In this blog post, we will cover key components of the important medical device standard ISO 13485 and cover steps for successful adherence.
In the complex world of medical device development, teams not only face challenges of innovation, but also a shifting regulatory environment and evolving standards.
Balancing the competing interests of customers and stakeholders with the guidance and regulations from different entities across global boundaries presents challenges that even the most organized and methodical teams may struggle to meet.
In this environment, systems thinking can greatly improve the ability of medical device development teams to get products from the idea stage to market. By breaking down complex problems into manageable pieces, teams can better evaluate their systems and streamline and strengthen processes.
Using an applied systems approach will also help resolve inefficiencies in the development process and produce the outputs necessary for the design history file (DHF).
A growing number of organizations and teams are already pursuing a general systems approach by applying the guidance in ISO 13485:2016. This standard helps define a framework for the Quality Management System (QMS) for medical device development and pushes the development process naturally toward a systems approach. But for those teams that have not yet adopted the standard, adding one more document or piece of guidance to the overall process can feel like another layer of complication.
It doesn’t have to be. Adopting this standard can help standardize and systematize the medical device development process. Though it may look daunting at first, once adopted, ISO 13485 can streamline processes and position organizations for a better outcome with regulatory requirements.
The standard was developed by the International Organization for Standardization (ISO) to outline the standard for a Quality Management System (QMS) for the design and manufacture of medical devices.
The ISO defines “medical device” as “a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.” It is a stand-alone document designed for use by organizations of any size involved in any stage of medical device development, from design to production to installation to service of devices. Both internal and external parties can use the standard to support the auditing process.
ISO 13485 is the most common standard for quality management in the field of medical device development across the globe. Adoption of the standard indicates a commitment to the highest quality and safety across the development process, and it provides a foundation for QMS requirements.
While not required by all government entities, the standard does provide a good foundation for addressing regulations such as the EU Medical Device Directive and the EU Medical Device Regulation. In 2018, the FDA proposed a rule that would align US FDA 21 CFR 820 with ISO 13485:2016; this rule would make this standard the mandatory QMS for medical devices.
Note: The rule was set for release in 2019; however, as of December 2020, the rule was still forthcoming. Check for current guidance.
Though adoption of ISO 13485 may look complicated or daunting, in reality, adhering to the standard helps eliminate some of the ad hoc nature of requirements and systems in the medical device field.
With increasing worldwide adoption of ISO 13485 by both companies and government entities, the medical device industry should start to realize some harmonization and consistency of processes and systems. This standardization will help streamline the industry overall and allow important innovations a smoother and potentially faster route to market.
The requirements to obtain ISO 13485 certification start with a QMS. ASQ defines a Quality Management System as “a formal system that documents the structure, processes, roles, responsibilities and procedures required to achieve effective quality management.” The QMS must include documentation that defines the overall scope and implementation of the QMS; important documentation includes Quality Policy, Quality Objectives, and Quality Manual.
Bottom Line These documents should be sure to address customer requirements. In addition, organizations need to create mandatory and additional processes and requirements necessary for all stages of development. Examples of documents required by ISO 13485:2016 can be found here.
Key Takeaways from Our Complete Guide
ISO 13485 and systems thinking go hand-in-hand; teams will find that adoption of ISO 13485 directs them toward systems thinking.
Adoption of this standard will streamline processes and position medical device teams for better regulatory outcomes.
ISO 13485 is a stand-alone document; however, it closely aligns with ISO 9001:2008 and EN ISO 13485.
ISO 13485 and ISO 14971 are related, but ISO 14971 is more focused on risk management – the two standards can be used in tandem.
This standard is not mandatory; teams can develop a Quality Management System (QMS) without the standard as long as it meets regulatory requirements. However, adoption of the ISO 13485 will create a QMS that is ideally positioned to meet the requirements of various regulatory and legislative entities, including the EU.
Jama Software’s Complete Guide to ISO 13485 for Medical Device Development covers requirements for adherence, the difference between ISO 13485 and other medical device standards, and steps for successful adoption and certification.
Download The Complete Guide to ISO 13485 for Medical Device Development to untangle everything there is to know about this important standard.
https://www.jamasoftware.com/media/2021/02/2021-02-18-ISO-13485-ebook-1024x512-1.jpg5121024McKenzie Jonsson/media/jama-logo-primary.svgMcKenzie Jonsson2022-09-08 03:00:002023-03-20 16:46:12[GUIDE] ISO 13485 for Medical Device Development
In many ways 2021 was a continuation of the changes brought about in 2020, a year that’s been described as “unprecedented” and “unparalleled.” In a unique way, 2021 has offered us an idea of evolving innovations and technology on the horizon for teams across industries. These changing conditions will present a variety of new landscapes and will offer unique challenges, opportunities, and more than likely, many surprises.
As we enter a new year of further changes, Jama Software asked select thought leaders – both internal and external – across various industries for the trends and events they foresee unfolding over the next year and beyond.
In the second part of our five-part series, we ask Steven Meadows, Solutions Lead from Jama Software, and Ryan Moore and Carleda Wade, Solution Consultants from Jama Software – along with Thierry Marchal, Program Director for Healthcare Solutions at Ansys, and Ivan Ma, Medical Device Program Leadership, to weigh in on product and systems development trends they’re anticipating for medical device teams in 2022.
Read our other 2022 Industry Predictions here: Part One – Engineering Predictions,Part Three – Automotive Predictions, Part Four – Aerospace & Defense Predictions, and Part Five – Insurance Development Market Predictions.
Medical Device Predictions
Q: What product, systems, and software development trends are you expecting to take shape in 2022?
Steven Meadows, Jama Software:
Artificial Intelligence (AI)
AI, and in particular machine learning (a subset of AI), has been expanding rapidly over the past decade and now has a market of over $6.7 billion across med tech. I see this trend continuing with extra guidance from the FDA helping developers produce safer software with AI elements. AI is particularly exciting as it can enable streamlined MRI and CT scans, instant blood and at-home rapid testing, and a whole host of otherwise manual and often error prone activities.
Minimally invasive devices
Another trend I see in medical continuing in 2022 and beyond is the rapid growth and development of minimally invasive devices. Open heart surgeries are becoming a thing of the past, with cardiothoracic applications becoming the norm. Minimally invasive devices are also becoming heavily utilized throughout most orthopedic surgeries, and increasingly in urology procedures. We have seen a lot of start-ups attempting to bring the next best minimally invasive device to market.
Wearables
Medical wearable devices demand continues to rise, with apps on wearable devices beginning to provide recommendations to users, to improve their health. Heart rate and temperature sensing continue to be the most popular features on wearable tech today but there is increased investment in smart glasses, ‘earables’, and clothing.
Software development
Software will continue to be an integral part of many medical devices next year and beyond. We consistently see that our software customers have adopted, or are transitioning to, an Agile methodology when creating their medical system, a shift that has been happening for some time. Gone are the days of slow waterfall-based development practices.
As I mentioned before, AI based software development will continue to trend and grow next year, and AI software development practices will be geared around a tailored regulatory framework, good machine learning practices, and a patient centered approach. The FDA will continue to refine guidance around AI/Machine Learning (ML.)
Cybersecurity and in particular data security will continue to be a top priority for our software customers, with data breaches and hacks on the rise. The FDA is planning to soon release extra guidance around cybersecurity in medical devices with a particular emphasis on quality system considerations and content of premarket submissions.
Ryan Moore, Jama Software:
I anticipate a trend toward more software-basedtoolsets and digitization. Also, an increased amount of automation and robotics.
Carleda Wade, Jama Software:
I expect greater integration of software tools such as with Requirements Management software with eQMS software.
Thierry Marchal, Ansys:
The dramatic COVID pandemic has amplified a trend that appeared a decade ago – progressively calling for the adoption and deployment of in silico medicine. Stormed with the COVID pandemic, the world could not wait for 10 to 15 years to get a new vaccine fully tested and approved using a traditional approach. Furthermore, this COVID disease is impacting people differently, while elderly people are impacted the most, possibly leading to long term disabilities and treatments.
EDITOR’S NOTE: According to The University of Sheffield’s Insigneo Institute, In silico medicine (also known as ‘computational medicine’) indicates modeling and simulation technologies that directly contribute to the prevention, diagnosis, prognosis, treatment planning & execution, or management of the disease. In silico methods complement traditional in vivo approaches (working with animals and human beings) and in vitro testing (working in a lab.)
Thierry Marchal, Ansys:
This pandemic highlights what we have been observing for decades: with an aging population, the cost of chronic diseases (especially for old people) is weighing a lot on the healthcare cost. The solution will come from personalized medicine and preventive medicine combining pathologies detection in its early stage to treat diseases before they impact people. The continuous monitoring of patients to detect pathologies early are calling for e-health and mobile health (m-health): wearable and implantable devices continuously and safely watching the patient and soon feeding your own digital twin or Personal Digital Avatar (a computer model of yourself, connected with you, and properly stored in the cloud to guarantee your data privacy) is now an emerging trend. Digital twins will be a crucial innovation for the software necessary to use patient specific data to predict the evolution of the connected patients.
As medical innovation will be essential soon, this evolution cannot be slowed down by an extremely long and costly regulatory approval process: a digitalization of drug and medical device approval, including in silico (clinical) trial is another major trend that we are observing.
Ivan Ma, Medical Device Program Lead:
Technologies that enable capabilities via telemedicine with more than just a face and a voice over the screen will make “seeing” the doctor digitally as common place as working from home.
Protecting patients, physicians, and staff by reducing or eliminating exposure to harmful forms of imaging such as fluoroscopy will always be a valuable endeavor.
Q: In terms of product and systems development, what do you think will remain the same over the next decade? What will change?
Steven Meadows, Jama Software:
A lot of the areas I mentioned that will trend in 2022, will more than likely trend over the next decade.
AI, not only in medical but across most industries, is on the rise and patients will continue to see improved outcomes, quicker diagnoses, and a better quality of life.
Medical wearable technology will continue to evolve, with improved functionality helping keep us fitter and safer.
Minimally invasive devices will continue to be expanded across different medical areas, improving recovery times, and surgery outcomes. Increasing emphasis on cybersecurity will resume, to prevent malicious actors from hacking sensitive data and for connected systems to remain operational.
COVID-19 is not going away any time soon so a reliance on collaborative product development tools, like Jama Software, will continue to be an integral part of any organization placing an importance on quality and overall product and patient outcomes.
Ryan Moore, Jama Software:
Medical devices will still be comprised of mainly hardware (HW)/software (SW), while automation and robotics will be a driving force.And users will still need to power devices.
Carleda Wade, Jama Software:
Medical device development will mostly stay the same as the regulations are fairly stable.However, I do expect increased usage of software in the process since much of the workforce may now be working in various locations. I also expect to see an increase in AI and Software as a Medical Device (SaMD)as a whole in the industry.
Q: What are some of the biggest challenges you think engineering firms will be working to overcome in 2022?
Thierry Marchal, Ansys:
Contrary to other industries, innovation in healthcare faces the challenge of human variability: as we are all different, it is not acceptable that a treatment would work well for a few people and poorly for most others. Using computer modeling and simulation (CM&S a.k.a. in silico methods) is a cost-effective way to test new treatments efficiently without compromising with patient safety, on large cohorts of virtual patients.
An accurate prediction of the treatment outcome for a given patient will require combining traditional modeling techniques with biological models, often extracted from big data observations using AI.
Finally, the community remains skeptical about the reliability of computer model and digital evidence to predict correctly and accurately what is happening in the real life. This credibility challenge will be continuously addressed by more validations and comparisons with in vitro and in vivo data.
Ivan Ma, Experienced Medical Device Developer:
The development of medical device hardware will always require teams to gather in front of and handle hardware. As the pandemic continues, and in-person work still not back to what it once was, it is time to think of strategies that maximize time on developing hardware with minimal people in the room. Could digital Operating Room technologies be reconfigured and brought in to support the verification and validation phases of medical device development? The tenets are the same. Minimize the number of people in the room, allow the expert to drive the hardware from afar, make data acquisition, observation and learning access as easy as clicking on a link.
Q: How do you foresee regulations shifting in medical device product and systems development over the next decade?
Steven Meadows, Jama Software:
Although AI has been utilized in medical device and life science products for decades, guidance has been lagging. It’s clear to see that AI has incredible benefits for patients, and so there will continue to be increased regulatory guidance available, to help developers build products which contain AI in a safer and standardized manner. Check out a blog Jama Software authored around machine learning in SaMD and shifting regulations here.
The medical device regulation (MDR), which was accepted and implemented in the EU in 2017, has been amended over the past few years. The latest change focuses on increasing the responsibility and accountability of medical device companies throughout the entire development of a product. Expect more guidance over the next decade, as gaps are addressed to ensure product safety is at the forefront of any market clearance.
Ryan Moore, Jama Software:
I would expect compliance and regulations to be more defined as we move forward. Currently, there is a lot of grey area in how standards/regulations are interpreted. The FDA will need clearer guidance for modern technology that arises
Carleda Wade, Jama Software:
With an uptick in AI and SaMD I expect the FDA and foreign regulatory bodies to begin providing more clarity on how these complex systems and softwareneeds to be developed, validated, and maintained.
Q: What changing regulatory guidelines do you anticipate having an impact on companies in 2022?
Thierry Marchal, Ansys:
The US authorities developed, without any doubt, the most advanced regulation in terms of adoption of computer model results for the regulatory approval process. However, the number of published cases reporting the actual use of in silico methods by sponsors remains limited. New results will be published in 2022 further encouraging companies to confidently follow this process.
The European Medical Device Regulation (MDR), in application in Europe since May 2021, is opening the door to digital evidence and in silico approach; unfortunately, the process to validate a model and report simulation results has not been clarified yet. Similarly, as the European authorities are updating their pharmaceutical strategy in 2022, this document is expected to make references to computer modeling and simulation.
In the rest of the world, we observe a growing interest for in silico methods and the need to regulate this approach. After years of compiling information and experience from other parts of the world, we are expecting that some Asian authorities will start to communicate about this topic in 2022.
Q: What sorts of process adjustments do you think medical device development teams will need to make to be successful in 2022?
Steven Meadows, Jama Software:
One of the biggest process issues we see across our customers is that they view quality as a secondary function and a necessary checkbox activity once a product is developed, or close to being finalized. Because of that, products tend to contain more defects, resulting in more in field CAPAs, negative patient outcomes and even have a greater chance of being recalled. Development teams should ensure quality is prioritized from the get-go.
Although we have noticed a large shift with software teams adopting an Agile approach when it comes to development, we can’t emphasize enough the importance of adopting a lean and iterative approach.
Ryan Moore, Jama Software:
Continue to follow standardized process with focus on aligning with FDA / compliance in parallel with building safe products
Carleda Wade, Jama Software:
Teams will need to find the sweet spot of trying to collaborate and innovate while not being physically in the same location at the same time. Due to the pandemic, many teams will now transition to being fully remote permanently or have a hybrid schedule and it may make things more difficult when developing new products with a cross-functional team.
Q: From an engineering toolset perspective, what are some of the processes you believe forward-thinking firms will be working to leverage or incorporate into their process and why?
Theirry Marchal, Ansys:
As we see the healthcare community adopting in silico method with more enthusiasm both for design and regulatory approval (not mentioning emerging clinical applications), the software community is rushing to deliver the supporting in silico tools. We could mention three major avenues followed by Ansys.
As in silico clinical trials requires a large number of simulations, specific Simulation Process and Data Management (SPDM) tools structuring the digital evidence following the ASME VVUQ40 standard will greatly facilitate the adoption of this approach. Ansys is customizing its Minerva tool in a Minerva VVUQ 40 template for medical device and pharmaceutical companies.
It is crucial to model the behavior of a new treatment in its working environment, usually the human body. Human organs such as the heart, the lungs, and the brain are extremely complex to model and validate: this requires a collaboration of various actors. Ansys is closely working with leading academics, global healthcare companies and startups, and clinicians to continuously update and validate virtual hearts, lungs, and brains in collaboration with a large ecosystem.
Although everybody recognizes the potential of digital twin and Personal Digital Avatar, the necessity of developing quasi-instantaneous modeling capabilities despite the complexity of the model is a real challenge. Ansys is taking advantage of its experience with other industries already using digital twin of equipment to help the pharmaceutical industry to develop digital twin of drug manufacturing equipment and initiate the first steps towards Personal Digital Avatars.
Ivan Ma, Medical Device Program Lead:
Engineers need tools that minimize the volatility and error that occurs when bringing hardware and electronics from the drawing board to parts in hand. How do organizations reduce hardware prototype cycles, recognizing that even if the design is right on paper, the production of that design can pass through many hands before it is made into a real part, thus decreasing the probability of a successful build.
Q: What do you think will be some of the differentiators between a company surviving to see 2030, and those that do not?
Steven Meadows, Jama Software:
Along the lines of what I mentioned companies should focus on in 2022 to be successful, medical device companies that embrace a proactive approach to quality(Link here – https://www.jamasoftware.com/blog/three-ways-to-proactively-vs-reactively-incorporate-design-controls-in-medical-device-product-development/ )will ultimately find fewer issues with their products, improve customer satisfaction, and stay competitive for the foreseeable future. Companies that invest in best-of-breed medical device development solutions like Jama Connect will have the upper hand in reducing risk and complying with various standards and regulations.
New cutting-edge technologies in the medical field – like robotics nanotechnology, AI, and wearable health tech devices – bring complexities for medical device companies and risk for patients and consumers. Jama Software will continue to serve as the leading solution and partner to help innovative companies bring medical products to market, in a collaborative, safe, and efficient way.
Defined process, building quality products that meet a specific market need
Carleda Wade, Jama Software:
Truly understanding the market needs and being willing to allocate resources so that you become a pioneer in a certain industry will help a lot of companies to succeed; however, having passionate and qualified personnel will be the biggest success factor. Companies that only want to develop “me too” devices will struggle to gain market share, and even if they are able to survive it will be difficult for them to thrive.
Q: Where do you see Jama Software fitting in as the product development landscape evolves, and what can our customers expect as 2022 approaches?
Steven Meadows, Jama Software:
Jama Software provides incredible value for hundreds of medical device companies ranging from start-ups to established corporations. With COVID-19, we’ve seen an uptick in customers looking for an easy-to-use product development tool that offers differentiating collaborative capabilities to keep people connected throughout different design stages. Jama Software continues to invest heavily in the application, and we will see improved core product capabilities as well as integrations, strengthening the tool’s ability to seamlessly work alongside other systems.
Ryan Moore, Jama Software:
Jama Connect can be used as the core toolset for requirements, testing, and review/approvals. Jama Software’s ability to branch out into further workstreams (in order of priority: risk management, test automation, modeling/design outputs) will bring exponential value to teams using Jama Connect.
Carleda Wade, Jama Software:
I can see Jama Software bringing value to not only the start-up but the established company in the future. As a medical device company, the first goal of the company is to make a good product that meets a market need, this happens even before establishing a quality management system in many cases. Having a tool like Jama Connect will ensure that as products are developed that all the bases are covered. Later, when it is time for regulatory approval having a tool like Jama Connect in place will make the regulatory submission process very simple.
Thanks for tuning into our 2022 Predictions Series! To see some of the incredible products, software, and systems our customers are building with Jama Connect, visit our CUSTOMER STORIES PAGE.
https://www.jamasoftware.com/media/2022/01/2022-01-11_2022-Predictions_medical_1024x512-1-1.jpg5121024Decoteau Wilkerson/media/jama-logo-primary.svgDecoteau Wilkerson2022-01-11 03:00:352023-01-12 16:47:462022 Predictions for Medical Device Development: Increased Focus On Cybersecurity, Clarity On Standard Compliance, and the Challenge of Human Variability
In this post, we pull out key takeaways from a recent whitepaper written in conjunction with Beanstock Ventures on the new EU medical device regulations (EU MDR) and how they might impact medical device development.
As medical device technologies have rapidly advanced in recent years, regulations governing definitions, testing, and post-market activities have struggled to keep up. The pace of change and adoption of these technologies has made it difficult for governments and agencies to create the kind of inclusive and expansive rules that will ensure safety.
In response to this expanding market, the European Union released new guidance governing medical devices. With the release of Medical Device Regulation (MDR) 2017/745/EU, in 2017, the EU has issued the first updated regulations in more than 20 years. The new Medical Device Regulation (MDR) 2017/745/EU addresses software as a medical device [SaMD], as well as other products. It also places stringent requirements for compliance with post-market activities and post-market surveillance. While enforcement of these new regulations was scheduled to begin in May 2020, it was postponed until May 2021 due to the COVID-19 pandemic. What do these new regulations mean for the medical device industry? Experts from Beanstock Ventures explain what you need to know for EU MDR compliance.
The EU Medical Devices Regulation (MDR) has replaced the EU Medical Device Directive effective 26 May 2021.
The EU MDR is greatly expanded to cover more devices, including Software as Medical Device, implantable devices, contact lenses, and many digital health technologies. It also promotes a lifecycle approach to regulation.
EU MDR requires improved device traceability by introduction of a unique identification system, or UDI (see section 05), for medical devices approved for use in the EU. To keep track of devices through every lifecycle stage, a device identifier (UDI) will be assigned, and all production series will be marked with a production identifier.
EU Medical Devices Regulation (MDR), adopted by the European Parliament and Council as REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017, has replaced the former EU Medical Device Directive (MDD) and went into effect 26 May 2021. After this date, the MDR is applicable for all medical devices sold (developed or imported) in the European Union.
The most important changes in the EU MDR include:
Increased scope of medical device definition;
New classification rules (including Rule 11 that specifically addresses software);
Increased scope of general safety and performance requirements, technical documentation, and clinical data and evaluation requirements;
Introduction of traceability and identification system and database; and
https://www.jamasoftware.com/media/2021/12/2021-12-28-new-eumdr-regulations-1024x512-1.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2021-12-28 03:00:462023-01-12 16:47:48Key Takeaways: What the New Medical Device Regulations (EU MDR) Mean for You
Machine Learning in Software as a Medical Device
Machine learning (ML), a subset of artificial intelligence, has become integral across software in all industries, and the medical and life science spaces are no exceptions. ML can help medical systems improve the identification and diagnosis of disease, create personalized medicine, and help with drug discovery and manufacturing (just to name a few areas). Current guidance and regulations require validation of the final version of the software prior to a release—so what does this mean for Software as a Medical Device (SaMD) systems that incorporate ML and ‘continual’ algorithms designed to accumulate and improve knowledge after a system’s release in the market?
The Current Situation
The FDA and other regulatory agencies currently lack the guidance needed for medical device manufacturers to include continual algorithms that adjust and improve post-market submissions. A changed algorithm would require a premarket review for each minor adjustment due to the potential impact on patient care.
There are many medical ML products on the market today, which currently use the DeNovo and 510(k) process, but the process is locked. Otherwise, the ML product would violate regulatory control. With this limitation, the FDA has been listening to input from the industry to help inform potential guidance and regulatory change.
The proposed framework includes elements from the FDA’s current premarket programs including:
IMDRF’s risk categorizing principles
FDA’s benefit-risks framework
Risk management approaches
IEC 62304 principles
Change management approaches
One of the key proposed expectations from the FDA would be a commitment from manufacturers to be transparent with the constant monitoring of artificial intelligence and machine-learning-based software providing periodic updates, including any changes to algorithm protocols.
The proposed framework received positive feedback from the industry, and the FDA has now decided to implement the discussion paper with guidance. It is expected to be released sometime in 2021. The intended premarket approval process will allow a trusted manufacturer (see below for definition) to make pre-approved post-release changes only if the manufacturer follows a predetermined change control plan.
What is a Trusted Manufacturer?
So what does the FDA mean by a trusted manufacturer?
Firstly, a trusted manufacturer should ensure they have an efficient and proactive quality system in place. Some of the key quality-related areas to focus on are:
Design controls and required documentation to prove to the FDA exactly how the manufacturer has provided for the safety and efficacy of a system or device.
Design verification and validation establishing that what the manufacturer has built works for the end user as intended.
Risk management, ensuring that any applicable hazards have been identified and that mitigations have been implemented.
Iterative design reviews, allowing risks and omissions to be seen quicker, reducing total in-field corrective actions or bugs.
Several other considerations are critical in becoming a ‘trusted manufacturer’ under the anticipated guidance, some of which include:
The ability to follow good machine learning practices during all design stages.
Ensuring that all algorithm changes that are implemented are done according to pre-specified objectives and any applicable change protocols.
Trusted manufacturers are expected to document how the system will learn both pre- and post-release.
Ensuring the integrity of reference data used by continual algorithms.
This is an exciting time for medical and life science companies embarking on or continuing their ML product’s journey. Connect with us to find out how Jama can help!
https://www.jamasoftware.com/media/2021/07/2021-07-16-regulatory-shift-machine-learning-samd_1024x512.jpg5121024Steven Meadows/media/jama-logo-primary.svgSteven Meadows2021-07-16 03:00:122023-01-12 16:48:59Regulatory Shift for Machine Learning in Software as a Medical Device (SaMD)
Editor’s Note: This posts on EU MDR was originally published here by MedTech Drive and written by Greg Slabodkin.
Dive Brief:
While the Medical Device Regulation’s May 26 go-live date marks a significant milestone, MedTech Europe warned in a statement that MDR challenges remain, limiting the industry’s ability to “seamlessly supply certified devices under the new rules.”
The European trade group contends that despite the EU MDR going into effect, “some key pillars” of the necessary infrastructure are “still not fully operational or even in place,” creating challenges in particular for many small and medium enterprises.
CEO Serge Bernasconi argued that the complexity of MDR and the delay in the new regulatory system’s full readiness is resulting in European patients “losing their previous opportunities to be the first to benefit from critical medical technology innovation.”
Dive Insight:
MedTech Europe had been sounding the alarm for some time about MDR’s potential to disrupt product supply due to issues around the ability of the EU’s infrastructure to ensure a smooth transition when the rules came into force on May 26. Now that the new regulatory regime has reached Wednesday’s date of application, the trade group is once again warning that significant challenges remain unresolved that could negatively impact the sector.
A range of MDR uncertainties and potential problems are hovering on the horizon. While the medical device industry has resolved some near-term pressures as the delayed landmark regulation goes into effect, MedTech Europe on Wednesday listed a litany of MDR challenges that are hindering the successful deployment of the new regulatory system.
These MDR challenges include:
Non-harmonized interpretation and application of MDR rules across the EU.
Limited capacity among notified bodies, especially for certification of new and innovative devices.
Uncertainties with regards to pending discussions on the rules and agreements between the EU and other countries such as Switzerland.
Unpredictable recognition of MDR certifications at the international level vis-à-vis regulatory approvals from other jurisdictions.
“Such challenges need ongoing attention and work by the EU Commission and Member States, if Europe is to ensure a workable system in the long-term,” MedTech Europe said.
The trade group also highlighted an urgent need for attention to be given to the In Vitro Diagnostic Regulation, a major overhaul of the diagnostics sector slated to go into effect in 12 months.
“As with the MDR, the medical technology industry fully supports the new regulatory regime for IVDs but due to many factors, the system is not yet ready to support its implementation. Urgent solutions are needed here as well, and lessons learned from the MDR implementation should be taken into account,” according to MedTech Europe.
The group added that it is working with the EU and stakeholders to “rapidly propose solutions to avoid disruptions” in supply of medical devices and diagnostics.
https://www.jamasoftware.com/media/2021/06/2021-06-23_MDR-MedTech-Post-1024x512-1.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2021-06-23 03:00:262023-01-12 16:49:03MDR Challenges Remain as Regulation Goes Into Effect: MedTech Europe
Editor’s Note: This posts on lessons learned around medical device development during COVID 19 was originally published here by MedTech Intelligence and written by Josh Turpen, Jama Software’s Chief Product Officer.
In the fall, I wrote about how the medical technology industry has struggled to keep pace with other, similar industries. In the piece, I discuss how important it is for engineers designing those products to move gradually and carefully, even when under immense pressure, to reduce time-to-market. Now, a year on from the stay-at-home order issuance across the United States, it’s time to take stock on what temporary measures need to be made permanent to grow as an industry.
As we move forward into a post-pandemic world, it is important that companies are explicit with the lessons that they have learned from this past year. Executive staff, rightfully so, have been focused on keeping things going. Now the focus should shift to “how do we exit the pandemic in a better place than when we entered?” This is where it becomes important to create an open dialogue about what was successful and what could have been done better. This will assist in making those temporary adjustments a permanent fixture in medical device production.
Before we look towards a post-pandemic world, though, we need to evaluate where things went wrong and how to better address them moving forward.
What Have We Learned?
If COVID-19 taught us anything it is that we need to be more efficient at speed-to-market when creating products, especially when it comes to medical product production. Additionally, gone are the days of person-to-person-only collaboration. Organizations now have the capabilities for a hybrid environment consisting of remote and in-person teams.
The complexities of product development within health and life sciences should not be a surprise. What is more alarming is that, as the complexity of medical devices increases, we still have many engineering teams that are relying on decades-old technology such as Word documents and spreadsheets to manage requirements, risk assessment and testing. These legacy tools have a place in most of the professional world, however, they are not adequate for development teams who need to achieve alignment with massive amounts of data, regulations and standards to ensure device safety and quality.
As these device management teams face immense pressure to innovate while collaborating across software, hardware and quality teams, it is essential that their work is tracked and seamless to meet the increasing pace of market demand. That’s why we have seen traceability evolve to account for the complex, ever-changing nature of requirements, test and risk management. For a growing company to be successful, everything must be able to work simultaneously, at scale and across teams. Legacy tools do not provide the agile capabilities that modern traceability does.
It hasn’t been easy for engineering teams to adjust to their fully remote workplace. Even organizations that offered a hybrid working model previously are struggling to ensure their teams are aligned to meet delivery dates and project deadlines. The organizations that will have a distinct advantage over others are those focused on collaboration and context within their teams. These teams will be best set up to quickly build high-quality products, further ensuring better patient outcomes.
As mentioned previously, the best course of action following this difficult year is to ensure company leaders are shifting their focus towards figuring out how to leave their companies in a better place following the pandemic, versus where they were when they entered. Based on my experiences as the chief product officer for a leading requirements, risk, and test management platform, I have noticed a few key ways that executives in the medtech industry can better prepare themselves moving forward.
1. Adaptability
In general, companies that have adaptability embedded in their DNA have already handled the peaks and valleys of the pandemic far better than those that remained rigid in their approach. Looking ahead, it will be immensely important to evaluate your process assumptions and determine how resilient you are to change.
Without a malleable business model, a company will constantly be scrambling any time it hits a road bump. However, with the right digital tools at your disposal, your company will be able to adapt quickly and effortlessly, allowing your employees and customers to remain calm in times of crisis.
2. Alignment
While companies in all industries adapt their business models to prepare for the new normal, innovative tech companies are transforming the devices and systems they build, and the technology and process they use to build them. Newer technologies in the medical field, like robotics nanotechnology and wearable health tech devices, bring added complexities for medical device companies. There is an additional risk for patients and consumers, which makes having the right product development solution in place even more important.
Medical device companies that embrace a proactive approach to quality will ultimately find fewer issues with their products, improve customer satisfaction, and stay competitive for the foreseeable future. To do this quickly and efficiently, though, teams must be aligned throughout the entire product development lifecycle. By leveraging an integrated platform for requirements management, teams can stay interconnected and deliver high-quality products that improve patient outcomes.
Benjamin Franklin once said, “by failing to prepare, you are preparing to fail.” As we look ahead into 2021, I believe it is unlikely we will see large regulatory changes in the medtech industry. However, over the next decade, a great increase in regulations for medical device development is definitely looming. So what can a company do in the meantime? Tighten up your risk management practices, before it’s too late.
The fact is, the medtech industry will always grow at a rapid pace, and regulations will follow. To avoid being left behind by events such as, finding regulatory issues in late-stage device development, and then having to implement confronting costly and time-consuming rework, your teams must align and future-proof the entire development lifecycle.
Future-proofing is the process of using digital tools to capture knowledge and ease accessibility for future employees, independent of the product development lifecycle stage. Employing future-proofing strategies helps company leaders and decision-makers ensure symbiosis throughout the entire process. Future-proofing is key in the age of digital transformation, as it helps address common concerns about collaborative environments, team efficiencies, and product integrations. A software that is up to this task will help you do this in three ways:
Comprehensively enables collaboration by giving users a single source of truth to track decisions, questions, and problems
Increase team efficiency by capturing knowledge within that single source—often without even realizing it—through feedback and team communication.
Seamlessly integrates digital tools that track development and with other information gathering and tracking solutions, knowledge is captured at multiple levels, streamlining future projects.
4. Harmony
Finally, to be successful, there will need to be harmonization on the development methodology across different devices, reducing the need to work off of different documents. Each product in development has its own particular set of customers, stakeholders and internal team members associated with it. Therefore, it is important that these individuals can be accurately connected to the items for which they are responsible. Enter traceability.
Traceability is all about relationships. To make informed choices, product development professionals need tools that allow them to see changes in real-time, within the team’s structure, and throughout the system where their product exists. Modern traceability makes it possible to manage and respond to change with confidence in a systematic and auditable way. When done correctly, traceability can be used as a key tool to allow for harmonious decision-making. Without it, accountability is incomplete and past decisions can’t easily be seen, learned from or built upon.
Overall, COVID-19 has been industry-defining as companies were made to quickly shift how their teams collaborated, now forced to have a remote workforce. As we see the light at the end of the tunnel it’s time to look towards the future of medical device development. Let’s take all that we’ve learned from this past year and use it to ensure that we’re putting out high-quality products, quickly and accurately.
https://www.jamasoftware.com/media/2021/05/2021-06-01-lessons-learned-med-device-covid.jpg5121024Josh Turpen/media/jama-logo-primary.svgJosh Turpen2021-06-01 03:00:132023-01-12 16:49:07Lessons Learned: Medical Device Development Through COVID-19 and Beyond
Let’s face it, even in a world filled with innovations we couldn’t have imagined a decade or two ago, the medical technology industry has struggled to keep pace with some other industries. Now, we are in the midst of a once-in-a-lifetime pandemic that is actually serving as a call to action for many organizations to build faster and build better.
But faster and better brings challenges for the companies and engineers designing and manufacturing medtech products. Teams feel immense pressure to decrease time-to-market, ensuring their company’s product is first to make an appearance. First to market can mean “disruptor” status—and the cache that comes with that distinction.
I’m tired of hearing about faster and better being the only way to get to market. It’s a myth, because it is based on assumptions about what the regulatory requirements management process involves during product development. And it could crush great teams.
We can all relate to the risk that moving too quickly in the process can lead to mistakes. What’s more: In this industry, or any safety-critical industry, making that mistake can put people’s lives at risk.
As I look ahead to 2021, the biggest trend for medical devices I see will be a keen focus on quality. Here’s why that’s true — and what your teams can do to prepare.
Regulation Is About to Experience an Upheaval
In what Deloitte has dubbed the most significant change to medical device regulation in nearly three decades, the new European Medical Device Regulations (EU MDR 2017/745) implementation date is fast approaching. Initially scheduled to go into effect in May of this year, the European Parliament and the Council of the EU adopted a proposal to extend the transitional period to May 26, 2021. And, if this year has taught us anything, “pandemic time” feels two-times faster and May will be here before we know it. The new regulation, which emphasizes patient safety, traceability, and transparency—key aspects under the quality umbrella—will impact all medical device developers as they are required to comply. It will prioritize fundamental changes throughout the entire device lifecycle and is expected to provide better, more comprehensive regulatory guidance.
A big portion of the MDR will focus on increased traceability and labeling for each device, including keeping detailed records of the unique identification number (UID) card, which is new for all developers. With the process for this becoming more rigorous, it is vital that product development groups have an easy way to capture and call on that information. Manually maintaining these details with a document like an Excel sheet is possible, but makes the process cumbersome, slow and prone to manual error. A better approach is a requirements management platform that lets teams trace data, upward and downward decomposition, and present it in a clean way makes exporting it to a design history file (DHF) simple.
Medical device recalls are on the rise this year with Stericycle’s latest “Recall Index 2020 Edition 2” stating recall activity exceeded “300 recalls for the first time since Q2 2018.” What’s further, is safety issues were noted as the highest contributing source. This demonstrates the growing complexity of device development and risk points, as well as the active regulatory enforcement for failed device testing. For engineering teams under pressure to bring products to market quickly, balancing the inherently intricate regulatory environment, can be a lot to handle. This is where mistakes start to happen—mistakes that are magnified for companies that haven’t modernized their approach to requirements management.
Medical device compliance is achievable with the right, well-documented product lifecycle and real-time collaboration tools. This is especially true for systems that are already aligned with industry standards, making traceability a simple process. Often they will come equipped with frameworks where industry regulations are inputted, saving precious set-up time and ensuring development can begin right away.
For any medical device company seeking to improve the development lifecycle of their products, simplify compliance and speed-time-to market in 2021, they can’t dismiss quality. Simply put, there’s too much on the line. From bottom-line impact to potentially life threatening implications, it is time to stop thinking about the next bigger and better thing. Let’s start making the best product possible the first time around.
To see more information specific to the medical device development industry, we’ve compiled a handy list of valuable resources for you!
https://www.jamasoftware.com/media/2021/01/2021-02-02_top-trend-medical-devices-2021-quality_1024x512.jpg5121024Josh Turpen/media/jama-logo-primary.svgJosh Turpen2021-02-02 03:00:392023-01-12 16:49:32The Top Trend for Medical Devices in 2021? Putting Quality First
Medical device development is inherently complex, with numerous ever-evolving regulatory statutes to comply with and especially high stakes for ensuring the ultimate safety of the product. In fact:
Medical device recalls rose 50% in 2019, demonstrating the growing complexity of devices and their points of failure, as well as active regulatory enforcement.
Class I recalls, the most serious type, having a “reasonable probability” of the affected device causing harm, have surged at an even higher rate.
Devices like software-driven pacemakers illustrate the tradeoff between more complex hardware and more extensive risks requiring mitigation.
Indeed, the growing centrality of software to modern medical devices is a particularly notable challenge for manufacturers in this context.
Not only do software-driven devices require a particular and extensive approach to risk and requirements management, but they also create pressure to accelerate time to market due to an increasingly competitive market. New entrants into the medical device space have used software design to rapidly differentiate their products and compete with incumbents, as the FDA’s 2018 Class II de novo clearance for EKG-equipped Apple Watches shows.
Bringing medical devices to market quickly while preserving their quality and complying with regulations is a balancing act, albeit one that can be executed successfully with the right requirements management platform. Medical device compliance is achievable via a coherent, well-documented product lifecycle and real-time collaboration, both of which require efficient processes.
Based on our work with hundreds of medical device developers, we’ve compiled this guide to navigating the complexity of medical device compliance. Let’s dive into six tips for improving your development practices.
Tip 1: Use a Tool That’s Already Aligned with Industry Standards
ISO 14971:2019 and ISO 13485:2016 both include detailed guidance on how to manage medical risk and quality management processesas part of the product lifecycle process. However, it can be difficult to know how to even start adhering to them under an requirements management (RM) methodology rooted in Microsoft Word or Excel. Teams can struggle to capture and export all of the necessary data to prove end-to-end traceability and pass audits.
Instead of reinventing the wheel for standards adherence for each project, take advantage of the standard frameworks in a platform like Jama Connect™ for Medical Device Development. These save precious setup time and keep development aligned with key industry regulations such as ISO 14971:2019, 21 CFR 820.30, and ISO 13485:2019.
Tip 2: Migrate Away from Document-Based Workflows
Medical devices take an average of three to seven years to reach market. During that time, they will require many tests that must be traced back to requirements, plus the requirements themselves will frequently change in response to stakeholder feedback. Add in the risk inherent in complicated medical device creation, and it’s a recipe for trouble without a modern, structured platform in place.
To keep pace with the complexity of medical device development, document-based workflows must be left behind. Circulating lengthy, discrete documents via email doesn’t scale to modern projects, nor is it the most efficient means of gathering and synthesizing feedback from remote engineering teams. A dedicated RM platform that offers a single source of truth makes medical device compliance processes much more straightforward.
Traceability is central to medical device development, as it is the only systematic way to demonstrate that design inputs are being met and verified as part of the design control process. Inadequate traceability can lead to errors when done manually, also making it difficult to produce audit documentation, manage change, and prove medical device compliance.
Beginning in the 2010s, software became a leading cause of medical device recalls. Accordingly, in order to avoid medical device recalls or worse, traceability must be sufficiently advanced to:
Link high-level requirements to sub-system requirements across the development lifecycle
Provide traceabililty between all requirements and tests in one system, ensuring requirements are verified and validated
Produce necessary documentation for audits and regulatory standards
Eliminate the need to manually rebuild traceability
By having an automated way to show the impact of change on requirements rather than a spreadsheet, it significantly reduces the amount of manual effort needed to look at siloed data and where changes may be needed.
Tip 4: Create a Detailed Audit Trail
Another benefit of traceability is the ability to create a detailed audit trail demonstrating why something was built the way it was, at what time, and by whom. These audit trails are required for medical device development but can be nearly impossible to produce effectively if done so too late in the development process or with manual tools.
Real-time reporting and baselining are necessary for accuratelytracking changes to information within a system. Make sure your RM platform can provide this type of “living” documentation of the development process, with all changes accurately captured as they happen. Plus, look for export functionality for sending data easily to other systems of record like a quality management system (QMS) if necessary.
Tip 5: Prioritize Secure Management of ElectronicSignatures and Records
The FDA’s 21CFR Part 11 defines criteria for how electronic signatures and records can be used as equivalent to paper records. In order to meet this regulation’s very high bar for proof of electronic record and signature compliance, the proper access controls and security mechanisms need to be in place, such as:
Authentication of users via unique usernames and passwords
Limitations on who has the authority to create an electronic signature
Full details on when the signature was created, what it means, and who authorized it
Options for accurately and safely exporting the data in it for other systems or formats
In Jama Connect, we consider reviews the electronic record, which the FDA defines as “any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.” Reviews in Jama Connect adhere to the requirements for closed systems and include electronic signatures and the requirements for linking between signatures and records.
Tip 6: Perform Risk Analysis Early and Continuously
Waiting until the later stages of development to perform risk analyses will complicate medical device compliance and uncertainty in the product development process. More specifically, it will slow down the entire project due to the need to gather documentation from multiple sources, make any necessary late-stage changes (for example, in response to missing traceability between requirements and risks), and ensure test results reflect the latest updates to risks.
Jama Connect allows for risk analysis aligned to industry standards like ISO 14971:2019, treating risk management as an integral part of the product lifecycle process. Your organization can standardize and integrate your risk analysis, evaluation, and management processes in our platform to create a single source of truth for everything risk related.
To see more information specific to the medical device development industry, we’ve compiled a handy list of valuable resources for you!
What Phases are Needed for Developing a Medical Device?
Developing a medical device is an inherently complex process, and one that’s becoming more complicated all the time. In addition to the increasingly stringent regulatory requirements that must be met for FDA approval and/or EU MDR compliance, medical device manufacturers must also navigate ongoing changes across the industry, including the rise of connected devices within the Internet of Things (IoT).
Making it all the way from initial device discovery and conceptualization through to FDA clearance and launch strategy requires a dedicated team, as well as a risk and requirements management strategy supported by modern tools. Without such solutions in place, the high costs and significant risks of developing a modern medical device become more challenging:
The average cost of development under the Food and Drug Administration’s Premarket Approval (PMA) program is $94 million. For the less strict 510(k) path, it’s still a considerable sum – $31 million.
Product recalls are more expensive. A McKinsey study estimated the cost of these events at as much as $600 million apiece. Indirect losses from reduced market cap and lost revenue can run into the billions of dollars.
Medical device security is also paramount in the age of the IoT. Internet connectivity can expose devices to cyberattacks and the healthcare industry is routinely among the most targeted sectors.
To fully account for the relevant challenges and also zero in on corresponding solutions, let’s look at the process a medical device must go through before it reaches patients.
The 5 phases of developing a medical device
Medical device development is a multi-phase process, typically with five main stages. A sample process – this one outlined by the FDA itself – proceeds as follows:
Phase 1: Device Discovery and Concept
There are several overarching questions to answer at this initial stage:
Is there an unmet need that a new device could potentially satisfy?
What risks would the device, if brought to market, pose to patients?
How might those risks translate into the device’s classification?
Can a proof of concept outline a workable path to regulatory approval?
The classification of the potential device, in particular, will greatly affect the product development process and necessary risk management procedures.
For example, Class I devices are subject only to general controls such as good manufacturing practices and recordkeeping requirements, while higher-risk Class II and Class III devices require additional special controls and PMA, respectively. Accordingly, risk management is more complex for Class II and Class III devices, plus the associated costs are higher.
Phase 2: Preclinical Research and Prototyping
At this point, the device isn’t suitable for human use yet, but it is ready for testing within controlled laboratory environments. Observing the prototype’s performance under these conditions provides some early insights on how it might be used by people, and into what specific risks might accompany it.
Phase 3: Pathway to Approval
The device’s classification/risk level will determine the subsequent steps.
A Class I device such as an oxygen mask has to comply only with general controls, and many devices in this low-risk class are exempt from any premarket submissions. Higher-risk Class II devices, such as pregnancy test kits, must adhere to special controls, like meeting device-specific performance criteria, on top of those general controls.
Non-exempt Class I and Class II devices require a 510(k) Premarket Notification proving “substantial equivalence” with a legally marketed device that isn’t subject to PMA. If such equivalence cannot be proven, the device is placed into Class III.
Class III devices – including those nonequivalents, along with devices that sustain or support life – require PMA, which is the most complex part of developing a medical device. Scientific evidence must be submitted showing that the device’s benefits outweigh its risks and that it will help a significant portion of the population.
Phase 4: Regulatory Review
Once a medical device company has sufficient data on how its device performs and the accompanying risks, it can apply for regulatory review. The exact process will vary by device classification/risk level.
PMA applications entail a thorough review of the laboratories and facilities for production for good manufacturing practices, and an evaluation of the results of related clinical and nonclinical studies. Other processes are simpler.
Phase 5: Post-Market Device Safety Monitoring
After the device reaches the market, it will be continually monitored for possible safety and performance issues. Regulatory bodies may inspect manufacturing facilities again, while consumers and medical professionals can report any observed issues through programs like MedWatch in the U.S. This would be the stage at which a recall would be initiated, if applicable.
Throughout all five phases, development teams will need to maintain many different documents, including design history files for each finished device. To ensure that their work stays on track and complies with key regulatory standards such as ISO 13485, ISO 1497, and EU MDR provisions, it makes sense to create a single source of truth that supports scalable, efficient requirements management.
Upgrading requirements management for modern medical device development
Providing a medical device’s compliance can be complex. Traditional document-driven models are not ideal for this purpose, either, as they can involve many discrete spreadsheets and other files that take a long time to retrieve, review, and organize. The inefficiency of these workflows also complicates the traceability of development activities back to requirements.
In contrast, a centralized platform, with all key information in one place, can provide clearer insight into design controls for device requirements and related risks. Teams can use Jama Connect to gain real-time visibility into how design inputs have been met and verified, providing necessary evidence from the design control process, for better-informed decision-making and a more streamlined overall development process.
Defects can also be identified earlier and more reliably, curbing the risk of noncompliance and recalls. To learn more about we can help support your medical device projects, get in touch with a Jama Connect expert today.
If you’d like to learn more about medical device development,
we’ve compiled some helpful resources all in one spot! LEARN MORE
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![[GUIDE] ISO 13485 for Medical Device Development](https://www.jamasoftware.com/media/2021/02/2021-02-18-ISO-13485-ebook-1024x512-1.jpg "[GUIDE] ISO 13485 for Medical Device Development")
In this post, we pull out key takeaways from a recent whitepaper written in conjunction with Beanstock Ventures on the new EU medical device regulations (EU MDR) and how they might impact medical device development. 
Medical device development is inherently complex, with numerous ever-evolving regulatory statutes to comply with and especially high stakes for ensuring the ultimate safety of the product