Medical device manufacturers to be hit hard with industry changes
Written by Dale McGeehon
The U.S. Food and Drug Administration (FDA) issued draft guidance July 9, 2013, for medical device manufacturers that proposes formal changes to existing 1997 guidance, most notably dropping the two-year rule for malfunctions and obligations after selling a 510(k).
The changes either are new or put into writing what has been FDA practice over the last few years, say two FDA and healthcare practice attorneys with Morgan, Lewis & Bockius LLP, who summarized the guidance in an articlein The National Law Review. Medical device manufacturers should carefully consider the draft guidance and determine whether they want to submit comments before the October 7, 2013, deadline, say the attorneys.
Medical Device Reports Revised
"The new draft guidance provides detailed recommendations and clarifications on manufacturers' obligations for submitting medical device reports (MDRs), maintaining MDR procedures, and related recordkeeping requirements," write the attorneys, Elizabeth Bierman and Michele Buenafe. "The draft guidance also includes sections addressing frequently asked questions and common reporting errors."
MDR regulations require manufacturers, importers, and user facilities to report significant adverse events -- such as a death or serious injury -- involving medical devices to the FDA. The manufacturers also must report to the FDA when they learn that one of their devices has malfunctioned and would likely cause or contribute to a death or serious injury if the malfunction occurred again.
Removal of Two-Year Rule on Reporting Devices Malfunctions
One of the changes involves the removal of the so-called two-year rule for malfunctions. Historically, the FDA has taken the position that if a malfunction causes a death or serious injury, future malfunctions of the same type must be reported. The existing 1997 guidance says that the presumption would cease if the malfunction did not cause or contribute to a significant event for two years.
The new draft guidance, however, says that if manufacturers want to stop reporting a malfunction that had contributed to a serious injury or a death they will need to send in a request to the FDA for an exemption. That request will need to be supported with evidence that the malfunction had not contributed to any other serious injuries or deaths.
The attorneys point out that it's not clear in the draft guidance how much data -- such as one year's or two years' worth -- would be needed support the request for the exemption. Perhaps that is what those who wish to comment on the guidance can speak about.
Changes to Contract Manufacturer Arrangements
"FDA would expect only one report from either the specifications developer or the contract manufacturer for one reportable event," says the agency in its 1997 guidance regarding contract manufacturer arrangements. "Nevertheless, there must be a written agreement which identifies which party is responsible for completing Form 3500A."
This is the form used by distributors, importers, applicants, and manufacturers to report adverse events and product problems. It is mandatory in such events.
In the past few years, the FDA has been requiring what is not stated in the 1997 guidance: that it needs an exemption when only one entity reports in a contract manufacturer arrangement. The new draft guidance puts into writing this practice. It states that both the specifications developer and contract manufacturer must submit MDR reports unless the agency issues an exemption to allow reporting by only one entity.
Obligations After Selling a 510(k)
The draft guidelines provide a clarification when a device requiring marketing certification is sold from one manufacturer to another. In such instances, manufacturers need to submit a 510(k) that demonstrates that the device to be marketed is safe and effective.
The draft guidelines say that seller of the device will remain responsible for submitting MDRs for all of the devices that it made before the sale. The requirement would be in effect even if the parties have agreed that the buyer will assume the MDR responsibility. However, FDA can grant an exemption.
Reporting Events in Scientific Articles
Manufacturers of medical devices may need to keep track of serious adverse events that are reported in scientific articles and other literature, under the new draft guidance. If those articles report adverse events, then the manufacturers may need to contact the authors and obtain additional information about those events.
The manufacturers may be allowed to describe multiple events in one report if the maker is unable to obtain sufficient information for a complete report for each reportable event. However, the draft guidance recommends that the maker submit a separate report for each event type, if multiple events are identified, and for each device, if more than one generic device type is implicated, the attorneys say.
Dale McGeehon is the head blogger for Polymer Solutions Incorporated, a medical device testing lab that solves complex challenges for medical product manufacturers. Dale has been a science journalist and editor for three decades, and covers material testing on the PSI blog.
Birdie aims to reinvent elderly care with tech
British startup Birdie has announced it has raised £8.2 million to invest in innovation and scale up the business.
The company's announcement is timely as it follows the criticism of the UK government over their lack of a plan for social care, despite acknowledging the sector is in crisis - around a quarter of the UK's home care providers are on the brink of bankruptcy due to a lack of funds and staffing.
Birdie was born with a mission to "radically improve the lives of millions of older adults", by using app-based solutions, IoT and machine learning to put preventative care at the forefront. The company was founded by Max Parmentier, after experiencing his own frustrations with the care system - his grandfather struggled with the impact of life in a care home, but lacked any other option.
In 2017 Parmentier partnered with venture builder Kamet Ventures to set up Birdie, in a bid to fix this problem. Since then, Birdie has partnered with almost 500 providers across the UK, and supports more than 20,000 older people every week. In the past 12 months alone the number of people Birdie supports has got six times greater.
Birdie’s solution is an app to help care providers deliver more coordinated, personalised and preventative care, by giving them access to digital assessments, medication scheduling and planning tools. By using digital tools to take care of admin, staff have more time to spend with their care recipients.
The new investment will be used to fund Birdie’s next phase of growth in the UK, as the company scales to meet the rapidly growing demand of the aging population. The company will also invest in product innovation, creating new features to address customer requests.
In addition, Birdie is piloting new care models, including partnering with the NHS to identify COVID-19 symptoms, building predictive pharmacy models with AI, and helping health authorities to detect early warning signs of patients’ health risks.
Internally, Birdie is committed to having a progressive company ethos. All salaries are transparent, and staff work asynchronously to maximise flexibility and equity. Staff members also volunteer in their local community during office hours, and the company offsets all its emissions.
These efforts have led to numerous awards, including having the best SME culture in the UK, an Honorable Mention in the Health category of Fast Company’s 2021 World Changing Ideas Awards, and innovation in care at the LangBuisson awards.
“We believe the future of care for older people should be helping them to live at home for as long as possible through the delivery of personalised and preventative care" Parmentier said.
"Birdie is already the partner of choice for caregivers up and down the UK, and this new funding will help us rapidly increase the number we partner with and what we can offer them - meaning more people benefiting from more affordable, quality care. We’re proud of our mission and the values we embody to pursue it.”