John Schwope

AI not only improves data collection and analysis, it impacts which products are engaged in clinical trials, determines necessary medical criteria, helps design the trials and can even choose the best participating facilities. The result is, organizations that leverage AI will be more successful and will go to market faster than those that don’t.

September 12, 2023
Soapbox

Revolutionizing Healthcare: Augmented Reality’s Unprecedented Impact

By David Goldman
David Goldman

Augmented reality (AR), with the help of artificial intelligence (AI), is providing healthcare professionals with the means to offer patients an unprecedented level of care and personalized treatments, and assisting MedTech and life sciences companies in product design and development. Yet, the potential of AR with AI in health care is still far from fully explored.

August 23, 2023
MEDdesign

MD PnP Presents Remote Control Care Testing and Verification Method

By MedTech Intelligence Staff
Patient on ventilator

For “Systematic Testing of a Ventilator Remote Control System Towards Safe Use in Tele-Critical Care and Prolonged Care,” researchers developed a prototype system for network-based far remote-control of the NKV-550 critical care ventilator, with the goals of identifying and implementing foundational remote-control capabilities, and exploring essential performance, interoperability, and cybersecurity requirements.

August 15, 2023
Soapbox

MedTech Marketing Pearls for FDA Clearance and Beyond

By Amanda Bloom
Amanda Bloom

As VP of Product Marketing for a MedTech startup, my role is to champion pioneering medical technology, strategically spark interest and drive it out of the design lab and into the field where it will ultimately change, or even save lives. Over the last two decades, I’ve seen the industry evolve in interesting ways, and I’ve learned some enduring lessons about market introduction and launch of market-making technologies post-FDA clearance.

August 2, 2023
From The Editor's Desk

Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference

By MedTech Intelligence Staff
Supply Chain and Adv Mfg 2023

Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced Manufacturing Conference and Supply Chain Summit, in partnership with Axendia, Inc. The two events will run back-to-back with registration options available for each program as well as a discounted rate for professionals who would like to attend both programs.

Upcoming Events & Webinars

September 28, 2023 – 1:00 pm – 2:00 pm
EU MDR & IVDR Lessons for Regulatory Strategy
November 7, 2023 – 8:00 am – November 8, 2023 – 12:00 pm
MedTech Intelligence ADVANCED MANUFACTURING Conference
November 8, 2023 – 12:00 pm – November 9, 2023 – 4:45 pm
MedTech SUPPLY CHAIN Intelligence Summit
November 13, 2023 – 8:00 am – November 14, 2023 – 3:00 pm
MedTech Regulatory Intelligence Summit


On Demand Events & Webinars

September 12, 2023
Bridging the GAP Agile/Compliance
July 12, 2023
Accelerating Corrective Actions for Rapid Introduction of New Products: Strategies for Success
June 8, 2023
Not All Medical Products Are Created Equal. Harnessing the Power PLM!
June 6, 2023
Mastering EU MDR: Essential Strategies for Effective Risk and Document Management
April 20, 2023
Regulatory Strategy as Competitive Advantage
March 29, 2023
Putting Quality Behind Intelligent Cancer Care at Varian
February 22, 2023
Quality Management and Regulatory Compliance for Medical Devices – What’s in for 2023?
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









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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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