Brain implant for some blind people shows benefits of FDA’s Breakthrough Device Program

Malvina Eydelman, M.D., Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation

Malvina Eydelman, M.D., Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation

FDA’s Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act to help patients gain timely access to breakthrough technologies.

Consider Second Sight Medical Products Inc.’s Orion Cortical Visual Prosthesis System, which recently qualified for the FDA’s voluntary Breakthrough program.

Eligible technologies must provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. In addition, there must be no approved or cleared treatment, or the device must offer significant advantages over existing approved or cleared alternatives.

The Orion is a brain implant for patients with blindness caused by damage to the optic nerve. With the designation, Second Sight qualified for interactive and timely communication with FDA, even before the Sylmar, Calif., company embarked on a clinical trial to study the device in patients. These early interactions resulted in the development of a flexible study design, review team support and senior management engagement, all of which may allow a sponsor to evaluate complex, innovative technologies more efficiently.

And, when the development and evaluation of a technology or device is more efficient, beneficial medical devices may be able to reach the patients who need them sooner, even though they may be more complex or challenging to study because they are breakthrough products.

For Second Sight, early interaction meant that specialists across disciplines such as ophthalmology and neurology, representing the sponsor and FDA, could pose questions and solve problems. Oftentimes, early interaction can be especially helpful in solving any potential stumbling blocks – for instance, how best to go about measuring the benefits or risks of devices.

In normal vision, the optic nerve connects the eye to the brain. The optic nerve carries the electrical impulses (signals) formed by the retina (specialized nerve tissue at the back of the eye) to the visual cortex. The brain processes these impulses into the images that we perceive when we “see.”

There was no standard way to evaluate the benefits or risks of a device like the Second Sight Orion, which mimics the perception of light through a miniature video camera worn by a patient that transmits signals to an implant in their visual cortex.

Thanks to the breakthrough program, which builds on the FDA’s Expedited Access Pathway program, FDA was able to work closely with the company on a novel way to measure benefit and risk, clearing the way for the company to proceed with a small clinical trial, a necessary step before the company could seek approval for their device.

The Second Sight trial, approved by FDA’s Center for Devices and Radiological Health (CDRH), involves five patients at two sites, Baylor College of Medicine and the University of California in Los Angeles. The first patient received the implant on Jan. 30.

The Orion isn’t the only device to take advantage of the Breakthrough program. Since the Cures Act was passed, CDRH has received 94 requests for breakthrough status for devices treating a variety of conditions and granted 54, with patients as the ultimate beneficiaries.

In FDA’s Breakthrough Device Program, the interaction among specialists across disciplines representing the sponsor and FDA, could lead to devices that have the potential to change patients’ lives, without compromising safety or effectiveness.

In short, it shows FDA at its best, committed to patient access and willing to balance benefits and risks in a scientifically robust manner led by compassion and respect for the perspective of patients.

Malvina Eydelman, M.D., is the Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation, at FDA’s 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 or its employees.

The post Brain implant for some blind people shows benefits of FDA’s Breakthrough Device Program appeared first on MassDevice.

Four steps to safety oversight: DSMBs, CECs and medical monitors


Rachel Silver-Kessler, Director of Clinical Support Services, IMARC

Research sponsors and sites know the importance of implementing quality assurance processes for their clinical studies. For safety oversight, what steps can be followed to incorporate Quality Assurance into data safety monitoring boards, clinical events committees and medical monitoring? Take a look at these four tips:

1. Follow thoughtful procedures

The FDA guidance, The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors recommends that data monitoring committees (DMCs) follow written procedures to guide its activities, including for composing safety groups and assessing potential conflicts of interest, holding meetings, and for the format of reports to the group.

2. Gain consensus and implement a charter

The FDA Guidance also encourages DMCs to operate under a written charter that identifies the procedures to be followed (see Step 1).  The charter will also outline roles and responsibilities of those in or interacting with the safety group, so collaboration and consensus from various stakeholders are important. The charter should also specify details for the study including scheduling of meetings, how a quorum will be defined, and how meeting minutes will be recorded and stored.

3. Maintain well-organized documentation

Speaking of meeting minutes, a safety oversight group should record the details of its activities and decisions. The charter will outline who is responsible for this, how issues should be communicated and how records will be retained during the study and archived after the study concludes. If an outsourced administrator is used to support safety oversight, maintaining this documentation should be a breeze, allowing the safety experts to focus on their study reviews.

4. Build quality control steps into processes

What better way to complement a focus on quality assurance than to add quality control into the picture? A DSMB, CEC or medical monitor has the ability to greatly impact a study through recommendations (such as to alter the protocol), adjudicated events or by providing other expert advice. Adding a QC step, such as a peer review, can ensure the accuracy of meeting minutes, consensus for adjudication decisions and consistent application of safety review criteria.

Following these four steps will bring quality assurance methods to your safety oversight groups for robust DSMBs, CECs and medical monitoring processes. For other best practices and qualities to look for from your safety administrator, download our guide.

What recommendations do you have for bringing quality into safety management for clinical studies?

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

FDA to expedite release of recall information

Douglas Stern FDA Voice

Douglas Stern, FDA’s Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs

By: Douglas Stearn, J.D.

When FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant public hazards, including those recalls associated with an outbreak.

Now, as part of a larger effort to increase transparency, empower consumers, and enhance public health, the FDA is working to alert the public sooner whenever a product has been recalled.

The public’s primary source for recall information is FDA’s weekly, web-based Enforcement Report. Historically, only recalls that have already been classified into one of three categories based on the severity of the hazard have been listed in the report. Through classification, FDA indicates the relative degree of health hazard presented by the recalled product. This enables consumers to better understand the severity of the problem posed by a recalled product so they can take appropriate action. FDA also provides guidance to companies on their recall strategies, taking into account the seriousness of the hazard presented by the recalled product.

However, recall classifications can sometimes take weeks – or even months when FDA needs to conduct a complex evaluation. Such analysis can involve determining whether any diseases or injuries have already occurred, the likelihood that a hazard might occur, or whether vulnerable segments of the population, such as children, are more at risk.

FDA has decided that the public would benefit by having recall information about FDA-regulated products as soon as possible, even though further evaluation remains to be done. Moving forward, FDA will include “not-yet-classified” recalls of human drugs, foods, and veterinary products in the weekly Enforcement Report, even while classification work is still ongoing.

As an example of how this will work, FDA recently posted a “not-yet-classified” recall of a certain lot of animal feed that contained monensin, which can be toxic to cattle at certain levels and could result in cardiovascular illness or death to cattle.

Posting “not-yet-classified” recalls will not affect current FDA protocols for working with companies to ensure that they quickly alert entities in the supply chain as soon as they have identified a problem with their marketed product. Also, FDA will continue to monitor the recalling company’s actions to correct or remove products held by retailers, pharmacies, grocery stores, and hospitals.

In addition to adding “not-yet-classified” recalls of human drugs, food, and veterinary products to the Enforcement Report, FDA recently began posting early summaries of correction or removal actions” involving serious problems with medical devices in the Medical Device Recalls Database. FDA has also enhanced the website’s search capabilities. Returning to the site after viewing “not-yet-classified” recalls is recommended because more information is often made available once a recall has been classified.

The public should recognize that recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product, while at other times a company acts after the FDA raises concerns. Whether FDA or the company discovers the problem, in every case FDA oversees a company’s recall strategy and assesses the adequacy of the recall.

If a product is believed to pose an immediate, serious hazard, FDA will also act quickly, even before classification is complete, to widely publicize a recall. FDA’s publicity efforts may include press releases, advisories, distribution of alerts to subscribers, and updates to the FDA website. This outreach has proven effective in bringing exhaustive TV, radio, and newspaper coverage about recalls. Increased coverage has occurred in recent years, for example, with certain brands and batches of medicines, injection pens, and contaminated foods such as smoked fish, peanut butter, spinach, frozen vegetables, and ice cream.

The FDA Consumer Update provides more details about the process. Subscribe to the Enforcement Report mailing list at Enforcement Report email subscription. To comment, e-mail

Douglas Stearn, J.D., is FDA’s Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs

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

Feistein Institute launches bioelectronic medicine trial for treating Lupus


Feinstein Institute

Researchers at the Feinstein Institute launched a clinical trial looking to explore the efficacy of bioelectronic medicine specifically designed to manage pain associated with lupus.

The study is exploring the use of a proprietary device, designed based upon previous research at the Feinstein Institute, which emits electrical pulses through a patient’s ear for five minutes a day over four days.

“Lupus is a painful disease, notoriously hard to diagnose and difficult to treat – new treatment options are desperately needed. This trial will study an innovative approach to controlling symptoms of a disease that affects millions. We hope to have encouraging findings very soon,” study lead investigator Dr. Cynthia Aranow said in a prepared statement.

Bioelectronic therapy is designed to help the body treat disease and injury without the use of pharmaceuticals and their associated side effects, the Feinstein Institute said.

In the current study, researchers hope to treat patients by stimulating the inflammatory reflex, and hope that the treatment will inhibit the body’s production of the molecule responsible for lupus-related inflammation.

“I am tremendously encouraged by the fast-paced advancement in this evolving field that we are seeing in the lab and in clinical trials. By intercepting and manipulating the millions of electrical messages that the body sends itself, we hope to produce therapies that are safer, more efficient and more cost-effective, and help the body heal itself,” Feinstein Institute Center for Bioelectronic Medicine director Chad Bouton said in a press release.

In July, the Feinstein Institute said it won a $1 million gift from the Knapp Family Foundation to launch a 4-year research program to explore bioelectronic medicine to treat diabetes.

Effective design considerations for medical device warning labels


Emergo GroupBy Michael Wiklund, Emergo Group

Some people believe that warnings are useless; printed on medical devices only to offer legal protection. Indeed, manufacturers can and have been held liable for the “failure to warn,” and adding warnings neutralizes this claim.

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 or its employees.

New harmonized standards for medical devices, IVD in Europe


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 or its employees.

The FAQs on encryption, FIPS 140 and medical devices


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 or its employees.

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


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 or its employees.

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

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

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    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 […]

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  • 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 […]

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    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

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  • 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


    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 or its employees.