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Implantable Medical Devices Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2016-2024

*Full Report Available for sale at Transparency Market Research

Implantable Medical Devices Market: Snapshot

An implantable device is a “device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more.” In recent past, the global market for implantable medical devices has undergone rapid growth, and the expansion is expected to continue in the near future. The expansion of the market is attributed to the technical innovations in the field of implants, which is motivating implantable device manufacturers to infuse more capital in the research and development of their products. However, high price of sophisticated implantable devices often demotivates the end-users and in turn is hindering the growth rate of the market.

The opportunity in the global market for implantable medical devices was valued at US$32.3 bn in 2015. Rising at a healthy CAGR of 4.9% during the forecast period of 2016–2024, the valuation is estimated to reach US$49.8 bn by the end of 2024. This substantiality and sustainability of the market is also attributed to factors such as rising geriatric population, and the rise in the incidences of musculoskeletal, dental, and other chronic degenerative health conditions.

Rising Geriatric Population Driving Reconstructive Joint Replacement Sub-segment

Damage to the joint is highly painful and results in loss of agility and hampers the normal activity of an individual. Such damage can be treated through pharmacological therapies and arthroscopy. But depending upon the severity of the damage to the joint, physicians often prescribe joint replacement, which is the most in-demand sub-segment of the orthopedic implants segment [...]

By |March 24th, 2017|Articles, Medical Solutions, MEDS|Comments Off on Implantable Medical Devices Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2016-2024|

Medical Devices, Trade Talks, Medicine Manufacturing: EU Public Policy March 13 Update

* Originally posted in National Law Review

Council adopts EU rules on Medical Devices

On March 7 2017, the Council of the EU adopted rules which would be contributing to the safety of medical devices in the EU. These rules comprise of two proposals, a Regulation on Medical Devices and a Regulation on Vitro Diagnostic Medical Devices. The adopted rules will give manufacturers the opportunity to improve any devices on a continuous basis, as well as to implement fast and effective measures when faced with safety problems.

The European Parliament is expected to adopt these rules in April 2017, after which the rules will be submitted for publication at the Official Journal of the EU.

EU-US agreement on Mutual Recognition of Inspections of Medicine Manufacturers
The European Commission and the United States Food and Drugs Administration adopted on March 2 2017 an agreement to mutually recognize inspections of premises where medicines are produced. The agreement will not affect the procedure of approving medicines but will allow the EU to identify problems at medicine factories faster and will reduce the administrative burdens and costs for pharmaceutical manufacturers.

EU Trade Talks
On March 10 2017, the EU and the Association of Southeast Asian Nations (ASEAN) agreed in a joint statement to take new steps to continue their trade talks for a region-to-region agreement.

Similarly, on March 7 2017, the EU Commissioner for Trade Cecilia Malmström and New Zealand’s Trade Minister Todd McClay met in Brussels to agree on the last elements of the preparatory talks over a Free Trade Agreement. The European Commission will now be seeking a negotiating mandate by the EU28 Member States to begin the trade negotiations with New Zealand.

White Paper about the Future of Europe
The European Commission published [...]

By |March 24th, 2017|Articles, Medical Solutions, MEDS|Comments Off on Medical Devices, Trade Talks, Medicine Manufacturing: EU Public Policy March 13 Update|

Wearable Medical Devices Market by Application, End Use, Type, Distribution Channel – Forecast to 2021

* Originally posted on Yahoo Finance

LONDON, March 14, 2017 /PRNewswire/ — wearable medical device market, in terms of value, is projected to reach USD 12.14 billion by 2021 from USD 5.31 billion in 2016, at a CAGR of 18.0% during the forecast period.

Download the full report: https://www.reportbuyer.com/product/4466097/

Growth in this market is mainly driven by technological advancements in medical devices, launch of a growing number of smartphone-based healthcare apps compatible with wearable devices, rising preference for wireless connectivity among healthcare providers, and increasing focus on physical fitness. Furthermore, growing trend towards home healthcare, offers significant growth opportunities for the wearable medical device market. On the other hand, factors such as high cost of wearable devices and data security issues may restraint the growth of the market.

The wearable medical services market is segmented based on type, distribution channel, end use, application, and regions. The wearable medical device, by distribution channel segment is expected to provide growth opportunities for market players in the forecast period. Based on distribution channel, the wearable medical devices market is segmented into pharmacies, online channel, and hypermarkets. Factors driving the growth in this segment are growing demand and usage of wearable medical devices, rising health concerns, increasing focus on physical activities and a healthy lifestyle among a large part of the population in a number of countries, rising focus on early diagnosis and monitoring of health conditions, increasing prescription of wearable medical devices by physicians, and development and launch of advanced products.

Based on the end use, the market is segmented into sports & fitness, remote patient monitoring, and home healthcare. Sports & fitness dominated the market in 2016, however, home healthcare end use to grow at the second [...]

By |March 24th, 2017|Articles, Medical Solutions, MEDS|Comments Off on Wearable Medical Devices Market by Application, End Use, Type, Distribution Channel – Forecast to 2021|

Blood Glucose Monitoring Systems Can be Accessed Remotely

 

Roche Diabetes Care has announced the Accu-Chek Connect system for blood glucose monitoring.  The system includes a meter, app (Android and iOS), and online portal. Patients can view, share, and access blood sugar data anytime, anywhere. Here is how it works. Blood test results are sent wirelessly from the Accu-Chek Aviva Connect meter to an app installed by the patient and /or the care takers. Data can also be stored in an online portal securely. The insulin requirement can be updated by the caretakers easily. Easy-to-understand charts are available to help patients to manage diet and physical activities. Photos can be added to remember the patient on what foods have been taken. Research has found that one of the most important requirements for healthcare device to work effectively is positive feedback. The Accu-Chek Connect system provides a 3-day profile tool lets patients view trends to learn how activity, food choices, and insulin affect their blood sugar results. The unit is available at Walgreens, Rite Aid, and select CVS and Kroger pharmacies. The app is offered at no charge and can be downloaded from the Apple App Store and Google Play. www.accu-chek.com/connect

The Accu-Chek Connect system provides a 3-day profile tool lets patients view trends to learn how activity, food choices, and insulin affect their blood sugar results.

By |December 17th, 2016|Articles, MEDS, RTC Magazine|Comments Off on Blood Glucose Monitoring Systems Can be Accessed Remotely|

Drug-free Wearable Pad Relieves Lower Back Pain



Drug-free Wearable Pad Relieves Lower Back Pain

Bayer has announced the Aleve Direct Therapy to help patients to temporarily relieve lower back pain. Based on a drug-free TENS technology (Transcutaneous Electrical Nerve Stimulation), the unit blocks the body’s pain signals with electrical nerve stimulation and releases endorphins in the areas of pain as a result of its patented waveform technology. The pad can be worn at the back throughout the day on the user’s lower back but not while sleeping, driving, operating heavy machinery or any other activity in which electrical stimulation can put one at risk of injury. A wireless remote control can be used to adjust the level of intensity as needed by the individual. The unit is Class II FDA medical device and priced at $49.99-$59.99 for single quantity. www.bayer.com

TENS technology (Transcutaneous Electrical Nerve Stimulation) blocks the body’s pain signals to help patient control pain.

By |December 17th, 2016|MEDS, RTC Magazine, System Integration|Comments Off on Drug-free Wearable Pad Relieves Lower Back Pain|

Safe and Reliable Software Must Also be Secure—and Tested



Safe and Reliable Software Must Also be Secure—and Tested

The Internet of Things involves such high connectivity that developers of safety-critical systems must build in both functional safety and protect their systems from outside attacks that would compromise that safety.

By Jay Thomas, LDRA

While the general public is largely unaware of how connected our world has actually become—with everything from gas pumps, medical instruments, factories, aircraft, and automobiles communicating critical information to internal and external networks—developers and engineers are acutely aware of this. They know that this universal connectivity presents a broad attack surface for hackers and for the propagation of malware. These systems are also increasingly involved with human safety where malfunctions can lead to serious injury or death. They must be designed for safety from the ground up and they must be reliable. And in order to be safe and reliable, they must also be secure from outside attack. Even such things as today’s pacemakers are being designed to prevent unauthorized access. Like safety, security cannot be an afterthought or add-on; it must be an integral part of the design from the very beginning.

A big help to the developer is the use of industry standards such as IEC 61508 for industrial and energy and its derivatives such as ISO 26262 for automotive, IEC 62304 for medical, EN 50128 for rail, IEC 62061 for machinery, and more. These functional safety standards offer a foundation that can prevent hazards that arise from malfunction. As defined by the Industrial Electrotechnical Commission (IEC), “Functional safety is part of the overall safety of a system or piece of equipment and generally focuses on electronics and related software. It looks [...]

By |December 15th, 2016|Articles, MEDS|Comments Off on Safe and Reliable Software Must Also be Secure—and Tested|

New Innoveative Medical Devices



Bayer has announces the Aleve Direct Therapy

Bayer has announced the Aleve Direct Therapy to help patients to temporarily relive lower back pain. Based on a drug-free TENS technology (Transcutaneous Electrical Nerve Stimulation), the unit blocks the body’s pain signals with electrical nerve stimulation and releases endorphins in the areas of pain as a result of its patented waveform technology. The pad can be worn at the back throughout the day on the user’s lower back but not while sleeping, driving, operating heavy machinery or any other activity in which electrical stimulation can put one at risk of injury. A wireless remote control can be used to adjust the level of intensity as needed by the individual. The unit is Class II FDA medical device and priced at $49.99-$59.99 for single quantity.

www.bayer.com 

  aleve_direct_therapy_front_remote_le

Roche Diabetes Care announces the Accu-Chek® Connect system

Roche Diabetes Care has announced the Accu-Chek® Connect system for blood glucose monitoring.  The system includes a meter, app (Android and iOS), and online portal. Patients can view, share, and access blood sugar data anytime, anywhere. Here is how it works. Blood test results are sent wirelessly from the Accu-Chek Aviva Connect meter to an app installed by the patient and /or the care takers. Data can also be stored in an online portal securely. The insulin requirement can be updated by the caretakers easily. Easy-to-understand charts are available to help patients to manage diet and physical activities. Photos can be added to remember the patient on what foods have been taken. Research has found that one of the most important requirements [...]

By |November 23rd, 2016|MEDS, RTC Magazine|Comments Off on New Innoveative Medical Devices|

Medical Device Market Trends



The overall healthcare market is changing in many ways. The healthcare market will rise from $3 trillion this year to $4.7 trillion in 2024, the real per capita health expenditure growth rate will decrease from 4% to 1.5% according to BMI Research (www.bmiresearch.com), a market research firm covering medical devices. (Figure 1). In other words the projected overall medical devices purchase will decrease. To compensate for the revenue short fall, medical device firms will diversify. This can be in the form of acquisitions and mergers. We have already seen changes taking place. In March 2016, the struggling Toshiba sold its Toshiba Medical Unit to Canon for $6.11 billion. Given Imaging, inventor of the swallowable camera was acquired by Covidien early 2014 for $860 million. Not bad for an exit strategy. Medtronic later acquired the Ireland-based Covidien for $42.9 billion while Becton Dickinson acquired the San Diego based CareFusion for growth reason. This trend is expected to increase over the next few years. Another trend we expect to see is more and more innovative products and solutions coming from start-ups and smaller firms. Separately, wearable devices are gaining momentum in the healthcare industry for process simplification such as clinical workflow and data analysis. According to Global Industry Analysts, Inc. (www.strategyr.com), a market research firm, the wearable devices market is expected to double from $2 billion in 2015 to $4.6 billion in 2020 worldwide with USA represents almost half of the market.

Break-through innovations

Sotera sets future trend of patient monitoring

Those who have stayed in the hospital overnights often complain it is difficult to get a good night sleep being waken up constantly for temperature and other types of measurement. [...]

By |November 23rd, 2016|MEDS, RTC Magazine|Comments Off on Medical Device Market Trends|

IEC standard on health software products nears completion



For several years, IEC Subcommittee 62A and ISO Technical Committee 215 have been collaborating on a new family of standards dealing with health software.  The first part of this series, which is designated IEC 82304-1, is about to enter the final approval stage leading to publication in the fourth quarter of 2016.

In the context of the ISO/IEC 82304 series of standards, health software refers to software that contributes to the health of individuals as observed and/or demonstrated using measurable health parameters or clinical expertise.  This is a subset of the World Health Organization’s (WHO) definition of health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity” (WHO, 1946).

IEC 82304-1 deals with general requirements for safety and security of ‘health software products’.  A health software product is the combination of the health software and the necessary accompanying documents, regardless if those documents are provided electronically or in hard copy.  To quality as a health software product, the health software must is intended to operate on any type of general computing hardware platform, which can include laptop computers, tablet computers and smartphones, and is placed on the market without dedicated hardware.  Such health software is sometimes referred to as ‘standalone software’.  This approach is congruent with the International Medical Device Regulators Forum’s (IMDRF) key definition of ‘Software as a Medical Device (SaMD)’.[1]

IEC 82304-1 does not apply to health software that is intended to run on dedicated hardware, which is sometimes referred to as ’embedded’ software.  Imbedded health software is considered to be a part of a physical device and not a product in its own right.  Therefore, IEC [...]

By |November 23rd, 2016|Articles, MEDS, RTC Magazine|Comments Off on IEC standard on health software products nears completion|

University of Virginia State-Wide Telehealth Network

University of Virginia State-Wide Telehealth Network

By University of Virginia

Since 1994, the University of Virginia Health System’s Off¬ice of Telemedicine has grown to become an international leader in telemedicine. Providing more than 40,000 consults in over 40 specialties, UVA’s telehealth services range from clinical consultations to medical education for providers and patients across Virginia, surrounding regions, and internationally.

Within the broad region served by the UVA Health System lies the coalfields of Southwestern Virginia, one of the largest medically underserved populations in the Commonwealth. Access to care is limited, resulting in increased burdens on patients who must incur additional travel time and costs.

“The coalfields in Southwestern Virginia have some of the worst outcomes in the country. We needed a way to provide care to patients in these regions without making them travel.”

– David Cattell-Gordon, Director, Off¬ice of Telemedicine, University of Virginia

The UVA Health System needed a solution to care for patients and their families without the negative impact of moving people great distances or displacing them from their homes. In the specific case of stroke care, every second directly impacts the outcome. A solution was necessary to connect the right patient to the right doctor at the right time.

Avizia’s telemedicine carts were incorporated into UVA’s comprehensive telemedicine program to extend its services into hard-to-reach areas, improve the quality of patient care, and reduce costs for both patients and the university.

“Avizia didn’t just help deliver the right product, their team took the time to understand our needs completely and consult with us on use cases. They trained our team on how to use the products effectively in order to get us up and running quickly.”

– David Cattell-Gordon, Director, Off¬ice of Telemedicine, [...]

By |October 26th, 2016|Articles, MEDS|Comments Off on University of Virginia State-Wide Telehealth Network|