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FDA to Create a Digital Health Unit

FDA to Create a Digital Health Unit

The FDA has announced that it is forming a digital health unit within the Center for Devices and Radiological Health (CDRH). The digital health unit will develop software and technical expertise to assist manufacturers with devices that incorporate digital health technologies, as well as assessing digital health improvements and monitoring and reporting on the digital health premarket review timelines. Digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. The creation of this unit is part of the Medical Device User Fee Act (MDUFA). MDUFA is the program that authorizes FDA to collect user fees from medical device manufacturers in support of streamlining the regulatory approval process. Negotiations between FDA and the medical device industry regarding the fourth version of MDUFA are currently underway. As part of the negotiation process, FDA proposed to hire technical experts to staff the new digital health unit. In addition to MDUFA, the 21st Century Cures Act requires FDA to develop a framework for evaluating real world evidence. FDA envisions that the digital health unit will monitor and implement the use of real world evidence to support the regulatory approval process. FDA issued a draft guidance in July 2016, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, that identifies how real world data will be evaluated to determine if it is sufficiently relevant and reliable enough to be used. While the FDA sees the digital health unit as a means of streamlining the regulatory approval process, it also recognizes it will require coordination with industry and other government agencies because digital health touches on...
Colliding Cultures: Software Development and the Medical Device Industry

Colliding Cultures: Software Development and the Medical Device Industry

Part 1 – Medical Device Software, the FDA and the US Congress Preface: In any given 2-week period, an average of 15% to 20% of the applications on my smartphone have new versions to fix software bugs. Others I speak with experience similar statistics. And, that doesn’t include how often my smartphone software crashes while executing tasks it was intended to perform. We don’t complain about it. Instead, we accept this state of constant, almost continuous, software revision to fix bugs as a matter of “how things are.” We have come to terms with the fact that the normal state of software is for it to be broken, in need of repair and “acceptably” functional, while simultaneously defective. One might think, given the prevalence and importance of software, we would reject software disrepair as normal – especially for critical applications that impact safety. But, the evidence suggests otherwise. If you perform a search on the FDA Medical Device Recall Database from January 1, 2013 to August 14, 2015, you will see 500 device recalls reported. This is the maximum number of rows the FDA report supports in a single query (meaning more than 500 devices were recalled). Enter the keyword “software” into the search, and the query returns 344 recalls due to medical device software. Reviewing randomly through these notices confirms that software issues played an instrumental – or the only – role in the recalls. And, all but nine are Class I or Class II recalls in response to a risk of temporary or serious adverse health consequences due to software problems. Is software so difficult and challenging...
Medical Device Data Systems and Data Integrity

Medical Device Data Systems and Data Integrity

Time to Take a Closer Look at FDA MDDS Moves The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and display medical device data. An MDDS does not modify the data, and it does not control the functions or parameters of any connected medical device. MDDS are not intended to be used in connection with active patient monitoring.” The core issue it raises, I believe, is one of data integrity. More on that later. Explaining the Medical Device Data Systems Draft Guidance The new draft guidance cites the growing trend “that many medical devices be interoperable with other types of medical devices and with various types of health information technology.” And further “since down-classifying MDDS, the FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public,” the FDA wrote. “Therefore, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, medical image storage devices and medical image communications devices.” The FDA’s interest in this kind of risk based approach has pleased a great many. On the one hand, the draft guidance demonstrates a proactive approach by the FDA for addressing the explosion of mobile health applications in the light of pending legislation on the same topic in the US Congress. It frees application developers to innovate without the additional burden of regulatory compliance, and it dovetails with the rapidly expanding electronic health ecosystem servicing the informational appetites of healthcare...
Cloud Vendor Selection for Life Sciences

Cloud Vendor Selection for Life Sciences

Benefits and Risks of Moving to the Cloud, Including Cloud Vendor Selection Migrating to the Cloud: What are the Benefits? According to the National Institute of Standards and Technology, the cloud is “a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.” Most companies’ IT infrastructure use less than 30% of their capacity. It took years to get the capacity to where it is today, and it takes months to increase capacity. Employing qualified resources to maintain such an infrastructure is difficult and expensive. Cloud providers utilize about 65% of their capacity and can add capacity quickly. In short, cloud providers benefit from economies of scale, which enables them to lower individual usage costs and centralize infrastructure costs. Companies benefit by only paying for what they consume. Companies can increase or decrease their usage rapidly, and can spend less time managing complex IT resources. Not only do efficiency improvements reduce costs, the nature of some costs can change from being capital investment in hardware and infrastructure (CapEx) to a pay-as-you go (OpEx) model. Maximizing IT capacity utilization, improving IT flexibility and responsiveness, and minimizing cost are not the only advantages of the cloud. Collaboration can be one of the most important advantages of cloud computing. Multiple users, from around the world, can collaborate more easily on documents and projects. Because the information is hosted in the cloud, and not on individual computers, business owners can collaborate with external stakeholders in a...