August 1, 2022

Ultrasounds are a huge milestone for a mother-to-be. It is a health check-up, a confusing picture, but most importantly a first chance to see the child with whom one will spend the rest of their life. It is also a huge hassle. In today’s age of overcrowded hospitals, highly infectious diseases and general uncertainty, just scheduling an appointment can be an ordeal. What if one didn’t have to?

MIT has just published a paper promising a revolution in the field of ultrasound imaging, not just for expectant mothers but for diagnostics as a whole. The researchers have developed a set of 48-hour stickers that when applied to the body can give continuous ultrasound imaging of the body. Unfortunately, this currently needs to be connected to a huge ultrasonic imaging machine to get pictures, but the team is working on artificial intelligence (AI) tool that allows these stickers to communicate directly to a user’s phone instead.

Depending how this technology develops, this could be a game-changer in several fields of medical devices. Not only does this provide a smaller, more compact method of ultrasound imaging, but if these stickers could be packaged and sent to remote locations, a doctor could perform an ultrasound screening of a patient from thousands of miles away. This would make diagnostics of organ health, disease, or pregnancy much more accessible in the world of remote patient monitoring (RPM).

Investors will be chomping at the bit to see the results and efficacy of clinical trials coming out in the future. The results of these trials will determine whether these stickers can revolutionize healthcare. Currently, this technology sits in the intersection of two dynamic fields in healthcare: RPM and diagnostic imaging.The RPM and diagnostic imaging markets are some of healthcare’s largest markets, and GlobalData estimated 2022 market sizes of $11.0m and $30.3m, with expected growth of 3.4% and 4.8%, respectively. With the advent of Covid-19, the usefulness of RPM has been made clear and GlobalData expects its growth to skyrocket in coming years with renewed government reimbursement support.

Should the ultrasound technology prove to be cheap and portable enough, it could cannibalize a significant portion of both of these technologies, but it could also carve out its own new, sizable niche. Currently, one of the largest untapped patient populations is those living in remote areas. These patients will often live very far from the nearest hospital. However, their medical needs are no less diverse, and the closest specialized hospital could be hundreds of miles away. This technology could counteract this setback. By being able to mail these diagnostic stickers to patients in remote areas, healthcare professionals could conduct diagnostic images ranging from pregnancy ultrasounds to checking organ health to looking for cancerous tumours. This opens up a huge range of possibilities in the diagnostic space and thus, a large potential market.

The post The revolutionary portable ultrasound tech could transform the healthcare space appeared first on Medical Device Network.

June 1, 2022

The Master Clinical Trial Agreement (MCTA) working group and Informed Consent and Institutional Review Board (ICF) working group within the Early Feasibility Studies (EFS) program have completed updates to two key EFS resources.

Building on the 2017 EFS project success, in 2018 the EFS Contracts working group set out, for the first time, to (A) develop an EFS-specific Master Clinical Trial Agreement (MCTA), and (B) make that EFS MCTA publicly available on the MDIC website for both medical technology and care provider EFS participants. With engagement of diverse stakeholders including industry, care provider organizations, and regulators, the goal of releasing this MCTA is to facilitate efficiencies in the EFS contracting process by developing an EFS MCTA providing (1) a starting point for contract negotiations with a priori agreement of 90% or greater, and (2) allow both parties to focus remaining legal resources on the remaining 10% (or less) of the EFS MCTA requiring negotiation. The Early Feasibility Study Master Clinical Trial Agreement can be found here.

A template of a patient Informed Consent Form (ICF) for adult patients considering participation in a study being conducted under an IDE through the FDA’s EFS Program was developed as part of the 2016 Blueprint for Early Feasibility Study Success. Updated for 2022, the ICF throughly outlines how those conducting studies can explain the process of participating in a study, the benefits of contributing to research as participant of early feasibility studies, the risks associated with participation and the patients rights to potential participants. Click here to see the full template.

May 6, 2022

The Draft Guidance entitled “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program” was published today in the Federal Register for a 60-day public commenting period.

The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals, and is intended to guide improvement to enhance the quality of devices.

You should submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions about this document, contact Compliance and Quality Staff within OPEQ:Office of Product Evaluation and Quality/IO:Immediate Office at CaseforQuality@fda.hhs.gov.

 

 

May 5, 2022

The Medical Device Innovation Consortium (MDIC), today announced the publication of the MDIC External Evidence Methods (EEM) Framework. This framework, developed by subject matter experts from industry, academia, and the U.S. Food and Drug Administration (FDA), is a document intended to help stakeholders navigate their way through the process of leveraging external data by harnessing the power of statistics. The 21st Century Cures Act, as well as the learnings from the COVID-19 public health emergency, underscored the need to expand the role of relevant external data in the total product lifecycle of medical devices.

 

To read the full release click here.