New harmonized standards for medical devices, IVD in Europe

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Emergo GroupBy Stewart Eisenhart, Emergo Group

The European Commission has issued updated lists of harmonized standards for medical devices and in-vitro diagnostic (IVD) products in the Official Journal of the European Union (OJEU).

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

The FAQs on encryption, FIPS 140 and medical devices

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Emergo GroupBy Stewart Eisenhart, Emergo Group

As cybersecurity vulnerabilities become a more urgent concern for the medical device industry, encryption requirements are emerging as a key tool to address medical device cybersecurity concerns. In the US, compliance with the FIPS 140-2 standard can help manufacturers of network-connected devices and software demonstrate encryption capabilities able to protect patient and user data.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

Conducting clinical research in medical device studies using a quality systems approach

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imarcMDFDA is encouraging a quality systems approach to conducting clinical trials. The Clinical Trials Transformation Initiative (CTTI) established the Quality by Design initiative for clinical research. Patients and those who care for them want access to new drugs, devices, and biological products as quickly as possible, while also being assured that the benefits of these products outweigh the risks.

Well-designed randomized clinical trials are the most reliable way to get unbiased information to achieve this outcome. However, poor quality and inefficiency in clinical research can seriously limit the number of questions that can be answered about the appropriate uses of new medical products, and also significantly delay access to new therapeutic innovations.

This whitepaper addresses what utilizing a quality systems approach to clinical research means, why a quality systems approach is important and initial steps to consider taking when conducting a clinical trial using a quality systems approach.

Have you implemented a quality systems approach to conducting clinical trials?

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

Pros and cons of MDNR and MDMA medical device registration in Saudi Arabia

  • How a versatile epoxy is enabling brain stimulation

    Rohit Ramnath, Senior Product Engineer, Master Bond In but another example of how useful and critical epoxies can be, researchers in Israel used a two-part epoxy to construct a magnetic coil to stimulate animal brain neurons via a magnetic field. Designers of medical electronics assemblies have many options to choose from when selecting one or […]

  • Pros and cons of MDNR and MDMA medical device registration in Saudi Arabia

    By Stewart Eisenhart, Emergo Group Now that Saudi Arabian medical device regulators have exempted some low-risk products from full registration requirements, qualifying manufacturers should consider whether standard or fast-track access to the Saudi market best suits their business needs. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]

  • How middleware is changing medtech

    Medtech developers can take advantage of middleware technology to gain a competitive advantage. By Tim Gee, principal of Medical Connectivity Two macro trends are affecting how medical devices and systems are designed: Adoption of off-the-shelf (OTS) computing technology to extend the power and capabilities of traditional embedded system medical devices; and the evolution of software […]

  • How have medtech launches and prototyping evolved with 3D printing?

    Here are three basic ways that 3D printing can help you get your medical device project off the ground. Jim Medsker, Keystone Solutions Group Additive manufacturing, commonly referred to as 3D printing, began to surface in the 1980s. Since then, the technology has quickly become a valuable tool for creating plastic prototype parts in a rapid […]

  • Appirio launches solutions for Salesforce Lightning Bolt

    Wipro company Appirio recently launched new solutions that are built on Salesforce Lightning to deliver personalized and industry-specific services. The solutions that the company is ordering are all Lightning Bolts which are frameworks that allow companies to create functional and customer-facing websites. It is designed to increase collaboration and communication during crucial interaction points while […]

  • Sterigenics parent company is now Sotera Health

    Sterigenics International said today that it has changed the name of its parent company to Sotera Health, with Nelson Labs, Nordion and Sterigenics as Sotera’s three operating companies. The new name drew its inspiration from the name of the Greek goddess of safety, Soteria, and is meant to reflect the company’s commitment to global health. […]

  • Scapa Healthcare introducing new ultra-flexible silicone gel adhesive

    Scapa Healthcare – maker of skin-friendly adhesives – will introduce its new ultra-flexible Scapa Soft-Pro Silicone Gel 6058 at the 2017 Medica Trade Fair, Nov. 13–16 in Düsseldorf, Germany. The Silicone Gel 6058 is the most flexible silicone in Scapa’s product portfolio, according to the Windsor, Conn.–based company. It is conformable and contours to challenging anatomical […]

  • Chesapeake IRB, Schulman IRB merge to form Advarra

    Chesapeake IRB and Schulman IRB have merged to form Advarra, a new provider of IRB, institutional biosafety committee (IBC) and research compliance services. “By coming together as Advarra, we are merging the highest quality review organizations in the industry,” Jeffrey Wendel, president and CEO of Chesapeake IRB said. “Through a customer-centric integration, we will be […]

  • Greenlight Guru adds Grow to quality management software platform

    Greenlight Guru recently announced the introduction of its Grow software product to assist medical device companies with quality management after product launch. The Indianapolis-based company’s first product, Go, focused on helping medtech companies utilize design control, risk management and document management software to bring FDA and ISO-compliant medical devices to market in less time. Many […]

  • Enhancing catheter steerability and deflection

    It’s all in the tip when it comes to making catheters with state-of-the-art steerability and deflection. Andy Black and Tanner Hargens, Medical Murray Steerable catheters Catheters often need to navigate tortuous anatomy with precise control of the catheter tip. Steerable catheters are often utilized for access into side branches from parent vessels to introduce guidewires […]

  • Report: Q3 medical device recalls down 39%

    Medical device recalls have declined 39% for the third quarter, settling at 167, the lowest quarter the US has seen since the fourth quarter of 2011, according to a new Stericycle Expert Solutions report. Recalled units were up, however, rising 1% to 68 million which positioned it higher than 16 of the last 19 quarters, […]

  • FDA’s role in medical device cybersecurity

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    FDA VoiceBy: Suzanne Schwartz, M.D., M.B.A.

    Virtually every aspect of our lives – including our health – has gone digital. Medical devices from insulin pumps to implantable cardiac pacemakers are becoming more interconnected and, like computers and the networks they operate in can be vulnerable to security breaches.

    A computer virus or hack resulting in the loss of or unauthorized use of data is one thing. A breach that potentially impacts the safety and effectiveness of a medical device can threaten the health and safety of an individual or patients using the device.

    Global cyber-attacks in 2017, including WannaCry and Petya/NotPetya, have had a significant impact on our nation’s critical infrastructure, including the health care and public health sector. Hospitals, pharmaceutical companies, and even the Kiev airport were among organizations affected by cybercriminals who unleashed copies of the ransomware earlier this year, with demands of payment to restore access to computer networks and crucial files.

    Because cybersecurity threats are a constant, manufacturers, hospitals, and other facilities must work to prevent them. There is a need to balance protecting patient safety and promoting the development of innovative technologies and improved device performance.

    It is the goal of FDA’s Center for Devices and Radiological Health to encourage a coordinated approach of vigilance, responsiveness, resilience, and recovery that fits our culture of continuous quality improvement.

    This means taking a total product lifecycle approach, starting at the product design phase when we build in security to help foil potential risks, followed by having a plan in place for managing any risks that might emerge, and planning for how to reduce the likelihood of future risks.

    Specifically, FDA encourages medical device manufacturers to proactively update and patch devices in a safe and timely manner. The concept of updates and patches, while not new to traditional information technologies, is complex when it comes to critical safety systems and requires a collaborative approach to finding solutions.

    FDA has published guidances – recommendations for manufacturers and others – that contain recommendations for comprehensive management of medical device cybersecurity risks throughout the total product life cycle. This includes closely monitoring devices already on the market for cybersecurity issues. And because we want to enable more expedient actions, our overall approach incentivizes industry to make changes to marketed and distributed medical devices to reduce risk.

    FDA continues to work closely with manufacturers and the public to dispel myths about medical device cybersecurity. On our website is a printer-friendly fact sheet where we address some of the more prevalent myths concerning FDA and our role in helping to maintain the security of medical devices.

    SuzanneSchwartz-FDAVoiceWith so many devices dependent on software and internet access today, having a plan in place to address cybersecurity risks is as essential to the device development process as coming up with a novel new product. Working with the medical device industry and other federal agencies, FDA will continue its work to ensure the safety and effectiveness of medical devices at all stages of their lifecycles against potential cyber threats.

    Suzanne B. Schwartz, M.D., M.B.A., is FDA’s Associate Director for Science and Strategic Partnerships, at the Center for Devices and Radiological Health

    The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

    FDA issues final guidance on medical device changes that need new 510(k) submissions

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    Emergo GroupBy Stewart Eisenhart, Emergo Group

    Medical device regulators at the US Food and Drug Administration have published final guidance explaining when changes to registered devices warrant filing new 510(k) premarket notifications to the agency.

    Get the full story here at the Emergo Group’s blog.

    The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

    FDA launches new market pathway for breakthrough medical devices

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    Emergo GroupBy Stewart Eisenhart, Emergo Group

    The US Food and Drug Administration plans to establish a new market authorization pathway for innovative and breakthrough medical devices that would replace current priority review programs including the Expedited Access Pathway (EAP) and the Priority Review Program.

    Get the full story here at the Emergo Group’s blog.

    The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

    FDA Guidance: Use of real-world evidence to support regulatory decision-making for medical devices

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    by Lisa Wickert/IMARC Research

    On Aug. 31, the FDA issued the finalized guidance manual for medical device companies’ use of real-world evidence (RWE) and real-world data (RWD) to gain FDA approval for their medical devices. The FDA draft guidance was originally issued on July 27, 2016 to the public to give those in the medical device industry an opportunity to provide comments prior to finalization. Additionally, the FDA hosted a webinar on the topic to provide additional guidance on October 10, 2017. Per the FDA, the guidance was issued “to clarify how we evaluate RWD to determine whether it may be sufficiently relevant and reliable to generate the types of RWE that can be used in FDA regulatory decision-making for medical devices.”  This includes whether or not FDA will require an Investigational Device Exemption (IDE) to determine the safety and effectiveness of a device.

    This FDA guidance is applicable to all devices as defined under section 201(h) of the Federal Food, Drug, and Cosmetic Act. However, this guidance does not apply to the use of non-clinical data, adverse events reports, secondary use of clinical trial data, or systemic literature reviews.

    RWD has the potential to facilitate FDA regulatory decisions in the interest of promoting public health and technological advancements while still protecting human safety. During the lifecycle of a medical device, there is a substantial amount of data that is collected over the course of patient treatment and management outside the scope of a clinical trial setting. Furthermore, it is quite common for devices to be used in a clinical setting for indications outside the approved use. As such, a large amount of data is generated throughout the lifecycle of a medical device that can impact patient outcomes.  

    The guidance is as the name implies; the FDA does not mandate a certain type of RWD nor does it specify a preferred type of RWD. The characteristics, type, and relevance of the RWD will be evaluated case-by-case. Thus, it is up to the sponsor to determine what type(s) of RWD is most applicable and should select appropriate RWD sources to address their specific regulatory questions.  It is the responsibility of the FDA to deem the RWD collected to support RWE of sufficient quality for regulatory use.

    Do you have experience with the collection or analysis of RWD to support RWE?  Has this led to a regulatory decision by FDA?

    The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

    Layoffs ahead for nearly 300 as J&J winds down Animas

  • This lab-on-a-chip is bringing point-of-care diagnostics to smartphones

    A new diagnostic platform that works using a smartphone is making point-of-care diagnostics easier for infectious diseases. Researchers from the University of Illinois at Urbana-Champaign and the University of Washington at Tacoma developed a device that diagnoses infectious diseases at the point-of-care. The devices uses a smartphone as the detection instrument with a test kit […]

  • How to mitigate heating in a handheld surgical tool

    Here are two main sources of power losses, and hence heating, when it comes to handheld surgical tool motors. Urs Kafader, Maxon Motor Motors operated at the rated torque limit can get very hot. In continuous operation, the winding can reach 155 °C, resulting in a housing temperature of some 120 °C. No surgeon would […]

  • Medtech stories we missed this week: Oct. 20, 2017

    From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD inks Chile distribution deal InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime […]

  • The 11 most innovative medical devices of 2017

    The nominees for the best medical technology of 2017 were recently announced for the 11th Annual Prix Galien USA Awards. The Galien Foundation, the host of the awards, hands out the the Prix Galien Award annually to examples of outstanding biomedical and technology product achievement designed to improve human condition. Before candidates can qualify for […]

  • How to add recyclability and sustainability into medtech plastics

    Recyclability and sustainability have become very important across the medical device marketplace, and some companies are taking note. Jason Middleton, Ray Products Some implement sustainability to appeal to consumers. Others look to cut costs or align their business practices with their company mission. Whatever the motivation, 13% of company CEOs see sustainability as their top priority, […]

  • Self-propelled catheter moves through bronchi like an earthworm

    Japanese researchers have created a catheter that can navigate by itself through some of the thinnest branches of the bronchi. Pulmonary lesions are biopsied to diagnose or treat respiratory illnesses like lung cancer. Bronchoscopy is the standard method for manual biopsies. The bronchi branches into different directions and progressively gets thinner and more difficult to […]

  • Crescent touts video on secondary services

    Crescent Industries has a new video out touting its contract assembly and packaging services. Crescent offers a wide range of contract assembly and packaging services. For Crescent, assembly – the process of making various plastic components into subassemblies or complete assemblies – includes: Build custom fixtures to aid in the assembly process Simple to complex assembly operations Some […]

  • Millstone Medical recruits microbiologist to sterile packaging facility

    Millstone Medical announced that it has added microbiologist Joshua Browning to its Fall River, Mass. sterile packaging facility staff. Browning has been a quality control analyst in microbiology at Nanotherapeutics prior to joining Millstone Medical. There, he was responsible for facility process qualifications and validations of ISO 7 and ISO 8 cleanrooms, validated gas systems […]

  • PE Firm Genstar Capital acquires TekniPlex

    Private equity firm Genstar Capital said this week it acquired advanced product manufacturer TekniPlex for an undisclosed amount. Wayne, Pa.–based Tekni-Plex develops products including medical tubings and compounds, pharma barrier films, dispensing components, closure liners and food packaging, the company said. “We are excited to be partnering with a proven, energetic and action-oriented management team.  […]

  • UK design firm touts new device as the ‘Nespresso of auto-injectors’

    People living with chronic diseases often have to treat themselves at home using a medical device like an auto-injector. The process can be nerve-wracking, because it requires the patient to follow a number of important steps – like properly storing their drugs and warming them to the correct temperature at the time of injection. These […]

  • This surgical glue seals wounds in 60 seconds

    A potentially life-saving surgical glue that is highly elastic and adhesive can quickly seal wounds in seconds without the need for common staples or sutures. The surgical glue, called MeTro, is a development from biomedical engineers at the University of Sydney and biomedical engineers from Harvard University. MeTro has a high elasticity that can seal […]

  • MassDevice.com +5 | The top 5 medtech stories for October 20, 2017

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    Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

    Get this in your inbox everyday by subscribing to our newsletters.

    5. This surgical glue seals wounds in 60 seconds

    MassDevice.com news

    A potentially life-saving surgical glue that is highly elastic and adhesive can quickly seal wounds in seconds without the need for common staples or sutures.

    The surgical glue, called MeTro, is a development from biomedical engineers at the University of Sydney and biomedical engineers from Harvard University. Read more


    4. FTC seeks more information on Fresenius’ $2B NxStage buy

    MassDevice.com news

    Fresenius Medical Care and NxStage Medical shave received a request from the US Federal Trade Commission asking for more information on Fresenius’ $2 billion acquisition of NxStage, according to an SEC filing.

    The companies originally announced the acquisition in August, with Fresenius looking to pay $30 per share for Lawrence, Mass.-based home hemodialysis developer NxStage. Read more


    3. Meet the two former Johns Hopkins residents disrupting the wound care market

    MassDevice.com news

    Ned Swanson and Denver Lough were plastic surgery residents at Johns Hopkins when they made a choice that would change the course of their lives – they decided to drop out and start a business.

    Lough had a technology that they thought could help patients if it ever made it to the market, but their intensely busy schedules at Hopkins didn’t allow for a side project to grow into something bigger. Read more


    2. Intuitive Surgical shares rise on Street-topping Q3 earnings

    MassDevice.com news

    Shares in Intuitive Surgical rose today after the robotic surgical platform maker handily topped expectations on Wall Street with its 3rd quarter earnings results.

    The Sunnyvale, Calif.-based company posted profits of $297.5 million, or $2.55 per share, on sales of $806.1 million for the 3 months ended September 30, for bottom-line growth of 34.3% while sales grew 6.6% compared with the same period during the previous fiscal year. Read more


    1. GE Healthcare profits, sales rise despite overall EPS miss

    MassDevice.com news

    Shares in GE fell today after the conglomerate met sales expectations but missed on earnings per share by a significant margin, though its healthcare biz saw both sales and profits grow for the 3rd quarter.

    GE Healthcare posted profits of $820 million on sales of $4.7 billion for the 3 months ended September 30, clocking gains of 14.4% and 5.4%, respectively, compared to its performance during Q3 2016. Read more