Perhaps no other sector of the life sciences is experiencing as much growth, transformation and opportunity as the medical device industry. Globally, the medtech arena is expected to grow every year by more than 5 percent, with annual sales worldwide reaching $800 billion by 2030, according to KPMG.(1) In the U.S. alone, Fitch Solutions estimates that the medical device industry with expand from $164 billion in 2018 to $208 billion in 2023.(2)
From the effect of new technologies on clinical data management, to an ever-changing regulatory landscape, to increased emphasis on the trial master file (TMF) Reference Model as an industry standard, medtech manufacturers have their hands full just keeping up with the latest clinical trends.
This article will provide an overview of some of the top clinical trends influencing the medical device sphere now and moving into 2020.
As has been the case for several years, major tech companies have seen the value and growth potential of the health care and medical device sectors and are investing heavily to move into those industries. One of the largest industries worldwide, health care rakes in $2.8 trillion annually in the U.S. alone, according to The Verge.(3) Blurring the lines between retail, IT and health products, behemoths like Google, Apple, Facebook and Amazon are emerging as key players in the medical industry and clinical research fields as consumers seek access to affordable health care.(4) These companies are utilizing cloud storage, wearable technologies and artificial intelligence in a way that is transforming the way people view and use medtech.
Though life sciences companies have been reluctant in the past to adopt cloud technologies, consumer electronics and tech companies and the advances in cloud technology are reversing the trend. According to KPMG, 64% of life sciences companies have moved or are moving to the cloud.(5) Medical device companies, including large companies and startups, are finding that digital innovations like cloud technology offer greater data security, help expedite regulatory compliance and approval, and real-time accessibility across departments, offices and regions.
“Cloud equals speed in getting to a digital environment,” said Matt Lowe, MasterControl executive vice president. “… This leads to the biggest benefit — leveraging big data, where all the data is there and connected. In this environment, companies can see trends, make predictions and understand how to stop quality events, and create huge time efficiencies.”
The development of personal health tech, such as the Apple Watch, which received Class II medical device approval from the U.S. Food and Drug Administration (FDA), is further evidence of the impact tech is having on clinical research. As more health-related personal devices enter the market there will be greater demand for expanding clinical data analytics and research in innovative ways, including the potential to be able to conduct entire clinical trials in the cloud to significantly reduce projected enrollment times, according to Deloitte.(6)
Europe’s new Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) replace the current Medical Device Directive in May 2020 (MDR) and May 2022 (IVDR), meaning that legacy devices without the MDR CE mark won’t be able to be sold in the European Union (EU), and thus won’t be available in member state health care systems.(7) Device makers have to act quickly to recertify their devices against MDR.
The new regulation is intended to create greater transparency of the approval and usage of devices while improving patient experiences and outcomes. MDR/IVDR will involve several changes for medtech makers, including increased clinical data requirements for medical devices. Essential premarket conformity requirements, called general safety and performance requirements, increase considerably under MDR. As such, manufacturers need to plan for and apply a systematic approach to continuously generate, collect and analyze clinical data pertaining to a device as part of postmarket follow-up (PMFU) and surveillance to verify a device’s safety and performance. The summary of this data will be collected and archived by a manufacturer’s Notified Body and submitted to the European Database on Medical Devices (EUDAMED).
EU MDR will also involve a reclassification of devices, which depending on an individual device’s purpose, may up-classify it to a higher class. For example, this includes devices using nanotechnology, orthopedic implants and life-saving therapeutic devices.
“The need to provide clinical data for a significantly increased number of medical devices, whether the data is collected on a predicate device, during pre-CE clinical trials or during [PMFU] studies, will present a big challenge to most manufacturers,” said Dietmar Falke, the author of an Emergo report on MDR’s amplified clinical evidence requirements.(8)
Though the Trial Master File (TMF) Reference Model originated as an initiative of the Drug Information Association (DIA) as a way to achieve Good Clinical Practice (GCP) through better organization and management of documents prior to clinical trials, it has evolved to be much more. The TMF Reference Model not only verifies the quality of the data it contains in a consistent, standardized format, it also compiles and maintains those records over the course of a clinical trial. Today, creating TMFs according to the globally recognized TMF Reference Model has become a clinical medical device industry best practice. This is partly due to its standardized nomenclature and metadata coupled with its wide acceptance and use which has proven the model to be one of the simplest and most effective resources for clinical practitioners for the preparation and organization of submissions. A recent survey conducted by DIA found that 85% of industry respondents either currently use the DIA TMF Reference Model trial master file structure, are in the process of implementing it or are considering using it in the future.
Not only does the TMF Reference Model maintain the data integrity of the clinical records and documents it contains but it also simplifies cross-referencing of information and maintains focus on data activities. These include making sure data is collected at key milestones; ensuring the execution of “Approve for Use” or quality control checks; noting changes to artifact names; and notifying users and recording when the TMF is missing required data artifacts. And because the TMF Reference Model provides a comprehensive view of all the segmented zones within a trial master file, it is well suited to act as “a single point of truth” for clinical studies.
To better comply with GCP, medtech manufacturers worldwide are increasingly adopting the TMF Reference Model, in effect making it an industry standard. Moreover, a TMF software solution allows companies to streamline and enhance the management of their clinical documentation and their TMF structure. A digital approach to TMF also enables sponsors and contract research organizations (CROs) to track in real time the progress of pending, ongoing and completed TMF-structured items.
Device manufactures can well position themselves in the marketplace by staying abreast of the latest industry movements that include the implications of advancing technology; the ever-changing regulatory landscape such as Europe’s MDR; and an intensified focus on the trial master file as a single point of truth.
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