Abbott inks deal to test blood donations in Japan

Abbott (NYSE:ABT) said today that it has been selected by the Japanese Red Cross Society (JRC) to partner in screening the country’s blood donations.

The eight-year contract is for the exclusive supply of serological instrumentation, tests, and consumables used for blood and plasma screening. The JRC screens approximately 5 million blood donations each year, helping ensure a safe supply of products needed for blood transfusions and plasma therapies. Abbott products are used to screen more than 60% of the world’s blood and plasma supply, according to a company statement.

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LivaNova touts studies of its sutureless aortic valve

LivaNova (NSDQ:LIVN) said today that three separate, recently published studies highlight the performance and cost savings of its sutureless aortic valve, Perceval.

The results from the Perceval Aortic Heart Valve Study in North America found that Perceval achieves positive safety and efficacy outcomes whether or not an open or minimally invasive surgical approach is used. The multi-center, prospective, non-randomized, single-arm clinical trial included 300 patients from 18 U.S. centers and was performed under an FDA Investigational Device Exemption. The results were published in the Journal of Thoracic and Cardiovascular Surgery.

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Critical impacts of the government shutdown on the FDA and clinical research

IMARC-logo-newRachel Martukovich, Clinical Research Associate for IMARC Research, Inc.

The recent partial government shutdown, which is now the longest in US history, has various stakeholders in the medical device and pharmaceutical industries concerned with the potential impact on the world of clinical research.  The FDA is one of the federal agencies most affected, as the budget for fiscal year 2019 is on hold until the shutdown ends and Congress can appropriate funds.

FDA Commissioner Scott Gottlieb recently tweeted that “The lapse in funding represents one of the most significant operational challenges in FDA’s recent history…It’s not business as usual at FDA. Many key functions aren’t getting done”.

Approximately 40% of FDA employees have been furloughed since December 22nd due to the shutdown. The reduced staff at the FDA has been allowed to continue performing specific duties associated with the regulation of clinical research using funding generated from carry-over user fee balances that were paid in 2018.  

As part of the review process for new medical device registration applications, the FDA charges what is known as Medical Device User Fees . Each type of FDA submission has an accompanying fee that must be paid by medical device companies in order for an application to be reviewed, such as $10,953 for a 510(k), $11,275 for an Annual Report, or $322,147 for a Premarket Approval Application (PMA). Similarly, under the Prescription Drug User Fee Act (PDUFA), user fees are charged for the review and approval of new pharmaceuticals, such as $2,588,478 for a new drug application when clinical data is required. 

While the FDA has been able to continue to carry out existing reviews that were funded during fiscal year 2018, this cannot serve as a long term solution as these funds are finite. The FDA Commissioner has already cautioned that agency funds from PDUFA user fees may run dry within a month’s time and medical device user fees may be close behind with only two-three months of funding remaining.   Below are additional impacts related to the shutdown.

No FDA acceptance of new applications or user fees. As long as the government shutdown is underway, the FDA is not legally authorized to accept any new medical device registration applications or human drug applications.  The user fees that are collected in association with these submissions cannot be processed during a lapse period, and thus these submissions cannot be accepted until the agency is fully operational and funding appropriations are authorized. Applications meeting the criteria for the 510(k) and PMA processes that were submitted and received before December 22nd will continue the review process, but the FDA cannot accept any new submissions or user fees for fiscal year 2019 until the shutdown ends. Additionally, the FDA has halted reviews of Investigational New Drug (IND) applications and Biologics License Application (BLA) applications that are not funded by user fees. Depending on the length of the shutdown, this will undoubtedly result in a backlog of applications that will need to be processed, further delaying the lengthy process of bringing novel medical products to market.

Ceasing support for certain routine regulatory activities. The FDA has reported that it will be unable to support “some routine regulatory and compliance activities” and will also pause some “routine establishment inspections, cosmetics and nutrition work and many ongoing research activities”. The specifics of what this will entail have yet to unfold, but some potential consequences may include delays in FDA correspondence or in scheduling of FDA inspections. This could also impact arranged activities such as meetings between the FDA regulatory authorities and key stakeholders and will likely reduce overall access to agency infrastructure.

Delay in release of guidance documents. Over the past year, the FDA has been at the forefront of promoting the release of several medical device guidance documents planned for 2019. This includes topics such as  the Breakthrough Devices Program, The Least Burdensome Provisions: Concepts and Principles, the Humanitarian Device Exemption Program, and the Special 510(k) Program to name a few. In addition multiple draft guidance documents are slated to be released in 2019 for public review and comment. Even when the FDA is fully operational, staff are often diverted from guidance development to more pressing activities, so the shutdown could cause postponements in both the release of guidance’s and processing public feedback on draft guidance’s.  The shutdown could then further impact the FDA’s efforts in increasing transparency in order to get safe and effective medical devices to market more efficiently.

Possible delays in FDA approval decisions. As part of the user fee program that accompanies new drug and device applications, the FDA agrees to either approve or deny each application by a certain date. Some upcoming decision dates for new drugs are set to occur shortly after the FDA is projected to run out of funds. The FDA has not currently released plans for when the money runs dry and whether this might affect decision timelines.   

The FDA is in the process of evaluating the current state of remaining funds and plans to release an update in the coming weeks. In the meantime, stakeholders in the medical device and pharmaceutical industry are left waiting for answers. One thing is certain, when the release of cutting-edge medical devices and novel drugs on the market is postponed; it is the patients in need of these treatments that suffer most.

What other long-term effects do you think the government shutdown could have on clinical research?   And have you experienced effects of the shutdown on your clinical research?

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

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Focusing on usability can limit medical device recalls: Here’s how

By Stephanie Van Ness and Rex Palmer of Boston UX

Building great software has always been challenging. Building software that safeguards patients while flawlessly controlling sensitive embedded and connected medical devices — from room-sized proton radiation systems to portable automatic external defibrillators (AED) — magnifies the challenge. It should be no surprise that design issues cause many device recalls.

So how do you mitigate potential problems when designing a medical device user interface (UI)? Begin with a strong focus on usability.

The importance of usability

According to researchers Martin A. Makary and Michael Daniel of Johns Hopkins University, medical error is the third leading cause of death in the U.S. They put the number at approximately 251,000 deaths per year. Many of these deaths (as well as non-fatal injuries) are caused by “misuse” of medical equipment.

Leading cause of death in U.S.

BostonUX-figure1

What causes misuse? According to researcher D. Jeffrey B. Cooper writing in BMJ, although the incidence of outright functional equipment failure may be low, “machines can have shortcomings or faults in design that encourage human error.”

For example, the Food and Drug Administration (FDA) reported that between 2005 and 2009 infusion pumps and related devices accounted for 35% of medical errors that resulted in significant patient harm. The agency said a large number of the adverse events stemmed from “programming errors attributed to poor device usability.” Essentially, that’s human error arising from a poorly designed UI

Design problems (relating to both hardware and software) accounted for more than a third of overall medical device recalls — with a large proportion of recalls traced to usability and the design of the user interface. Here’s an example: because of a confusing UI clinical staff enters patient weights in pounds rather than kilograms, a mistake that results in medication overdoses.

Causes of device recalls in fiscal years 2010-2012

BostonUX-figure2

The mismatch between user needs and the design of the device’s UI is the likely cause of unintentional use errors. According to Human Factors Engineering – Design of Medical Devicesmedical devices that are not designed with usability in mind are frequently “unsafe, prone to use error, difficult to use, difficult to learn to use, or detract from user efficiency or satisfaction.”

And according to the FDA, making design modifications to a device and its UI are generally the most effective means for eliminating or reducing these types of use-related hazards. So, applying usability design techniques is one of the best ways to guard against use errors and the harm they can cause.

What is usability?

Usability is defined as the ease of use and learnability of a designed object. Highly usable device controls function like a lens that makes information and processes crystal clear, allowing users to stay focused on their work. Usability results from user-centered design, a discipline that has evolved along with the software industry. User-centered design makes technology serve human clinicians and patients rather than making humans strain to adapt to the technology.

It may seem obvious that usability should be a top priority for medical devices. But, unfortunately, devices with poor usability still find their way into the market, posing serious risks to patients.

Here’s a chilling real-world example:

At 4:30 pm on Feb. 27, 2000, a heavily pregnant Danielle McCray was admitted to Tallahassee Memorial Hospital for what should be a joyous event: the birth of a child. To ease the discomfort of labor, at 6:45 pm that evening she was connected to a patient-controlled analgesia machine, a programmable infusion pump.

Just eight hours later, at 2:30 am on Feb 28, instead of delivering a healthy baby, McCray was pronounced dead from a morphine overdose.

How did this happen? While human error was cited, the facts of the case point to deeper issues with the infusion pump’s usability and UI design. For instance, the pump required up to 27 programming steps. How could someone reasonably have been expected to safely operate this device?

And McCray and her care team were not the only ones who had issues with this device. During a 12-year period, improper programming of this pump caused at least 65 deaths, with estimates suggesting that as many as 667 people may actually have died using it.

Human error had caused 68% of the fatalities and serious injuries associated with this device. The manufacturer had received prior warnings, including one in 1996 calling out potential interface issues, and another in 1997 suggesting the device was “susceptible to misprogramming.”

Though the device maker’s view was that the problem was not the design, but rather lack of user training, the company agreed to make design modifications to the UI. These included:

  • A dialog structure with fewer steps
  • A dialog overview showing the user’s location in the programming sequence
  • Better command feedback
  • Easier error recovery
  • Clearer labels and messages

Old device interface (L) vs. revised interface (R)

BostonUX-figure3

The results of these design modification were dramatic. The number of required programming steps decreased by 55% and user errors dropped by 56%. Most significant, the specific programming error that had been linked to patient deaths was eliminated. Clearly, usability and effective UI design matter.

Are you asking the right questions?

If you want to bolster usability, start by asking the right questions — and then test carefully.

Here’s a brief list of some questions to ask, which are applicable to an existing device if you are considering creating a generational product or to a high-fidelity prototype if you are developing something new.

  • How easy is it to learn to use the device?
  • How soon will the intended user feel comfortable using the device?
  • Once learned, how efficiently can the device be used?
  • Do users remember how to use the device after several days, weeks or months of non-use?
  • Does the device prevent users from making errors or help users recover from their errors?
  • Is the device design appropriate for the capabilities and limitations of users?
  • Are users satisfied with the device?

Getting the right answers to these questions requires a disciplined, user-centered approach to design. This means applying the right expertise at the right time in the product development cycle. As we have seen, failing to do so can have tragic consequences.

The takeaway

When designing medical devices, always remember: the goal of clinical users is to improve patient outcomes. Period. Prioritizing usability and incorporating a user experience carefully designed to mitigate user error is the path to success.

Stephanie Van Ness is senior marketing communications manager and chief storyteller at ICS and Boston UX. An experienced copywriter with a J-school degree from Boston University, Stephanie has spent her career helping Fortune 1000 firms shape their communications strategies. Her work has been focused on the technology, risk management and healthcare sectors.

Rex Palmer is principal user experience Ddsigner at ICS and Boston UX. He holds a Master’s of Science degree from Rensselaer Polytechnic Institute and has designed user-centered software interfaces for more than 15 years. His experience includes embedded systems design, as well as design and development for enterprise business management software.

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

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European scientists develop absorbable bandages

Study co-author Elizaveta Permyakova of Russia’s National University of Science and Technology worked on developing the absorbable bandage.

An international research group has developed a biocompatible bandage material that has antibacterial properties and will not require changing, a potential boon for burn patients.

The material is self-absorbable, and a new bandage can be put directly on top of the old one, alleviating the need for the frequent and often-painful changing of a burn patient’s bandages. The bandages could also help patients with other wounds in which the healing skin is damaged by the changing of dressings.

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RFPi wins FDA nod for non-contact blood flow imaging tech

RFPi’s iCertainty shows images of blood flow and perfusion without contact with the patient.

FDA has cleared RFPi’s iCertainty real-time, noninvasive blood flow and perfusion imaging medical device for use during surgical procedures, the company said.

iCertainty is the first medical imaging device to show blood flow without interrupting a surgical procedure or requiring injections, dyes, radiation or direct patient contact, according to the Greenville, N.C. company. Use of iCertainty during surgery could reduce procedural complications or repeat surgeries, reduce hospital costs, and objectively measure and help to improve clinical outcomes, the company said in a prepared statement.

Get the full story on our sister site, Medical Design & Outsourcing.

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Kyocera buys part of Renovis Surgical

Kyoto, Japan-based Kyocera (TYO:6971) said it will buy the major assets of Renovis Surgical Technologies’ artificial joint and spinal products businesses to expand its U.S. footprint.

Kyocera will transfer the assets into a new, wholly owned, California-based company to be named Kyocera Medical Technologies in March 2019. Kyocera manufactures medical products, including artificial joints and dental implants, primarily for the Japanese market. The company obtained 510(k) clearance for its artificial hip joints in 2017 and began selling them in the U.S. the following year.

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Researchers develop speedy 3D printing

 

A new 3D printing method developed at the University of Michigan enables complex shapes to be pulled from a vat at 100 times the print speed of conventional 3D printers. (Image by Evan Dougherty/Michigan Engineering)

University of Michigan researchers said they have developed a 3D printing method that’s up to 100 times faster than conventional 3D printing processes.

Rather than building up plastic filaments layer by layer, the new approach lifts complex shapes from a vat of liquid at high speed, potentially allowing manufacturers to produce up to 10,000 objects without the need for a mold and in much less than the conventional week or two.

Get the full story on our sister site, Medical Design & Outsourcing.

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How AI can detect cervical cancer

Cervical cancer cells (Image from National Cancer InstituteWinship Cancer Institute of Emory University)

Researchers have developed a computer algorithm that they say can analyze digital images of a woman’s cervix and accurately identify precancerous changes that require medical attention. This artificial intelligence approach, called automated visual evaluation, has the potential to revolutionize cervical cancer screening, particularly in low-resource settings.

Led by investigators from the National Institutes of Health and humanitarian tech investment fund Global Good, the researchers used comprehensive datasets to “train” a machine-learning algorithm to recognize patterns in complex visual inputs, such as medical images. The findings were confirmed independently by experts at the National Library of Medicine. The results appeared in the Journal of the National Cancer Institute (NCI).

Get the full story on our sister site, Medical Design & Outsourcing.

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Transforming the 510(k) program

imarcRachel Martukovich, clinical research associate, IMARC Research

Recently the FDA released an announcement outlining plans to further modernize the 510(k) clearance pathway. This briefing falls in line with the latest efforts by the FDA to promote and improve safety and effectiveness in an efficient manner. The current 510(k) framework, which has been in existence since the 1976 Medical Device Amendments will undergo some much-needed updates in the near future to adapt to the ever-evolving medical device landscape. The FDA has already taken steps this past year to begin the transformation process, including the release of a draft guidance regarding the abbreviated 510(k) program. Additionally, the agency recently shared a “performance report” describing various measures implemented in the last 10 years to improve the 510(k) pathway, with a spotlight on recent efforts. These actions taken by the FDA include:

Increasing premarket expectations for 510(k) submissions. The release of several device-specific guidance documents and policies over the past decade has raised the bar in regards to submission content expectations. This increase in transparency of what is expected has resulted in a 150% increase in the length of 510(k) submissions since 2009.

Implementing a “Refuse-to-Accept” policy to improve quality of submissions. The FDA’s “Refuse-to-Accept Policy” ensures that submissions will not be accepted for review unless 52 specific submission elements are present and complete. This has not only improved the overall quality of submissions but has also increased the efficiency of FDA review process, ensuring that valuable time is not spent reviewing incomplete applications.

Improving consistency and thoroughness of 510(k) review.  FDA staff has increased the time spent reviewing each submission by 32% in the last decade and has also initiated the use of a SMART memo template which has guided device reviewers towards increased consistency.

Moving towards eliminating the use of 510(k) for Class III devices. As recent as 2009, there were still 25 Class III device types which had been on the market prior to the 1976 Medical Device Amendments, that were still eligible for the 510 (k) process. The FDA has worked to remedy this situation in two ways. One includes releasing specific final rules and orders that require submissions of a Premarket Approval application for some of these devices. The other method is appropriately down-classifying some of the devices to Class I or Class II. As a result, in 2018, there were zero Class III devices cleared for marketing through the 510 (k) pathway.

Eliminating the use of more than 1000 510(k)s as legal predicates. The FDA has worked to discontinue the use of a 510 (k) cleared device as a predicate when it raises safety concerns. In some cases, devices can be up-classified such as from a Class II to a Class III when it becomes evident that the device should be regulated as high-risk. Since 2012, the FDA has eliminated the use of 1477 previously cleared devices as legal predicates.   

So what is on the horizon?

Encouraging the use of more modern predicates. FDA Commissioner Scott Gottlieb has recently emphasized that “the most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria when they seek to bring new devices to patients.”  The FDA plans to develop a proposal to potentially “sunset” older predicates and is also considering publishing a list of devices cleared using predicates that are more than 10 years old. The reasoning behind this is that when conducting comparative testing on new devices, the benefits and risks of more modern technology should be taken into account and older predicates might not closely replicate the new technology embedded in modern devices. As technology continues to advance new devices have the potential to become more interconnected, smaller and more portable, and incorporate advanced materials and processes such as mechanization and robotics. It will be interesting to see how this scenario unfolds, as changes to this process will undoubtedly affect various stakeholders.   

New final guidance document: Alternative 510(k) Pathway. The FDA plans to issue a final guidance document to establish an alternative 510(k) pathway for “well-understood” devices. The proposed “Safety and Performance Based Pathway” would enable manufacturers to demonstrate substantial equivalence by using objective safety and performance criteria and it would remove the need for manufacturers to compare the safety and performance of their new devices to a specific predicate device, which may be decades old. The hope here is that this will alleviate some of the challenges of demonstrating equivalence between inventive new devices and older predicate devices that may contain outdated technology.

As the FDA continues to update and reform policies to keep pace with the ever-changing world of medical device advancement, one thing is certain, change is on the horizon. What are your thoughts on the future directions of the 510(k) clearance pathway?

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

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