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What's ahead in 2015.

Q: What's in store for the medical device sector in the coming year?

The medical device industry is always providing an exciting environment that I love to cover. While the biggest news in 2014 seemed to revolve around M&A, there were still stories of incredible innovations in development that will hopefully enhance the level of healthcare in the near future. Meanwhile, with another year on the horizon, I wanted to take the "temperature" of members of industry to see what they were expecting in 2015.--Sean Fenske, Editor-in-Chief

Deb Kacera

Regulatory & Industry Strategist, Pilgrim Quality Solutions

In 2015, the medical device industry will be focused on meeting the regulations that support the speed and quality of capturing electronic information and the efficiency of sharing information. While 2014 saw the initiation of the Unique Device Identifier (UDI) regulation for Class III devices, 2015 will see the implementation of this regulation as well for Class II implant and life-supporting device manufacturers. More device manufacturers will be getting involved in submitting and maintaining UDI attribute information in the GUDID. In addition, the post-market electronic MedWatch reporting regulation will require all manufacturers with FDA-CDRH post-market mandatory reporting requirements to finally submit their MedWatch reports in an .xml file format in August 2015. The FDA is embracing technology to communicate discrete information more efficiently and they are bringing the medical device manufactures with them this coming year.

Walt Maclay

President, Voler Systems

During 2015, sensors will continue to be a driving force for innovative medical devices. We will see advances in chemical sensors, especially "lab on a chip," and paper-based sensors. Driven by faster analysis time and extremely small fluid requirements, we will continue to see integration of more laboratory functions on a single chip. Additionally, we will see paper-based sensors being used in clinical diagnosis, food quality control, and environmental monitoring. Fiber optic sensors, early in their adoption by industry, will continue to break new ground; since they don't use wires and are non-conducting, they are safe to touch and you can insert them into the human body without fear of shock. Fiber optic sensors are also small (only a quarter of a millimeter in diameter), which makes them suitable for a wide variety of tasks. They are able to handle harsh environments where they can measure pressure, temperature, strain, and flow depending upon how you configure them. You can also take measurements along the length of the fiber, which means that you have effectively hundreds of sensors in one strand.

John Smith

Partner, Hogan Lovells

Three notable items for 2015: Data supporting marketing applications FDA's premarket data requirements continue to increase, with a broader range of devices subject to clinical data requirements and expectations for pre-clinical data continuing to increase. The result has been a significant increase in the regulatory burden for many companies and, in many instances, the need for extensive pre-submission discussions before a marketing submission is even filed.

Continued issues with the "refuse to accept" process --The agency's relatively new "refuse to accept" (RTA) process continues to confuse applicants who infrequently file 510 (k) notices and creates delays as companies frequently encounter negative RTA determinations. The RTA program has driven many sponsors "in the know" to substantially increase the level of detail in 510(k) submissions, leading to lengthier and more complex applications. It's uncertain at best if such complexity is necessary for many devices.

Standalone software--FDA continues to struggle with the rapid development of sophisticated analysis software across a wide range of clinical applications. In many instances, FDA applies its traditional regulatory paradigm of data-supported safety and efficacy determinations to this software, significantly slowing or even preventing the introduction of new software-based technology.

Michael McNeil

Product Security & Services Officer, Philips Healthcare

In April of 2 014, Wired Magazine made the rattling proclamation that "it's insanely easy to hack hospital equipment," citing cybersecurity researcher Scott Erven's two years of medical device vulnerability investigations and the many ways in which such equipment can be compromised. The research portrayed by the tech magazine's article was dead-on, and as a result, medical device manufacturers like Philips Healthcare and other leading companies are taking risk assessment, security by design, and incident response management policies to the next level, implementing thorough security programs and new technologies that will mitigate threats against end-user patient information and health in 2015.

Such new policies will only grow in scope of complexity and importance. Gartner estimates that almost 26 billion devices will be connected to the Internet of Things by 2020, with medical devices accounting for a significant portion of that total. With added connectivity comes increased risk of exposure to security breaches, so the year 2015 will play an integral role in the molding of effective defensive protocols developed in collaboration between leading medical device manufacturers, healthcare providers, and the security community at large.

Dan Piekarz

Vice President of Business Development--Life Sciences, DataArt

Technology implemented well is greatly increasing our ability to understand the human body and how to care for it. In 2015, next generation genetic sequencing techniques will be revolutionizing diagnosis of infectious disease, but the FDA's recent move for tighter regulation of laboratory developed tests may slow progress. As this technology becomes readily available, it will speed up diagnosis and eliminate diagnostic errors. Telehealth virtual doctor visits will also begin to bring back low cost, at-home virtual visits, making physicians more accessible and reducing the time and effort it takes for a patient to receive the care they need. We also see mHealth and wearable technologies advancing quickly in healthcare, as they are being used to improve the quality of data collected in clinical trials, and improving the lives of patients with chronic conditions like diabetes and heart conditions. These are just three trends out of many advances that will provide early prevention, quicker diagnosis, and better overall healthcare.

Brian Beahm

CTO, Beahm Designs Inc.

As the medical device industry continues to face complex challenges in new product development and launch, the trend in 2015 will increasingly migrate toward automation at every level of the supply chain. When we founded Beahm Designs in 1990, the industry was so new that companies routinely kluged solutions together to get the job done. Beahm Designs' initial product line actually emerged 30 years ago as a solution to this problem.

With catheter designs becoming smaller and more complex while manufacturing processes requiring higher precision and repeatability, automation has begun to extend to every level of the manufacturing process. As ISO and similar certification compliance requirements remain stringent, medical device manufacturers are put to the test every time they attempt to bring a new product to market.

In response to customer demand, our challenge in 2015 is to automate as much of the manufacturing process as possible, eliminating the possibility of user error, increasing throughput, and protecting the operator from injury every step of the way.

David Surber

VP of Medical Products, TUV Rheinland

It is estimated that 500 million smartphone users worldwide will use healthcare applications in 2015--from using the phone to detect glaucoma in the eye to taking cardiac measurements. The users include healthcare professionals, consumers, and patients. In contrast, only about 100 of the almost 100,000 mHealth apps on the market are approved by the U.S. Food and Drug Administration.

Patient data stored on many apps is the prime target for cyber theft and is worth 10 times more than credit card data on the black market. To help protect consumers from cyber theft and the app provider from liability if the data is stolen, developers will be turning to cybersecurity experts to help ensure the devices are designed with security in mind and in compliance with the FDA's "Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff" issued on September 25, 2013. Additional regulations may also apply depending on how the app is used.

Rob Kim

Strategic Marketing Director, Honeywell Sensing and Control

Medical equipment, driven by patient convenience and cost reduction, is moving from the hospital to the home. In addition, typical home-use products, like CPAP machines are becoming smaller and more sophisticated. In a hospital or clinical environment, medical professionals are entrusted to maintain and operate the equipment, but in a home environment that responsibility often resides with the end user, their family, and caregivers. The lower level of oversight requires that medical equipment be simple to operate and extremely safe. To make the product simpler for the user often means additional demand is placed on having smart sensors inside the medical devices. Products like CPAP machines, infusion pumps, and peritoneal dialysis are getting smarter, smaller, and providing new levels of performance.

These products require high-performing sensors. The sensors must be highly robust, accurate, consistent, and durable. As equipment gets smaller, the space available for sensors is also reduced. Pressure sensors, for example, are getting smaller by combining MEMS structures with sophisticated electronics to obtain better accuracy in a smaller package. Some pressure sensors contain integrated ASICs, which reduces the need for additional circuitry for signal conditioning and A/D conversions.

Some sensors are used to measure the pressure of fluids in the body. Sensors that contact body fluid are often single-patient use, enhancing safety against communicable diseases such as AIDS and Ebola. Today's pressure sensors are provided at high volumes and price points that facilitate single-use applications.

Mila Heeman-Ilieva, Ph.D.

Senior Marketing Manager, Teledyne DALSA

The introduction of thin-film-transistor (TFT) flat X-ray detectors in the late 1990s rapidly changed the landscape of the dynamic X-ray imaging market. In less than 10 years, the incumbent technology, the image intensified CCD (IICCD), has been replaced in more than 90% of the Cath Labs worldwide with flat detector (FD) technology. The many advantages flat detectors provide have made the transition possible and justified the significant price difference between FD and IICCD.

In the mobile C-arms market, however, the situation is different. Nearly 10 years after the first introduction of TFT flat detectors in mobile C-arm systems in early 2001, barely 10% of those systems are equipped with flat panel. The major reason is the unsatisfactory performance of the TFT flat panels at low dose, which cannot outweigh the advantages of their slim form factor.

This is about to change. The next generation of CMOS flat X-ray detectors, combine and, by far, surpass the advantages of the two established technologies in dynamic X-ray imaging--the low dose image quality of the IICCDs and the flat form factor of the TFT flat detectors. In 2015, we will witness new offerings, including new mobile C-arm systems with CMOS detectors.

Sam Pelonis

President, Pelonis Technologies Inc.

Heating technology will continue to become more precise in the New Year. The introduction of heating solutions such as the ultra-thin flexible heater--a product Pelonis Technologies introduced in late 2014. What makes the ultra-thin flexible heater an important alternative to printed or wired circuits in heating elements? The flexibility, low EMI, and operable temperature range (and precision) make them an ideal fit for the medical device industry.

Specifically, these heaters are less than 0.22 mm thick and weigh only 0.04 g/cm2, allowing for targeted heating in limited space settings such as laboratories. Where previous heating solutions were fragile and often imprecise, the new flexible heating technology will provide better control. For example, a blood analyzer will be able to control temperatures increments of [+ or -] 0.1.

As the technology behind electronic device continues to evolve, so too will the ability of portable heating and cooling solutions to meet their very precise requirements. In 2015, this precision will only further increase.

Dr. Mark Carlson

Chief Medical Officer, St. Jude Medical

This year has been a dynamic year as the medical device sector continues to adapt to the changing healthcare environment. As an industry, we are called to develop innovative solutions that address prevalent, devastating, and costly conditions in ways that improve patient outcomes, quality of life, and lessens the financial burden on society.

Cardiovascular diseases like atrial fibrillation and heart failure are among the most complex and costly healthcare problems facing our society today. Heart failure alone affects more than five million Americans and costs society more than $31 billion annually.

In 2015, we will see significant emphasis on these expensive diseases and more innovative, cost-effective technologies that add value to healthcare system.

St. Jude Medical is leading the charge with pioneering solutions like Cardio-MEMS HF System, which is poised to redefine heart failure management and reduce its economic burden. The Cardio-MEMS technology is the first and only heart failure monitoring device proven to significantly reduce hospital admissions when managed by physicians.

Today, innovation focuses on reducing mortality, improving health, and enhancing healthcare efficiency. Physicians and hospitals can now--more than ever before --improve the lives of more patients at a lower cost and without added burden to patients.

Neil Smiley

Founder and CEO, Loopback Analytics

The healthcare industry is shifting toward fee-for-value payment models based on outcomes. For this to reach its full potential, healthcare providers need to develop systems that span the full continuum of care.

In 2015, 1 foresee three trends emerging. Community Coalitions--Most healthcare spending is local. When a patient goes out of network to receive care, providers lose visibility of interventions and outcomes. One response to this challenge is health coalitions comprised of competing healthcare providers that span the care continuum. I predict in 2015, healthcare IT infrastructure will allow coalition providers to communicate, collaborate, and coordinate with other providers, without sacrificing each provider's distinct competitive interests.

Rob Phillips

Managing Director, Accutronics Ltd.

Medical technology is one of the world's fastest growing industries. We are excited at Accutronics to have launched our latest smart-battery range at COMPAMED. We are looking forward to some great innovations in 2015.

We will see a trend for portable, battery-powered medical devices delivering high power discharge from batteries with high energy densities used in mobile hospital setups and emergency services use.

However, this rise in portability will see companies push further into securing their products. Accutronics has already made headway into improved security by making available a hardware-embedded software algorithm (SHA-1) that can identify and isolate fake batteries, stopping them from being used in critical-care devices. This also provides better batch traceability and deters fraudulent warranty claims.

As the Asian market matures, 2015 will also see the trend for European and North American medtech OEMs to begin to establish a more permanent presence in Asian and Far East economies to secure and win market share of the fast growing premium industry sector.

Finally, 2015 will see OEMs begin to widely consider the role of antimicrobial polymers and coatings for use in device moldings, casings, and on touchable surfaces to minimize the spread of superbugs such as MRSA.

Narrow Networks--Health systems and other referral sources are no longer content to refer their patients to just any post-acute provider. Narrow networks of post-acute care providers that are committed to quality and provide ere dible outcome data are replacing the traditional relationship-based referral process. In 2015, I believe we will see substantial momentum toward a new data-driven informed referral process to match the right patient with the right care setting.

Evidence-Based Models--Because of the growing emphasis on outcomes, there is strong interest in evidence-based models that have shown efficacy through a peer-reviewed study. However, there is seldom any feedback system to ensure that the steps of the models are followed. In 2015, I predict healthcare IT will enable providers with the tools to measure program implementation fidelity and manage continuous improvements.
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Title Annotation:Perspectives On
Author:Fenske, Sean
Publication:Medical Design Technology
Date:Nov 1, 2014
Words:2591
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