Ontogen Medtech News & Articles

News, articles, and resources for medtech leaders—covering regulatory strategy, design controls, quality systems, and scalable manufacturing.

Understanding Breakthrough Device Designation

Breakthrough Device Designation is an initiative introduced by the FDA to accelerate the development and approval of innovative medical devices that offer significant advantages over existing alternatives. This designation is primarily aimed at devices that address life-threatening or irreversibly debilitating conditions, with the potential to revolutionize patient care and outcomes.

UPDATE

January 21, 2022

Methods of Sterilizing Medical Devices: an Overview

Many medical devices are sterilized by the manufacturer and packaged and shipped in a way to maintain the device sterility until it is ready for use in the hospital or clinic. These sterilization processes help mitigate the risk of exposing the patient to pathogens which may result in infection. Although many methods of sterilizing medical devices exist, we will focus on three of the most common methods used by medical device manufacturers and review some of the trade-offs and key considerations which inform the selection of a suitable sterilization process for a medical device.

UPDATE

October 3, 2021

Cell Phones vs. Pacemakers & ICDs | Study supports risk of magnetic interference

A study published in August 2021 provided further evidence of a potential risk that some cell phones and smart watches produce enough magnetic field to interfere with implanted pacemakers. This latest study supports a notification from the FDA earlier this year about the potential risk of magnetic interference between cell phones and pacemakers.

UPDATE

September 12, 2021

FDA releases Guidance Document for Nitinol Devices

In July 2021, the FDA released its final version of a Guidance Document titled “Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol.” This guidance provides clear expectations from the Agency with respect to benchtop testing of medical devices which incorporate nitinol features.

UPDATE

September 6, 2021

How Long Does a 510(k) Approval Actually Take? 2021 edition

We ran the numbers, thanks to the availability of data from open.fda.gov. The FDA has a goal of providing 510(k) decisions within 90 “FDA days.” FDA days are the number of calendar days between the date the 510(k) was received and the date of final decision, excluding the days the submission was on hold for an Additional Information (AI) request.

UPDATE

August 21, 2021

3 Tips for Medical Device SBIR Grant Budgets

SBIR grants are an excellent way to generate non-dilutive funding for early stage medical device startups and entrepreneurs looking to develop an idea into a product. The National Institutes of Health (NIH) and the National Science Foundation (NSF) are two organizations which accept SBIR grant applications throughout the year and are frequent vehicles for early stage funding.

UPDATE

August 16, 2021

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