Category: Medical Tools

Global Refurbished Medical Devices Market Report to 2027: Featuring Auxo Medical, Canon Medical Systems, GE Healthcare and Siemens Healthineers Among Others – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Refurbished Medical Devices: Technologies and Global Markets” report has been added to ResearchAndMarkets.com’s offering.

This report incorporates an in-depth analysis of the refurbished medical device market, including market estimates and trends through 2020. Major players, competitive intelligence, market dynamics and regional opportunities are discussed in detail.

The report examines recent developments and product portfolios of major players. The report presents a market analysis and estimates the compound annual growth rate (CAGR) for refurbished medical devices.

The scope of the report extends to only those medical device technologies that can be refurbished and generate the most revenues. Devices that cannot be refurbished and are recycled, and other small surgical instruments that are refurbished, are outside the scope of this report.

This report segments the global market by these geographic regions: North America, Europe, Asia and the Rest of the World. For market estimates, data is provided for 2020 as the base year, 2021, and forecast through year-end 2027.

Companies Mentioned

  • Auxo Medical LLC
  • Avante Health Solutions
  • Block Imaging International Inc.
  • Canon Medical Systems Corp.
  • Everx Pvt. Ltd
  • GE Healthcare
  • Hilditch Group Ltd.
  • Integrity Medical Systems Inc.
  • Koninklijke Philips Nv
  • Lbn Medical
  • Master Medical Equipment
  • Radiology Oncology Systems Inc.
  • Siemens Healthineers
  • Soma Technology International

Report Includes

  • 56 data tables and 25 additional tables
  • A comprehensive overview and up-to-date analysis of the current and future global markets for refurbished medical devices/instruments
  • Analyses of the global market trends, with market revenue data for 2021, estimates for 2022 and 2023, and projections of compound annual growth rates (CAGRs) through 2027
  • Market outlook and estimation of the actual market size for refurbished medical devices, revenue forecast, and corresponding market share analysis based on device type, application, and region
  • Highlights of the current state and future market potential of refurbished instruments, along with a detailed analysis of the competitive environment
  • Identification of the key growth driving factors and constraints that will shape the market for refurbished medical devices as the basis for projecting demand over the next five years (2022-2027)
  • Coverage of regulations and guidelines on refurbished devices followed in the U.S and Europe
  • Holistic review of the impact of COVID-19 on refurbished instruments, with pandemic implications on the demand and supply, pricing analysis, and various government strategic decisions to boost the marketplace
  • Analysis of the vendor landscape for refurbished medical devices market, and company value share analysis based on their segmental revenues

Major factors driving the market include cost benefits provided by the refurbished devices, the growing elderly population in many countries, declining healthcare margins and expenditures, and environmental advantages. Challenges in the market include the lack of uniform regulations, and restrictions in the Indian and Chinese markets.

The COVID-19 pandemic’s impact on the global economy cannot be ignored. Lockdowns and the cessation of many non-essential medical treatments had a negative impact on the revenues of makes of refurbished medical devices. The industry is slowly rebounding from the impact, and the market for refurbished medical devices is expected to grow at a steady pace during the forecast period.

The circular economy is a major consideration by many of the top original equipment manufacturers (OEMs) such as Philips Healthcare and GE Healthcare, for their increased focus on refurbished devices. Environmentally conscious end users also prefer refurbished systems.

Key Topics Covered:

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Market Overview

3.1 Introduction

3.2 Definition

3.3 Drivers, Restraints and Opportunities

3.3.1 Drivers

3.3.2 Restraints

3.3.3 Opportunities

3.3.4 Threats

3.3.5 Challenges

3.4 Regulations for Refurbished Medical Devices

3.4.1 Overview

3.4.2 Europe

3.4.3 U.S.

3.4.4 Japan

Chapter 4 Impact of Covid-19 Pandemic

4.1 Introduction

4.1.1 Supply Chain Disruption

4.1.2 Impact of Covid-19 in the U.S.

Chapter 5 Global Market for Medical Devices

5.1 Overview

5.2 Medical Imaging Equipment

5.3 Operating Room Equipment

5.4 Patient Monitors

5.5 Cardiology Equipment

5.6 Urology Instruments

5.7 Neurology Devices

5.8 Icu Equipment

5.9 Endoscopes

5.10 Dental Devices

5.11 Other Instruments

5.12 Global Market for Refurbished Medical Devices by End-user

Chapter 6 Global Market for Medical Devices by Region

Chapter 7 Competitive Landscape

Chapter 8 Company Profiles

Chapter 9 Appendix: Acronyms

For more information about this report visit https://www.researchandmarkets.com/r/2l2p0h

Children’s medical equipment damaged on Frontier flight

CASTLE ROCK, Colo. (KDVR) — A Castle Rock couple with two disabled children told FOX31 they were heartbroken to discover expensive medical equipment was damaged after their flight on Frontier Airlines.

The Leao family faces challenges, but they take them on with patience and love. When asked about 2-year-old son Bellamy and 4-year-old daughter Annabel, Morgan Leao said, “they are nonverbal but their lives and their smiles tell everything.”

Annabel copes with a seizure disorder that can be triggered by a lack of rest, so she needs to sleep in a specially-designed bed.

“It just provides her with an enclosed space to stay in her bed at night and really be able to relax,” Morgan Leao said.

Charges, missing and damaged parts

On Nov. 30, the family flew from Atlanta to Denver on Frontier Airlines. Morgan Leao said she was shocked to be charged for the medical equipment.

“I had to open the bag for her, and I was like, even with proof, you have the audacity to charge me?” Morgan said.

When the family got home, they discovered seven parts from Annabel’s bed were missing.

“We went to put her bed up and it was just like a nightmare,” Annabel’s father, Waltier Leao, said.

A special stroller was damaged as well. The cost to replace the items is nearly $8,000, but Morgan Leao said she had trouble getting the airline to respond to her request for compensation.

“I’m obviously not enough to fight for myself. I need help,” she said.

Frontier Airlines responds

The Problem Solvers contacted Frontier and asked what could be done. The company provided FOX31 with the following statement:

“Since the customer reached out to us, we have been actively working with our third-party vendor that specializes in assistive device repairs and replacements. Upon evaluation, replacement for both a pediatric stroller and safety bed was approved. In the meantime, we have refunded the checked bag and overweight fees associated with the equipment. We extend our sincere apologies to the family for the inconvenience they have experienced.”

Frontier Airlines

Annabel’s new bed will arrive in seven weeks.

“I am relieved, I’m grateful for being able to receive those items and grateful to have such support on my side and people to fight for me,” Morgan Leao said.

Consumer protection experts advise all parents to carry proof of the need for medical equipment and check policies before boarding any airline’s flight. Ask about how customer service can be contacted before you go on your trip.

Exclusive: EU to propose delay to medical device law amid supply worries

LONDON, Dec 8 (Reuters) – The EU Well being Commissioner will on Friday suggest extending the deadline for organizations to comply with a new legislation regulating healthcare gadgets, she instructed Reuters on Thursday as medical professionals alert the laws is creating shortages of lifesaving products.

Stella Kyriakides informed Reuters that worries in employing the regulation had been threatening provides of vital gadgets, this kind of as catheters applied for surgeries on newborns with coronary heart conditions.

“Our individuals hope that medical gadgets are harmless and of maximum quality. We have created important progress to set in area new needs for individual security, but troubles however stay,” mentioned Kyriakides in published emailed comments to Reuters.

“This is why, to mitigate any brief-term pitfalls, we will tomorrow announce an extension of the changeover time period to mitigate any danger of shortages.”

Kyriakides will make the proposal at a meeting of EU health and fitness ministers on Friday. She reported in parliament previous month she was contemplating amendments.

A Commission supply said the extension will need an modification to the legislation. Any authorized adjustments would need to have to be authorised by the Council and Parliament.

Kyriakides did not comment on how extensive the extension would be for.

The Healthcare Products Regulation (MDR) came into effect final 12 months and was launched immediately after the 2010 scandal of exploding breast implants created by a French organization that exploited loopholes to provide defective products at profit.

It has extra stringent needs and greater safety benchmarks than the directive it replaced.

Below the new law, all health-related devices, from implants and prosthetics to blood glucose meters and pacemakers sold in the EU need to be re-licensed by May possibly 2024.

A dozen health professionals and producers interviewed by Reuters say supplies of some merchandise are running lower even just before the 2024 deadline.

That is simply because certificates which very last for 5 many years beneath the aged program are expiring and companies are having difficulties to get new types beneath the new legislation. They say the new certification system is sluggish, cumbersome and expensive.

“From the standpoint of medical practitioners, the circumstance is starting to be extra and much more stressing. We are by now observing shortages of some vital healthcare devices, and in a lot of circumstances option products are lacking,” Christiaan Keijzer, president of the Standing Committee of European Doctors (CPME), told Reuters.

He reported that healthcare associations throughout Europe have noted complications with the provide of surgical instruments, in particular in paediatrics, orthopaedics and cardiology, as very well as other gadgets these kinds of as binocular endoscopes, silicone adhesives and blood assortment items.

Facts unveiled by the Fee in a assertion this 7 days ahead of Friday’s conference highlights the issue.

Makers have submitted apps for around 8,000 devices, but a lot less than 2,000 have been permitted.

At that speed, only 7,000 certificates less than the new program will be issued by the May well 2024 deadline, the Commission explained.

The Fee reported there are about 23,000 certificates less than the outdated system which will expire by Could 2024 without having an extension. About 4,300 of those will expire subsequent yr, it explained.

Certificates address a number of units, generating it challenging to estimate the full number of merchandise potentially affected.

Reporting by Maggie Fick editing by Josephine Mason and Elaine Hardcastle

Our Criteria: The Thomson Reuters Trust Ideas.

How CESI Is Helping Develop the Next Generation of Medical Devices | Hartford HealthCare

<< Back How CESI Is Helping Develop the Next Generation of Medical Devices | Hartford HealthCare

December 05, 2022

When Zoll, a global maker of medical devices used to treat patients with serious heart conditions, had an idea for how to build a better defibrillator, they turned to the experts at Hartford HealthCare’s Center for Education, Simulation and Innovation (CESI).&#13
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“They brought in a half-gallon milk carton with markings on the sides to show us what the new defibrillator could look like,’’ said Stephen Donahue, co-founder and director of operations for CESI, describing Zoll’s low-tech prototype.&#13
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The idea was to build a hospital defibrillator that was much simpler to use and provided guidance to inexperienced users, while enabling doctors and nurses familiar with the device to grab it and go if a patient’s heart stops.&#13
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The new defibrillator, now on the market, is just one example of how CESI is fueling life-saving innovation by providing an incubator for the development and testing of medical devices and therapies.&#13
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> Learn much more about Hartford Healthcare’s Middle for Education, Simulation and Innovation (CESI)&#13
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“People appear to us at all stages,’’ stated Steven Shichman, MD, a surgeon and CESI’s govt director. Sometimes they want to kick the tires on an plan, operate it by practitioners. Occasionally, we test a prototype so they can discover out how it performs in the real globe.”&#13
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For example, a company was developing packaging for instruments made use of in working room and intensive care units. To make sure the packaging was straightforward to open up, CESI invited suppliers and nurses to test it in a simulated OR. Organization engineers watched from a remote site so they could identify challenges they may perhaps not have anticipated. HHC end users also provided opinions for how to make the item improved.&#13
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Not too long ago, just one of the world’s most significant health care system organizations accomplished the the vast majority of the Foodstuff and Drug Administration testing of a new robotic surgical platform working with CESI’s state-of-the-artwork labs.&#13
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CESI has been instrumental to HHC’s innovation efforts. This 7 days HHC is celebrating “Innovation Week,” which celebrates how the process is establishing innovative applications, functioning with pioneering partners and advancing new methods to make health care additional accessible, economical, equitable and outstanding for the individuals and communities it serves.&#13
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> Linked: Connecticut Innovations and Hartford Healthcare Announce Partnership&#13
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In its 53,000-square-foot building across the street from Hartford Hospital, CESI homes large-fidelity simulation rooms that appear and feel exactly like genuine operating rooms, ICUs and labor and shipping and delivery rooms. Mannequins can simulate every thing from childbirth to a coronary heart assault. All health care suppliers and product sales reps from health care device corporations can also practice on cadavers and inanimate tissue styles.&#13
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Contracts with some of the world’s major professional medical system companies and the U.S. armed service provide in more than enough profits to assistance CESI’s most important mission to assistance coach all providers in HHC to offer safer and larger excellent treatment to our individuals.&#13
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“We’re not a believe tank,” Shichman stated. “We’re built and staffed to be a resource for the [medical device] market so they can acquire new merchandise.”&#13
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Here’s a enjoyment actuality: CESI’s simulation rooms are so sensible that they have been used as film sets. If you are viewing holiday getaway flicks, examine out “Next Cease, Christmas” on the Hallmark Channel. The clinic scenes ended up filmed at CESI.&#13
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> Want much more health and fitness news? Textual content MoreLife to 31996 to indicator up for textual content alerts

Palo Alto Networks Announces Medical IoT Security to Protect Connected Devices Critical to Patient Care

SANTA CLARA, Calif., Dec. 5, 2022 /PRNewswire/ — As healthcare providers use digital devices such as diagnostic and monitoring systems, ambulance equipment, and surgical robots to improve patient care, the security of those devices is as important as their primary function. Today, Palo Alto Networks (NASDAQ: PANW) announced Medical IoT Security — the most comprehensive Zero Trust security solution for medical devices — enabling healthcare organizations to deploy and manage new connected technologies quickly and securely. Zero Trust is a strategic approach to cybersecurity that secures an organization by eliminating implicit trust by continuously verifying every user and device.

“The proliferation of connected medical devices in the healthcare industry brings a wealth of benefits, but these devices are often not well secured. For example, according to Unit 42, an alarming 75{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of smart infusion pumps examined on the networks of hospitals and healthcare organizations had known security gaps,” said Anand Oswal, senior vice president of products, network security at Palo Alto Networks. “This makes security devices an attractive target for cyberattackers, potentially exposing patient data and ultimately putting patients at risk.”

While a Zero Trust approach is critical to help protect medical devices against today’s innovative cyberthreats, it can be hard to implement in practice. Through automated device discovery, contextual segmentation, least privilege policy recommendations and one-click enforcement of policies, Palo Alto Networks Medical IoT Security delivers a Zero Trust approach in a seamless, simplified manner. Medical IoT Security also provides best-in-class threat protection through seamless integration with Palo Alto Networks cloud-delivered security services, such as Advanced Threat Prevention and Advanced URL Filtering.

The new Palo Alto Networks Medical IoT Security uses machine learning (ML) to enable healthcare organizations to:

  • Create device rules with automated security responses: Easily create rules that monitor devices for behavioral anomalies and automatically trigger appropriate responses. For example, if a medical device that typically only sends small amounts of data unexpectedly begins to use a lot of bandwidth, the device can be cut off from the internet and security teams can be alerted.
  • Automate Zero Trust policy recommendations and enforcement: Enforce recommended least-privileged access policies for medical devices with one click using Palo Alto Networks Next-Generation Firewalls or supported network enforcement technologies. This eliminates error-prone and time-consuming manual policy creation and scales easily across a set of devices with the same profile.
  • Understand device vulnerabilities and risk posture: Access each medical device’s Software Bill of Materials (SBOM) and map them to Common Vulnerability Exposures (CVEs). This mapping helps identify the software libraries used on medical devices and any associated vulnerabilities. Get immediate insights into the risk posture of each device, including end-of-life status, recall notification, default password alert and unauthorized external website communication.
  • Improve compliance: Easily understand medical device vulnerabilities, patch status and security settings, and then get recommendations to bring devices into compliance with rules and guidelines, such as the Health Insurance Portability Accountability Act (HIPAA), General Data Protection Regulation (GDPR), and similar laws and regulations.
  • Verify network segmentation: Visualize the entire map of connected devices and ensure each device is placed in its designated network segment. Proper network segmentation can ensure a device only communicates with authorized systems.
  • Simplify operations: Two distinct dashboards allow IT and biomedical engineering teams to each see the information critical to their roles. Integration with existing healthcare information management systems, like AIMS and Epic Systems, helps automate workflows.

Healthcare organizations are using Palo Alto Networks products to secure the devices that deliver cutting-edge care to millions of patients all over the world.

“Establishing and maintaining acute situational awareness of the Internet of Medical Things (IoMT) environment is paramount to establishing an effective enterprise cybersecurity program. The ability to accurately detect, identify and respond to cyber threats is critical to ensuring minimal operational impact to clinical operations during a cyber event,” said Tony Lakin, CISO, Moffitt Cancer Center. “Palo Alto Networks IoT capability seamlessly integrates with our continuous monitoring processes and threat-hunting operations. The platform consistently provides my teams with actionable information to allow them to proactively manage the threat surface of our medical device portfolio.”

“With thousands of devices to manage, healthcare environments are extremely complex and require intelligent security solutions capable of doing more. Palo Alto Networks understands this requirement and is leveraging machine learning (ML) for Medical IoT security. Adding intelligence will enable providers to improve operational efficiency, which will enhance patient and practitioner experience and alleviate the burden of an ongoing IT skills shortage,” said Bob Laliberte, principal analyst, ESG.

“Healthcare providers continue to be high-value targets for attackers. This reality, combined with the diversity of medical IoT devices and their inherent vulnerabilities, points to a real need for device security that is purpose-built for healthcare use cases. The ability to defend against threats targeting critical care devices while maintaining operational availability and strengthening the alignment of device governance responsibilities between IT and Biomed engineering teams is quickly becoming a necessity for the protection of patient data and lives,” said Ed Lee, research director, IoT and Intelligent Edge Security, IDC.

More Information

  • Learn more about Medical IoT Security here.
  • Read the Medical IoT Security announcement blog here.
  • Register to attend the Palo Alto Networks Ignite Conference on December 12th – 15th, 2022, here.
  • Follow Palo Alto Networks on Twitter, LinkedIn, Facebook and Instagram.

Availability

Medical IoT Security will be available in January 2023.

About Palo Alto Networks

Palo Alto Networks is the world’s cybersecurity leader. We innovate to outpace cyberthreats, so organizations can embrace technology with confidence. We provide next-gen cybersecurity to thousands of customers globally, across all sectors. Our best-in-class cybersecurity platforms and services are backed by industry-leading threat intelligence and strengthened by state-of-the-art automation. Whether deploying our products to enable the Zero Trust Enterprise, responding to a security incident, or partnering to deliver better security outcomes through a world-class partner ecosystem, we’re committed to helping ensure each day is safer than the one before. It’s what makes us the cybersecurity partner of choice.

At Palo Alto Networks, we’re committed to bringing together the very best people in service of our mission, so we’re also proud to be the cybersecurity workplace of choice, recognized among Newsweek’s Most Loved Workplaces (2021), Comparably Best Companies for Diversity (2021), and HRC Best Places for LGBTQ Equality (2022). For more information, visit www.paloaltonetworks.com.

Palo Alto Networks and the Palo Alto Networks logo are registered trademarks of Palo Alto Networks, Inc. in the United States and in jurisdictions throughout the world. All other trademarks, trade names, or service marks used or mentioned herein belong to their respective owners. Any unreleased services or features (and any services or features not generally available to customers) referenced in this or other press releases or public statements are not currently available (or are not yet generally available to customers) and may not be delivered when expected or at all. Customers who purchase Palo Alto Networks applications should make their purchase decisions based on services and features currently generally available.

SOURCE Palo Alto Networks, Inc.

Switzerland eyes allowing FDA-approved medical devices onto its market

Switzerland eyes allowing FDA-approved medical devices onto its market

Swiss Liberal Councilor Damian Müller (Source: Swiss Federal Assembly)wiss

The Swiss parliament has asked the country’s Federal Council to adapt its laws to allow medical devices that have been vetted by non-European regulators, such as the US Food and Drug Administration (FDA) to be marketed in Switzerland. Currently, only EU-certified products are allowed on the country’s internal market based on a mutual recognition agreement between Switzerland and the EU.
 
On 28 November, the lower house of the Swiss Federal Assembly, also known as the National Council, approved a motion that mandates the Swiss Federal Council to develop regulations to allow medical devices approved by non-EU regulators into the country. The motion had already been approved by the upper house, also known as the Council of States, on 30 May.
 
The Federal Council now must adapt its national law and present an implementation proposal to allow non-EU regulated medical devices for use in Switzerland, which could open the door to allowing FDA-approved devices onto the market.
 
The motion was first introduced into the Swiss parliament by Liberal Councilor Damian Müller in May 2020. He argued that the EU Medical Device Regulation (MDR), Switzerland’s own legal requirements for medical devices and the country’s limited resources have created serious hurdles for medtech manufacturers that could deprive patients of treatments.
 
Peter Biedermann, managing director of the lobby group Swiss Medtech, called the decision “forward-thinking” in a press release.
 
“It is a response to circumstances that could no longer be ignored,” he said. “Specifically, problems with the implementation of the new European medical device regulation and the negative consequences concerning availability, product range, and quality of medical devices throughout Europe.
 
“As innovations are increasingly being introduced first to the market in the USA, new products reach Europe with a delay, at best,” he added.
 
By allowing products into the Swiss market that had already been vetted in the US, proponents argue that manufacturers will have easier access to the Swiss market, while the public can have confidence in the safety and efficacy of the products that have been reviewed by US regulators.
 
“The problems associated with the implementation of the new European Medical Device Regulation (MDR) are becoming increasingly apparent – throughout Europe,” Sandra Rickenbacher-Läuchli, legal counsel at Swiss Medtech told Focus. “The additional administrative workload leads to cost increases for medtech companies and ties up a lot of research and development capacities at the expense of innovations.”
 
The group says more than 1,000 of the approximately 5,000 foreign medtech manufacturers have already stopped supplying products to Switzerland. The lobby group Medtech Europe also says that according to its survey, half of medtech manufacturers in Europe say they plan to reduce their portfolio due to the added burdens from the MDR.
 
“Due to its size, Switzerland is – like other countries – not in a position to supply itself with all the medical devices it needs and is therefore dependent on imports,” said Rickenbacher-Läuchli. “At the moment, only medical devices with an EU certificate are allowed on the Swiss market.”
 
Rickenbacher-Läuchli did not address whether there are potential local legal hurdles the Swiss government may face trying to implement the decision and whether it would apply not just to FDA-approved products but also those that have been cleared or otherwise authorized by the agency. She said that for now, the Swiss government has two years to implement the proposal which will be written by the responsible administrative bodies. The issue will be examined by stakeholders in more detail in the coming months, she added. It also remains to be seen whether the proposal applies to any other foreign regulators besides FDA.
 
Rickenbacher-Läuchli added that Swiss Medtech plans to stay engaged to bring the industry perspective to policymakers as they go through the implementation process.