Tag Archive for: medical device development

Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from Medical Device and Diagnostic Industry – Celebrating the 2022 Medical Design Excellence Awards Winners & Finalists  – which was originally published on April 8, 2022, by MDDI Staff.

Celebrating the 2022 Medical Design Excellence Awards Winners & Finalists

The medtech industry’s premier awards program honors significant achievements in medical product design & engineering that improve the quality of healthcare delivery & accessibility.

The Medical Design Excellence Awards (MDEAs), the medtech industry’s premier awards program, organized by Informa Markets – Engineering, publisher of Medical Device + Diagnostic Industry (MD+DI), today announced the winners and finalists for the 2022 MDEA competition. This year, nearly 30 winners and finalists were announced in 10 product categories on www.mddionline.com.

Since its inception in 1998, the MDEA program has honored significant achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility. More than just a beauty contest, the MDEAs convene an independent panel of esteemed jurors—made up of clinicians, engineers, and designers—to select up to six finalists, as well as Bronze, Silver, and Gold winners in each of the 10 product categories, along with overall Best-in-Show winner and Readers’ Choice. The annual competition recognizes products that are moving the $450 billion medical device industry forward through life-saving innovations and remarkable technological advancements.

Entries are scored based on five criteria: design and engineering innovations, user-related innovations, benefits to overall healthcare, benefits to patients, and differentiation in the market.

Related: Requirement Debt™: A Medical Product Program Risk

“This year’s entrants were amazing; each playing a significant role in changing the direction of the industry and bringing viable new innovations that overcome today’s most pressing challenges in the healthcare field,” said Daphne Allen, editor of MD+DI. “Congratulations to our winners and finalists who are shaping much-needed progress in a meaningful and impactful way.”

2022 MDEA Winners are as follows:

Best in Show: HemoScreen (PixCell Medical)
MD+DI Readers’ Choice: CT in a Box (GE Healthcare)

Cardiovascular Devices

Gold: TYRX Absorbable Antibacterial Envelope (Medtronic)
Silver (tie): HydroPICC and HydroMID (Access Vascular, Inc.), TELLTALE Electrosurgical Guidewire System (Transmural Systems)
Bronze: ASSURE Wearable Cardioverter Defibrillator System (Kestra Medical Technologies, Inc.)

Digital Health Products and Mobile Medical Apps

Gold: Minuteful Kidney Test (Healthy.io)
Silver: Oregon Capacity System (GE Healthcare)
Bronze (tie): Bigfoot Unity Diabetes Management Program (Bigfoot Biomedical), FreeStyle Libre 3 (Abbott)

ER and OR Tools, Equipment, and Supplies

Gold: MOLLI (MOLLI Surgical Inc.)
Silver (tie): Baxter EASYGRIP FLO41 (Baxter), Hugo Robotic-assisted Surgery System (Medtronic)
Bronze: TN-Advanced Tibial Nailing System (DePuy Synthes, the Orthopaedics Company of Johnson & Johnson)

Gastrointestinal and Genitourinary Devices

Gold: The iTind Procedure (Olympus Corporation)
Silver: CarePath (I-O Urology)
Bronze: EnteraLoc (Vonco Products, LLC)

Related: Why Your Medical Device Risk Management is NOT Effective

Implant and Tissue-Replacement Products

Gold: ApiFix (OrthoPediatrics)
Silver: Leith Medical Patented Ankle Plating System (Leith Medical)
Bronze: KG2 Surge Interbody Flow-Thru System (Kleiner Device Labs/BAAT Medical)

Nonsurgical Hospital Supplies and Equipment

Gold: Rediroom — Instant Patient Isolation Room (GAMA Healthcare / Care Strategic)
Silver: Flusso TFI (McArthur Medical Sales Inc.)
Bronze: HydroPICC and HydroMID (Access Vascular, Inc.)

Over-the-Counter and Self-Care Devices

Gold: Quick Fold and C-Grip Canes Collection (Michael Graves Design)

Radiological, Imaging, and Electromechanical Devices

Gold: Imagio Breast Imaging System (Seno Medical)
Silver: Smart-C (Turner Imaging Systems)
Bronze (tie): AquaBeam Robotic System (PROCEPT BioRobotics Corporation), CT in a Box (GE Healthcare)

Rehabilitation and Assistive-Technology Products

Gold: INSIGHT System (Adapttech)
Silver: TrueLimb (Unlimited Tomorrow, Inc.)
Bronze: ArmMotus EMU (Fourier Intelligence)

Testing and Diagnostic Products and Systems

Gold: HemoScreen (PixCell Medical)
Silver: KneeKG (Emovi)
Bronze: ASP Device (ASP Health)

A complete list of finalists in the 2022 MDEA competition can be seen on MD+DI’s website.

The MDEA program accepts entries worldwide from companies and individuals involved in the design, engineering, manufacture, or distribution of finished medical devices. The competition is open to finished medical devices, including instruments, machines, implants, in vitro reagents, mobile medical applications, or other related products that are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease or other conditions in humans or animals.

To learn more about the MDEA program, visit www.mdeawards.com.


Requirement Debt™

In this blog, we discuss key takeaways from a recent whitepaper, written by Ivan Ma, discussing Requirement Debt™.

What is Requirement Debt™

Requirement Debt is defined as the gap between product requirements + requirement traceability and the perceived maturity of the program + product.

How Reducing Requirement Debt Reduces Project Risk

It is imperative that development teams understand the value of having written requirements early in the process to increase program predictability and reduce downstream risks. The impact of poor requirement definition and closed loop requirements (i.e. traceability) is real and can be significant in time, scope, and cost. 

The holy grail of any program is to deliver a product on time, within budget, and that meets specifications. It is a rather simple measure, with a massive number of variables along the way from concept to product shipped to customers. 

Leadership teams often apply a disciplined program risk management process to identify and be proactive in managing risks that can impact the timely delivery of a product. 

To objectively evaluate which risk to prioritize, the following action table can be used. 

Requirements Debt Action Table


Most organizations do not identify requirement clarity and management as a high effort, high impact to the product item, if it is even identified at all. Some organizations believe requirements do not pose a traditional existential threat to the program because the cost of poorly defined or missed requirements is not immediately measurable. 

In fact, some individuals in an organization see requirements management as a high effort low impact activity.

RELATED POST: The Costly Impact of Ineffective Requirements Management in the Medical Device Industry

The Impact of Requirements Debt on Medical Device Development 

Medical product development efforts are often driven by the need to show tangible results. Agreeably, there is nothing more tangible than a physical prototype, functioning experiment on the bench, or an interactive software user interface. However, increasing adoption of the Agile development method encourages bringing tangible demos to potential customers early and often leads development teams to take on Requirement Debt to satisfy short term needs. 

Further magnifying the Requirement Debt issue is the occasional misconception among the team that design control and by proxy, requirements, is the responsibility of the quality group. When in fact, if applying a responsibility assignment matrix (RACI Model), the quality group is accountable for design control — the one who ensures the prerequisites of the task are met. The rest of the organization (research and development, systems, test, manufacturing, etc.) is responsible for implementing design control – those who do the work to complete the task. 

It’s absolutely ok and even encouraged during the feasibility phase to build prototypes with no requirements. A smart organization will build prototypes to help clarify requirements. However, as the feasibility phase comes to an end, direct output of the feasibility phase should be a set of draft requirements to enter into the design phase. 

With each successive round of prototyping, requirements and requirements trace should mature just as the product does.

If product teams are building prototypes for verification with incomplete requirements, broken loop trace, and TBD acceptance criteria, Requirement Debt is at its maximum. 

The smaller the Requirement Debt gap, the higher probability of a successful product launch.

Requirements Debt Matrix

RELATED POST: Medical Device Startup, Proprio, Chooses Jama Connect® to Drive Innovation

Per 21 CFR Part 820 Subpart C, manufacturers of Class III, Class II, and some Class I devices “shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.”

The following are direct excerpts from 21 CFR Part 820 Subpart C:

(c) Design input. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

(d) Design output. Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented.

(f) Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.

The code of regulation is very clear about the role design inputs, design outputs, and design verification play in design control.

To learn more about the value of proactively writing traceable requirements, mitigating costly late-stage changes,  and the benefits of proactive traceability, download the full whitepaper. 


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 productsystems, 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. 


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 cyber security 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-based toolsets 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. HoweverI 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 software needs to be developed, validated, and maintained.  

RELATED POST: EU MDR What You Need to Know

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.    

RELATED POST: Realigning Engineering Teams for Remote Work with Minimal Disruption

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. 

RELATED POST: Improving Quality Processes for Medical Device Development

Ryan Moore, Jama Software:  

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. 



This post on Software as a Medical Device (SaMD) development is written by Mercedes Massana, the Principal Consultant of MDM Engineering Consultants

SaMD software is software intended to be used for one or more medical purposes that do not require embedding in a medical device. These purposes can range anywhere from helping to diagnose or treat disease, helping in the clinical management of a disease, or providing information to help with the clinical management of a disease. SaMD differs from other medical device software in that it will operate on different platforms and will interconnect with other devices, carrying with it an increased cybersecurity risk and a commensurate increase in the use of off-the-shelf software. 

On the surface it may appear that the development of SaMD software is no more difficult than the development of Medical Device embedded software, but appearances can be deceiving, and the development of SaMD products can be quite challenging. In order to deal with these challenges, there are four key best practices that should be followed for SaMD software development.  

These practices are:  

  1. Make use of standards and guidance documents  
  2. Apply the right level of rigor 
  3. Understand the difference between Verification and Validation  
  4. Implement a post-market monitoring program

Best Practice #1– Making Use of Standards and Guidance Documents 

Although standards development organizations and regulatory bodies have only started to scratch the surface in the creation of standards and guidance documents to help SaMD development organizations, there is a sufficiently detailed body of work available to help development organizations succeed. The most relevant of these are the documents generated by the International Medical Device Regulators Forum (IMDRF) related to SaMD and IEC 82304 Safety and Security of Health Software Products. The IEC standard points to other well-known standards, such as IEC 62304 Software Development Lifecycle, IEC 62336 Usability Engineering and ISO 14971. Additionally, several FDA guidance documents are available that apply to all medical device software and are useful for the development of SaMD, these include General Principles of Software Validation, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Off-The-Shelf Software Use in Medical Devices and the FDA pre and post market cybersecurity guidance, as well as other guidance documents 

Best Practice #2 –Applying the Right Level of Rigor  

Within the development of SaMD, a clear understanding of the scope and intended use of the product is necessary, and to that end, it is necessary to have a method to gauge the risks associated with SaMD use. The IMDRF “Software as a Medical Device” Possible Framework for Risk Categorization and Corresponding Considerations, IEC 62304 , and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices all provide a method for risk based classification of SaMD. The rigor applied to the development of SaMD should be commensurate with the level of risk. IEC 62304 uses the Safety Classification to define the level of rigor of activities to be performed in the software lifecycle based on the level of risk. Ideally, the development process is sufficiently flexible to avoid the over-engineering or under-engineering of the SaMD in question. A development process that is adaptable requires organizational maturity and experience, in order to perform the right set of activities and understand the value provided by those activities.

RELATED: Regulatory Shift for Machine Learning in Software as a Medical Device (SaMD)

Best Practice #3 – Understanding the Differences Between Verification and Validation  

SaMD is a medical product, a system in and of itself. Therefore, SaMD system requirements must be verified to have been implemented correctly, and  SaMD user’s needs must be validated to ensure that the product satisfies the user’s need and that the right product was built for the customer. Validation typically includes human factors testing, clinical evaluation to determine the efficacy of the software for its intended use, and a demonstration that risk controls are effective. This requires more than just your standard set of software testing, which typically consists of code reviews, unit testing, static analysis, integration testing and requirements-based testing. 

Best Practice #4 – You Are Not Done When the Software is Released  

Your SaMD software has successfully completed verification and validation, has been cleared by regulatory agencies, and is now ready to go live. Time to breathe a sigh of relief and congratulate the team for a job well done. Pop the champagne and throw a party, you have all earned it. Enjoy the festivities, but afterwards turn your attention promptly to monitoring the performance of the SaMD post launch. Rigorous and exhaustive as your testing was, you can never anticipate every possibility. Be ready to respond to identified software defects and emerging cyber threats and deploy patches or software fixes as issues are identified.  The nature of cybersecurity risks is ever-changing, and no system, regardless of how well-designed, or rigorously-tested, is free of software defects. Additionally, customer input can provide opportunities for enhancements and improvement.  However, be aware that proposed changes can impact the intended use of the device, the classification of the SaMD, and can ultimately result in additional regulatory submissions. It is paramount that prospective SaMD developers evaluate changes thoroughly and plan actions related to these changes to avoid surprises that can delay, or outright derail, SaMD implementation. 

In summary, SaMD can provide great benefits to the user; however, to successfully launch SaMD that meets the user’s needs, several best practices should be utilized in their development. These best practices, making use of standards and guidance documents, applying the appropriate level of rigor in the development of SaMD, understanding the difference between Verification and Validation, managing change appropriately, and implementing a good post-market monitoring program.  These best practices are indispensable in ensuring a safe and effective SaMD product. 

Machine Learning in Software as a Medical Device

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.

Future FDA Regulatory Process

In April 2019, the FDA released a paper called “Proposed Regulatory Framework for Modifications to Artificial Intelligence/ Machine Learning (AI/ML) Based Software as a Medical Device (SaMD).” The paper describes and outlines a possible approach to a premarket review for artificial intelligence and machine learning-driven software modifications.

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!

Trend for Medical Devices

Editor’s Note: This post on the top trend for medical devices was originally published here by MedTech Intelligence on November 17th, 2020, and was written by Josh Turpen, Chief Product Officer at Jama Software.

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.

RELATED: Your Guide to Selecting a Medical Device Development Platform

Medical Device Recalls on the Rise

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.

medical device

2020 has been a year that’s been described as “unprecedented” and “unparalleled” – as well as other descriptors probably best left out of our blog. As we close out this year, it’s hard to say what awaits us in the new one. One thing that we can be sure of is that innovation in medicine, science, and technology shows no sign of slowing down.

As we enter a new year of technological advancements, 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 Part I of our four-part series, we ask Steven Meadows, Medical Device Solutions Lead at Jama Software, and Founder & CEO, Shawnnah Monterrey at Beanstock Ventures to weigh in on trends they see in the medical device industry for 2021.

Note: Now that our 2021 Predictions Series is complete, you can also go back and read, Part II, Part III, and Part IV.

What are the biggest trends you’re seeing in the medical device industry right now? How will they impact products, systems, and software development? 
Steven Meadows:

From a product perspective, there are a number of areas in the medical space that are set to grow in 2021 and beyond, including robotics nanotechnology, wearable health tech, and extended reality devices.

With more medical devices incorporating software components and connecting to systems, like hospital networks, enhanced cybersecurity is becoming increasingly important. Medical device companies will continue to invest heavily in this area through 2021 and beyond.

Shawnnah Monterrey:

There are three primary trends that I am seeing: A shift in initial product launches from Europe to the United States; An increase in Software as Medical Device products; and an increase in IVDs from lab-developed tests. 

We are seeing a shift in initial product launches from Europe to the United States, due to the upcoming EU MDR regulations. Typically, USbased companies would launch medical products in Europe first, followed by a US launch shortly after due to the rigor and lag time in receiving FDA approval. CE Mark was typically more straightforward, required less clinical evidence, and was a faster process, especially when companies could self-certify. EU MDR is currently being perceived to be more onerous than the FDA regulatory clearance process and is therefore creating a trend of product launches occurring first in the United States and then in Europe. The cascading impact would therefore be the need for more services providing expertise in regulations to support EU MDR and a need for a more harmonized regulatory strategy. 

The second trend we are seeing is an increase in Software as a Medical Device (SaMD)There have been numerous healthcare, fitness, and consumer products launched into industry recently that were not previously considered a medical device. As a result of the SaMD FDA guidance combined with the EU changes from CE, MDD to EU MDR, many products that were not originally deemed clinical products or medical devices are now falling into that category. Products that were previously not classified as medical devices were not necessarily held to the same standards that are required to produce a medical-grade product such as quality management, design controlrisk managementclinical studies, and post-market surveillance. This shift will cause companies to delay product launches in order to satisfy the regulatory requirements, resulting in an increased need for training, systemssoftware, and tools to make it easier for companies to make that transition.  Since these companies generally lack quality and regulatory expertise, additional support will be required to deliver medical-grade software products. 

The last trend we are seeing is an increase in IVDs from lab-developed tests (LDTs), research use only (RUO) and emergency use authorization (EUA). There are numerous laboratory-based tests and associated software that have been developed to support very complex assays that are being used clinically which has recently been deemed outside of the scope of LDT guidance.  Products that were covered under CLIA are now required to be cleared with the FDA and EU as an IVD.  From a CLIA perspective, the focus is on validationValidation is centered on the intended use of the product and workflow. But with medical devices such as IVDs, there needs to be a shift to bringing it down to verification levels  namely design verification. Design verification is quite different than validationdesign verification is looking at the design aspects of the product, not from a workflow perspective, but from a design feature perspective. Design verification occurs at the subsystem and system level, where the subsystem is the breakdown of the system from the architecture. The scrutiny will be from a hazard perspective for the entire system and a failure mode analysis perspective at the subsystem level. Finally, ensuring that there is a full product definition and full verification associated with the product. The impact is that it is going to require taking a different look at the software that has been provided and looking at it differently from a process software perspective to an IVD perspective this might require looking at the architecture and redesigning the system to break apart the items that were allocated to CLIA and the lab system processes versus the actual product that performs the clinical interpretation and the diagnosis.  

An overarching impact will be evolving medical device product development from a methodology perspective. Many companies are lean and agile and are performing continuous integration and development of their productsIt will be important to set up processes and procedures to still allow for that while continuing to meet the regulations. From a systems perspective, it would be beneficial to take advantage of available tools. There is a myriad of tools in place that can assist in developing quality management systems, manage design control, support requirement and risk management, testing, test automation, and deployment.  There is an opportunity for companies to start investing in tools to help with compliance and save time and money while still maintaining their efficiencies.

RELATED: Your Guide to Selecting a Medical Device Development Platform

In terms of product and systems development, what do you think will remain the same over the next decade? What will change? 
Steven Meadows:

Software is becoming an increasingly used component in medical devices and we expect this trend to continue. More of our customers are adopting an Agile methodology when developing their software, a shift that has been happening for some time, and will continue to over the next decade.

Shawnnah Monterrey:

Over the next decade, I see the use of Artificial Intelligence (AI) supporting the creation of sophisticated data-driven algorithms such as autonomous diagnosisAI is gaining renewed tractioneven though it has been used in medical products since the 2000s.  I believe there will continue to be a tremendous amount of investment in the development and understanding AI in the healthcare space and how it could be used to improve clinical outcomesAI will continue to progress over time as the industry develops an understanding of the utility and how it can contribute to guiding clinical decisions as an autonomous tool.  There is FDA draft guidance around AI, however, I think the biggest potential constraint will be how to continuously improve upon the algorithms as new data comes in, without requiring a new regulatory submission.  

The other trend I see progressing over the next 10 years is one we are already seeing, cybersecurity. This trend is a bi-product of the increasing numbers of clinical cloud applications that integrate with or use medical devices. As the need for sharing clinical data, advanced computing, remote diagnostics, and accessibility increases, so will the migration of healthcare applications to the cloud.  This increased need will be the catalyst that pushes up the demand for securing patient data not only in terms of patient privacy but also in terms of patient safety. We have seen several instances now whereestablished medical device manufacturersmedical device cloud softwarecould be hacked by an unauthorized person and potentially cause adverse side effects to the patient. Such hazards could trigger a class I recall, the most serious type of recall.  Not only do these hazards put patients at risk, but they also impact a company’s reputation and financial viabilityOccurrences like this will justifiably result in growing emphasis on creating software systems, processes, and tools to support the industry in maturing standards and guidance around cybersecurity. 

In terms of what will remain the same in the medical device industry throughout 2021, I would say that the regulations will remain unchanged It is unlikely we will see a change in this coming year.  To the contrary, we will likely see an increase in the regulation. I previously discussed the potential for harmonization. However, I do not believe that will happen until there is a push for it or until the FDA acts on the overlap between many of the guidance documents Additionally, there will need to be harmonization on the development methodology across different devices so there is not a need to have different guidance documents. In short, I do not see the regulations changing over the coming year.   

In discussing 2021, we should also take a moment to discuss Covid-19.  Its not my belief that things will change from a Covid perspective. The trend that I see continuing involves businesses increasingly going digital, putting pressure on products to focus on cybersecurity. Specialties, such as telemedicine will likely increase, requiring true patient authentication and there will be progress, but a delay in medical device development in areas of selected surgeries. 

Regarding development teams, I think Agile is here to stay. I think that development teams will continue to use the agile approach and methodology. The organizational struggle of internal alignment of the quality management system will persist until there is a disruption in the regulatory environment itself. Relative to the need for systems as software tools become more useful and more integrated. The main area I see increasing are the new entrants into the market. There has been a large amount of new investment and I believe that will continue. I think we can assume that there will still be quite a bit of investment opportunities for new players. 

What sorts of process adjustments do you think development teams will need to make to accommodate these changes? Do you think they’ll need to make technology investments, process adjustments, or both? 
Steven Meadows:

As we continue to deal with the new normal, I expect medical device teams to continue to invest in collaborative product development software, enabling their teams to continue bringing new devices to market in a safe and competitive way. Development teams, using legacy product development platforms and Word/Excel need to switch to a modern alternative, in order to be as successful as possible in 2021.

Shawnnah Monterrey:

My belief is that development teams are going to need both technology investments and process adjustments to accommodate the changes that are coming. There will be a heavy reliance on technology as the software realm moves more towards focusing on core IP and leveraging the existing software components availableFor example, there could be an organization successfully providing cybersecurity packages where other organizations may not have that expertise, so they would be leveraging assets from another organization.  In short, software re-use will be important.   

My sense is that the industry will shift more towards investing in technology such as AI and mechanisms to improve data sharing. There is an opportunity to really understand the clinical value that the data brings. Currently, the healthcare environment is comprised of disparate systems that will eventually need to come together to be able to fully leverage the data and use the data in unique yet meaningful ways  

We are currently seeing a big shift where the medical device companies and their quality management systems do not satisfy the way in which engineers perform medical device development. For example, software engineers are very agile and tool oriented by nature, while many established companies still utilize a paper-based quality management system or document control system.  We’d like to see software teams and the Agile methodologies drive changes to the quality system so that the quality system can be nimbler and more adaptive allowing them to release compliant products faster.   

We have observed a hindrance in the companies and auditors themselves to adopt a more progressive and nimble approach that is not necessarily driven by the regulationsOur interpretation is that the intent of the current regulations is to be nimble and still provide safe and effective products.  My belief is that if we do not make a change to the current way in which we develop medical devices in the corporate environment, innovation from these larger organizations will be stifled.  The innovation gap will ultimately be filled by startups entering the marketplace and experiencing immediate success because the old way of doing things is no longer sustainable or effective. I foresee a trend in an increase in the volume of new, emerging, small players. These players are going to be nimble and will look at the regulations from a different perspective

RELATED: How to Executive a Successful Design Review When Building Medical Devices

How do you foresee regulations shifting in the medical device industry over the next decade?
Steven Meadows: 

Key medical device standards and regulations are constantly changing. Notably, EU MDR is undergoing a number of changes and will need to be fully implemented by May 2025. Key standards like ISO 14971 go through multiple iterations and Jama can help our customers stay current with these changes.

Shawnnah Monterrey: 

I will say something that ‘should’ happennot that ‘will’ happen, relative to regulatory changes in the medical device industry over the next decade.  Ideally, there would be harmonization across the guidance documents. There are too many guidance documents and many of them are repeating the same requirements but in different waysWith a harmonization effort, it would remove the perceived burden of applying multiple guidance and standard documentsWith the current format, there is a need to understand each and every guidance and standard document and to be able to apply them all correctly. With more alignment and more harmonization, it would facilitate adoption and push forward innovation.  

The impact of harmonization would certainly be in facilitating development With one cohesive guidance document and less confusion in applying multiple regulations and guidance documents across development, it would result in more development.  If there was more alignment across the agencies to create cohesive processes, it would be easier to get consistency in the application of it. Additionally, the FDA’s time to approve products would be reduced because the FDA would be seeing similar submissions and be able to focus on the critical aspects of the product.    

Another regulatory change that I expect to grow over the next decade is with the FDA’s adoption of third-party review organizations.  The FDA has begun utilizing third-party vendors to streamline and offload their burden of reviewing Class I & II devicesBy working with approved partners to facilitate the review, the FDA can focus on higher risk devices.  This allows a company’s submission to get reviewed more quickly.  Over the next decade, the FDA will likely become more sophisticated in this partnership with third-party organizations.  The impact would be a faster time to market, possibly launching products months more quickly. 

What do you think will be some of the differentiators between a company surviving to see 2030, and those that do not?
Steven Meadows: 

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. 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, 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.

Will those trends still be prevalent 5 years from now? 10 years?  
Shawnnah Monterrey: 

I believe there will be disruption in the regulatory space in the next five to ten years, so I do not see the trends staying the same 

It will be important to have industry guidance by having industry experts partner with the FDA to help make those improvements.  Based on the FDA approach currently, I believe they will welcome industry guidance.  In relation to the previous discussion of the FDA 510(k) Third-Party Review Program, if we want to put it into a broader bucket, this is really the FDA utilizing external resources to support the industry.  However, the collaboration is not simply due to a lack of resources, it is also because there is a very challenging, difficult infrastructure to navigate.  I believe that there is a push to simplify the system and there will be a reliance on industry partners to do so.  The industry partners will include those that are doing software product development, providing quality regulatory services, and providing tools to help facilitate medical device development. 

What innovations in regulation in the medical device industry do you hope to see in 2021? 5 years from now? 10 years?  
Shawnnah Monterrey:

The innovations in regulation in the medical device industry that I hope to see is the increasing opportunities for companies to collaborate with the FDA. I also hope to see more companies, larger organizations, or startups, take a more lean, nimble approach and be more receptive to the Agile methodology that software development teams are currently using.  Current processes and procedures were generally derived from good engineering practices; however, perspectives of quality and regulatory experts and independent auditors remain the same.   I would like to see them be more adaptive towards compliance, as compared to the typical approach of checking the box, and instead, establish a partnership with their medical device development team to help facilitate compliance without sacrificing the quality of the product.   

More specificallyI would like to see more efficient uses of tools and technology to support medical device development. There are many tools out there, but they are very disparate.  I believe that with more cohesion between those tools it would better facilitate medical device development to comply with the regulations.    

In five years, my hope would be that there would be a first pass at simplifying the guidance documents. 

In 10 years, I hope to see a streamlining of the processes. I hope for standardization of the submissions. I would hope to see a simplification of the current guidance documents across the board in the form of a standard method for supporting 510(k) and PMA submissions.  

Stay tuned in the coming weeks for additional 2021 predictions! In the meantime, to see more information specific to the medical device development industry, we’ve compiled a handy list of valuable resources for you!


Medical Device ComplianceMedical 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 processes as 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.

RELATED: Your Guide to Selecting a Medical Device Development Platform

Tip 3: Upgrade Your Approach to Traceability

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 accurately tracking 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 21 CFR 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!



Jama Connect for Medical Device Development

In this post, we’ll explore how Jama Connect for Medical Device Development is designed to help you get ramped up quickly with a platform, training, and documentation aligned to industry regulations ISO 13485:2016, 21 CFR 820.30, and ISO 14971:2019, while applying a proven systems engineering approach to product development.

With this solution, medical device teams can manage design controls for device requirements and related risks, simplifying regulatory submissions and audit preparations while accelerating time to market.

Manage Design Controls for Device Requirements and Related Risks in a Single Platform

Easily Demonstrate Traceability

Traceability ensures that design inputs have been met and verified, providing necessary evidence from the design control process. Jama Connect allows you to easily produce traceability documentation required by regulators.

Manage Risk Analysis

Manage risk analysis, aligned with ISO 14971:2019. Jama Connect helps teams identify and mitigate risks earlier in medical device development, saving teams from frustrating late-stage design changes and supporting the path to regulatory compliance.

Maintain Audit Trails and Export Data

Real-time reporting and baselining allows you to track all changes to information within the system, including timestamps and associated users. Data is easily exported from Jama Connect if your current process dictates storage of documentation in a quality management system (QMS).

Reuse and Baseline Management

Compare versions of a requirement, generate branches to develop a variant, and create catalogs of reusable requirements to improve medical device development.

Compliant Reviews and Approvals

Increase early stakeholder visibility and participation in the review process with electronic signatures that are compliant with FDA 21 CFR Part 11.

Design Verification and Validation

Seamlessly manage traceability to verifications and validations, providing evidence to comply with government regulations and standards, like 21 CFR Part 820.30.

Flexible, Scalable Options with Jama Connect for Medical Device Development

Jama Connect for Medical Device Development Solution’s license model is fully scalable, ensuring rapid deployment and easy adoption of the solution across your product development team. It also allows flexibility and can be customized to your team’s unique needs. Download this datasheet to learn more about key product benefits and features, unique licensing types, and templates templates provided as part of the solution.

To see more information specific to the medical device development industry, we’ve compiled a handy list of valuable resources for you!


Medical device companies are on the cutting-edge of advancing health care. Along with facing relentless pressures to innovate and release quality products, they also must comply with regulations and standards to remain competitive.

On Tuesday, August 4th, we’ll be hosting a webinar specifically designed for product and engineering teams building medical devices. We’ll be covering how to move beyond the frustrations of disconnected, document-based requirement systems, streamlining your design and development and risk management processes while maintaining compliance with applicable regulations and standards.

Date:        Tuesday, August 4th, 2020
Time:        8:00 – 9:00am PST

In this webinar, we’ll examine how Jama Connect for Medical Device Development helps free your teams from document-based requirements management, streamline your processes, and spend more time on innovation. Register now to learn more about:

  • Bringing systems thinking into design control and risk management activities using Jama Connect for Medical Device Development
  • Aligning how you work with the development of the artifacts needed for compliance, the Design History File (DHF) and the Risk Management file (RMF)
  • Defining products and risk controls through the lens of tracing
  • Using Jama Connect to align your design control and risk management processes with relevant parts of governing regulations and standards ISO 13485:2016, 21 CFR 820.30, and ISO 14971:2018
Presented by:

Zeb Geary Principal Consultant, Jama Software

Zeb brings more than 10 years of experience in software consulting and business analysis to Jama’s enterprise customers and helps them deploy and optimize their use of the platform. Over the past 3.5 years, he’s worked closely with many regulated customers, especially within the Medical Device industry, to provide best practices and deployment assistance to better align Jama Connect to regulated activities pertaining to design control and verification.

Watch the recording now!