Tag: medical

We need to include energy for home medical equipment in covered medical costs

As a pulmonary and significant care health practitioner at Yale, I have a front row seat at the health care financial debt crisis. Though many persons associate healthcare charges with visits to a healthcare facility, medical doctor, or the acquire of medication, there is one particular often neglected charge that can have a profound affect: resilient professional medical devices.

In my apply, I normally prescribe strong clinical gear (DME), this sort of as oxygen concentrators, walkers, ventilators, or other equipment to assistance my clients are living a much healthier everyday living. While patients’ insurers will normally pay out for the products alone, the resulting improve in their electrical expenditures can be substantial. My research, published in the Journal of the American Health-related Association, has revealed that these bills can simply be hundreds of dollars a yr, and in some circumstances, extra than $1,000.

This cost can be particularly burdensome for my sufferers who are on Medicaid, as their severe overall health difficulties generally make it tricky to keep work and live on a fastened income. They just cannot manage these substantial costs. I, together with my colleagues, have seen firsthand how this economic load can have a devastating impression on their top quality of lifetime and health care care. 

As a society, we should acknowledge that the charge of professional medical treatment is not constrained to visits to the health care provider or the charge of treatment. The monetary burden of DME can have a long lasting impact on the life of our most vulnerable citizens. We will have to consider actions to address this situation and make certain that everyone has access to the professional medical tools they have to have to direct healthier and fulfilling life.

There are various likely solutions to this difficulty. One alternative is to grow funding for the Low-revenue Residence Vitality Support Method (“LIHEAP”), which assists much more than 5 million small-earnings households every year with payments on the electric, gas, oil and propane charges, assisting them to continue to be warm in the winter season and awesome in the summer months. But existing funding is insufficient to attain the 30 million households that are suitable. A lot more funding would be desired to focus on supplemental payments to these with terribly significant electric expenses due to reliance on DME.

One more alternative would entail payers of clinical payments (Medicare, Medicaid, non-public insurers) to pay back not only the cost of the equipment alone but also to defray the price of the enhanced electrical payments.

A 3rd solution is to present tax incentives to folks who need to have DME, so they can offset the prices affiliated with it.

Ultimately, the option will most likely entail a combination of these ways and potentially some others. However, what is most critical is that we consider action. The expense of healthcare treatment is a complex and demanding issue, but we can’t afford to disregard the effects it has on the life of sufferers.

Dr. Peter Kahn is a fellow in the Part of Pulmonary, Vital Treatment and Sleep Medication at Yale Faculty of Medication. He graduated from the Albert Einstein University of Drugs with honors and his M.P.H. from the Johns Hopkins Bloomberg Faculty of General public Health in the section of Wellness Plan and Administration. Dr. Kahn’s investigate has concentrated on health policy with a unique desire in the impact of weather change and utilities on wellness plan. Comply with him on Twitter @PeterKahnMD

Charlie Harak is senior legal professional for electricity and utilities challenges at the Countrywide Consumer Law Centre. He represents customers right before regulatory agencies, testifies at legislative hearings, and offers legal and coverage counsel to lower-revenue advocates, legal companies legal professionals, and federal government officials. He is the co-writer of “Guarding Seriously Sick Consumers from Utility Disconnections: What States Can Do to Help save Life Now” (Feb. 2021).

Updates to 2022 Equine Medical Research Fund Projects

Feb 17, 2023

Updates to 2022 Equine Health care Investigate Fund Initiatives

Updates to 2022 Equine Medical Research Fund Projects
USEA/Meagan DeLisle picture

Given that 2014, more than $300,000 in contributions have been created to the USEA’s Equine Health-related Exploration (EMR) Fund via USEA member $1 starter expenses and additional donations been given. These funds are then allotted to accredited exploration scientific tests becoming executed by dependable parties of the USEA. For 2022, the EMR recommended a few studies being carried out by the Morris Animal Basis and the Grayson-Jockey Club Exploration Foundation. In the August 2022 USEA Board of Governors (Bog) meeting, the adhering to scientific tests had been presented to and authorised by the Bathroom:

  • Understanding Hazard Components for Transportation-Connected Colic in Horses | Morris Animal Basis
  • Predicting Working out Arrhythmias with Resting ECGs | Grayson Jockey Club Study Basis
  • Studying Postoperative Ileus Involved with Colic | Morris Animal Foundation

The initial of people 3 scientific tests, “Understanding Threat Components for Transportation-Associated Colic in Horses,” was allotted $28,100 in help from the EMR’s offered resources for the yr. This review, which is projected to run about the class of two a long time, will enable researchers the possibility to research whether or not adjustments to gut motility in horses are affiliated with article-vacation colic and use this new data to make improvements to administration suggestions for the care of transported horses. The study crew assigned to this task will collect knowledge pre-vacation, promptly soon after transportation, and two several hours following arrival to evaluate the gut motility data vital to make recommendations for the welfare of horses throughout transportation in hopes of lessening the incidence of write-up-journey colic. The USEA’s contribution of $28,100 absolutely funded this analyze.

Morris Animal Foundation is also conducting an added study job with funding from the EMR titled, “Studying Postoperative Ileus Involved with Colic.” This two-calendar year study is a section of North Carolina State University’s fellowship method, founded to assistance early career scientists. The Fellow assigned to this study will analysis the position of signaling cells in inflammatory processes associated with postoperative ileus, a everyday living-threatening complication of colic surgical procedure that success in the extended absence of bowel motion. Researchers are researching important organic mechanisms that may possibly lessen intestinal wall functionality and induce swelling. The EMR specified $3,005.83 to support with this review.

The sole investigate job getting upheld by the Grayson-Jockey Club Investigate Foundation beneath 2022 funding is truly a continuation of a 2021 challenge which was specific to consider two decades in advance of completion. The study, “Predicting Working out Arrhythmias with Resting ECGs,” is utilizing resting echocardiograms to determine horses with irregular heart rhythms at exercising that can cause unexpected cardiac demise, allowing for elevated checking and enhanced understanding of sudden cardiac loss of life.

For 2021, $17,000 of EMR funds have been allotted to this study, with an supplemental $15,000 in cash permitted during the 2022 12 months to keep on the crucial get the job done being researched by the Grayson-Jockey Club Investigate Basis. In complete, the EMR has contributed $32,000 toward the full research value of $119,477.

For an update on scientific tests previously picked for funding by the USEA Equine Clinical Exploration Committee, click on in this article. To study more about how the Equine Healthcare Research Fund bought began, simply click right here. For further facts about the Fund, simply click right here.

Demystifying UDI Requirements for Medical Devices

Distinctive Device Identification (UDI) demands will enhance close to conclusion world-wide traceability for health care equipment, but gray areas exist concerning how to operationalize a resolution that encompasses a assortment of worldwide variation and complexity. You may well question, why is a world wide solution wanted now? As a lot more health care system options are introduced globally, a harmonized strategy for traceability all through the offer chain that supports article-market place security things to do and regulatory pursuits is crucial. It empowers organizations to target on bringing health care units to sector with extra predictability and to enhance submit market place pursuits.

The adhering to four benefits outline why a solitary UDI technique is wanted, particularly to take out redundancy, streamline merchandise launches and assistance crucial article-market place activity:

Analyzing the 4 levels in the UDI procedure

1. Traceability

With a UDI selection, solutions have strong sourcing and producing data constructed in which assists with making sure uniformity and regulatory data compliance. The UDI is made up of the System Identifier (DI) and Item Identifier (PI) with just about every taking part in an critical role. The DI incorporates the regulatory info and appears as the permanent marketing on the gadget. On the other aspect, the PI helps with good quality management and operations these as the serial range, production day and shelf existence of the gadget.

The Intercontinental Health-related Device Regulators Discussion board (IMDRF) has unique suggestions for diverse products on what DI or PI have to be on the packaging or machine by itself. Organizations should come to be acquainted with the needs for the device becoming introduced to current market to recognize what quantities and wherever it should really be positioned on the remedy. Furthermore, it is critical to glimpse how just about every region interprets complex formats on reporting these figures. There are some versions amongst the GS1 to HIBC to ICCBA Specifications that all consists of parts of the DI and PI figures. This is a gray region exactly where further more guidelines on how common implementations that are really world wide is necessary to travel larger harmonization.

2. International Operations

Each individual process in the lifecycle of the solution will impression and change the UDI number. At this amount, the UDI quantity is joined to the world wide offer chain, stock and distribution, so any product or service lifecycle management (PLM) transform requirements to be captured.

For occasion, in structure manage, mandatory knowledge in the regulatory databases are employed to register products in different international locations. Generation and logistics should use UDI needs to decide how to package deal and generate labels for worldwide compliance. After a products is launched with a UDI quantity, the numbers are made use of to keep track of publish industry routines such as adverse occasion reporting, recollects and subject security corrective actions. Moreover, adopting UDI traceability helps with the transform administration course of action by trickling the alterations throughout the product or service lifecycle. It will allow for dynamic knowledge administration throughout various databases and quicker facilitation of the mentioned adjustments.

However, the issue is localization of the UDI systems and specifications. This implies the have to have for now acquiring and managing neighborhood UDI remedies in the product-stock administration units. Also, some country obtaining bodies go past the requirement to have a UDI and condition, for illustration as a tender prerequisite, the will need to use a particular UDI alternative. This can final result in a business needing to choose irrespective of whether it is commercially feasible to satisfy the prerequisites of this obtaining entire body as operating several UDI options (or establishing a client certain UDI solution) can insert an extra layer of complexity and price to an organisation. A solid regulatory intelligence team will be essential to keep track of the evolving requirements to this sort of labeling and to additionally overlay the UDI necessity into just one of numerous, international labelling specifications for health-related gadgets.

3. Basic safety

A important intention of a world-wide UDI is to maximize affected individual safety and greatly enhance the efficiency of adverse function reporting and associated write-up current market action. In searching at PI figures, this focuses on the manufacturing aspect with producer and expiration dates. The DI selection is connected to the industry acceptance and submit start information together with clinical investigations, registrations, certifications and products vigilance. It enables for increased traceability and regularity as the UDI is the key to all the information and facts. Obtaining a worldwide process allows for enhanced patient security and the uncovering of trends speedier. Incidents at international concentrations are traced and tracked which in transform could enable travel improved clinical conclusion making and individual security.

4. Marketplace Influence

1 significant effect of a international UDI application would be the efficiencies in supply chain and clinical tactics. It ensures steady documentation by a related databases system, streamlines health care promises and reimbursements. It drives increased affected individual safety and procedure effectiveness although also giving life science companies with bigger charge discounts. This effect for all spots of business enterprise demonstrates the want for a world-wide UDI method.

In analyzing these four added benefits of a centralized UDI process, a world-wide, harmonized technique is necessary to travel forth a one typical for bigger traceability and duty for MedTech Sector. UDI performs a direct purpose in the regulation procedure for goods given that info made use of and tracked through the UDI process is necessary for compliance submissions.

Most importantly UDI is the crucial that can help integrate numerous fragmented tracking techniques across basic safety, regulatory and publish industry surveillance. It goes over and above just optimizing units to groundbreaking the transformation of compliance from a prerequisite to a competitive edge. It supplies bi-directional trace and transparency by mapping item to course of action to paperwork to true use. It simplifies world-wide operations by integrating merchandise trace in provide chain and for this reason the stock administration at the healthcare supplier. This in turn provides to huge cost savings and superior medical results.

For additional details on UDI, view the on-demand webinar, “UDI Specifications – The Panic Of The Not known.” To speak with an IQVIA skilled and understand far more, mail a observe to RegulatoryTechnology@iqvia.com .

Who are the leading innovators in robotic dental surgery tools for the medical devices industry?

The healthcare equipment field carries on to be a hotbed of innovation, with action pushed by greater need to have for homecare, preventative treatments, early diagnosis, lessening affected person recovery occasions and enhancing results, as very well as a developing worth of technologies these kinds of as device mastering, augmented reality, 5G and digitalisation. In the final three several years alone, there have been more than 450,000 patents submitted and granted in the clinical devices marketplace, in accordance to GlobalData’s report on Robotics in Clinical Devices: Robotic dental surgical procedure resources.

Having said that, not all improvements are equivalent and nor do they abide by a regular upward craze. In its place, their evolution requires the type of an S-shaped curve that displays their normal lifecycle from early emergence to accelerating adoption, just before ultimately stabilising and achieving maturity.

Figuring out in which a unique innovation is on this journey, specially those people that are in the emerging and accelerating stages, is essential for comprehending their current amount of adoption and the very likely foreseeable future trajectory and effect they will have.

150+ improvements will condition the healthcare products sector

In accordance to GlobalData’s Technologies Foresights, which plots the S-curve for the healthcare units market employing innovation depth products created on above 550,000 patents, there are 150+ innovation areas that will shape the upcoming of the business.

In the emerging innovation stage, HUDs for surgical navigation, robotic biopsy endoscope, and camera-guided surgical robots are disruptive technologies that are in the early phases of software and should be tracked closely. Robotic exoskeleton, surgical robots, and robotic catheters are some of the accelerating innovation parts, where by adoption has been steadily escalating. Among the maturing innovation areas are robotic reduced limb rehabilitation and microfluidic lab-on-a-chip, which are now properly founded in the field. 

Innovation S-curve for robotics in the clinical devices sector

Who are the leading innovators in robotic dental surgery tools for the medical devices industry?

Robotic dental operation instruments is a important innovation space in robotics

Robotic dental surgical procedures applications deliver a better quality of care as they supply elevated accuracy and precision, protection, streamlined work processes, and much better workflows when when compared with regular methods. As the dental markets mature and treatment prerequisites adjust, these robotic instruments are anticipated to become commonplace in the treatment method of compact and significant dental interventions.

GlobalData’s examination also uncovers the providers at the forefront of just about every innovation region and assesses the opportunity achieve and impact of their patenting action across various purposes and geographies.  According to GlobalData, there are 10+ firms, spanning technological innovation suppliers, set up health-related equipment organizations, and up-and-coming start-ups engaged in the enhancement and software of robotic dental surgery tools.

Essential gamers in robotic dental operation equipment – a disruptive innovation in the clinical devices field

‘Application diversity’ actions the quantity of distinct applications discovered for each individual pertinent patent and broadly splits providers into either ‘niche’ or ‘diversified’ innovators.

‘Geographic reach’ refers to the selection of unique nations around the world just about every suitable patent is registered in and reflects the breadth of geographic application intended, ranging from ‘global’ to ‘local’.

Neocis and Zimmer Biomet are top patent filers in the subject of robotics dental surgical treatment. Some other essential patent filers in the subject contain Navigate Surgical Systems and X-Nav Systems.

In phrases of software variety, Brain Navi Biotechnology prospects the pack, followed by Dental Monitoring and TROPHY. By signifies of geographic access, Mind Navi Biotechnology retains the major posture, adopted by Dentsply Sirona and Neocis in the next and third spots, respectively.

Though robotics in dentistry gives quite a few benefits, the future relies upon on the acceptance of the two dentists and people to use this know-how in each day apply. Also, additional innovations are required to make treatment method additional precise, available, and precise.

To additional fully grasp how robotics is disrupting the clinical equipment market, accessibility GlobalData’s newest thematic study report on Robotics in Professional medical (2021).


Opinion: Promoting high-risk, high-reward medical research

The overall health treatment community’s reaction to COVID-19 has been heroic and transformative. Considering the fact that early 2020, physicians, nurses, personnel customers and scientists have pushed on their own to their limits while corporations have observed new techniques to deliver and streamline care — specifically with the unexpected and wide embrace of telemedicine.

Even as we stand in awe of this grace under stress, this necessary focus on the pandemic has exacted rigid price ranges. Though much attention has been paid out to the vital challenge of burnout, I also believe a creeping cultural shift has happened at educational health-related facilities like the a single I lead at Michigan Medication. Phone it the “lifestyle of no” as in, no we are not able to do this or that for the reason that we ought to muster our restricted useful resource to struggle the disaster. In response, we ought to work to foster a “society of sure,” 1 that evokes our outstanding colleagues to feel the liberty to go after big suggestions that can develop transformative improvements in individual care.

We should cultivate this culture of of course across our business, creating channels so that just about every member of our community knows that their excellent strategies will be read and can flourish. It is in this spirit that I want to spotlight a person of the most remarkable initiatives percolating not just at Michigan Drugs but at educational health-related centers throughout the state: guidance for substantial-hazard, superior-reward study.

As the title implies, these kinds of investigate often will take area on the edges of science. It often consists of a Eureka instant notion for which there is small evidence of its efficacy. These kinds of exterior-the-box pondering poses a problem to the classic funding mechanisms — primarily those used by the most important funder of research, the Nationwide Institutes of Wellness — which really adequately request to direct methods to established thoughts.

But, as a write-up past 12 months released at the web site operated by the Good Science Task noticed, “A typical complaint is that NIH’s peer evaluate method can be overly conservative, mainly because it is so concentrated on preliminary knowledge guaranteeing that a venture will operate. That outcome of peer overview is probably even worse in today’s hypercompetitive natural environment, wherever it isn’t abnormal for only the top rated 10 percent of grant purposes to get funded. In that context, peer reviewers typically search for any cause at all to continue to keep a grant from acquiring funded.”

Large-threat, higher-reward study often receives shunted apart in this funding design. To draw an analogy from Silicon Valley, it is like a startup with a terrific thought that may perhaps or may well not get the job done out. As venture capitalists know, you have to drill a lot of dry holes to find the unicorn good results story like a Facebook or Spotify. But the globe of large-tech also shows us that a tradition that states of course to innovation — one particular that encourages visionaries to consider and aspiration significant — can alter the entire world.

The NIH has regarded this have to have through its Large-Threat Large-Reward Investigation Program, which supports “extremely innovative researchers pursuing really innovative exploration with the probable for broad influence in biomedical, behavioral, or social sciences in just the NIH mission.” In 2022, the NIH gave 103 this sort of awards totaling somewhere around $285 million. That may possibly audio like a great deal, but consider that each and every yr the NIH awards more than $30 billion to 60,000 exploration and instruction grants.

To electrical power innovation, a number of educational clinical centers have developed their possess applications to guidance higher-chance, substantial-reward analysis. Michigan Medicine’s efforts, for case in point, are staying turbocharged by a $20 million grant from the Maxine and Stuart Frankel Foundation. Open to innovators at all phases of a investigate project, the Frankel Innovation Initiative gives financial support and know-how and direction from an advisory committee consisting of entire world-renowned scientists and technology improvement specialists to enable researchers build their strategies.

Recipients involve Dr. Paul S. Cederna, whose pioneering get the job done is revolutionizing the industry of prosthetics. As Cederna explains, while we have extended experienced synthetic limbs, they have been difficult to command. His Eureka moment –—it pretty much came to him in the shower — was that by connecting the current nerves (which have fairly thin pathways) to muscle mass (which have reasonably huge pathways) he could vastly increase the signal sent from the prosthetic to the mind. This provides end users with a vary of fine motor abilities that can vastly strengthen their lives and livelihoods.

One more grant supports the get the job done of a group led by Dr. Molly Stout that seeks to battle the disaster of premature births — which complicates additional than 10 p.c of the country’s just about 4 million yearly births and prices about $26 billion each year. Even with the substantial stress of disorder and significant prices, meaningful progress is hampered by the incapability to forecast, with precision, when labor will come about. Dr. Stout and her workforce are getting supported in their effort to improve the standard transvaginal ultrasound probe now in use to more accurately predict the time of supply and help save the lives of mothers and their toddlers.

This and other groundbreaking do the job would be tough to maintain without a commitment to large-risk, significant-reward study. Transformative suggestions generally start off with an personal, but those people insights are only the commencing. In our intricate planet, even geniuses need nurturing environments to prosper. At root, our programs need to be as inspiring as the folks who perform inside them.

As we glance to the foreseeable future, generating a culture of certainly will promote and really encourage all people in overall health care to discover new approaches to make improvements to affected person treatment. Thomas Edison when claimed, “There is certainly a way to do it better.” The leaders of educational medical facilities need to have to do that, and we are right here to aid you find them.

Dr. Marschall S. Runge is executive vice president for healthcare affairs and dean of the health-related college for the University of Michigan. He serves on the board of directors for Eli Lilly and Co.

The Top 25 Women Leaders in Medical Devices of 2023

The Top 25 Women Leaders in Medical Devices of 2023

The Healthcare Technology Report is pleased to announce The Top 25 Women Leaders in Medical Devices of 2023. Technology is advancing at a rapid pace across industries, and perhaps nowhere is that more true than in the medical device market. In fact, according to Fortune Business Insights, the global market is projected to grow from roughly $495 billion in 2022 to nearly $719 billion by 2029 at a CAGR of 5.5{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}. There is intense competition in the market, and the women on this year’s list and the companies they represent have found success innovating across a range of specialties, from insulin management systems to regenerative technologies, electrotherapy, and wireless surgical solutions.

Some of the distinguished leaders on this year’s list include Tania Saison, SVP and CCO/CRO of Edwards Lifesciences, who oversees the company’s Global Integrity Program, which establishes a comprehensive framework for ensuring compliance with applicable laws, regulations, and standards of conduct. Meanwhile, Jennifer Ernst, CEO of Tivic Health, built her company from founding to IPO in 5 years and put an award-winning medical device into market within 3 years. And Manisha Shah-Bugaj, COO of Activ Surgical, oversees the ongoing development and commercialization of the company’s products, including ActivSight™ Intelligent Light, which aims to provide enhanced visualization and real-time, on-demand surgical insights in the operating room.

The awardees on this year’s list lead from a range of positions, from President and CEO to SVP, EVP, and COO. What they have in common is their dedication to innovation in the medical device space, bringing revolutionary new devices to market and improving the lives of patients and clinicians alike. Please join us in celebrating The Top 25 Women Leaders in Medical Devices of 2023.

 

1. Tania Saison
Company: Edwards Lifesciences
Title: Senior Vice President and Chief Compliance Officer/Chief Responsibility Officer

Tania Saison is Senior Vice President and Chief Compliance Officer/Chief Responsibility Officer for Edwards Life Sciences, the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. As CRO, Saison oversees the company’s Global Integrity Program with unwavering support from the Board of Directors and executive leadership. The program establishes a comprehensive framework for ensuring compliance with applicable laws, regulations, and standards of conduct, and reinforces Edwards’ culture of integrity and ethics. Saison is a member of the global senior leadership team.

Prior to Edwards, Saison served as VP and Chief Compliance Officer for Agilent Technologies. She got her start at Agilent as Senior Compliance Counsel. Previously, she was Assistant General Counsel and Head of Global Compliance for Beckman Coulter, Senior Counsel for Diageo plc, and served as an attorney for Hunton & Williams and Dewey Ballantine LLP. Saison earned her JD from Columbia Law School, her MBA from Harvard Business School, and her Bachelor of Arts in history from Columbia University.

 

2. Simona Serban
Company: Fresenius Medical Care
Title: Chief Operating Officer

Simona Serban is based in Bucharest, Romania. She currently serves as the Chief Operating Officer of Fresenius Medical Care, the world’s leading provider of products and services for individuals with kidney diseases. Fresenius aims to create a future worth living for chronically and critically ill patients — worldwide and every day. Thanks to the company’s decades of experience in dialysis, its innovative research, and its value-based care approach, it is helping patients enjoy the very best quality of life.

Prior to her COO role, Serban held assignments of increasing responsibility in the healthcare industry. This includes stints serving as a customer solutions manager and sales representative for Merck Sharp & Dohme Romania SRL. Her areas of expertise include pharmaceutical sales, product launch, market analysis, marketing management, and hospital sales, among others. She holds a degree from the Universitatea Alexandru Ioan Cuza, which is located in Iasi, Romania.

 

3. Aviva McPherron
Company: NuVasive
Title: Chief Information Officer and Senior Vice President of IT

Aviva McPherron serves as NuVasive’s Chief Information Officer and Senior Vice President of IT, and is responsible for the company’s information technology organization. NuVasive is committed to transforming surgery, advancing care, and changing lives through less invasive, procedurally integrated solutions. Since its inception in 1999, it has continually outperformed the market as the largest, spine-focused company in the world. With more than $1 billion in revenues, NuVasive has approximately 2,600 employees and operates in more than 50 countries serving surgeons, hospitals and patients.

McPherron’s previous roles include VP of Enterprise Applications and Senior Director of Business Solutions. Before joining NuVasive, she was Director of Operations for Tapestry Solutions, a Boeing Company, and has held multiple technical leadership positions delivering transformative solutions. McPherron holds a Bachelor of Science in mechanical engineering from Stanford University.

 

4. Elizabeth Sebern McCombs
Company: BD
Title: Executive Vice President and Chief Technology Officer

Elizabeth Sebern McCombs serves as Executive Vice President and Chief Technology Officer of BD (Becton, Dickinson and Company), a leading global medical technology company headquartered in Franklin Lakes, New Jersey. In this role, she is responsible for leading all R&D activities for BD, advancing new product innovation and development from early-stage concepts through launch, and sustaining the current product portfolio. She is also a member of the BD Executive Leadership Team.

McCombs joined BD in 2019 as the Senior Vice President, R&D for the BD Medical Segment, where she co-led the segment portfolio strategy and growth acceleration initiatives. Prior to joining BD, she spent more than 20 years at Johnson & Johnson (J&J), most recently as Vice President, R&D for Ethicon, J&J’s surgical device franchise. Aside from her technical credentials, McCombs has been recognized for her work driving inclusion and diversity efforts, including the support and mentorship of fellow female professionals. She holds an MBA from the University of Pennsylvania’s Wharton School of Business and both a Master of Science and Bachelor of Science in mechanical engineering from the Massachusetts Institute of Technology.

 

5. Niamh Pellegrini
Company: Nevro
Title: Chief Commercial Officer

Niamh Pellegrini currently serves as Chief Commercial Officer for Nevro, a global medical device company focused on delivering innovation to improve the quality of life for patients suffering from debilitating chronic pain. Pellegrini is a proven commercial leader with over 30 years of experience in the healthcare industry. Prior to joining Nevro, she was Vice President of Global Commercial Operations for Abbott Vascular.

Before Abbott, Pellegrini served as CEO and President at Autonomic Technologies, Inc. and President, North America at Thoratec Corporation. Prior to Thoratec, she served in progressively responsible global business development, strategy, and commercial roles at Johnson & Johnson. Pellegrini currently serves on the Board of Directors of Acutus Medical. She graduated from Santa Clara University with an MBA and a Bachelor of Science in finance.

 

6. Lena Hagman
Company: XVIVO
Title: Chief Operating Officer

In December 2022, Lena Hagman was appointed Chief Operating Officer of XVIVO, the first global all organ company. Founded in 1998, XVIVO is the only medical technology company dedicated to extending the life of all major organs — so transplant teams around the world can save more lives. Hagman has extensive global operational experience within the medical device industry, and has for the last 12 years been in different executive roles within the Getinge group, a Swedish global MedTech company. Her most recent role was as Executive Vice President for Quality compliance, Regulatory and Medical Affairs, which she held for 7 years.

Throughout her career, Hagman has been active in the medical device industry, with more than 20 years in leading positions with global responsibilities in R&D, supply chain, and quality/regulatory/medical affairs. Over the years, she has led many strategic and efficiency programs and company integrations. She has deep knowledge and experience in different global medical device quality regulations and with a high customer and patient centricity focus. She holds a Bachelor of Science in chemistry and textile engineering from Chalmers University of Technology, Sweden and is based at XVIVO’s headquarters in Gothenburg.

 

7. Jennifer Ernst
Company: Tivic Health
Title: Co-Founder and Chief Executive Officer

Jennifer Ernst is the Co-Founder and Chief Executive Officer of Tivic Health, a commercial phase healthtech company focused on advancing bioelectronic medicine. Ernst has more than 20 years of experience in the commercialization of breakthrough innovation and a history of developing markets from frontier technologies. As CEO of the U.S. subsidiary of Thin Film Electronics, she helped build the company from eight to 130 people, achieved a $480 million market cap in five years, and launched international award-winning products.

Ernst has held positions at Xerox PARC, positioning research for productization through strategic partnerships and licensing, and served as chairperson of Flex, the U.S. National Consortium for Flexible and Printed Electronics, now part of SEMI. She participated in the launch of the Global Women’s Leadership Network and was named to the Inc. Female Founders 100 and to the Healthcare Technology Report Top Women Leaders in Consumer Healthtech. She received an MBA from Santa Clara University and a Bachelor of Arts from San Francisco State University.

 

8. Manisha Shah-Bugaj
Company: Activ Surgical
Title: Chief Operating Officer

In December 2022, Manisha Shah-Bugaj was promoted from Activ Surgical’s Chief Operating Officer, a position she had held for just under a year, to its newest Chief Executive Officer. In addition to engaging with company partners, customers, and investors, Shah-Bugaj oversees the ongoing development and commercialization of Activ Surgical products, including ActivSight™ Intelligent Light, which aims to provide enhanced visualization and real-time, on-demand surgical insights in the operating room.

Prior to joining Activ Surgical, Shah-Bugaj architected the gynecology unit at Olympus from the ground up in the U.S., ultimately serving as General Manager and Global Vice President for the company, and played an integral role in expanding the gynecology business internationally. She has more than two decades of experience, including building and implementing corporate business plans, directing regional and global businesses aligned to financial and operational targets, hiring and establishing new teams, and managing product portfolios. She holds a Master of Engineering Management and a Bachelor of Engineering in biomedical engineering, both from Dartmouth College.

 

9. Anna Lucsok
Company: Zynex Medical
Title: Chief Operating Officer

Anna Lucsok currently serves as Chief Operating Officer for Zynex Medical. Zynex, founded in 1996, markets and sells its own design of electrotherapy medical devices used for pain management and rehabilitation. The company’s proprietary NeuroMove device is designed to help the recovery of stroke and spinal cord injury patients. Zynex has also developed a blood volume monitor for use in hospitals and surgery centers.

Previously, Lucsok served as Vice President of Reimbursement and Sales Operations with Zynex. In this position, she was responsible for leading and expanding Zynex’s order, reimbursement, patient experience, and inside sales support operations. During her tenure, each of these teams consistently achieved quarterly targets, while also expanding in size. Lucsok brings more than nine years of healthcare operations experience as well as critical knowledge of revenue cycle management and medical care collections. She has been involved in various operations positions as well as management positions with Zynex since her start in 2018, including serving as Billing Manager. She previously held key positions with companies such as the University of Colorado Hospital, the U.S. Air Force based in Germany and Japan, and Schryver Medical. Lucsok holds certification in medical billing and earned her Bachelor of Science in healthcare administration and management from Colorado State University.

 

10. Sreelakshmi Kolli
Company: Align Technology
Title: Executive Vice President, Chief Digital Officer

Sreelakshmi Kolli is Executive Vice President Chief Digital Officer for Align Technology. She is responsible for leading software, data, enterprise, cloud, and infrastructure engineering teams focused on the design and development of digital products and services. This includes defining the technology strategy and development of product software, consumer, customer, manufacturing, and enterprise applications enabling the Align Digital Platform. In addition, Kolli led Align’s global business transformation initiative aimed at delivering platforms and technology to support customer experience and simplified business processes across the company.

Kolli joined Align in June 2003 as Manager, Software Engineering and held positions of increasing responsibility leading business operations and engineering for customer-facing applications. She was promoted to Senior Vice President, Global IT in December 2012 before being promoted to her current position in April 2020. Prior to joining Align, Kolli held technical lead positions with Citadon and Accenture. She is also a member of the Board of Directors at Zimmer Biomet Holdings, Inc. Kolli earned a Master of Science in computer applications at the National Institute of Technology in Trichy, India and is a graduate of the Stanford Executive Program offered by the Stanford Graduate School of Business.

 

12. Deborah Gordon
Company: Insulet
Title: Vice President, Investor Relations

Deborah Gordon has served as Vice President, Investor Relations for Insulet Corporation since January 2015. Insulet is a roughly $1 billion medical device company dedicated to making the lives of people with diabetes easier through its OmniPod Insulin Management System. Gordon also serves on the Board of Directors of the L.S. Starrett Company, serving on the Audit Committee since July 2020 and the Compensation Committee since July 2021.

Prior to joining Insulet, Gordon served in a number of roles of increasing responsibility during her 10 years at Hologic, Inc. and Cytyc Corporation (which merged with Hologic in October 2007). Notably, she served for seven years as Hologic’s Vice President, Investor Relations and Corporate Communications and prior as Assistant Corporate Controller and Director of SEC Reporting and Technical Accounting at Cytyc. Before joining Cytyc, Gordon served in the audit practice at Deloitte & Touche for 11 years. She earned her Bachelor of Arts in business administration, with concentrations in accounting and economics, from Clark University and is a certified public accountant.

 

13. Suzanne Winter
Company: Accuray
Title: President and Chief Executive Officer

Since July 2021, Suzanne Winter has served as President of California-based medical equipment manufacturer Accuray, and in July 2022 she was promoted to Chief Executive Officer as well. In her position at the head of the company, Winter has continually driven the expansion of Accuray’s radiotherapy cancer treatment technologies, yielding record order volume and the approval of numerous novel treatments in China and beyond. She has had a significant impact on Accuray’s product portfolio and commercial momentum since joining the company.

Prior to joining Accuray, Winter held senior executive roles spanning general management, commercial operations, and business development across a range of healthcare industry segments, including radiology, neurology, and surgery. Most recently, she served as Group Vice President – Americas region at Medtronic Diabetes, where she was responsible for leading the 2,000 person commercial organization. Before Medtronic, Winter was the General Manager of GE Healthcare’s Detection and Guidance Solutions operations. She earned an MBA from Harvard Business School and a Bachelor of Science in chemistry from Saint Lawrence University.

 

14. Sandra Hirsch
Company: Zyris, Inc.
Title: President and Chief Executive Officer

Sandra Hirsch is the third founding member of Zyris, Inc., pairing decades of experience as a financial manager and CPA with a zeal for entrepreneurship sparked by her Bachelor of Science in business administration from the University of Southern California. Under her leadership as President and Chief Executive Officer, Zyris has grown from a struggling start-up to the world leader in dental isolation, distributing Isolite products throughout North America and in more than 20 countries overseas. Hirsch is defined by her family, the Zyris team, and unwavering resolve to forever change the experience of dentistry for patients and clinicians.

In 2001, Hirsch founded Innerlite Inc. with her husband Jim Hirsch, an industrial designer, and her brother-in-law Tom Hirsch, a practicing dentist. Together, they rebranded the company as Isolite Systems and launched their flagship product, the Isolite illuminated dental isolation system, in 2002. Isolite enables dental practices of all sizes to implement a technique for controlling the oral environment, providing an innovative solution for dental isolation. Offering a full line of isolation products that are minimally invasive and easy-to-use, Isolite Systems allows dental professionals to work more productively and effectively with less stress and fatigue for both themselves and their patients.

Today, Hirsch serves as President and CEO of Isolite Systems. Under her leadership, the company has grown from a single game-changing idea to an international phenomenon, with over fifty employees at their Santa Barbara-based manufacturing and distribution center and representatives worldwide. Thousands of dentists in over twenty countries are loyal fans of the safety, comfort, and control that Isolite dental isolation provides. In the U.S., over 20{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of all dental schools have adopted their products, which will soon become the standard of care for everyday dental procedures. Hirsch and the Isolite team continue to develop products that make a difference in people’s lives. They are relentlessly focused on the pursuit of a better dental experience for every patient and have earned numerous awards and accolades for their efforts.

 

15. Tavia Walsh
Company: Pulse Technologies
Title: Co-Founder Chief Technology Officer

Tavia Walsh is a Co-Founder and the Chief Technology Officer of Pulse Technologies, an entrepreneurial startup based in Vancouver designing innovative, low-cost consumer wearable devices using emerging new conductive materials and 3D printing methods. As a biomedical engineer with both an electrical and mechanical background, Walsh has an interest in complex problem solving and design thinking; and as a founder of Pulse, she has experience in the biomedical start-up space.

Walsh co-founded Pulse Technologies in 2016. While working on Pulse, she served as a biomedical engineer for 4M BioTech from 2020-2021 and as a mechanical engineer for ViVitro Labs Inc. from 2021-2022. Walsh earned her MD from University College Dublin, her Master of Applied Science in mechanical engineering from the University of Victoria, and her Bachelor of Applied Science from The University of British Columbia.

 

16. Jennifer Honeycutt
Company: Danaher
Title: Executive Vice President

As Executive Vice President, Jennifer Honeycutt provides strategic and operational leadership for Danaher’s Environmental and Applied Solutions businesses, which includes the Product Identification and Water Quality platforms. She also oversees Danaher’s High Growth Markets and regional teams outside of China. Honeycutt originally joined Danaher with the 2000 acquisition of Hach and has held positions of increasing responsibility across multiple industries over the past 20+ years.

Leadership roles at Hach Ultra Analytics, Anderson Instrument Company (now part of Fortive), Linx Printing Technologies, Beckman Coulter Life Sciences, and Pall have given her deep knowledge of the Danaher Business System (DBS) and a unique perspective on the many ways Danaher can help realize life’s potential across its businesses. Honeycutt is a champion of the power of diversity, and a longstanding member of Danaher’s Diversity + Inclusion Council. Throughout her tenure, she has consistently delivered strong results by building high-performing teams and driving strategic M&A, innovation, and commercial execution. Honeycutt earned a Master of Arts in Technology Management from the University of Denver and Bachelor of Arts degrees in chemistry and French from Grinnell College.

 

17. Pooja Pathak
Company: LumiraDx
Title: Chief Product Officer

Since June 2021, Pooja Pathak has served as Chief Product Officer for LumiraDx, a next-generation point of care diagnostics company based in the U.K. Founded in 2014, the company provides a comprehensive portfolio of testing solutions used by governments and leading healthcare institutions. Pathak, who previously served as LumiraDx’s Vice President of Platform Strategy, is currently responsible for product management, marketing, and medical affairs.

Prior to LumiraDx, Pathak most recently worked at Abbott as VP of Global Marketing for the Infectious Disease Emerging Markets business, which included 170 countries across Asia, EMEA, and Latin America. In this role she was responsible for a $500 million portfolio. Additionally, she has held leadership roles with Alere and Novartis Vaccines, where she focused on bringing new innovations to market, implementing integrated diagnostic and treatment programs, and rolling out global public health solutions. Pathak holds a Master of Science in chemical engineering from MIT and a Bachelor of Science in chemical engineering from the University of Illinois Chicago.

 

18. Kelli Howell
Company: Alphatec Spine
Title: Executive Vice President, Clinical Strategies

Kelli Howell has served as Executive Vice President, Clinical Strategies of Alphatec Spine since March 2018. Alphatec improves lives by providing innovative spine surgery solutions through its relentless pursuit of superior outcomes. The company is dedicated to the design, development, launch, and the delivery of spinal fusion products. Alphatec accomplishes this by working with spine surgeons to design and develop products and systems that address the entire spinal fusion procedure in the most effective and efficient way possible. Its product designs and platforms provide innovation through a focus on simplifying procedures for the surgeon with the ultimate objective of superior outcomes.

For the 18 years prior to joining Alphatec, Howell held various management positions at NuVasive, Inc., including Vice President, Research & Health Informatics from January 2017 to March 2018, Vice President, Research & Education from February 2015 to January 2017, and Vice President, Research from April 2012 to February 2015. Prior to joining NuVasive, Howell was involved in research at Orthopedic Biomechanics Laboratory (OBL), Beth Israel Deaconess Medical Center in Boston. Howell received a Master of Science in biomedical engineering from Boston University and a Bachelor of Arts in engineering sciences from Dartmouth College.

 

19. Alison Burdett
Company: The Surgical Company
Title: Chief Scientific Officer

Alison Burdett has over 30 years of experience in electronic engineering and semiconductor design, particularly in the field of ultra-low-power wireless communication for medical applications. She co-founded Toumaz in 2001 and served as the Technical Director. She became the Chief Technical Officer in 2006, responsible for delivering silicon and advanced technology programs for both consumer and healthcare divisions of the business. In 2016, the healthcare business unit of Toumaz, Sensium Healthcare, became part of The Surgical Company Group and she joined Sensium, where she became the Chief Scientific Officer, responsible for all engineering and scientific programs for the company’s digital health products.

Prior to joining Toumaz, Burdett spent time both in industry as an integrated circuit designer, and also in academia (as a Senior Lecturer of Analog IC Design with Imperial College London). She is a Visiting Researcher with the Institute of Biomedical Engineering, Imperial College. She has more than 80 peer-reviewed publications and is a named inventor on more than 20 patents. Burdett was a member of the Technical Programme Committee for the IEEE International Solid-State Circuits Conference (ISSCC) from 2009 to 2018, serving as the European Regional Chair 2012–2014 and the Technical Program Chair for ISSCC 2018. She has been an Associate Editor of IEEE Transactions on Biomedical Circuits and Systems since 2008, and is the Associate Editor-in-Chief of the IEEE Open Access Journal of Circuits and Systems. She is a Chartered Engineer and a Fellow of the Institute of Engineering and Technology. Burdett earned her PhD in analogue IC design and her bachelor’s degree in electrical and electronics engineering from Imperial College London.

 

20. Rhonda Robb
Company: Cardiovascular Systems, Inc.
Title: Chief Operating Officer

From January 2018 to June 2022, Rhonda Robb served as Chief Operating Officer of Minnesota-based medical device manufacturer Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional treatment systems for peripheral and coronary artery disease. In her time at the company, Robb was renowned for her agile, forward-thinking leadership style, and her efforts helped bring the company to numerous new patients and a greatly expanded product line.

In the time since her departure from Cardiovascular Systems, Robb has continued to serve on the board of 4C Medical Technologies. Robb formerly served as Vice President and General Manager of the Heart Valve Therapies business at Medtronic. In that role, she was responsible for the transcatheter and surgical valve franchises. Previously, Robb held additional leadership positions in Medtronic’s Coronary, Peripheral, and Cardiac Rhythm businesses. She has strong experience leading complex businesses, growing new markets, extensive commercial experience, and a strong track record of building teams and product portfolios that have improved the quality of care for patients with cardiovascular disease. Robb holds an MBA from the University of Minnesota’s Carlson School of Management.

 

21. Jessica Lynch
Company: DentalMonitoring
Title: Chief Operations Officer – North America

Since April 2022, Jessica Lynch has been Chief Operations Officer – North America at DentalMonitoring, the leading Intelligent Platform globally which provides connected, smarter and more sustainable dental care. DentalMonitoring creates with doctors and partners an environment to deliver the best dental care to patients, synchronized with their treatment needs. Showcasing a unique, people-first leadership style, Lynch has helped the company improve financial results while enjoying sustainable organizational growth. Recent achievements by DentalMonitoring have included new advances in AI-driven dental technologies and a unique new gamified feature in its signature platform.

Prior to DentalMonitoring, Lynch served as Vice President of Operations Excellence and Vice President of Strategy for Smile Doctors. Before that, she was Chief Operating Officer for DN Orthodontics for four years. She also served as Senior VP, Doctor Relations (2010-2014) and Director of Operation Consultants (2009-2010) for OrthoSynetics, and was a physician liaison for Louisiana Medical Center and Heart Hospital, LLC. Lynch holds a Bachelor of Science in business administration from the University of Louisiana at Lafayette.

 

22. Rebecca Lin
Company: Potrero Medical
Title: Chief Strategic Officer

With her unique blend of business acumen and technical expertise, Rebecca Lin is a dynamic leader with many years of success in the healthcare industry. Today she serves as the Chief Strategic Officer for Potrero Medical, a Hayward, California-based predictive health company developing the next generation of medical devices with smart sensors and artificial intelligence. Lin, who has been with the company since October 2016, previously served as the Senior Vice President of Sales and Marketing. In that role, she built and led the commercial organization that developed go-to-market strategies for Potrero’s Accuryn Monitoring System.

Over the years, Lin has achieved success at both large corporations and startups. Prior to her work at Potrero, she was the VP of Business Development at Theranova and led marketing initiatives for C. R. Bard (now owned by Becton Dickinson), in both Shanghai and the U.S. She has also worked as a Board Fellow at the American Red Cross Bay Area, currently serves as a guest lecturer at the University of California, San Francisco and Berkeley, and spent several years in sales and training at Johnson & Johnson. Lin holds a Master of Science in management from the Stanford University Graduate School of Business and a master’s in marine biology from Sun Yat-sen University in Guangdong, China.

 

23. Kristie West
Company: Orchid Orthopedic Solutions
Title: Chief Operating Officer

Kristie West is the Chief Operating Officer at Orchid Orthopedic Solutions, a global leader in medical device outsourcing services. Founded in 2005, the company’s 1,500 employees work to provide a broad array of capabilities in the world of orthopedic devices, including design, regulatory affairs, implant manufacturing, and instrument manufacturing, among other areas. West, who is a Six Sigma Black Belt and a Master Black Belt, joined Orchid in January 2022.

West came to Orchid from General Electric’s Edison Works Programs and Operations team, where she was the Senior Executive Director supporting the future of military combat and space. Prior to joining the Edison Works team, West was the Senior Executive for the Tubes & Ducts Value Stream in GE Aviation’s Supply Chain organization. She also held a number of leadership roles within GE, including Director of Operations for Unison Industries (a GE company); Executive Plant Leader for Avio Aero (a GE company), in Torino, Italy; Supply Chain Strategy Leader for GE Aviation; and CF6 Customer Programs Leader. Prior to GE, West held various leadership roles in manufacturing with Navistar and Carrier Global Corporation. She holds a Bachelor of Science in organizational leadership from Purdue University’s Polytechnic Institute.

 

24. Liz Hammack
Company: Pristine Surgical
Title: Chief Manufacturing Officer

Liz Hammack is Chief Manufacturing Officer of Pristine Surgical, a medical device company with a mission to simplify endoscopy. While Hammack joined the company in September 2021, her career began more than 30 years ago. During this time, she has worn many hats: from working on the factory floor, to holding multi-plant leadership, to operating in the boardroom. In addition to her work at Pristine, she is also the principal owner of Hammack Manufacturing Solutions, which is based in Portland, Oregon.

Prior to Pristine, Hammack spent 16 years at Medtronic, most recently serving as a Vice President of Manufacturing and Operations, AFS. In that position, she led operations, manufacturing, and supply chain integration activities for the newly formed AF Solutions business at Medtronic-CRDM. In 1981, she graduated from Oregon State University with a Bachelor of Science in industrial engineering. A proud alum, she has since served on numerous boards for the university’s College of Engineering. Furthermore, in 2013, she received Oregon State’s distinguished engineer award.

 

25. Dina Dubey
Company: Teleflex
Title: Chief Operating Officer

Dina Dubey is the Chief Operating Officer of Teleflex. Dubey’s roots with the company go back to 2011, when she started off as Director of Research and Development for Z-Medica, which was acquired by Teleflex in 2020. In this position, Dubey drove a pipeline of projects and developed and drove QuikClot Control+, the organization’s first-of-its-kind, new-generation hemostatic dressing, which ultimately resulted in commercialization of the product. On top of that, Dubey was a vital member of the executive leadership team that grew Z-Medica’s revenue from $28 million to $64.8 million.

Dubey started her career at Kensey Nash Corporation (now DSM Biomedical), where she spent eight years in engineering and management roles. In 2003, she received a Bachelor of Science in biomedical engineering from Case Western Reserve University. She also holds a Master of Science in engineering management and a Master of Science in biomedical engineering from Drexel University. More recently, Dubey completed a leadership development program from Harvard Business School Executive Education.