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How Medtronic & #039;s Pacemakers Are Now Harder to Hack
FDA approved Medtronic's Azure pacemakers, which feature the company's new BlueSync technology to protect patients from having their device hacked. The BlueSync technology is also now available with the Medtronic Percepta portfolio of quadripolar, MR-conditional cardiac resynchronization therapy pacemakers (CRT-Ps), the company said. BlueSync is intended to enable more secure wireless remote monitoring via Medtronic's CareLink Network, by limiting access to the device functionality and also by protecting patient data. Connected medical devices like pacemakers add value to patient care by enabling remote patient monito...
Source: MDDI - November 21, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Cardiovascular Source Type: news

Why LivaNova Is Unloading Its CRM Business
LivaNova, formerly known as Sorin Group, has decided to get out of the cardiac rhythm management (CRM) business and shift more focus to its areas of strength.  The London-based company plans to sell its CRM business to Shanghai-based MicroPort for $190 million in cash. The business, which makes high-voltage defibrillators, cardiac resynchronization therapy devices and low-voltage pacemakers, generated about $249 million in net sales in the fiscal year 2016. The business has roughly 900 employees with operations chiefly in Clamart, France; Saluggia, Italy; and Santo Domingo, Dominican Republic. The company said in Sept...
Source: MDDI - November 20, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Medical Device Business Source Type: news

Could the Next Big Thing in Medtech Stem from Your Idea?
So, you have a great idea for a new medical device that could improve outcomes, save lives, and make your company lots of money. You just need to get your idea in front of the right person to help make it a reality—which, of course, is easier said than done. Selling ideas to upper management was the topic of discussion during a plenary session at the recent MD&M Minneapolis Conference. Experts on the panel shared these tips to give your pitch its best chance of success. Don't miss your chance to network with your medtech colleagues in Silicon Valley at the BIOMEDevice San Jose Conference and Expo, December 6&ndas...
Source: MDDI - November 20, 2017 Category: Medical Devices Authors: Jamie Hartford Tags: MD & M Minneapolis Medical Device Business Source Type: news

Is There Hope for an Endologix Comeback?
A year ago, Endologix CEO John McDermott walked into the VEITHsymposium at the New York Hilton-Midtown, saw the look on the face of his head of regulatory and clinical affairs as he approached the Endologix booth, and knew something was wrong. Sure enough, FDA had just asked Endologix to provide two-year patient follow-up data from its EVAS-FORWARD study of the Nellix endovascular aneurysm sealing (EVAS) system. "So that night we worked through the night to get out our press release first thing the next morning to inform the world that there was going to be pushback in the timeline and the clinical requirements,&...
Source: MDDI - November 19, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

Is the First Bioprinted Heart Just Around the Corner?
A Chicago bioprinting startup that seeks to 3-D print human hearts for transplantation has added to its scientific advisory board of heavy hitters. But its CEO won’t say how close the company is to producing its first viable heart. Biolife4D just announced it has added regenerative biomaterials expert Adam  Feinberg, PhD to lead its scientific advisory team. Feinberg is associate professor of materials science & engineering and biomedical engineering at Carnegie Mellon University and principal investigator of the regenerative biomaterials and therapeutics group. Feinberg uses materials-based engine...
Source: MDDI - November 17, 2017 Category: Medical Devices Authors: Nancy Crotti Tags: Cardiovascular Implants Source Type: news

Developing a New Score: How Machine Learning Improves Risk Prediction
Composite risk scores have been used for decades to identify disease risk and health status in the general population. However, current approaches often fail to identify people who would benefit from intervention or recommend unnecessary intervention. Machine learning promises to improve accuracy, ensuring targeted treatment for patients that need it and reducing unnecessary intervention. Framingham Risk Score, the gold standard for predicting the likelihood of heart disease, predicts hospitalizations with about 56% accuracy. It uses factors such as age, gender, smoking, cholesterol levels, and systolic blood pre...
Source: MDDI - November 17, 2017 Category: Medical Devices Authors: Heather R. Johnson Tags: R & D Source Type: news

Medical Device Design Is Critical to Bringing Healthcare into the Home
Medical technology is going consumer. Both patients and care givers hold an increasing expectation that the devices they use to manage care will operate with the same ease and usability as the digital products they use every day to manage their lives. As healthcare moves to a home setting, patients require design elements that make the technology easier to use, more intuitive, and more accessible. Medical device companies are responding by focusing during design and development on those needs that are harder to tease out. To succeed in this potential consumer market, the biggest asset to any device is good design and ...
Source: MDDI - November 17, 2017 Category: Medical Devices Authors: Scott Thielman Tags: Design Source Type: news

Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?
There are so many different technical terms, documents, and acronyms you need to know working in the medical device field. There are three types of files specifically that cause a great deal of confusion: the design history file, 510(k) submission, and the technical file. As with any kind of files in medical device development, these require a lot of effort. However, if you have good background knowledge, I think you will find there are similarities between each. Design History File The design history file is an FDA term described in 21 CFR Part 820.30, which talks about design controls and how they must be kept in a ...
Source: MDDI - November 17, 2017 Category: Medical Devices Authors: Jon Speer Tags: Regulatory and Compliance Source Type: news

FDA Turns to Emerging Tech for Opioid Crisis
It will take more than medication alone to win the battle against opioid addiction, and now U.S. clinicians finally have a device-based therapy to help reduce the symptoms of opioid withdrawal. FDA granted a new indication to Innovative Health Solutions for its NSS-2 Bridge nerve stimulator. The new indication was reviewed under FDA's de novo pathway. “There are three approved drugs for helping treat opioid addiction. While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy,” said FDA Commissioner Scott Gottlieb, MD. G...
Source: MDDI - November 16, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

This $100M Asset Deal Has Merit
Merit Medical Systems has agreed to pay $100 million for assets that BD (Becton, Dickinson and Company) and C.R. Bard need to sell in order to finalize their $24 billion merger. Included in the proposed asset sale are BD's Achieve programmable automatic biopsy system, Temno biopsy system, and Tru-Cut biopsy needles. These products are currently sold worldwide through a combination of a direct sales force and distribution partners. Additionally, Merit agreed to acquire Bard's Aspira pleural effusion drainage kits and the Aspira peritoneal drainage system. These systems are primarily sold in the Unit...
Source: MDDI - November 16, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

How a Tiny Breast Cancer Device Carries Big Value
With all the uncertainty in today's healthcare system, the one thing everyone seems to agree on is that value-based care is here to stay. Cianna Medical understands that particularly well, and the company's latest FDA clearance is expected to add even more value to the continuum of care for breast cancer patients and their providers. Cianna's Savi Scout reflector can now be implanted in breast cancer patients without restrictions on the length of time that it can remain in the breast. The device is a non-radioactive implant used in wire-free localization. It is only activated when a special handpiece, which acts as the rad...
Source: MDDI - November 16, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news

GI Dyanamics Takes Another Kick in the Gut
GI Dynamics has lost its right to sell its EndoBarrier device in the European Union under a CE mark. The company reported this week that its notified body SGS United Kingdom has withdrawn the CE Certificate of Conformity for EndoBarrier as of Nov. 12.  The company first received word in May that its CE mark was being suspended pending resolution of nonconformances related to ISO 13485 compliance. GE Dynamics said it has been working to address the issues raised by SGS. The company said it is considering its options, including grounds for appeal of the decision, and that it has reached out to SGS to clarify c...
Source: MDDI - November 15, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

GI Dynamics Takes Another Kick in the Gut
GI Dynamics has lost its right to sell its EndoBarrier device in the European Union under a CE mark. The company reported this week that its notified body SGS United Kingdom has withdrawn the CE Certificate of Conformity for EndoBarrier as of Nov. 12.  The company first received word in May that its CE mark was being suspended pending resolution of nonconformances related to ISO 13485 compliance. GE Dynamics said it has been working to address the issues raised by SGS. The company said it is considering its options, including grounds for appeal of the decision, and that it has reached out to SGS to clarify c...
Source: MDDI - November 15, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

How to Reduce the Burden of Iterative Design and Evaluation
Conclusions HFE is an integral part of the medical product development process, helping manufacturers develop safe, effective, and usable products. It has a much broader remit than just conducting usability testing such as a formative or validation study. It utilizes a number of complementary activities and techniques including Preliminary Analyses which has been the focus of this article. Preliminary Analyses—Identification of Known Use Problems, Task Analysis, and Use-related Risk Assessment—should be conducted at the outset of the design and development process of a medical product in order to iden...
Source: MDDI - November 15, 2017 Category: Medical Devices Authors: Suresh P. Gupta Tags: Design Source Type: news

Could CDC ’s New Catheter-Site Dressing Advice Curb Infections?
To help prevent intravascular catheter-related infections, the Centers for Disease Control (CDC) has updated its guidelines on catheter-site dressing regimens. The CDC now advises that for patients aged 18 years and older, “Chlorhexidine-impregnated dressings with an FDA-cleared label that specifies a clinical indication for reducing catheter-related bloodstream infection (CRBSI) or catheter-associated bloodstream infection (CABSI) are recommended to protect the insertion site of short-term, non-tunneled central venous catheters (1A)." Previously, according to its 2011 guidelines, the CDC recommended the use of ...
Source: MDDI - November 15, 2017 Category: Medical Devices Authors: Daphne Allen Tags: Medical Device Business Source Type: news

Q & amp;A: How to Evaluate New Technologies for Success
When it comes to product development, there’s rarely a shortage of innovative technologies that can help take your product to the next level — but how do you know which technology is right for your device? Evaluating emerging technologies can be a tricky business, and can often make the difference between success and failure for your product. Megan Moore serves as marketing director and program manager at Battelle, a global R&D organization that helps bring together science and technology to produce products and applications. For over a decade Moore has managed her groups’ technology scouting and...
Source: MDDI - November 14, 2017 Category: Medical Devices Authors: Kristopher Sturgis Tags: BIOMEDevice San Jose R & Source Type: news

Beware of Illegal Breast and Butt Implants
FDA is cracking down on illegal products intended to boost the size of a person's breasts, butt, or other body parts. “We have significant concerns with unsafe injectable silicone that’s being marketed for body contouring by unlicensed providers. We’ve seen serious adverse events result from products, which are sometimes industrial-grade silicone, being used for these unapproved medical purposes,” said FDA Commissioner Scott Gottlieb, MD. “The FDA has stepped in to take enforcement actions against unscrupulous actors who promote and provide these services, but we also want to make the public a...
Source: MDDI - November 14, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

The Grass Is Green for Medtech on the Emerald Isle
You don’t have to be a medtech veteran to have heard of Ireland’s ties to the industry. Still, even those who have spent years working in medical devices and diagnostics may be surprised to learn that 14 of the top 15 global medtech companies—including Boston Scientific, DePuy Synthes, Medtronic, Teleflex, and many more—have facilities in Ireland. Why Ireland? Just what is drawing medtech to Ireland? The country has gained recognition as a frequent target for corporate inversion deals that enable companies to fall under more favorable corporate tax rates, but a 12.5% tax rate is just part of what br...
Source: MDDI - November 14, 2017 Category: Medical Devices Authors: Marie Thibault Tags: Medical Device Business Source Type: news

Medtech Employers Need to Keep Pace with Job Market
The medical device and diagnostics industry is a smart place to build a career. Professionals working in the field say they enjoy the work for the chance to pioneer new medical advances, to solve challenges, and to make a positive impact for patients. For the past few years, medtech employees have been able to call the shots, with an abundance of well-paying, meaningful roles and continued growth in the sector. As the trend toward crossover with consumer tech continues and as other industries piles on cool perks, high salaries, and prestige, leading medtech recruiters are urging medtech companies to keep an eye on their ke...
Source: MDDI - November 14, 2017 Category: Medical Devices Authors: Marie Thibault Tags: Medical Device Business Source Type: news

How to Identify Crossover Technologies That Work for Medtech
Cross-pollination, the idea of taking something that has proven useful in one industry and applying it to another industry, has become an interesting trend in innovation-oriented fields like medtech. Sometimes borrowing seemingly-simple ideas from other corners of the technology world can lead to surprisingly impactful solutions to challenging healthcare problems. So how do identify and adapt technologies from other industries for use in medical devices? What level of maturity does a technology need to achieve in another industry before you can take it and consider it for medtech? And why is it so important for medtech pro...
Source: MDDI - November 13, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis R Source Type: news

The Making of a Surgical Robot
  Designing a surgical robot for minimally invasive surgery can be quite daunting, especially with the myriad of advanced technologies that we have access to today. This presentation provides an overview of key findings and considerations for designing a minimally invasive surgical robot and includes a view to the future.  1. Identifying the Need through ethnographic research.  "This is immersing yourself in the environment. The first thing I do is I go into a clinical environment and watch the procedure. I want to be a fly on the wall, I don't want to interrupt the process or make t...
Source: MDDI - November 12, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis R Source Type: news

Take Charge of Your Future in Medtech
Are you ready for a new job, or maybe a first job, in medtech in 2018? Be proactive and make a plan that gets you closer to your dream medtech role by educating yourself on today’s job market. MD+DI is hosting a webinar, “Jumpstart Your Career in Medtech,” on Tuesday, November 14. Hear from two Boston-area experts with decades of experience in talent acquisition and recruiting for the medtech industry—Phil Nachman of Nachman BioMedical medical device and diagnostics industry search firm, and Jessica Levesque, senior manager of human resources at Instrumentation Laboratory. Nachman and Levesque will ...
Source: MDDI - November 11, 2017 Category: Medical Devices Authors: Marie Thibault Tags: Medical Device Business Source Type: news

How to Get a Thumbs Up Every Time
Correcting major misconceptions around the process of medical device product development makes for a more elegant approach. What many may think is a best practice is probably not ideal and is actually an inefficient process. A lot of conventional wisdom is flat out backwards and contradicts simple logic. Topics covered will include: Defining current development vs. ideal development practices Rethinking our standard tools and techniques to "bust myths" Creating and utilizing an efficient development strategy Looking at a case study of serial commercial success (Source: MDDI)
Source: MDDI - November 10, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis R Source Type: news

Embrace This 4-Letter F Word
Medical device success stories are everywhere. But the savvy R&D experts recognize the importance of pulling the plug on a project that just isn't cutting it, and those are the stories that provide the best learning opportunities.  The ability to embrace failure became a recurring theme throughout the MD&M Minneapolis conference, and at least three speakers bit the bullet and shared stories of projects that, for one reason or another, fell short. Dale Larson, director of commercial initiatives at Cambridge, MA-based Draper Laboratory, was among the first to share a failure story Wednesday during a panel d...
Source: MDDI - November 10, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis R Source Type: news

Smart Devices to ‘Revolutionize’ Treatment, says CPhI Award Winner
Biocorp, a developer of connected devices, has been recognized in CPhI’s annual Pharma Awards announced during CPhI Worldwide. Honored in the "IT, mHealth, and Digitalization" category, Biocorp offers technologies such as Inspair (an intelligent sensor that transforms a conventional inhaler into a connected device) and DataPen (reusable and communicating pen injector).Eric Dessertenne, deputy chief officer of Biocorp, tells MD+DI that connected health “will be a new way to treat patients with more direct contacts between patients and healthcare professionals. It will also provide an incredible source ...
Source: MDDI - November 9, 2017 Category: Medical Devices Authors: Daphne Allen Tags: Digital Health Source Type: news

Designing Connected Medical Devices: Overcoming Key RF Challenges
As medical devices become more sophisticated and are marketed as “wellness devices” instead of medical equipment, their form factor is also shrinking. That’s making Internet of Things (IoT)-based medical devices even more popular with patients who don’t want or need to be tethered to a hospital or healthcare facility for real-time monitoring. Analyst firm Berg Insight says in 2016, 7.1 million patients enrolled in some form of digital health program featuring “connected” medical devices as a core part of their care plan. Berg expects the number of remotely monitored patients will reach 5...
Source: MDDI - November 9, 2017 Category: Medical Devices Authors: Dermot O & #039;Shea Tags: Digital Health Source Type: news

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Source: MDDI - November 9, 2017 Category: Medical Devices Authors: Jamie Hartford Tags: Adhesives Source Type: news

5 Reasons Big Medtech Companies Can (and Should) Innovate
Given how much money big medical device companies spend each year on acquisitions, it's clear that those companies have a desire for true innovation. And yet, they hold back on R&D spending because larger corporations need predictability, repeatability, and scalability. Simply put, they are less risk tolerant than startups. Steve Geist, director of R&D within the transcatheter mitral and tricuspid therapies division at Edwards Lifesciences, gave MD&M Minneapolis attendees five solid reasons why big medtech firms can, and should, innovate beyond line extensions. 1. They already have an R&D infrastructur...
Source: MDDI - November 8, 2017 Category: Medical Devices Tags: MD & M Minneapolis R Source Type: news

New Global Compliance Requirements Will Impact Medical Device Industry
The medical devices and diagnostics (MD&D) industry is on the verge of disruption, as new global compliance requirements are set to take effect. In March 2019, the 2016 revision to ISO 13485 will require the incorporation of risk management into every aspect of the quality management system. Also, the European Commission ratified new medical device regulations (MDR) for all European member states, while FDA released more than a dozen new medical device guidance documents in 2016 and 2017 that set new expectations for risk assessment. As a result of these changing regulations, MD&D companies are urgently working to ...
Source: MDDI - November 8, 2017 Category: Medical Devices Authors: Melonie Warfel Tags: Regulatory and Compliance Source Type: news

Initiatives to Reduce Catheter-Related Complications Drive U.S. Vascular Access Devices and Accessories Market
Conclusion The U.S. market for vascular access devices will continue to grow through 2024, and will be spurred by new catheter technology and accessories intended to improve patient outcomes. Going forward, healthcare workers will follow appropriate usage guidelines in greater numbers, and purchasers will exercise preference towards catheters and other products that reduce complications. The specialized catheter securement market is poised to benefit considerably from these trends. References U.S. Vascular Access Device Market – 2018. iData Research. Chopra V, Flanders S, Saint S, Woller S, O'Grady N, Safdar N et al...
Source: MDDI - November 7, 2017 Category: Medical Devices Tags: Tubing Medical Device Business Source Type: news

Cybersecurity Vulnerability Tops 2018 Health Tech Hazards List
Recent alarming incidents involving hacking, ransomware, and vulnerable medical devices have made it clear that cybersecurity needs to be a top priority in healthcare. The ECRI Institute is highlighting its importance, placing “Ransomware and Other Cybersecurity Threats to Healthcare Delivery Can Endanger Patients” as the top issue on its list of Top 10 Health Technology Hazards for 2018. The issues are chosen by considering criteria including preventability, frequency, severity, and potential scope. The ECRI Institute authors wrote in an executive brief, “In a healthcare environment, a malware attack can...
Source: MDDI - November 7, 2017 Category: Medical Devices Authors: Marie Thibault Tags: Medical Device Business Source Type: news

Q & amp;A: How to Prepare for an AI-Driven Future
For years the role of robotics and artificial intelligence within the realm of medtech has been hyped as the future of innovation and device development. Now that technological advances are beginning to catch up to our imagination, how will advanced robotic and AI technologies begin to reshape the medtech landscape?  Srihari Yamanoor With advances in machine learning and robotic design, artificial intelligence is poised to have a dramatic impact on the medical device field. With innovative opportunities on both the diagnostic and therapeutic sides of medicine, AI technologies could be the key that unlocks...
Source: MDDI - November 7, 2017 Category: Medical Devices Authors: Kristopher Sturgis Tags: BIOMEDevice San Jose Assembly and Automation Digital Health Source Type: news

Medtronic & #039;s Tiny Pain Treatment Device Approved in Europe
Medtronic has seen its pain stimulation sales slip in recent quarters, but that could be about to change.  The company just received a CE mark for its Intellis platform for both spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) as an aid in the management of certain types of chronic pain. This clearance to sell Intellis in Europe follows FDA approval of the Intellis SCS in September. The platform has a lot going for it, including its size. According to Medtronic, this is the world's smallest fully implantable SCS neurostimulator. The device is designed to simplify and improve the patient experience ...
Source: MDDI - November 7, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news

Three Steps Toward a Successful Clinical Trial for a Combination Product
This study should use comparative clinical endpoints in patients with a clinical diagnosis for the indication of interest. Patients should be randomized to three groups in a 2:2:1 ratio, where the treatment arms receive the combination product, the drug or biologic alone, and the device alone (or in some cases, with a placebo), respectively. If a double-blinded design is not possible, FDA will accept an unblinded design if all trial evaluations occur in a single, blinded core facility. To demonstrate bioequivalence, both active treatments must be superior to the device alone. 2) Run a Small Pilot Study Next, sponsors ...
Source: MDDI - November 7, 2017 Category: Medical Devices Authors: Cynthia Pritchard, PhD Tags: R & D Source Type: news

Abbott Scores Japan Approval for MitraClip
Patients in Japan who previously had limited options for mitral regurgitation (MR) can potentially benefit from Abbott's MitraClip device. Japan's Ministry of Health, Labour, and Welfare (MHLW) has approved the catheter-based therapy for MR, a progressive heart disease in which the mitral valve does not close properly, allowing blood to flow backward into the heart. During Abbott's third-quarter earnings call, as transcribed by Seeking Alpha, CEO Miles White told investors that a continued global uptick of MitraClip sales led double-digit growth in the structural heart category. Now that the device has been approved in Jap...
Source: MDDI - November 6, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Intuitive is Giving Thoracic Surgeons Something to Talk About
Results from the first clinical study assessing the safety and performance of Intuitive Surgical's new flexible robotics platform were released this week at the CHEST annual meeting. The findings suggest that the surgical platform is both safe, and provides a practical approach for sampling lung tissue. The study was carried out at Australia’s Royal Brisbane and Women’s Hospital where the platform was used on 30 different patients to evaluate both the safety and feasibility of the surgical system. The new system is a catheter-based technology that was designed to access some of the more difficult-to-reach areas...
Source: MDDI - November 3, 2017 Category: Medical Devices Authors: Kristopher Sturgis Tags: R & D Source Type: news

Should Medical Devices Come with Expiration Dates?
The concept of an expiration date was created to help consumers realize when a product should be discarded. The concept has taken hold and has become an expected and regular part of daily decision-making for people around the world. Though the concept can be misused, it has merit because the manufacturer knows best when it comes to the shelf life or useful life of a product! Shelf life is supposed to be assessed by the manufacturers using a scientific analysis of the product to determine when the key chemical(s) within the product lose effectiveness and/or the compound changes composition and becomes something el...
Source: MDDI - November 3, 2017 Category: Medical Devices Authors: Nader Kameli Tags: Medical Device Business Source Type: news

How Stryker Made Q3 Look Easy
Like a lot of medtech companies, Stryker faced both external and internal challenges during the third quarter. But the Kalamazoo, MI-based company still managed to impress investors with 5.5% organic growth compared to the same period last year. Stryker's revenue growth took a 2.4% hit from an ongoing recall combined with a negative impact from recent hurricanes. The company also had to adjust for one less selling day in the quarter, which brought the organic growth down by another 1%. Styker cut its guidance for the year in August as it recalled certain lots of oral care products sold by the company's Sage Produ...
Source: MDDI - November 3, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Orthopedics Source Type: news

BD ’s Insulin Patch Pump Is Coming . . . a Bit Later Than Expected
BD last year announced its intention to dive into the emerging market for insulin patch pumps for patients with type 2 diabetes, with an expected product launch sometime in the company’s 2018 fiscal year. But in the company’s fourth-quarter 2017 earnings call November 2, management revised that timeline. “. . . [W]e had said before we were expecting to launch that at the very end of FY 2018,” said BD president Thomas Polen, according to a transcript from Seeking Alpha. “Based on some learnings actually from other product launches, we did add in an additional patient clinical trial there, and s...
Source: MDDI - November 3, 2017 Category: Medical Devices Authors: Jamie Hartford Tags: Medical Device Business Adhesives Source Type: news

Philips Forced to Stop Making AEDs Until Problems are Fixed
As part of a consent decree with FDA, Philips is prohibited from manufacturing, processing, packing, holding, or distributing devices made by its Emergency Care and Resuscitation (ECR) business at its Andover, MA and Bothell, WA facilities until quality control problems are fixed. Philips' ECR unit makes automatic external defibrillators (AEDs) and Q-CPR meters. FDA said the consent decree is with Philips North America, Carla Kriwet, business group leader for the Patient Care and Monitoring Solutions (PCMS) group, and Ojas Buch, vice president and head of quality and regulatory for PCMS. The ECR unit is part of the company...
Source: MDDI - November 2, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Regulatory and Compliance Source Type: news

Can a New CEO Right the Ship Before Zimmer Sinks?
It's been a touch-and-go sort of year for Zimmer Biomet, and the company continues to batten down the hatches. FDA hit the Warsaw, IN-based orthopedic device maker with an unusually long Form 483 last December based on quality control problems at its legacy Biomet facility. In January, the company went back to the drawing board and unveiled plans to invest $170 million to fix its supply chain and manufacturing and quality systems. Then, in July, David Dvorak resigned as CEO.  This week the company cut guidance for the second quarter in a row after missing the...
Source: MDDI - November 1, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Orthopedics Source Type: news

Medical Device Sales Reps in the Operating Room: An Asset or a Liability?
In this age of rapidly developing technologies, medical device sales representatives fill a unique role. In the business of surgery, sales reps not only deliver medical devices to hospitals as needed, but they ensure that surgical teams know precisely when and how a device and its components are to be used. Often knowing more about their devices than the surgeons who use them, medical device sales representatives have therefore become commonplace in operating rooms across the United States. As a result, manufacturers have seen an increase in products liability claims based upon their sales reps’ alleged representatio...
Source: MDDI - November 1, 2017 Category: Medical Devices Authors: Lisa Rice and Katie Stricklin Tags: Regulatory and Compliance Source Type: news

Digital Transformation May Be Key for Medical Device Compliance
Medical supply chain executives find regulatory compliance, and the associated complexity, increased administration, and bureaucracy a major hurdle. However, there is hope on the horizon for medical device manufacturers (MDMs) struggling to comply with UDI guidelines and other regulatory requirements governing the medical device industry. A Much-Needed Transformation in the Wings In order to keep up with the demands placed on it by regulatory entities, the medical device industry needs to transform itself. The transformation in question is a digital one. It involves taking all of the technological developments that have tr...
Source: MDDI - October 31, 2017 Category: Medical Devices Authors: Ken Moir Tags: Labeling Source Type: news

Cordis Comes Back for Another Stent
Cordis is getting back into the coronary stent game. The company, which is now owned by Cardinal Health, landed exclusive rights to sell Medinol's coronary stent portfolio in the U.S. Milpitas, CA-based Cordis is already selling Medinol's NIRxcell cobalt-chromium bare-metal stent and, assuming FDA approves Medinol's EluNIR drug-eluting stent (DES), Cordis will distribute it as well. Medinol is based in Israel. In addition to the Medinol agreement, Cordis recently launched the Tryton Side Branch Stent and two percutaneous transluminal coronary angioplasty (PTCA) balloon catheters. The Medinol agreement, along with the ...
Source: MDDI - October 31, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Why Baxter is on the Prowl for Acquisitions
Baxter International realized its strongest growth of the year in the third quarter, CEO Joe Almeida said, and he noted that the company's acquisition of Claris Injectables Limited was among the drivers of that growth. Baxter added Claris to the pharmaceuticals side of its business in July and the $625 million deal is expected to provide a foundational growth platform for the company. According to Seeking Alpha transcripts of the third-quarter earnings call, Almeida gave analysts reason to expect more acquisitions to fuel the company's growth going forward. "M&A deals like Claris will continue to play an impo...
Source: MDDI - October 30, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

Will This Device Change the Orthopedic Rehab Game?
Physical therapists have a new tool to help them treat patients at various stages of rehabilitation. FDA cleared the Med4 Elite, an orthopedic rehabilitation device, from Game Ready, which is part of Concord, CA-based CoolSystems Inc. The new technology comes with four options in one device: iceless cold therapy, heat therapy, rapid contrast therapy (which alternates heat and cold), and intermittent pneumatic compression therapy. The flexibility of the different treatment options will allow physicians and physical therapists to treat a wide range of injuries in various stages of rehabilitation to help patients recover more...
Source: MDDI - October 27, 2017 Category: Medical Devices Authors: Kristopher Sturgis Tags: Orthopedics Source Type: news

How Medtech Can Brace for Future Natural Disasters
Hurricanes Harvey, Irma, and Maria have firmly underscored the need for medtech companies to make sure their disaster plans are up to date and familiar to everyone in the organization. Puerto Rico’s more than 50 medtech plants are still reeling from the effects of Irma and Maria, which slammed into the island in September and crippled its electric power grid. FDA is working closely with 10 medtech manufacturers to prevent shortages of about 50 devices that are life-sustaining, life-supporting, or have only one source, according to a recent statement by FDA Commissioner Scott Gottlieb, MD. Reliance on genera...
Source: MDDI - October 27, 2017 Category: Medical Devices Authors: Nancy Crotti Tags: Medical Device Business Source Type: news

Clinical Wearables: Navigating the Next Health Technology Boom
Wearables have undoubtedly made their mark in the health and wellness industry. With the market slated to double in size by 2021 as vendors plan to ship a total of 125.5 million wearable devices this year, according to the International Data Corporation, tracking your steps during your work day, your reps during your workouts and even analyzing your personal sleeping patterns has become the new normal. While consumer wearables have seen a monumental level of success across the board, clinical wearables have struggled to reach a similar level of notoriety until recently. However, in the past several years we have seen ...
Source: MDDI - October 27, 2017 Category: Medical Devices Authors: Ravi Kuppuraj Tags: Digital Health Source Type: news

How Genomic Research is Changing Heart Care
Genomic testing is most frequently associated with cancer testing, but this area of research is beginning to make an impact on cardiovascular care. A recent scientific statement by the American Heart Association shined a spotlight on how the expressed genome can potentially be used to diagnose diseases and predict who will develop diseases such as coronary artery disease (CAD), stroke, heart failure, and arrhythmias. According to the statement, scientists now have the ability to address disease at many levels that were inaccessible during the past century. This includes the genome, transcriptome, epigenome, proteome, metab...
Source: MDDI - October 27, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: IVD Cardiovascular Source Type: news

Leveraging Government Innovation to Provide Mainstream Solutions
The U.S. government has a rich history of sponsoring innovative programs that bring about technological advances that benefit people everywhere. Prime examples include NASA’s space program, which led to products such as memory foam, advances in solar panels, and personal heart rate monitors, and DARPA advances that enabled internet communications and GPS devices. Although the complexity of intellectual property rights and government contracting can be intimidating, there are substantial potential benefits for companies who partner with the government in research and development. In the field of wound care, a new prod...
Source: MDDI - October 26, 2017 Category: Medical Devices Authors: Erik Edwards, PhD Tags: MD & M Minneapolis Design Source Type: news