Medical Devices Packaging Market

 The medical devices packaging market was valued at USD 29.32 billion in 2020 and expected to reach USD 41.91 billion by 2026 and grow at a CAGR of 6.13% over the forecast period (2021-2026). The healthcare industry has evolved from its erstwhile traditional form of practices to the current position, where high-tech equipment and instruments are being deployed to improve efficiency. These developments have been providing scope for the expansion of medical appliances and other medical devices, driving the growth of the market studied.

- Medical device packaging provides a sterile environment for the contents within, and the sterility needs to be preserved until the package is opened for use. All the interfering procedures involve contact between a medical device or surgical instrument and a patient's sterile tissue or mucous membranes. A significant risk of all such methods is the introduction of pathogenic microbes that could cause an infection. Failure to disinfect or sterilize reusable medical equipment carries a risk associated with a breach of the host barriers. Therefore, the level of disinfection or sterilization on the intended use of the object is an essential aspect of the usage of medical devices.
- With this trend of sterile instruments expanding rapidly, the market is being driven by the increasing number of hospitals, therapeutic equipment manufacturers, and diagnostic centers. Manufacturers are required to address these changes through constant innovations in packaging designs with changing end-user requirements and innovations in medical devices. The growing demand for tamper-proof, non-reactive, and sterile packaged products is driving technological advancements in the medical device's packaging market.
- New companies in the market studied are innovating in terms of economical ways and smart labeling of medical devices. For instance, CleanCut Technologies' Vault packaging system for devices is well suited for tray-style packaging. What such technologies imply for packaging companies is that they can use the same methods with a few modifications for similar medical devices, thus reducing their validation time and ultimately achieving smaller batch packages, in line with customer requirements. Counterfeiting, an evident problem in medical devices, is expected to promote the usage of NFC and RFID tags on the packaging materials.
- Also, as COVID -19 cases continue to rise in parts of the United States, the country is still struggling to secure the volume of PPE necessary to keep up with the spread of the virus. To help arm frontline workers, in May 2020, BIC North America announced to produce 2,000 medical-grade face shields every day at its factory in Milford. The face shields, approved by the FDA along with Level 1 medical devices, are all made of materials typically used in packaging (plastic) or would otherwise be scrap from materials used in the lighters. Besides, the shields are designed so the plastic can be removed and sterilized by the hospitals, rather than disposed of.

Key Market Trends

Pouches is Expected to Hold Major Share

- Pouches are widely used containers for small- to medium-sized soft and semi-soft medical goods sold in unit quantities and are not vulnerable to damage during shipment and storage. Pouches' specific applications include intravenous (IV) catheters, IV administration sets, dialysis disconnect caps, wound dressings, small surgical instruments, diagnostic test packs, sutures, and dental supplies. Many films are used in medical device packaging applications. These materials offer a high degree of versatility and are available in a variety of forms in mono films, laminations, and coextrusions.
- Pouches have been manufactured from laminated paper with polyolefin layers. Uncoated nonwoven polyolefin materials for use in the manufacture of heat-sealable pouches are highly being used. Applications, such as the sterilization method (e.g., the material must tolerate high temperature) and protection requirements (e.g., high puncture resistance), are some features that cater to the demand. Further, selecting the appropriate pouch size prevents the overloading of instruments and allows penetration of the sterilant with adequate air removal and less puncture or tearing.
- Also, the partnerships and contracts to improve the product quality of pouches significantly cater to market growth. In July 2019, Diener Implants GmbH, a contract manufacturer for medical devices, announced its strategic partnership with 3dpac by Steripac, a German specialist for medical device packaging, to offer implants sterile packed to its customers. The 3dpac is a proprietary blister system developed by Steripac that ensures the optimal position fixation of sensitive products like 3 D printed implants within the sterile barrier. This provides flexibility and solves the typical problems of standard blister and pouch packaging of different geometries and sizes, like spinal fusion cages.
- Moreover, growth in the demand for pouches is expected to result from expanding applications in the unit -of -use packaging of small - to medium-sized medical instruments, appliances, and supplies. The expanding use in the secondary packaging of diagnostic test packs, prefilled inhalers and syringes, and surgical and dental trays are also expected to influence the demand for pouches. However, competition from lower-cost boxes will hold down the overall demand for pouches. Moreover, poor adaptability to rigid devices vulnerable to breakage and large multiple item kits will preclude medical device pouches from penetrating a number of the high value-added applications.

North America is Expected to Hold Significant Share

- The United States and Canada are developed countries, with prosperous economies, aging population segments, and advanced medical delivery systems. Still, the countries vary measurably in population size, healthcare spending intensities, aggregate gross domestic product (GDP) levels, and the structure of health insurance plans. With advanced primary medical community, extensive medical and life science research activities, high healthcare spending intensity, and large pharmaceutical and medical supply and device industries, the United States accounts for one of the world's largest geographical markets for medical devices and related packaging products.
- In May 2020, Packaging Compliance Labs LLC announced to invest USD 2.57 million for the expansion of its headquarters in the greater Grand Rapids area. The medical device packaging, engineering, and testing firm were awarded a USD 135,000 Jobs Ready Michigan grant from the Michigan Strategic Fund. The expansion of the packaging company significantly contributes to the overall market growth. Further, the US Food and Drug Administration (FDA) regulates sterilization packaging intended for use in healthcare under CFR Title 21 880.6850 and classifies it as a class II medical device.
- In May 2020, MedAccred announced to continue its expansion and support for the medical device industry. The company has added new plastics mechanical assembly and sterile device packaging audit processes and accredited a lot of new suppliers within the last year. The program also entered its second year of partnering with the United States Department of Commerce through the Medical Manufacturers MedAccred Accreditation Pathway for manufacturers and suppliers seeking accreditation.
- Further, anticipated strong growth in the Canadian diagnostic product industry is expected to broaden applications for parenteral vials and specialty multiple-well trays, thus driving the country's market. Moreover, in Canada, the Federal Minister of Health approved the interim order respecting the import and sale of medical devices for use concerning COVID -19 in March 2020. Under the temporary measure, Health Canada will allow certain products to be sold in Canada, where the requirement of packaging should be fully compliant with Health Canada requirements.

Competitive Landscape

The medical devices' packaging market is quite fragmented. The major players have used various strategies such as new product launches, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market, which increases the rivalry in the market. Key players are Amcor Limited, Bemis Company, Inc., Berry Plastics Pvt Ltd, etc.

- April 2020 - April 2020, Amcor's ULTRA pouches were certified for vaporized hydrogen peroxide sterilization as well as steam sterilization at 134°C. This means that the pouches can provide a solution for the sterilization of all reusable medical devices. The new accreditation assures that ULTRA pouches are compliant with the latest international and European EN 868 and ISO 11607 standards, including the Sterile Barrier System (SBS) requirement.
- November 2019 - Wipak launched a new pouch specifically developed for packing robotic instruments and other long devices. The pouch keeps the devices sterile during transportation and storage. It is made with an extra-strong paper for better protection, with high puncture resistance and resistance to penetration of any microbial. The pouch also incorporates Wipak's acclaimed Multi - X 9 multilayer film, which consists of nine layers, each with its features and functions.

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Medical Device Security Market

 The medical device security market is expected to register a CAGR of approximately 8.3% during the forecast period from 2021 to 2026. The healthcare industry has been witnessing a significant transformation throughout the past few years, aided by the transformative nature of IoT technologies and advancements in computing power, wireless technologies, and data analytics techniques, such as the Big Data, which is currently being deployed in the medical facilities and in the medical research sector for the analysis of a large amount of complex heterogeneous medical data that involves proteomics, genomics, and pharmacogenomics, across the globe. Medical devices and software were generally deployed to control the medical equipment and the display reading. However, the increasing potential of the current software and their offerings dominates the need for the advanced sensory and connected medical hardware equipment.

- The advances in healthcare technology have driven wearable devices' growth, with multiple biosensors monitoring diverse parameters. These advances enable collecting, transferring, and storing real-time data in the cloud, helping healthcare professionals (HCPs) predict and adjust the precise and accurate drug dosage levels. The healthcare sector has been adopting new technologies, such as wearables, home/remote monitoring equipment embedded with IoT, IoT -enabled hygiene monitoring devices, etc., to offer life-critical services and treatments. Owing to the digital transformation, the healthcare industry is witnessing a shift in information security's operational process. As per the 2019 Mid-Year Data Breach Barometer Report, 31,611,235 healthcare records were exposed between Jan 2019 and Jun 2019, double the number of data breaches compared to 2018.
- Modern healthcare endpoint security and protection often feature patch management and other endpoint management capabilities that cater to the healthcare sector. The endpoint security is being incorporated by many healthcare industry players, alerting their IT security team when a device doesn't have a security patch or if it uses outdated information. It further helps them schedule a time to automatically download or update the patch when it doesn't interfere with business processes. This helps ensure a consistent security layer. The growing number of connected devices used by employees in the healthcare sector leads to more information sharing. Still, it's also placing the endpoint at higher risk than ever before. For instance, according to an ETNO report, in the EU region alone, the number of IoT connected devices in healthcare for FY2019 amounted to 2.79 million.
- Additionally, cyberattacks, such as WannaCry ransomware and Windows' vulnerability, such as Blue Keep, hinder the market's growth. The CyberMDX report analysis shows that over 45 % of medical imaging devices, including X -rays, MRIs, and ultrasound machines, with outdated Windows versions are vulnerable. Additionally, CHIME reported over 18 % of the connected medical devices used by medical organizations had been impacted by malware or ransomware in the 18 months since 2018. In March 2020, the FDA announced a set of vulnerabilities that are affecting the usage of Bluetooth Low Energy (BLE) in specific medical devices, such as the glucose monitors, insulin pumps, pacemakers, and stimulators, among other larger devices in the healthcare facilities, such as the ultrasound devices or monitors.
- As the global healthcare sector is currently battling the ongoing Covid-19 pandemic, the number of cyberattacks targeting it has increased. In Mar 2020, the Czech Republic hospital responsible for running most of the country's Covid-19 testing, the Brno University Hospital, was held to ransom and was then forced to shut down its IT Network. Moreover, data from the artificial intelligence endpoint security platform SentinelOne showed that from Feb 23 to Mar 16, with the onset of the Coronavirus outbreak, there was an upward trend of attempted attacks with peaks at 145 threats per 1,000 endpoints, compared to 30 or 37 at the start of that period. These instances are expected to drive the demand for medical device security solutions in the healthcare industry primarily created with the outbreak of COVID-19, positively affecting the market.

Key Market Trends

Demand for IoT Security Solutions is Expected to Increase Due to the Increase in Demand for Connected Devices

- The healthcare sector continues to adopt new technologies, such as wearables, home/remote monitoring equipment embedded with IoT, and IoT-enabled hygiene monitoring devices, to offer life-critical services and treatments. Critical healthcare services have evolved to remain online to capture patient data to provide better health services. The increasing adoption of wearable medical devices is driven by technological advancements and innovations, along with the improvement in care availability and patients' lifestyle. These wearable medical devices are gaining immense popularity due to improved technologies and their compatibility with regularly used devices, such as smartphones.
- With cyberattacks rising exponentially each year, the security of connected medical devices has never been more critical. And as more medical devices are integrated into clinical networks, real-time connected medical device utilization data adds greater accuracy to emergency preparedness and capital planning initiatives across hospitals and health systems. In July 2020, Healthcare technology company TRIMEDX announced a strategic partnership with Medigate to meet the unique demands of clinical asset management (CAM) and medical device safety and healthcare systems security.
- TRIMEDX and Medigate deliver an integrated solution that merges the TRIMEDX CAM Advanced and CYBER Advanced solutions with Medigate's real-time visibility, utilization data, and threat/vulnerability detection. The Medigate platform discovers and precisely identifies every connected device on a clinical network, automatically doing so, in real-time, through proprietary algorithms specifically built to identify devices and communication protocols.
- Increased usage of medical devices connected to mobile networks or through IoT in the healthcare sector can significantly increase the risk of security issues, which is forcing more and more medical technology companies to implement security solutions for external and wearable medical devices.
- As the healthcare data carry critical records and the financial information, the threats to expose these digitally stored data are on the rise. Hence, with the advent of IoT and its increasing adoption, the healthcare providers must secure the connected medical devices more than ever before. According to Wipro's State of Cybersecurity Report 2019, 485 significant data breaches were reported in 2018 in the healthcare industry, making it one of the most popular breach attempts. Therefore, the industry's adoption of IoT security is expected to grow significantly during the forecast period.

North America is Expected to Dominate the Market

- The healthcare industry is one of the most regulated industries in North America due to privacy and security concerns associated with digital patient records. Regulations, such as Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act, are ensuring steady growth in the penetration rates of cybersecurity solutions in the country’s healthcare sector. Recently, in March 2019, over 12 healthcare sector companies and groups submitted a proposal to the FDA for updating the guidelines for the cybersecurity of premarket medical devices. Initiatives such as these are expected to increase further the adoption of cybersecurity in the country’s healthcare sector.
- Some vulnerabilities inadvertently enter the devices, software, and servers, or patches are other driving factors for the cybersecurity market. In the case of GE Aestiva and Aespire Anesthesia devices, which are used in the US hospitals, and improper authentication vulnerability was identified in June 2019, allowing a remote attacker to modify the parameters of a vulnerable device and silence the alarm system. Companies are rolling out innovative products to safeguard patient data. For instance, Cisco released the latest version of the “Cisco Umbrella” in 2018 and deployed it in the University of Kansas Hospital to protect the medical devices and financial information from ransomware.
- Apart from the US, Canada is also actively focusing on enhancing medical device security. In August 2019, to address cybersecurity risks in medical devices, Health Canada has recently released a Guidance Document: “Premarket requirements for Medical Device Cybersecurity. According to the guidelines, manufacturers should incorporate cybersecurity into the risk management process for every device containing the software. Manufacturers are also being encouraged to develop and maintain a framework for managing cybersecurity risks throughout their organizations.
- Also recently, in 2020, Healthcare is the sector most impacted by a group of 19 critical vulnerabilities known as Ripple20, found in the TCP/IP communication stack of hundreds of millions of IoT and connected devices. First reported by security researchers JSOF in June 2020, the Department of Homeland Security Cybersecurity and Infrastructure Security Agency followed the report with an alert that detailed potential exploits hackers could take to control an affected device. With such instances increasing in the region, the demand for medical devices security is anticipated to increase significantly.

Competitive Landscape

The medical device security market is fragmented, highly competitive, and dynamic. The dynamic nature of the market is primarily due to information technology and software companies' ability to enter freely in the market. Key players in the market include Check Point Software Technologies, Cisco Systems, FireEye, IBM, Imperva, Mcafee, Palo Alto Networks, and Symantec Corporation. These players are making innovative product developments and forming strategic partnerships and collaborations to boost the adoption of their offerings further and, hence, enhance their market presence.

- February 2020 - GE Healthcare introduced a new cybersecurity service offering that primarily brings together the medical device expertise, artificial intelligence, and process management tools to help the hospital groups fight against the cybersecurity threats. The new solution, called Skeye, will augment the hospitals' existing resources and capabilities by providing proactive monitoring through a remote security operations center (SOC), helping them detect, analyze, and respond to any cybersecurity threats events in real-time.
- November 2019 - Cybersecurity company Check Point Software Technologies (San Carlos, CA) has announced a new IoT cybersecurity technology that hardens and protects IoT devices' firmware and makes them secure against the most sophisticated attacks. With the latest technology, it is possible to take a medical device such as an infusion pump, and rapidly, harden and protect it against advanced zero-day attacks.

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3D Printed Medical Devices Market

 The 3D printed medical devices market is estimated to grow at a CAGR of about 16% over the forecast period 2021 - 2026.

- As per the Organ Procurement and Transplantation Network (OPTN), in 2018, around 27,281 organ implantations were performed in the United States. Further, over 120,000 people in the country were waiting for an organ transplant by the end of 2018. This shortage could likely be reduced by using 3D bioprinting. The 3D bioprinting method deposits “bioink,” droplets of living cells or biomaterials, onto a substrate according to digital instructions to reproduce human tissues or organs.
- Moreover, this technology is providing the benefits of personalized treatments at an affordable price to the patients. For instance, 3D printed skin are incorporated on the body of a burnt victim. By using bio-printed skins, doctors minimize the need for skin grafting surgeries. Thus, by applying 3D bio-printed skin, doctors can transfer healthy skin cells to those injury parts, thus making the treatment faster and easier.
- All the above factors are expected to contribute significantly toward the growth of the market. However, securing approval from regulators might impede the widespread medical application of 3D printing during the forecast period.

Key Market Trends

Orthopedics and Prosthetics is Expected to Have the Fastest Growth

- One of the advantages that 3D printers in medical devices provide is customized medical products and equipment. Thus the custom-built prosthetics and implants provide value addition for both patients and doctors. Also, customized implants, have a positive impact in terms of the time required for surgery, patient recovery time, and the success of the implant.
- For instance, in January 2019, Apollo Hospitals, at Mumbai in India performed a 3D printed titanium skull implant on one it's patient. 3D-printed titanium implant was opted because it would closely replicate the shape of the patient's skull. These 3D printed implants are MRI compatible, decrease the risk of infections and most importantly can be made to fit the patient's form.
- Moreover, 3D printed prosthetics help in improving the posture and balance for people suffering from Achondroplasia, a genetic disorder characterized by short-limbed dwarfism that is apparent at birth. According to the National Organization for Rare Disorders, the estimated frequency of achondroplasia has ranged from about one in 15,000 to one in 35,000 births.
- Further, according to the World Bank, the estimated share of the U.A.E.’s population above the age of 65 will increase to 4.4% by 2030 from 1.1% in 2018. This will stimulate demand for healthcare in general and geriatric care in particular which will create a demand for orthopedics products related to knee and hips.
- The Governments of the UAE has pledged to create a world-class healthcare facility in the UAE. They also want to boost medical tourism in the UAE by establishing Dubai as the center. The Emirate’s good connectivity to the rest of the world through its airline and airport ensures that health tourists will be able to get to the Emirate in an expeditious manner.

North America to Account for the Largest Market Share

- The United States medical devices industry is known for offering high-quality products using advanced technology resulting from significant investment in research and development.
- According to the American Society for Aesthetic Plastic Surgery, around thirty thousand breast augmentations were performed among women in the United States in 2018. This breast augmentation is one of the five most common surgical cosmetic procedures among women in the United States in 2018. Further, the use of 3D implant avoids the complications and side effects that are associated with other implants such as implant leaking, contracting, rippling, or rupturing. Additionally, it also reduces surgery time and increases patient recovery time.
- Moreover, opportunities for expansion of U.S. medical device comes from specific key ongoing policy and activities. For instance, the U.S. Food and Drug Administration (FDA) in 2017 has reviewed more than 100 devices that were produced on 3D printers. These include knee replacements and cranial implants.
- Additionally, the FDA is also working to establish a regulatory framework with regards to applying existing laws and regulations that govern device manufacturing patients they are treating. To keep pace with evolving technology as well as encourage and support innovation, the FDA is involved in several research activities.
- For example, in 2016, the Radiological Society of North America (RSNA) launched the 3D Printing Special Interest Group (SIG). Intending to support radiology-centered, hospital-based, point-of-care 3D printing to impact more patients, they had set up several committees to work in different areas. The areas include prosthetics, Anaplastology, regulatory and compliance, and simulations amongst others.
- Apart from being the world's largest producer of medical devices, the United States is the largest consumer of these as well. Thus, 3D printed medical devices market is expected to witness significant adoption in several areas of the United States healthcare sector.

Competitive Landscape

The 3D printed medical devices market is moderately competitive in nature. Increasing interest in the adoption of this technology from the hospital and surgical centers across the globe is creating an immense opportunity for investors who are looking to capitalize on the future. Further, the increasing number of innovative start-ups in the 3D printing ecosystem is fuelling the growth of the industry. Some of the key players are Materialise NV, 3D Systems Corporation, and Hewlett Packard (HP) amongst others. Some of the recent developments are:

- November 2018 - 3D Systems launched Simbionix ARTHRO Mentor Express training simulator. This is a portable training solution to help medical professionals to learn surgical procedures for knees, shoulders, and hips on a portable and affordable tabletop platform.
- August 2018 - 3D Systems launched NextDent 5100 which enabled dental labs and clinics to produce dental devices faster while reducing material waste and capital equipment expenditure.

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Connected Medical Device Market

 The connected medical devices market was valued at USD 28.24 billion in 2020, and it is expected to reach USD 94.32 billion by 2026, at a CAGR of 18.92% over the forecast period from 2021 to 2026. The healthcare industry has witnessed a significant transformation throughout the last few years, aided by the transformative nature of IoT technologies and advances in computer power, wireless technologies, and data analytics techniques, such as Big Data, which currently is deployed in medical facilities and the medical research sector for the analysis of a large amount of complex heterogeneous medical data involving genomics, proteomics, and pharmacogenomics, worldwide.

- In the past, medical devices and software were generally deployed to control medical equipment and display reading. However, the growing potential of current software and their offerings dominates the need for the advanced sensory and connected medical hardware equipment. Hence, there is a rise in the number of connected medical devices and advancements in software that are capable of capturing and transmitting medical data, along with data analytics services, that help medical practitioners drive insights into, and promote the delivery of, predictive, preventive, personalized, and participatory medicines.
- According to a report published by Telegraph, Apple Watch, equipped with a heart rate sensor fed with a history of medical data, was able to save a man's life by always alerting when the heart rate dropped below 40 bpm and recommending to visit the nearest ER hospital. Additionally, Phillips introduced the Philips IntelliVue Guardian wearable patch, which can be used to monitor patients at homes and in hospitals. Similarly, the deployment of these devices has enabled Mt. Sinai Medical Center, a hospital in New York, to cut down the waiting time of patients in the emergency ward, by up to 50%
- This factor further broadens the scope for remote monitoring devices offered in the connected medical devices market. It is estimated that remote monitoring for healthcare could be worth USD 1.1 trillion by 2025. As part of their strategies related to customer engagement, the attempts to deploy these devices by healthcare vendors have gained traction. It was estimated that pharmacy and medical technology companies, on an average, spend around 5-12% of their revenues on R&D (including clinical trials), to bring efficient and safe products to the market. It is known that using connected devices in clinical settings can reduce the total cost of the trials, thereby reducing the overall product cost
- However, COVID-19 has positively impacted the market growth. This is due to the drastic increase in the number of patients, pressure on doctors to provide advanced healthcare services, and governments developing apps based on connectivity technologies. The pandemic has brought out new ways in which patients can interact with the doctors. There is a rising trend of telemedicine services as governments across the world have advised citizens to avoid any movement outside their homes. As the entire concentration of hospitals is on treating COVID-19 patients, people are discovering new ways to monitor their health themselves and only approach doctors in case of emergencies. Thus, the sales of smart wearables, especially smartwatches, have increased in the last few months.

Key Market Trends

Wearable Device is Expected to Hold Major Share

- Wearable technologies in the healthcare industry offer convenient means to monitor physiological features. A multitude of medical solutions are not restricted to consumers but provide current data for doctors to analyze patients at remote locations. Wearable medical technologies have a vast range of applications in the healthcare segment, from Apple Watch's glucose monitoring systems to its EKG capabilities. Apart from being convenient, wearable devices were proven to be cost-effective, as the data generated by these devices may help doctors make decisions remotely, thus reducing the patients' repeated visits to hospitals for regular checkups.
- The healthcare wearable devices comprise more than fitness bands. Smartwatches, smart glasses, smart footwear, smart apparels, posture monitors, movement sensors, wrist devices, heart straps, headbands, wearable patches, pain management devices, and medicine delivery pods are some of the devices that make up the vast and growing healthcare wearables market. The adoption of wearable devices in the healthcare segment has been gaining traction over recent years. This, in turn, is one of the significant factors influencing the connected medical devices market.
- The number of shipments from the modular segment was slightly more than 2.5 million, which was almost sixteen times the number of shipments from the wrist wearable segment, thus indicating the immense opportunities that the sector offers. Moreover, the devices related to cardiac-related diseases are expected to be worth USD 800 billion by 2030, which shows a significant opportunity in the cardiac segment, for various healthcare wearables.
- With the growing health awareness among people, it is evident that the use of apps that support fitness and health is increasing. Studies show that more than 30% of mobile owners use fitness apps, and their usage has risen by 60% since 2014. Currently, over 97,000 health and fitness apps are available for download. With this growth in global smart wearable device unit shipments, healthcare and fitness applications dominate the growth of the market studied.

North America Holds Highest Market Share

- The United States connected medical devices market is defined by the presence of established medical device manufactures, an advanced healthcare ecosystem, and significant healthcare expenditure. According to Synopsys, US hospitals have an average of 10–15 connected medical devices per bed. The sale of blood pressure monitoring equipment in the region is expected to cross USD 1.92 billion in 2018, which would be a 370% increase from that in 2013. This makes blood pressure monitoring the most lucrative segment in the US connected medical devices market, which is the major contributor in the region.
- The region has witnessed a considerable rise in the use of connected medical devices. The size of the US medical devices industry is expected to cross USD 175 billion by 2020, which clearly indicates the immense potential offered by the region for connected medical devices. The country’s healthcare industry has shown keen focus on the protection of patient health information through the HIPAA Act of 1996 and the subsequent HITECH Act of 2009, while also favoring the IoT aligned to federal standards for the manufacturing, deployment, and support of the connected devices for patient care.
- According to Synopsys, a computer integrated systems design company, US hospitals have an average of 10-15 connected medical devices per bed. A critical factor for companies looking to bring connected devices to the market is the wireless device certification process. In North America, this is separate from the FDA testing, and is required for all wireless devices. Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device.The FDA allows devices to be marketed when there is a reasonable assurance that the benefits to patients outweigh the risks.

Competitive Landscape

The connected medical devices market primarily comprises multiple domestic and international players in quite a fragmented and highly competitive environment. Technological advancements in the market are also bringing sustainable competitive advantage to the companies, and the market is also witnessing multiple partnerships and mergers.

- March 2020 - Royal Philips announced the HealthSuite System of Engagement which is an integrated, modular set of standards-based capabilities that support the development of digital health propositions, including new capabilities for cloud-based managed AI workflow and DICOM interoperability. HealthSuite System of Engagement is helping a wide range of both Philips and 3rd party connected healthcare applications, including a smart cloud-based application that connects homecare providers, physicians, and payers with patients quickly and efficiently to critical data across connected devices and locations.
- February 2020 - GE Healthcare introduced a cybersecurity service that combines medical device expertise, artificial intelligence, and process management tools to help the connected medical devices in the hospital groups to fight against cybersecurity threats. A SOC team provides monitoring and warning detection and remediation for connected medical devices under a GE Healthcare service contract.

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Wearable Medical Devices Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

 The wearable medical devices market was valued at USD 19,450 million in 2020 and is expected to reach USD 47,837 million by 2026, registering a CAGR of about 16% over the forecast period.

Wearable devices play a crucial role in predicting certain disorders by integrating essential vital signs with clinical symptomology. The use of wearable devices in a bid to combat COVID-19 has therefore been ramped up. Research has recently expanded on which if the extensive data that wearable devices collect can predict the onset of the virus or not.

For instance, in 2020, researchers at Rockefeller Neuroscience Institute in the United States reported that data from the Oura ring, a wearable sleep and activity tracker, can be combined with an app that measures vital signs that predict in advance if an individual is likely to develop Covid-19 symptoms. The device successfully predicted that an individual would experience symptoms such as shortness of breath, cough, fever up to three days before they manifested.

The wearable medical devices market is growing at a faster pace owing to the rising technological innovations and advancements, as they can improve the lifestyle of general population as well as patients population. Wearable technologies proffer a convenient mode of monitoring physiological symptoms, featuring a multitude of medical solutions. These are devices are not only easy for the consumer use, but they also offer real-time data for physicians to analyze as well. From the Apple Watch’s EKG capabilities to new continuously glucose monitoring systems, wearable medical technologies have a broad range of potential applications in healthcare industry.

Also, Current Health’s artificial intelligence (AI) wearable device that measures multiple vital signs has recently received FDA-clearance for patients to use at home. In February 2020, the Edinburgh, Scotland-based company received clearance for the AI-enabled device in monitoring patients while in the hospital, but this recent approval means it can now be used between doctor visits at home too.

In 2019, Omron Healthcare launched HealthGuide, which looks like a typical smartwatch but is incorporated with feature to monitor blood pressure. Thus, all the above mentioned factors are responsible for the growth of the market.

However, the lack of awareness about the availability of some wearable devices in developing and underdeveloped countries and the high cost of wearable devices are some of the major challenges for the growth prospects of the market.

Key Market Trends

Remote Patient Monitoring is Expected to Exhibit Fastest Growth Rate Over Forecast Period

The essential and healthcare workers are the most vulnerable to coronavirus infections due to their required proximity to potential coronavirus patients. Wearable technology may potentially help in these regards by providing symptoms prediction, real-time remote monitoring and contact tracing, etc.

In April 2020, the Scripps Research Translational Institute has started the DETECT (Digital Engagement & Tracking for Early Control & Treatment) Study, which uses devices such as Garmin, Fitbit, Apple Watch among others for recording activity, heart rate, and sleep data and matching it with symptom reports submitted by participants to track potential cases of Covid-19. Early results from the study showed that Fitbits can predict Covid-19 in 78% of the 14 patients studied.

The process in which patients can use a mobile medical device to perform a routine test and send this data to healthcare professionals in real-time is known as Remote patient monitoring (RPM).

The implementation of remote patient monitoring may improve the management of chronic disorders by measuring critical risk indicators, such as blood pressure and glucose. RPM has several advantages for hospitals and end users, such as reduction in extended hospitalization, low cost of healthcare and fewer doctor appointments. This can also help to lower the cost associated with the treatment of chronic disorders.

The increase in the number of people with chronic disorders and an rising elderly population are the major factors boosting the growth of RPM services across the globe. For instance, the number of deaths of neurological disorders has increased in the past three decades, i.e., from 6.5 million in 1990 to 9 million in 2018, as per Feigin V.L. published in the Neuroepidemiology Journal 2019. This rising prevalence is anticipated to further increase the demand for remote patient monitoring devices.

North America Captured the Largest Market Share and It is Expected to Retain its Dominance over the Forecast Period

The COVID-19 has altered collective and individual behavior, changing both workplace and healthcare. Technology offers devices to meet these new challenges. When it comes to health, work, and economics amid COVID-19, wearables play an important role in the entire continuum of care, as well as in our work and leisure lives. In 2020, Philips launched a next-generation wearable biosensor for early patient deterioration detection, including clinical surveillance for COVID-19 in the United States.

Also, in 2020, researchers in Washington have developed a stamp-sized device, consisting of a suite of sensors, including ones that record blood oxygen levels and body temperature, an advance that can be used to catch early symptoms and signs of COVID-19 and help to monitor patients as the illness progresses.

North America dominated the overall wearable medical devices market, with the United States emerging as the major contributor to the market. The United States holds the largest share in the wearable medical devices market, due to the high prevalence of cardiovascular and lifestyle-related diseases and an increased adoption of wearable medical technology along with high per capita medical expenditure. Combined with the rising incidence of diseases in the region, the market for wearable medical devices is expected to grow at a moderate rate, over the forecast period.

Additionally, most of the major players such as Garmin Ltd, Fitbit, Inc and Biotelemetry, Inc of the studied market are concentrated in United States and has been investing in the research and development of innovative wearables. For instance, in Oct 2020, Garmin Ltd has launched Vivofit jr, 3 kids fitness tracker watch, which would help kids to be motivated to meet their activity goals in order to see what happens next in the app adventure.

Competitive Landscape

The rising number of market players is intensifying the competition. Players, such as Fitbit, Lifesense, Apple, Garmin, and Samsung, are disrupting the market by launching several new products. In Aug 2020, Fitbit, Inc launched Fitbit Sense, advanced health smart watch that helps in detecting the body’s responses to stressors by measuring electrodermal activity responses.

Moreover, new competitors are emerging in the form of start-ups. Start-ups like Overlap, Royal Philips, Vivify Health, Validic, and Doximity Dialer are in the process of developing technology to enhance wearable health technology and enable EHR integration for health systems. This has made the market very competitive.

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Refurbished Medical Devices Market

 The Refurbished Medical Devices market is expected to be valued at approximately 10,130 million in 2020 and expected to reach USD 20,210 million in 2026, witnessing a CAGR of 12.2% over the forecast period.

Amidst this pandemic situation of COVID-19, the demand for refurbished medical devices, like mechanical ventilators is expected to observe a significant increase. However, the healthcare industry is still coping with the massive disruption in the supply chain which has negatively impacted the refurbished medical devices.

Certain factors driving the market growth include cost containment pressure on healthcare organizations, a large inventory of old or used medical devices, the rising trend of medical tourism, and the increasing rate of private healthcare institutions.

With the emerging technologies, there has been an increasing trend of ‘affordable buying,’ which is the basic reason for the emergence of the refurbished devices market. For example, today, a customer who is looking for any CT scanner under 4-slice opts for a refurbished unit, rather than a brand new system. The refurbished equipment allows buying of necessary devices at affordable prices, without compromising on quality; therefore healthcare facilities, including small and medium ones, purchase refurbished medical devices.

Along with the demand for new equipment, there is an increasing demand for refurbished medical equipment around the world. In fact, an increasing number of hospitals, which are new, are opting for alternate options to cut down on the capital investments. As per the GCC Healthcare Industry 2018 report, the total number of hospitals in the GCC region was around 700 in which Saudi Arabia had 470 hospitals. Hospitals, especially in such developing regions would prefer refurbished medical devices as it requires less capital investment, enabling them to provide healthcare services at affordable costs to the patients.

Moreover, the demand for refurbished medical devices are much higher in low- and middle-income countries. One of the primary reason being poor health infrastructure and limited access to healthcare resources. And refurbished devices are easily affordable in such countries, thereby boosting the market growth. Hence, the refurbished medical devices market is increasing at a high growth rate.

Key Market Trends

Medical Imaging Equipment is expected to hold a Significant Market Share in the Product Type

Medical imaging is the process of making a visual representation of the interior of the body for medical intervention. The usage of medical imaging devices is expected to slightly decline due to the sudden drop in hospital visits. Furthermore, as per the issued guidelines of the American College of Radiology, the United States, CT-scanners and x-rays are not an appropriate first-line diagnostic tool for COVID-19.

These instruments help in establishing a database of the normal anatomy and physiology of internal organs so that any abnormality can be noticed immediately and as their technological complexity increases, the total cost of it also increases. Hence, refurbished versions of these products provide greater options to the customers. For instance, Summus Medical Solutions are retail partners of Philips which offer Philip's C-arms refurbished medical systems such as BV Pulsera, BV Endura, Philips Veradius, and Philips BV Libra. Hence, the availability of such technologically advanced systems at cheaper rates is expected to drive the market in this segment.

The majority of the clinics and hospitals that have purchased, used, or refurbished medical equipment generally have neutral-to-positive experiences with the purchase. Most end users have been found to indicate that they purchased used or refurbished equipment due to budgetary constraints.

Asia-Pacific to Witness the Fastest Growth in Refurbished Medical Devices Market

Asia-Pacific region is expected to show the fastest growth of the refurbished medical devices market. Amongst the pandemic situation the adoption and usage of refurbished medical devices such as patient monitoring devices are expected to increase in the emerging economies present in this region.

Furthermore, the reform in regulatory policies is expected to support the market growth. For instance, in February 2020, Malaysian Medical Device Authority (MDA) has drafted guidelines related to the requirement of the document submission about refurbished medical devices. Thus, a positive impact of COVID-19 can be expected in this region.

In addition, the increasing number of hospitals and diagnostic centers, with the increasing focus on rural development, both by government and private organizations, led to a great demand for refurbished medical instruments. As per the data provided by a study titled ''COVID-19 in India: State-wise estimates of current hospital beds, intensive care unit (ICU) beds and ventilators'' published in April 2020, India has around 43,486 private hospitals and about 25,778 public hospitals.The increasing number of hospitals and diagnostic centers, with increasing focus on rural development, both by government and private organizations, led to a great demand for refurbished medical instruments.

In addition to, presence of well-established companies in this region is further expected to support the market growth. For instance, SANRAD Medical Systems is one of the leading company in India dealing with refurbished medical imaging equipment. It mainly offers products in Magnetic Resonance and Computed Tomography. Thus, such factors are expected to boost the market growth in Asia-Pacific region.

Competitive Landscape

The global refurbished medical devices market is highly competitive and consists of a number of major players. Companies, like Agito medical A/S, Avante Health Solutions, Block Imaging International, Inc., Everx Pvt Ltd., GE Healthcare, Integrity Medical systems Inc., Koninklijke Philips N.V., Radio Oncology Systems Inc., Siemens Healthcare Systems, and Soma Technology, among others, hold substantial market shares in the refurbished medical devices market.

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