FDA Moving Ahead with Rulemaking On Lab Developed Tests Without Waiting for Congress: BioWorld
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
Different digital platform pillars are key in this.
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.
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.
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
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.
“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.
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.
In this blog, we recap the “Driving Business Outcomes with Jama Software’s Success Programs” webinar.
When you buy Jama Connect, you’re not just buying the #1 requirements management solution on the market. Our Customer Success team stands behind you, delivering the expertise, guidance, and resources you need to see a quick return on your investment and achieve your business goals.
Our adoption-oriented approach balances industry best practices with the practicalities of how you plan, build, and test your products.
In this webinar, we discuss how Jama Software has created specific diagnostic tools and customer success offerings to achieve higher value with Jama Connect. We also explore how Jama Connect can enable transformational value to positively impact your business, and how our specific customer success offerings can help your team increase traceability compliance and requirement quality.
Learn more about our new customer success programs, and how they lead to better outcomes such as:
Higher percentage of passing tests
Lower product defect rates
Faster time to market
Below is an abbreviated transcript and a recording of our webinar.
Driving Business Outcomes with Jama Software’s Success Programs
John D’Addario: Good morning. Good afternoon. Good evening. I’m John D’Addario, senior director of customer success here at Jama Software. I’m responsible for our global customer success team here, and we are so excited to share with you some of insights around how our new success program can help you and your company drive business outcomes with Jama Connect. I’ve asked my colleague Preston to join me today. Preston, can you give a brief introduction of yourself?
Preston Mitchell: Yeah. Thanks John. Hey everybody. It’s great to be here. As John mentioned, I’m really excited to share with you some of the things we’ve been working on here to make the success programs even better. For those of you that don’t know me, I am the director of the global solutions team. I’ve been with Jama for about 10 years. My background is kind of in requirements management. I’ve been a business analyst, I’ve been an Agile program manager. So I’m really excited about all of the best practices when it comes to system development and requirements authoring. So yeah, I’ll pass it back to John and we’ll dive in.
John D’Addario: Thanks Preston. So as the number one in requirements management software, our purpose is to ensure that innovators succeed with customer success at the forefront of everything we do. Through years of industry specific experience and thousands of customer engagements, we bring the best practices to bear, to maximize the success rate of the product development process. There are six core business outcomes we focus on helping you drive with Jama Connect. They are reduced cycle time, increased process efficiency, streamline and accelerate reviews, speed time to market, gain visibility and control, ensure compliance and manage risk. We do this across our five key verticals, medical device, automotives and semiconductor, space, airborne and defense systems, software development, and industrial manufacturing.
We have a really exciting agenda for you today. We’re going to go through four topics. We’re going to give an overview of our success program. Preston’s going to go on and talk about measurements and outcomes. We’re going to do a double click on the success programs and then leave some time at the end for some Q and A. So let’s get into it. We are the experts when it comes to requirements management and traceability. We have years of experience between our customer success managers, solution consultants, and technical support engineers. Through our success program, we help our customers achieve faster time to value with Jama Connect.
Preston Mitchell: Hey John, maybe for some of the folks we could give a breakdown of the different team roles here. I’m not sure if everyone has actually interacted with their entire success team at Jama Software. So maybe we could give a background of each of the roles and what their goals are at Jama.
John D’Addario: Sure, sure. So starting with our customer success manager, really think of your customer success manager as you’re trusted advisor, focusing on understanding your business outcomes. We work together to build what we call a success plan. We use that success plan to help marshal resources across the genre enterprise. We also help you with all your commercial needs, like renewals, buying more licenses, adding a success program subscription, adding services, things like that. Our technical support engineers are there to help you with any technical questions that come up during your time with Jama Connect. They are well versed in the ins and outs of all things technical. Preston, why don’t you give a little bit more detail around the solution consultants?
Preston Mitchell: Yeah, definitely. The solution consultants are part of my team. They really bring a lot of industry experience to bear. So a lot of them have been product managers, system engineers, quality managers in their prior roles. So they bring industry experience like requirements authoring experience, quality management, specific industry experience. Then they also of course have a lot of deep practical experience using Jama Connect the product. So they combine those to really recommend best practice uses of the tool. They very much understand the pain points and the outcomes that you all are trying to drive with your products every day. So any kind of deep product questions, or asks of how to use Jama Connect in order to achieve their goals, that’s really what their purpose is.
John D’Addario: Great. Great. When I look at this team and the resources we have here at Jama, I’m a little partial to think that, not only do we have the best team and the requirements management industry, I think we have the best team of any team that I’ve worked in over the last 10, 15 years. It’s really exciting to have this level of engagement between these three teams with this one mission of driving customer success. Let’s do a little bit of a deep dive into our success program. So through this continual engagement with your teams, we really focus on measurable improvements to your process. We do that by forming focus areas, helping you drive adoption and usage of Jama Connect, helping eliminate trace debt, and increasing your Traceability Score™, improving requirements quality score, increasing verification compliance. When you think about the success program, one of the main benefits of the success program is what we call the success catalog.
John D’Addario: This success catalog brings together four great resources for our customers to use. The first one being training resources. The second one being benchmark assessments. The third one being solution consulting. And lastly, fourth, our technical services. When you think about your journey with Jama Connect, think about it in three stages, implement, measure, and optimize. The success program is at the foundation of helping you achieve those business outcomes. We do that by mixing different services in our success catalog together, and what we call a success path. In these three examples, you can see here, we have three different success path that brings this prescriptive use of these services in the catalog to help you achieve business outcomes during the different phases of your journey with Jama Connect.
![[Webinar Recap] Driving Business Outcomes with Jama Software’s Success Programs](https://www.jamasoftware.com/media/2022/07/WB-2022-07-21_Driving-Business-Outcomes-with-Jama-Connect-1.png "[Webinar Recap] Driving Business Outcomes with Jama Software’s Success Programs")
