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How Artificial Intelligence (AI) and Deep Learning Impact the Future

How Artificial Intelligence (AI) and Deep Learning Impact the Future

An Interview of Dr. Maya Dillon, Head of Data Science, Global Centers of Expertise at Luxoft, a global technology consulting company focused on business transformation solutions for Fortune 500 companies.

By John W. Koon, Editor-in-Chief

Dr. Dillon provides support for data science solutions across Luxoft’s Lines of Business. She helps clients make sense of large, disparate data sources to extract real actionable insight. As a result, she helps businesses deliver new, differentiated products, driving competitive advantage. Dillon is a member of the Tech London Advocates organization and a supporter of The Royal Astronomical Society. She received her Doctorate in Astrophysics from the University of Warwick.

1. Can you provide an overview of what Artificial Intelligence (AI) and Deep Learning and how it will impact the future development of technologies? Please include an example or two.

There are two particular arenas of AI that are fascinating to me:

Healthcare: Diagnosis and Treatment of Diseases:

AI is now capable of diagnosing diseases with greater accuracy than human doctors by taking into account a larger number of factors. The use of AI in subsequent treatment is also compelling, particularly in the case of cancer. AI now supports everything from the identification of tumors, to implementing therapy, to aiding the excision of masses. Such methods are vastly improving the efficacy of current treatment plans, and consequently improve the quality and longevity of patients’ lives.

Automotive: Self-Driving Vehicles:

The key to a successful self-driving vehicle is ensuring the AI controlling the vehicle is constantly aware of the events occurring around it, in order to recommend or enforce a course of action.

However, [...]

By |October 15th, 2017|Articles, Editors Report, MEDS, RTC Magazine, Special Feature, Technology In Context|Comments Off on How Artificial Intelligence (AI) and Deep Learning Impact the Future|

Engineered Success: The Engineer’s Contributions to FDA Medical Device Market Commercialization

The FDA process for medical device clearance is a frequently heard story … but not from the engineer’s perspective. When it comes to commercializing a medical device, the engineering team plays a key role in facilitating successful market entry.

When it comes to regulatory compliance and public safety, most medical device companies rely upon the skills of a professional engineer to ensure their product effectively fulfills its intended use. The contributions the technical team can make to facilitate the commercialization process are both critical and substantial. In fact, thinking of commercialization strategies that include engineering expertise from product concept through completion may help your product get to market faster, more easily and more affordably.

Preparing for and Anticipating the FDA Commercialization Process

One of the most common questions we hear from emerging medical device companies is, “When should we begin preparing for the FDA?” The answer is, “As soon as possible.” Emerging companies often devote their time, talent and treasure to product development. During the R&D phase, companies are typically driving toward the completion of their pre-clinical program or a final prototype. Because the focus is so intent on product development, and commercialization seems to be in the distant future, it can be easy for activities like documentation related to meeting FDA expectations to be pushed aside.

Documentation, however, is critical for an FDA submission. There are a number of activities the engineering team will be involved in supporting, such as the development of technical documentation that is part of a submission. At minimum, these activities include preparing documentation like completing risk assessments and performing validation activities. Engineers are vital for these [...]

By |September 15th, 2017|Articles, MEDS, RTC Magazine, Technology Deployed, Technology focus|Comments Off on Engineered Success: The Engineer’s Contributions to FDA Medical Device Market Commercialization|

Human Factors and Medical Device Development

Human Factors can truly be a win-win for manufacturers, engineers and consumers, but you must PLAN. Human Factors is NOT a “wait and see what happens” activity solely at the end of medical device development.

Virginia A. Lang, PhD

Medical Device Human Factors by HirLan, Inc part of HirLan Institute of Human Factors

You plan for weddings, graduations, holidays and other significant events. Why would you not plan for the successful market launch of a medical device that is going to impact the health and well-being of patients? You plan so that you have a clear picture of costs, timing, profit, etc. You bring in experts from different functions. But, are you including Human Factors/Usability experts at the early planning stages? It has been consistently shown that integrating Human Factors expertise and processes into the early phases of development decreases overall costs and time to market.

Be a Planner. Don’t “wait and see”.

The FDA requires human factors/usability testing of medical devices and in all their guidances they discuss the importance of early integration of human factors/usability. By the way, so do all the ISO/IEC standards for granting the CE mark. They do this because it is known that Human Factors/usability processes and testing is not only a win-win for medical device manufacturers, but also for end users.Human Factors: FDA and CE MarkHuman Factors Engineering is grounded in scientific research methodology, statistics, human physiology, and cognitive information processing. It is the intersection of engineering, human physiology, behavioral performance, [...]

By |September 15th, 2017|Articles, Industry Insider, MEDS, RTC Magazine|Comments Off on Human Factors and Medical Device Development|

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|