Tag Archive for: Jama Company and Community News

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share excerpts from an article, sourced from MedTech Dive, titled “Q&A: How Monogram’s CEO Plans to Disrupt Robotic Joint Replacement Surgery” – originally written by Susan Kelly and published on August 4, 2023.

Q&A: How Monogram’s CEO plans to disrupt robotic joint replacement surgery

The robot developer’s CEO, Benjamin Sexson, tells MedTech Dive why he believes the orthopedics market needs a fresh approach to joint reconstruction.

Permission granted by Monogram Orthopedics

Seven-year-old surgical robotics company Monogram Orthopedics, which went public in May, is aiming to take on medtech heavyweights such as Stryker and Zimmer Biomet as well as smaller challengers in the growing market for robot-assisted joint replacement. CEO Benjamin Sexson, an engineer by training, sees a pressing need for personalized implants made to fit each patient’s specific anatomy.

This interview has been edited for length and clarity.

MEDTECH DIVE: What are some of the challenges in knee replacement that you are trying to solve with your surgical robot?

BENJAMIN SEXSON: The idea is to move away from what’s called mechanical alignment, which is how we’ve always done it with manual instruments. A lot of the robots on the market today are just basically helping surgeons put the knee into mechanical alignment – everybody gets the same knee, the joint line is basically restored to be parallel to the floor.

With functional, or more personalized, alignment approaches, surgeons are tweaking the plan based on, I have my patient’s specific data, I have the CT scan, and I can assess intraoperatively what do I think looks best? And they can make very, very precise and accurate tweaks to the surgical plan that, over time, we’re seeing are enhancing patient satisfaction.

Stryker and Zimmer both have the ability to use a CT scan or advanced imaging to preoperatively plan. Stryker has been driving this trend. Stryker is showing that patients are happier when you can do some degree of personalization of the surgery.

Other players in the space have been struggling [because] they are imageless. They made the bet that insurance companies would not be as accommodative in the future to reimbursing the cost of the CT scan, and so their surgeries correlate to generalized models. We think that over time, this is going to be increasingly problematic for those other players.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Monogram Orthopedics plans to seek FDA clearance for its mBôs TKA System, a surgical robot that it aims to use for multiple orthopedic procedures, starting with knee replacements.
Permission granted by Monogram Orthopedics

What gives you confidence that there is room for another robot in the orthopedic marketplace?

Investors generally [say], “Well, everybody already has an orthopedic robot.” OK, but really only two companies are CT-based, and only one of those companies is actually [using surgeon-initiated] cutting. So there’s really only one navigated, efficient, cutting, CT-based robot, and that’s Stryker, and they have 90% of the market. And only 10% of knees today are robotic. So there’s a huge opportunity.

It’s inefficient for a small-footprint private clinic to be forced to buy five-plus different robots, one that’s good for the spine, one for the hips, one for the knees, one for the shoulders, one for the ankles, etc. The fundamental difference between our philosophy and our competitors is that Monogram seeks to develop one robot optimized for many applications.

Why did you decide to focus first on the knee market?

I’ll start by saying that our robot is not a knee robot. It’s an orthopedic robot. It just so happens that knees are our first application for a number of reasons. One is that we didn’t want to go on a missionary effort trying to convince people in, say, the shoulder space, to use an orthopedic robot and develop a whole new surgery. We wanted to come into a market that already had billing codes and an established market presence and some level of acceptance.

There are about a million knee replacements a year in the United States, and about 10% of those fail every year. And a lot of people are not satisfied with their knee replacement. We think we can make it a lot less scary and a lot less risky.

Where are you in the process toward gaining FDA approval?

We’ve had what’s called a pre-submission meeting with the FDA. This is a 510(k) submission, so we’re going to be claiming substantial equivalence to a system that’s already on the market. Where we are is, the FDA is accepting of our clinical pathway. They’re accepting of our predicate [Stryker’s robot] and intended use. The question that’s still outstanding is whether or not the technical differences with our predicate need to be tested with clinical data. Our plan is to take a defensive approach and submit to the FDA with clinical data. Our plan is to lean heavily on capturing that data outside the U.S.

RELATED: Revolutionary Surgical Robotics Company, Monogram Orthopedics, Selects Jama Connect® For Its Unique Cloud Based Services and Ease of Use


MDR/IVDR

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Regulatory Focus™, titled “MDR/IVDR Survey Shows NBs Have Increased Capacity” – originally written by Ferdous Al-Faruque and published on July 31, 2023.

MDR/IVDR Survey Shows Notified Bodies (NBs) Have Increased Capacity

A recent survey published by the European Commission shows a promising trend for devices and diagnostics transitioning to Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) but it’s still too early to say how successful the transition is going, two experts told Focus.

The European Commission published a survey of data from notified bodies (NB) conducted by the Austrian National Public Health Institute (Gesundheit Österreich GmbH), and research groups Areté and Civic Consulting on 25 July. The survey provides an overview of the MDR/IVDR transition process as of the end of March 2023. The results show that compared to October 2022, the number of MDR/IVDR applications and certificates has increased significantly.

Between 22 October 2022 and 31 Marodiech 2023, the number of MDR applications rose more than 40% from 8,120 to 11,418. The number of MDR certificates also rose almost 50% during that time from 1,990 to 2951.

The survey found that in October 2022 there were 22,793 products on the market with valid certificates under the Medical Device Directive and Active Implantable Device Directive (MDD/AIMDD) which means that applications for about half of those products have been submitted for transition by March 2023, and about 35% of MDD/AIMDD products submitted for transition to MDR were submitted since October 2022.

Similarly, the data shows the number of IVDR applications received by NBs has gone up more than 15% from 822 in October 2022 to 950 in March 2023, and the number of certificates they have issued for the products has gone up 24% from 268 to 331 during the same period.

“This progress is good news, [but] the survey results should be interpreted with some caution,” Sabina Hoekstra-van den Bosch, global director for regulatory strategy at TÜV SÜD GmbH and vice-president of Team-NB, told Focus.

RELATED: An Overview of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR)

While the survey takes into consideration data through 31 March 2023, Hoekstra-van den Bosch says it doesn’t take into account any potential effect of the MDR extension that went into effect on 23 March 2023. She says it is likely the effects of the delay are only now showing up in the data and notes NBs have shared new data through the end of June with the European Commission which may offer a clearer picture. (RELATED: Council votes unanimously to extend MDR deadlines, Regulatory Focus 7 March 2023)

“Everyone hopes and expects, that the number of applications will increase rapidly,” said Hoekstra-van den Bosch. “[But] another expectation is that the number of certificates will rise much more slowly than the number of applications, as Regulation 2023/607 gives time until 2027/2028 to finalize certification, while in the meantime manufacturers are allowed to keep the legacy device on the EU market.”

Hoekstra-van den Bosch says calculating the transition rate for products getting MDR certified is complicated and can be interpreted differently.

She notes that the current number of AIMDD/MDD products that need to be recertified is probably being underestimated since under MDR certificates will need to be given out for products such as class IIb implantable devices that require separate certificates. On the other hand, grouping basic UDI-DI products under MDR may also mean an increase in the number of certificates.

Hoekstra-van den Bosch says the MDR extension and publication of a Medical Device Coordination Group (MDCG) guidance encouraging manufacturers to not wait until the last minute are all good signs and if left unheeded may still result in bottlenecks for products getting recertified. (RELATED: Euro Roundup: EU answers questions about the extension of MDR transition, removal of ‘sell off’ periods, Regulatory Focus 30 March 2023)

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

“The [Austrian National Public Health Institute] survey shows some hopeful signs, but the ‘proof in the pudding is the eating,’” Hoekstra-van den Bosch said. “We are eagerly anticipating the publication of the next editions of the European Commission’s survey results.”

Gert Bos, executive director of the Qserve Group, says his main concern about products transitioning to MDR/IVDR has to do with communication between NBs and manufacturers.

“On the one hand many notified bodies indicate they can handle more applications, whereas manufacturers are not all speeding up their processes to get to the application phase,” he told Focus. “Meanwhile, companies on their second and third dossier may currently be waiting for 12 to 18 months to get feedback on their responses to the previous rounds of questions.”

Bos says there is plenty of guidance on how the new MDR system should work but there is still not enough guidance on what is considered sufficient evidence regarding clinical support, toxicity, biocompatibility testing, and general performance testing.

“The good news is that the structured dialogues between manufacturers and notified bodies are starting to bring clearer expectations,” he added. “So, we are going slowly in the right direction.”

Bos is also concerned that when applications do get feedback from NBs, they may contain deficiencies that could have been addressed in the first review round.

The survey sheds some light on the topic and lists the key reasons for why an MDR application was refused and shows some interesting trends.

In October 2022, the top two reasons were insufficient NB resources or because the application was outside the scope of the NB’s designation, with 61 and 66 applications being refused for those reasons, respectively. However, the top three reasons given for an application refusal in March 2023 were the wrong qualification or classification of a product with 74 refusals, the application was not complete with 80 refusals and the application was outside the NB’s designation with 208 refusals.

RELATED: European Union Medical Device Regulation (EU MDR): What You Need to Know

The number of refusals due to insufficient NB resources dropped to 31 which shows that NBs have started to significantly increase their capacity to handle incoming applications.

Bos is also worried that while global production processes have significantly improved in the past three decades, it has come to a halt due to delays in the MDR transition process.

“The problems rise to the level that such reviews on supply chain and production change approvals are starting to take priority over the more lengthy full MDR review processes,” he said. “This might in the coming 12 months fill the spare notified body capacity, in which case we’ll be walking straight into a further bottleneck when too many MDR and IVDR applications come in the second half of next year.

“Again the message is clear: Don’t delay your MDR and IVDR applications, but talk with your notified body about having the elements of the continued improvement reviewed in parallel,” he added. “It might free up the blocked production processes and will be useful in the full application as part of the new production has already been reviewed by the notified body.”

Gert Bos is the chair of RAPS and Sabina Hoekstra-van den Bosch is a director of RAPS, a nonpartisan, nonprofit professional society. Their comments represent their views only.

Survey

© 2023 Regulatory Affairs Professionals Society.


Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Reuters, titled “EU Seals New US Data Transfer Pact, But Challenge Likely” – originally written by Foo Yun Chee and published on July 10, 2023.

EU Seals New US Data Transfer Pact, But Challenge Likely

European Union flags flutter outside the European Commission headquarters in Brussels, Belgium, June 5, 2020. REUTERS/Yves Herman/File Photo

BRUSSELS, July 10 (Reuters) – The European Commission announced a new data transfer pact with the United States on Monday, seeking to end the legal uncertainty plaguing thousands of companies that transfer personal data across the Atlantic.

The move was immediately criticized by a non-profit group noyb, led by privacy activist Max Schrems, which said it would challenge the agreement.

The commission and the United States had been struggling to reach a new agreement after Europe’s top court annulled two previous pacts that underpinned the transfer of personal data across the Atlantic for services ranging from cloud infrastructure to payroll and banking.

The commission, the EU’s executive arm, said measures taken by the United States ensured an adequate level of protection for Europeans’ personal data transferred across the Atlantic for commercial use.

It said new binding safeguards, such as limiting U.S. Intelligence services’ access to EU data to what is “necessary and proportionate” and the establishment of a Data Protection Review Court for Europeans, address the concerns raised by Europe’s top court.

RELATED: Why It Makes Sense to Store Cybersecurity Risk Management Items Inside a Requirements Management System

U.S. President Joe Biden welcomed the data transfer pact and said it reflected a “joint commitment to strong data privacy protections.”

EU justice chief Didier Reynders said he was confident of fending off any legal challenge.

“The principles of the data privacy framework are solid, and I am convinced that we have made significant progress which meets the requirements of the European Court of Justice case law,” he told a news conference. “I am very confident of fighting, defending the new data agreement.”

But Schrems said the latest revision was inadequate.

“Just announcing that something is ‘new,’ ‘robust’ or ‘effective’ does not cut it before the Court of Justice. We would need changes in U.S. surveillance law to make this work,” he said in a statement.

“We have various options for a challenge already in the drawer, although we are sick and tired of this legal ping-pong. We currently expect this to be back at the Court of Justice by the beginning of next year,” Schrems added.

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Lobbying group DigitalEurope, whose members include Airbus (AIR.PA), Amazon (AMZN.O), Apple (AAPL.O), Ericsson (ERICb.ST), Nokia (NOKIA.HE), Philips (PHG.AS) and Samsung (005930.KS), welcomed the deal.

“Data flows underpin the EU’s annual 1 trillion euros of service exports to the United States, and this decision will give companies more confidence to conduct business and help our economies to grow,” its director-general, Cecilia Bonefeld-Dahl, said.

Earlier this year, the EU’s privacy watchdog, the European Data Protection Board, said the latest data agreement still fell short and urged the commission to do more to protect Europeans’ privacy rights.

Europe’s top court scuppered the previous two deals after challenges by Schrems because of concerns about U.S. Intelligence agencies’ accessing European citizens’ private data.

Reporting by Foo Yun Chee; Additional reporting by Kanishka Singh in Washington; Editing by Philip Blenkinsop, Christina Fincher and Leslie Adler

The Thomson Reuters Trust Principles.


Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Beyond Type 1, titled “Tandem’s Mobi Approved by the FDA” – originally written by Christine Fallabel and published on July 11, 2023.

Tandem’s Mobi Approved by the FDA

On Tuesday, July 11th, 2023, the Food and Drug Administration (FDA) announced the approval of Tandem’s newest insulin pump, called Mobi. This insulin pump is fully controllable from a mobile app and is now the world’s smallest durable automated insulin delivery system.

THE MOBI INSULIN PUMP

The Mobi will join a growing selection of Tandem products that support people with diabetes. Their human-centered approach to design, develop and support innovative products and services for people who use insulin is evident in this latest approval.

John Sheridan, president and chief executive officer for Tandem Diabetes Care said, “Through this expansion, we are delivering on our commitment to bring greater choice, along with the proven benefits of Tandem’s technology, to more people living with diabetes.”

The San Diego-based company also manufactures the T:Slim X2 insulin pump with Control-IQ technology, a feature that is also part of this new release.

Control-IQ technology utilizes compatible continuous glucose monitor (CGM) sensor readings to predict blood sugar levels 30 minutes ahead of time. It then adjusts insulin delivery every five minutes to help prevent both high and low blood sugars levels. The system also delivers automatic correction boluses of insulin for up to an hour to help prevent high blood sugars.

The user can still manually bolus for snacks and meals.

The Mobi has been approved for people with diabetes aged six and older who require insulin.

RELATED: Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know

MOBI FEATURES

The new Mobi has some great features that will make pumping not only easier for people, but more convenient and flexible too.

  • 200-unit insulin cartridge
  • Less than half the size of the T:Slim X2 pump
  • Detachable infusion sets that are compatible with all existing Tandem infusion sets, allowing users to mix and match infusion sites and tubing length combinations for greater flexibility
  • Control IQ technology designed for use as part of an automated insulin delivery system
  • Mobile app control with an on-pump button, providing an option for the user to utilize phone control for bolusing insulin
  • Inductive charging and capable of wireless remote software updates from a compatible smartphone

MORE CHOICES FOR PEOPLE WITH DIABETES

This new approval will greatly expand the choices people with diabetes who use insulin pumps will have, and it is the smallest and most convenient insulin pump yet.

According to the manufacturer, the Mobi is small enough to fit in a coin pocket, be clipped to clothing or fit into an adhesive sleeve—expanding where and how and insulin pump fits into your life and lifestyle.

Additionally, the Mobi insulin pump is completely controllable from a user’s mobile phone via an app, a feature many people with diabetes are looking for in newer tech releases.

People don’t want to always be juggling multiple devices, and having both blood sugar readings and insulin pumping capability from a smartphone just makes life with diabetes easier.

RELATED: Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®

MARKET AVAILABILITY COMING SOON

A limited release is expected to start in late 2023 with full commercial release planned for early 2024. To sign up for updates, please visit tandemdiabetes.com/mobi.

If you are interested in trying the Mobi insulin pump when it is available, start talking to your provider now about any necessary steps you may need to take like getting a prior authorization.


Aerospace

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Reuters, titled “Canada investing C$350 million to boost drive for sustainable aerospace industry” – originally reported by David Ljunggren, edited by Jonathan Oatisand, and published on June 19, 2023.

Canada Investing C$350 Million to Boost Drive for Sustainable Aerospace Industry

Aerospace

Canada’s Minister of Innovation, Science and Industry Francois-Philippe Champagne speaks during Question Period in the House of Commons on Parliament Hill in Ottawa, Ontario, Canada April 25, 2022. REUTERS/Blair Gable/File Photo

OTTAWA, June 19 (Reuters) – Canada is investing C$350 million ($265 million) to help fund efforts to make the aerospace industry more environmentally sustainable, Innovation Minister Francois-Philippe Champagne said on Monday.

The focus will be on hybrid and alternative propulsion, aircraft systems, the transition to alternative fuels, and aircraft support infrastructure, he said in a statement.

RELATED: New Research Findings: The Impact of Live Traceability™ on the Digital Thread

“(This) … will help drive and accelerate the green industrial transformation of Canada’s aerospace industry, generating high-value jobs while strengthening supply chains and supporting the transition to a net-zero economy,” he said.

Earlier this month, global airlines called for broad co-operation to reach “very tough” emission targets. Aviation, which produces around 2% of the world’s emissions, is considered one of the hardest sectors to decarbonise.

RELATED: Functional Safety (FuSA) Explained: The Vital Role of Standards and Compliance in Ensuring Critical Systems’ Safety

The C$350 million includes a C$49 million aerospace innovation investment announced in 2019.

Airbus said in 2021 it was working on hybrid-electric propulsion among the options for reducing jetliner emissions. It has pledged to introduce the first hydrogen-powered commercial plane in 2035.

In 2019, Vancouver-based seaplane operator Harbour Air carried out the world’s first fully electric, commercial flight.

($1 = 1.3202 Canadian dollars)


Au

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from NPR, titled “After years of decline, the auto industry in Canada is making a comeback” – originally authored by H.J. Mai and published on March 12, 2023.

After Years of Decline, the Auto Industry in Canada is Making a Comeback

A car hauler carrying Chrysler Pacificas’ approaches the Ambassador Bridge that connects Windsor, Canada, to Detroit, Michigan,on October 5, 2018 in Windsor, Ontario, Canada. – AFP via Getty Images

When most people think of Canada, they rarely think of cars. But the country, known for hockey, maple syrup and endless wilderness, is one of the largest car producers in North America. And with the growing importance of electric vehicles, Canada hopes to breathe new life into its automotive industry and maintain a more than 100-year-old tradition.

Canada’s automotive industry is primarily located in Ontario and Quebec, with Windsor, Ontario, claiming the title of Canada’s automotive capital.

“We’ve been the auto capital of Canada since about 1904, when the first auto plant opened in Canada,” said Windsor Mayor Drew Dilkins.

Windsor, just across the river from Detroit, has benefited from its proximity to the United States and the three major carmakers headquartered there.

Stellantis, formerly Fiat Chrysler, and South Korean battery maker LG Energy Solutions (LGES) announced last year that they will invest more than 5 billion Canadian dollars ($3.5 billion) in building a new large-scale battery manufacturing plant in Windsor. The plant is expected to be operational by 2024 and will create an estimated 2,500 jobs.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Automotive

“It’s a massive, game-changing investment, and I’m not even sure these two words are big enough to describe how important it is for our community,” Dilkins says. “This will have a generational impact. [Companies] will look at the new world of automotive and will start looking at Windsor Essex as a place to do business.

Investment by Stellantis and LGES is part of a larger trend that has seen more than CA$17 billion in announced investment in Ontario’s automotive sector since the beginning of 2021.

“Ontario has had the greatest new investment in vehicle production in its history over the past two years,” says Flavio Volpe, president of the Canadian Automobile Parts Manufacturers’ Association.

Most of this investment, worth nearly CA$13 billion, is in electric and battery production. And by passing the Inflation Reduction Act, U.S. lawmakers have given Canada a further boost to its EV ambitions.

“This is good news for Canadians, for our green economy, and for our growing EV manufacturing sector,” Canadian Prime Minister Justin Trudeau said in a tweet shortly after President Biden signed the law.

The law includes tax credits for EV buyers, but only if the car is largely made and assembled in North America, and its battery uses locally mined components. According to GM Canada’s David Paterson, this could give Canada an advantage over the U.S. and Mexico.

General Motor’s Canadian Technical Center at Oshawa is a vehicle development facility in Ontario, Canada. – HJ Mai/NPR

“What goes into our [sic] batteries are cathode active materials, which are mainly made of nickel and other critical minerals that we happen to have in abundance here in Canada,” he says.

“As we see less demand for gasoline, we see more demand for minerals, and Canada is an economy built on natural resources.”

In an effort to encourage the shift in the auto industry toward battery-powered EVs, Canada’s federal government along with Ontario’s provincial government have been investing billions of dollars.

“Our incentive is that you have a job because we invest about $2.5 billion in taxpayer money in these [car companies,” says Vic Fedeli, Ontario’s Minister of Economic Development, Job Creation and Trade.

The recent investment streak is a welcome sign for an industry that has gone through many ups and downs. Increased automation and competition from lower-wage regions have led to plant closures and job losses over the past two decades.

“We have been coming from a whole generation since about 2000, watching this critical sector decline. We have seen disinvestment in the sector, we have seen job losses in the sector, we have seen plants closed and communities are basically disappearing,” says Angelo DiCaro, research director for Unifor, a union representing about 230,000 Canadian auto workers.

The North American Free Trade Agreement, or NAFTA for short, contributed to this downturn as car companies moved their assembly lines to places like Mexico or the U.S. Southeast to cut costs. The USMAC, which replaced NAFTA in 2020, has somewhat leveled the playing field by boosting regional content requirements and instituting a minimum wage of at least $16 an hour.

DiCaro says that despite the uncertainty surrounding certain jobs that could be lost in this transition to electric vehicles, Canada’s auto workers have a sense of optimism and hope.

RELATED: Jama Connect® for Automotive Solution Overview

According to government data, the auto sector plays a key role in Canada’s economy, contributing CA$16 billion to its gross domestic product (GDP). With nearly 500,000 direct or indirect jobs, automotive is one of the country’s largest manufacturing sectors and one of its largest export industries.

Volkswagen and its battery company PowerCo announced Monday that they selected Ontario, Canada as the location of Volkswagen’s first cell manufacturing facility in North America.

The new battery plant in Canada will be the third group in the group, after Salzgitter, Germany and Valencia, Spain.

“Canada offers ideal conditions, including the local supply of raw materials and wide access to clean electricity,” the group said in a press release.

Production is expected to start in 2027.

Tesla is another company that publicly stated it is actively looking at Canada as a potential site for a new battery and / or assembly plant. The company would join Ford, General Motors, Honda, Stellantis and Toyota, which already have production facilities in Ontario.

“The success of the [Ontario] government and the federal government [sic] will not be defined by what we have landed at the moment. It will be whether we can lend a sixth automaker or a seventh,” Flavio Volpe says. “It will mean that our vision was worthy of the rhetoric and convince the best automakers in the world that the future runs through Ontario.”


FDA

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from MedTech Dive, titled “FDA moving ahead with rulemaking on lab developed tests without waiting for Congress: BioWorld” – originally authored by Nick Paul Taylor and published on March 2, 2023.

FDA Moving Ahead with Rulemaking On Lab Developed Tests Without Waiting for Congress: BioWorld

FDA headquarters in White Oak, Maryland. Sarah Silbiger/Getty Images via Getty Images

Dive Brief:

  • The U.S. Food and Drug Administration is “moving forward with rulemaking” on laboratory developed tests (LDTs) without waiting for new powers from Congress, a senior FDA official said at an industry conference.
  • Elizabeth Hillebrenner said on a panel Wednesday that the agency cannot “just stand by” given the perceived public health problem created by LDTs and the failure of Congress to pass legislation.
  • The FDA has yet to set a timeline for LDT rulemaking or provide a close look at its plans, Hillebrenner said, noting that the agency will follow a three-tier risk framework, but giving few other details.

RELATED: Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part I

Dive Insight:

Lawmakers have been trying to pass LDT legislation for years. An earlier form of the Verifying Accurate Leading-Edge IVCT Development (VALID) Act was introduced to Congress in 2018. Key aspects of the draft advanced as part of the FDA’s user fee package last year, only to be cut from the final version. A push to pass the VALID Act as standalone law fell short late last year.

The FDA identified a need to reconsider its policy of enforcement discretion for LDTs in 2010, reflecting the increasing complexity and risks of the tests, and shared a discussion paper in 2017. However, the paper is not enforceable.

RELATED: 2023 Predictions for Medical Device Product Development

Legislation would clarify the FDA’s authority to regulate LDTs and give the agency new powers, but in the ongoing absence of action from Congress, work is now advancing under the current statutory authority. Hillebrenner, associate director for scientific and regulatory programs at the FDA’s Center for Devices and Radiological Health, outlined the situation at an American Clinical Laboratory Association event.

In comments reported by BioWorld, Hillebrenner noted that FDA Commissioner Robert Califf “has already said all options are on the table, including rulemaking, and we are moving forward.” The FDA continues to support legislation such as the VALID Act that provides a regulatory framework in line with modern diagnostics but is no longer willing to wait on Congress to address the problems posed by LDTs, she said.


FDA

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from MedTech Dive, titled “FDA Class I Recalls Hit 15-year High in 2022” – originally authored by Nick Paul Taylor and published on March 3, 2023.

FDA Class I Recalls Hit 15-year High in 2022

The exterior of the Food and Drug Administration headquarters is seen on July 20, 2020 in White Oak, Maryland. Sarah Silbiger via Getty Images

Dive Brief:

  • The number of Class I medical device recalls by the U.S. Food and Drug Administration hit a 15-year high in 2022, according to a report by Sedgwick.
  • In 2022, the FDA oversaw 70 Class I recalls, its highest risk classification, compared to an average of 47 over the previous five years. Eighteen of the Class I recalls happened in the fourth quarter.
  • Mislabeling was the most common reason for recalls in three of the past five quarters.

RELATED: 2023 Predictions for Medical Device Product Development

Dive Insight:

Last year, companies including Abbott, Baxter, GE HealthCare, Medtronic and Philips were the subject of Class I recalls, a category that the FDA reserves for problems with the potential to cause serious injury or death. The activity added up to a record year for Class I recalls.

Sedgwick reported the 15-year high for Class I recalls after tallying up the data for the fourth quarter. Over the final three months of the year, the total number of recalls of any type rose 8.1% sequentially, and the number of recalled units increased by around 10 million to 61.98 million.

Mislabeling was again the most common cause of recalls in the fourth quarter, as it has been for three of the past five quarters, followed by quality. There was a decline in the number of recalls related to software, the most common cause of recalls in the third quarter. Having been responsible for 46 events over that prior period, software accounted for 15 recalls in the final three months of the year.

RELATED: Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part I

Based on data for January, the increase in recalls between the third and fourth quarter may continue in 2023, the report said. Sedgwick counted 135 recalls in January, compared to a monthly average of 80 in the fourth quarter. The number of recalled units is also tracking above the rate seen in the fourth quarter.

Sedgwick identified the FDA’s use of Section 518 authority, which allows it to order manufacturers to notify patients and providers of risks, as one of the most significant developments in medical device recalls. The FDA used the power one year ago to order Philips to tell patients about its respiratory device recall because the company’s efforts to that point had been “inadequate,” the agency said.


Aircraft Certification

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Air & Space Forces Magazine, titled “Digital Transformation of Verification Process for Faster Aircraft Certification” – originally authored by Thierry Olbrechts and published on March 13, 2023.

Digital Transformation of Verification Process for Faster Aircraft Certification

 

The certification of new aircraft programs is expensive. Whether it is an advanced air mobility system, a (hybrid-) electric aircraft or a military aircraft with new weapon systems, new and innovative aircraft programs are very complex. The application of new materials, additive-manufactured structures, electrical propulsion systems and an increase in onboard software requires extensive virtual and physical testing to verify whether the aircraft is safe, reliable and cost-effective to fly.

Managing verification from the start of the program, as soon as the requirements have been defined and validated, is a good practice. As the verification job is huge, especially for start-up programs, a digital verification management platform can significantly reduce the risk and related over-budget costs of aircraft certification.

Challenge – Aircraft Complexity

There’s a reason why airplanes are the safest mode of transportation: certification. For aerospace manufacturers, aircraft certification is everything. No certificate means no product to market.

In addition to already strict EASA, FAA, and other regulations, companies face additional demands for advancements, including – but not limited to – sustainability targets and the ambition to fly autonomously, which require more integrated systems driven by software and electronics.

New technologies like this are exponentially complex. They impact all aspects of product development, including design, validation, and testing. Instead of a few components and hundreds of interfaces, there are now thousands of components with tens of thousands of interfaces. More and more functions are implemented through software.

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Implications – Aircraft Programs at Risk

Therefore, it’s no surprise that today, aircraft certification is more costly than design. This is a huge challenge. Many companies have great ambitions with new aircraft configurations. It is now technologically and financially feasible to build and fly prototypes and validate concepts. The big financial challenge and risks that a company faces are the costs of aircraft certification and industrialization. Indeed, Porsche Consulting estimated in 2018 that the series development and type certification of an eVTOL urban air mobility aircraft would cost between $500 million and $1 billion1, and Archer Aviation CEO Adam Goldstein says, “the price-tag for one aircraft design to reach certification could be up to $1 billion”.2

This represents a serious risk to many companies. As an aeronautical engineer, I cannot be more delighted when I see all the initiatives taken to exploit the possibilities of new propulsion systems into radical new aircraft configurations. In that sense, the last 5 to 10 years are comparable to the 1950s, when a lot of new aircraft configurations were explored. However, I’m worried that many companies with exciting new ideas will financially fail before getting aircraft certification.

One should not forget that many of these companies have to build the elements for proof of compliance from a blank sheet. They cannot count on data from previous programs to alleviate the verification process by comparison. This puts them at a competitive disadvantage against legacy companies, which might be less innovative but have an abundance of verification data at hand.

Because of the above, new organizations tend to postpone addressing the verification and certification aspects.

Figure 1. Implications of increased program complexity and integrated systems: the current approach does not work anymore.

Opportunity – Certify During Development

Digitalization environments offer a lot of capabilities to pre-empt the aircraft certification aspects and associated risks.

Process-wise, companies should consider including the verification and certification process within the aircraft design, development production and quality process from the start of the program.

Figure 2. Building the verification and certification Digital Twin: actively manage the plan from start to finish.

Different digital platform pillars are key in this:

Figure 3. Key technologies to support aircraft programs.

It Starts with the Digital Twin

Throughout the development of aircraft, digital twin capabilities make it possible to design, engineer and optimize the aircraft and its systems. They provide engineering insight into how the aircraft is built and how it performs behaviorally. The use of a digital twin model enables manufacturers to become exponentially more accurate in all aircraft domains, covering all “engineering physics,” which define how well it operates.

Given good management and validation of the modeling assumptions, these digital twin models can be further exploited to verify the behavior of electro-mechanical systems, coupled to the software-based control functions. Indeed, once one gets confidence in how well the models represent reality, these models can be used to perform virtual testing and alleviate the burden and costs of physical testing.

The ability to author these virtual test models is dependent on having the necessary skill tools for generating the engineering analysis data.

An additional benefit of digital twin models is that they not only help with accelerating the verification based on virtual testing, but they also have an under-recognized value in preparing and de-risking the physical tests, which will be needed anyway.

Indeed, as long as innovation continues to occur in this industry, it will be necessary for companies to prove the accuracy of their modeling assumptions, methods, and processes to aircraft certification authorities and organizations.

Digital twin technology is essential when programs want to reduce the risks related to aircraft certification. However, there is a closed-loop process needed between virtual and physical testing in order to make this a viable strategy.

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Digital Data and Process Backbone

The amount of engineering analysis data a digital twin generates is enormous and requires a digital data and process management backbone to control it, keep it in configuration, manage the processes and make sure all data is traceable.

This backbone is also very important for the next programs. Indeed, stored data does not only serve current programs, but also can be reused in future programs to avoid verifying aspects multiple times on different programs. This drastically reduces verification costs of future programs, whether by simply re-using data or proving digital twin modeling assumptions were right and avoids physical verification on these aspects on the next program.

Digital Thread

The generation of engineering data using digital twin technology along with excellent data management is a start, but to be truly effective, the digital platform needs to keep all data generated and managed in the context of the aircraft program, as it assures the digital continuity of engineering data with the engineering decisions taken. As part of a model-based systems engineering (MBSE) approach, a verification management digital thread can provide a traceable link between the requirements and the artifacts that lead to the proof of compliance of that requirement, including all its intermediate data like the eBOM, test-BOM, etc.

Solution – Verification Management

A verification management digital thread should be a vital part of the digitalization strategy of all aerospace and/or defense companies. It can help make certification an integral part of the overall product development process and enable companies to have a robust certification execution plan and incorporates all the needed certification activities within the overall program plan.

It is vital that companies embrace not only a verification management digital thread, but also a full digitalization strategy. Digitalization enables aerospace manufacturers and their supply chain partners to make better-informed decisions based on extensive data and analysis as well as full traceability. It is the only way to turn the increased level of complexity and integration inherent in new programs into a competitive advantage.

The aerospace and defense industry is going through a time of immense innovation, and I’m excited to see what the future holds as A&D companies and teams of all sizes adopt digitalization to deliver on the promise of this innovation.

References

1. The Future of Vertical Mobility, Sizing the market for passenger, inspection, and goods services until 2035, A Porsche Consulting study, 2018

2. Can UAM developers turn their electric dreams into a reality? Pilar Wolfsteller, 2022

About the Author

Thierry Olbrechts is the Director of Simcenter Aerospace Industries Solutions, Siemens Digital Industries Software. In 1996, he joined Siemens Digital Industries Software. Since 2000, Thierry has been responsible for Siemens simulation and test business development and go-to-market strategies for the aviation, space and defense industry segments.


 

MDR

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from MedTech Dive, titled “Medtech industry relieved as Europe’s MDR extension nears final approval” – originally authored by Susan Kelly and published on March 6, 2023.

Medtech Industry Relieved as Europe’s MDR Extension Nears Final Approval

MDR

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The Council of the EU is expected to vote Tuesday on an extension of deadlines for complying with Europe’s Medical Device Regulation (MDR), in a move to keep critical treatments on the market during the transition period.

The revised timeline would give notified bodies that certify devices in the European Union longer to prepare for the new regulatory framework.

Companies that operate in the European market were expected to have devices recertified by May 2024 under the regulation, but with the deadline approaching, notified bodies faced a backlog, prompting the European Commission to propose extending the time frame.

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“Industry is relieved that these amendments have been introduced – they are the culmination of many warning signs about a potential shortage of medical devices in the EU,” Brussels-based life sciences lawyer Josefine Sommer, a partner at Sidley Austin, wrote in an email.

The extension would stagger deadlines until 2027 or 2028, based on device risk classification, allowing manufacturers and notified bodies more time to complete conformity assessments. Products placed on the market under the predecessor Medical Devices Directive (MDD) could remain, under certain conditions.

“Once the amendments have been adopted, it will be interesting to see how the conditions for benefiting from the additional transitional periods are to be interpreted and implemented in practice,” Sommer said.

The upcoming European Council vote follows the European Parliament’s approval last month of the new timetable. EU procedure calls for both branches of the legislature to approve the plan.

“This will be the final step in the process,” an EU official said in an email.

Member state health ministers in the EU’s Employment, Social Policy, Health and Consumer Affairs Council backed the plan in December, after European medical societies called for urgent action to address device supply shortages reported by physicians.

“The Health Council supported the European Commission’s proposal to delay the transitional deadlines to avoid causing harm to EU health systems and, most critically, patient care,” London-based attorney Lincoln Tsang, partner and head of Ropes & Gray’s European life sciences practice, wrote in an email.

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The MDR was adopted in 2017 following the recalls of breast implants and metal hip replacements due to safety problems. The regulation tightens controls for the safety and performance of medical devices and includes stricter monitoring and certification procedures to ensure compliance and traceability. The new rules also are intended to reflect technological and scientific advancements in the sector.

With the extended deadlines, higher-risk devices such as implants must transition to the new requirements by December 2027, and medium- to lower-risk devices such as syringes or reusable surgical instruments have until December 2028.

But Erik Vollebregt, a founding partner of Axon Lawyers in Amsterdam, said the timeline still requires manufacturers to be MDR-ready, “with an MDR application in the door at a notified body” no later than May 26, 2024.

“The current state of the market is that everybody is still figuring out what the proposal will mean for them specifically, both industry and notified bodies. Some manufacturers have seen 2027 and 2028 as dates and do not understand that these are dates for notified bodies and not for manufacturers,” Vollebregt said in an email.

Reuters reported in December that medical device manufacturers were dropping products from their European portfolios because of the cost of complying with the new regulations.

Although six new notified bodies received MDR designation in the second half of last year, it created a pool of 36 organizations to process around 23,000 certificates of current devices on the market, prompting EU Health Commissioner Stella Kyriakides to propose delaying enforcement of the MDR.