{"id":59357,"date":"2022-01-11T03:00:35","date_gmt":"2022-01-11T11:00:35","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?p=59357"},"modified":"2023-01-12T16:47:46","modified_gmt":"2023-01-13T00:47:46","slug":"2022-medical-device-predictions","status":"publish","type":"post","link":"https:\/\/www.jamasoftware.com\/legacy\/blog\/2022-medical-device-predictions\/","title":{"rendered":"2022 Predictions for Medical Device Development: Increased Focus On Cybersecurity, Clarity On Standard Compliance, and the Challenge of Human Variability"},"content":{"rendered":"

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In many ways 2021 was a continuation of the changes brought about in 2020, a year\u00a0that\u2019s\u00a0been described as \u201cunprecedented\u201d and \u201cunparalleled.\u201d 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.\u00a0<\/span>\u00a0<\/span><\/p>\n

As we enter a new year of further changes, Jama Software asked\u00a0select\u00a0thought leaders \u2013 both internal and external \u2013 across various industries for the trends and events they foresee unfolding over the next year and beyond.<\/span>\u00a0<\/span><\/p>\n

In the second part of our five-part series, we ask Steven Meadows, Solutions Lead from Jama Software, and Ryan Moore and\u00a0Carleda\u00a0Wade,\u00a0Solution Consultants\u00a0from Jama Software \u2013 along with Thierry Marchal, Program Director for Healthcare Solutions at\u00a0<\/span>Ansys<\/span><\/a>, and Ivan Ma,\u00a0Medical Device Program Leadership, to weigh in on product and systems development trends they\u2019re anticipating for medical device teams in 2022.\u00a0<\/span>\u00a0<\/span><\/p>\n

Read our other\u00a02022 Industry Predictions<\/strong>\u00a0here:\u00a0Part One<\/a><\/em>\u00a0\u2013\u00a0Engineering Predictions<\/em>,\u00a0Part Three<\/a> – Automotive Predictions, Part Four<\/a> – Aerospace & Defense Predictions, and Part Five<\/a> – Insurance Development Market Predictions.<\/em><\/span><\/p>\n

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Medical Device Predictions\u00a0<\/span><\/h2>\n
Q:\u00a0What product<\/span><\/i>,\u00a0<\/span><\/i>systems, and software<\/span><\/i>\u00a0development trends are you expecting to take shape in\u00a02022?<\/span><\/i>\u00a0<\/span>\u00a0<\/span><\/h6>\n

Steven<\/span><\/b>\u00a0Meadows<\/span><\/b>,<\/span><\/b>\u00a0Jama Software<\/span><\/b>:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

Artificial\u00a0<\/span><\/i>I<\/span><\/i>ntelligence (AI)<\/span><\/i>\u00a0<\/span><\/h5>\n

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\u00a0<\/span>$6.7 billion<\/span>\u00a0across med tech. I see this trend continuing with extra guidance from the\u00a0<\/span>FDA<\/span>\u00a0helping 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<\/span>,<\/span>\u00a0and a whole host of otherwise manual and often error prone activities.\u00a0<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>Minimally invasive devices\u00a0<\/span><\/i>\u00a0<\/span><\/h5>\n

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\u00a0<\/span>a thing of the past<\/span>, with cardiothoracic applications becoming the norm. Minimally invasive devices are also becoming heavily\u00a0<\/span>utilized<\/span>\u00a0throughout most orthopedic surgeries, and increasingly in urology procedures. We have seen a lot of start-ups\u00a0<\/span>attempting<\/span>\u00a0to bring the next best minimally invasive device to market.<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>Wearables<\/span><\/i>\u00a0<\/span><\/h5>\n

Medical wearable devices demand continues to rise, with apps on wearable devices beginning to\u00a0<\/span>provide<\/span>\u00a0recommendations 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, \u2018<\/span>earables<\/span>\u2019,<\/span>\u00a0and clothing.<\/span>\u00a0<\/span><\/p>\n

Software development<\/span><\/i>\u00a0<\/span><\/h5>\n

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\u00a0<\/span>A<\/span>gile\u00a0<\/span>methodology<\/span>\u00a0when creating their medical system, a shift that has been happening for some time. Gone are the days of slow waterfall-based development practices.<\/span>\u00a0<\/span><\/p>\n

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\u00a0<\/span>refine guidance<\/a> around AI<\/span>\/<\/span>Machine Lea<\/span>r<\/span>ning (<\/span>ML.<\/span>)<\/span><\/p>\n

Cyber<\/span>security\u00a0<\/span>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\u00a0<\/a><\/span>extra guidance around cyber<\/span>\u00a0<\/span>security in medical devices <\/span>with a particular emphasis on quality system considerations and content of premarket submissions.<\/span>\u00a0<\/span><\/p>\n

Ryan<\/span><\/b>\u00a0Moore<\/span><\/b>, Jama Software<\/span><\/b>:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

I anticipate a\u00a0<\/span>t<\/span>rend to<\/span>ward<\/span>\u00a0more\u00a0<\/span>software-based<\/span>\u00a0<\/span>toolsets and digitization.\u00a0<\/span>Also,<\/span>\u00a0an increased amount of\u00a0<\/span>a<\/span>utomation and robotics<\/span>.\u00a0<\/span>\u00a0<\/span><\/p>\n

Carleda<\/span><\/b>\u00a0Wade<\/span><\/b>, Jama Software<\/span><\/b>:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

I expect greater integration of software tools such\u00a0as with\u00a0Requirements Management software with\u00a0<\/span>eQMS<\/span>\u00a0software.<\/span>\u00a0<\/span><\/p>\n

\"requirements-management-hub\"<\/p>\n

T<\/span><\/b>hierry Marchal<\/span><\/b>, Ansys<\/span><\/b>:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

The dramatic COVID pandemic has amplified a trend that appeared a decade ago\u00a0\u2013\u00a0progressively calling for the adoption and deployment of in\u00a0silico medicine.\u00a0Stormed 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\u00a0impacting\u00a0people differently, while elderly people are\u00a0impacted\u00a0the most,\u00a0possibly leading\u00a0to long term disabilities and treatments.<\/span>\u00a0<\/span>\u00a0<\/span><\/p>\n

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E<\/b>DITOR\u2019S NOTE:\u00a0<\/b>According to\u00a0The University of Sheffield\u2019s\u00a0Insigneo\u00a0Institute<\/a>,\u00a0In\u00a0silico medicine (also known as ‘computational medicine’) indicates\u00a0modeling and simulation technologies<\/b>\u00a0that directly contribute to the prevention, diagnosis, prognosis, treatment planning & execution, or management of\u00a0the\u00a0disease. In silico methods complement traditional in vivo approach<\/span><\/span><\/span>es<\/span><\/span><\/span>\u00a0(<\/span><\/span><\/span>w<\/span><\/span><\/span>orking with animals and human\u00a0<\/span>beings<\/span>) and in vitro testing (working in a lab.)<\/span><\/span><\/span><\/em><\/p>\n

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T<\/span><\/b>hierry Marchal, Ansys:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

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\u00a0<\/span>personalized medicin<\/span><\/b>e and preventive medicine<\/span><\/b>\u00a0combining pathologies detection in its early stage to treat diseases before they impact people. The continuous monitoring of patient<\/span>s<\/span>\u00a0to 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<\/span>\u00a0own digital twin or Personal Digital Avatar<\/span><\/b> (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 patient<\/span>s.<\/span><\/p>\n

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,\u00a0<\/span>including in silico (clinical) trial<\/span><\/b>\u00a0is another major trend that we are observing.<\/span>\u00a0<\/span><\/p>\n

Ivan Ma,\u00a0Medical Device Program\u00a0Lead:<\/span><\/b>\u00a0<\/span><\/p>\n

Technologies that enable\u00a0capabilities via telemedicine\u00a0with more\u00a0than just a face and a voice over the screen will make\u00a0\u201cseeing\u201d\u00a0the doctor digitally as common place as working from home.<\/span>\u00a0<\/span><\/p>\n

Protecting patients, physicians, and staff by reducing or eliminating exposure to harmful forms of imaging such as fluoroscopy will always be a valuable endeavor. \u00a0<\/span>\u00a0<\/span><\/p>\n

Q:\u00a0In terms of product and systems development, what do you think will remain the same over the next decade? What will change?<\/span><\/i>\u00a0<\/span><\/h6>\n

\u00a0<\/span>Steven<\/span><\/b>\u00a0Meadows<\/span><\/b>, Jama Software<\/span><\/b>:<\/span><\/b>\u00a0<\/span><\/p>\n

A lot of the areas I mentioned that will trend in\u00a02022,\u00a0will more than likely trend over the next decade.<\/span>\u00a0<\/span><\/p>\n

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.\u00a0<\/span>\u00a0<\/span><\/p>\n

Medical wearable technology will continue to evolve, with improved functionality helping keep us fitter and safer.<\/span>\u00a0<\/span><\/p>\n

Minimally invasive devices will continue to be expanded across different medical areas, improving recovery times, and surgery outcomes.\u00a0Increasing emphasis on cybersecurity will resume, to prevent malicious actors from hacking sensitive data and for connected systems to remain operational.<\/span>\u00a0<\/span><\/p>\n

COVID-19 is not going away any time soon so a reliance on collaborative product development tools,\u00a0<\/span>like Jama Software<\/span><\/a>, will continue to be an integral part of any organization placing an importance on quality and overall product and patient outcomes.<\/span>\u00a0<\/span>\u00a0<\/span><\/p>\n

Ryan<\/span><\/b>\u00a0Moore<\/span><\/b>, Jama Software<\/span><\/b>:<\/span><\/b>\u00a0<\/span>\u00a0<\/span><\/p>\n

Med<\/span>ical\u00a0<\/span>d<\/span>evices will still\u00a0<\/span>be\u00a0<\/span>comprise<\/span>d<\/span>\u00a0of mainly\u00a0<\/span>hardware (<\/span>HW<\/span>)<\/span>\/<\/span>software (SW),<\/span>\u00a0while automation and robotics will be a driving force<\/span>.<\/span>\u00a0<\/span>And\u00a0<\/span>users will still need to power devices<\/span>.<\/span>\u00a0<\/span>\u00a0<\/span><\/p>\n

Carleda<\/span><\/b>\u00a0Wade<\/span><\/b>, Jama Software<\/span><\/b>:<\/span><\/b>\u00a0<\/span>\u00a0<\/span><\/p>\n

Medical device development will mostly stay the same as the regulations are\u00a0<\/span>fairly stable<\/span>.<\/span>\u00a0<\/span>H<\/span>owever<\/span>,\u00a0<\/span>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\u00a0<\/span>AI<\/span>\u00a0and\u00a0<\/span>Software as a Medical Device (<\/span>SaMD<\/span>)<\/span>\u00a0<\/span>as a whole in<\/span>\u00a0the industry.\u00a0<\/span>\u00a0<\/span><\/p>\n

Q:\u00a0<\/i>What are some of the biggest challenges you think engineering firms will be working to overcome in 2022?<\/span><\/i>\u00a0<\/span>\u00a0<\/span><\/h6>\n

Thierry Marchal, Ansys<\/span><\/b>:\u00a0<\/span>\u00a0<\/span><\/p>\n

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.<\/span>\u00a0<\/span><\/p>\n

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.<\/span>\u00a0<\/span><\/p>\n

Finally, the community\u00a0remains\u00a0skeptical about the reliability of computer\u00a0model\u00a0and digital evidence to predict correctly and accurately what is happening in\u00a0the real\u00a0life. This credibility challenge will be continuously addressed by more validations and comparisons with in vitro and in vivo data.<\/span>\u00a0<\/span><\/p>\n

Ivan Ma, Experienced Medical Device Developer:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

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.\u00a0Could digital\u00a0Operating Room\u00a0technologies 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\u00a0data\u00a0acquisition,\u00a0observation and learning access as easy as clicking on a link.<\/span>\u00a0<\/span><\/p>\n

Q:\u00a0How do you foresee regulations shifting in\u00a0<\/span><\/i>medical\u00a0device\u00a0product and\u00a0systems\u00a0development<\/span><\/i><\/b>\u00a0over the next decade?\u00a0<\/span><\/i>\u00a0<\/span><\/h6>\n

Steven<\/span><\/b>\u00a0Meadows<\/span><\/b>, Jama Software<\/span><\/b>:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

Although AI has been\u00a0<\/span>utilized<\/span>\u00a0in medical\u00a0device\u00a0and life science products for decades, guidance has been lagging.\u00a0<\/span>It\u2019s<\/span>\u00a0clear 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\u00a0<\/span>contain<\/span>\u00a0AI in a safer and standardized manner. Check out a blog Jama Software authored around machine learning in\u00a0<\/span>SaMD<\/span>\u00a0and shifting regulations\u00a0<\/span>here<\/span><\/a>.<\/span>\u00a0<\/span><\/p>\n

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.\u00a0<\/span>\u00a0<\/span>\u00a0<\/span><\/p>\n

Ryan<\/span><\/b>\u00a0Moore<\/span><\/b>, Jama Software<\/span><\/b>:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

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<\/span>\u00a0<\/span><\/p>\n

Carleda<\/span><\/b>\u00a0Wade<\/span><\/b>, Jama Software<\/span><\/b>:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

With an uptick in AI and\u00a0<\/span>SaMD<\/span>\u00a0I expect the FDA and foreign regulatory bodies to begin providing more clarity on how these complex systems and\u00a0<\/span>software<\/span>\u00a0<\/span>n<\/span>eeds<\/span>\u00a0to be developed, validated<\/span>,<\/span>\u00a0and maintained.\u00a0<\/span>\u00a0<\/span><\/p>\n

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RELATED POST:<\/strong> EU MDR What You Need to Know<\/span><\/b><\/span><\/a><\/span><\/h4>\n
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Q:\u00a0What changing regulatory guidelines do you\u00a0anticipate\u00a0having an impact on companies in 2022?<\/span><\/i>\u00a0<\/span><\/h6>\n

Thierry Marchal, Ansys:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

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\u00a0of in silico methods\u00a0by sponsors\u00a0remains\u00a0limited. New results will be published in\u00a02022\u00a0further encouraging companies to confidently follow this process.<\/span>\u00a0<\/span><\/p>\n

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\u00a0validate\u00a0a 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.<\/span>\u00a0<\/span><\/p>\n

In the rest of the world, we observe a growing\u00a0interest for\u00a0in\u00a0silico methods\u00a0and 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.<\/span>\u00a0<\/span><\/p>\n

Q:\u00a0What sorts of process adjustments do you think\u00a0medical device\u00a0development teams will need to make to be successful in 2022?<\/span><\/i>\u00a0<\/span>\u00a0<\/span><\/h6>\n

Steven<\/span><\/b>\u00a0Meadows, Jama Software<\/span><\/b>:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

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\u00a0<\/span>CAPAs<\/span>, negative patient outcomes and even have a greater chance of being recalled. Development teams should ensure quality is prioritized from the get-go.\u00a0<\/span>\u00a0<\/span><\/p>\n

Although we have noticed a large shift with software teams adopting an\u00a0Agile approach\u00a0when it comes to development, we\u00a0can\u2019t\u00a0emphasize enough the importance of adopting a lean and iterative approach.<\/span>\u00a0<\/span>\u00a0<\/span><\/p>\n

Ryan\u00a0Moore, Jama Software:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

Continue to follow standardized process with focus on aligning with FDA \/ compliance in parallel with building safe products<\/span>\u00a0<\/span><\/p>\n

Carleda\u00a0Wade, Jama Software:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

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<\/span>,<\/span>\u00a0many 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.\u00a0\u00a0<\/span>\u00a0<\/span>\u00a0<\/span><\/p>\n

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RELATED POST:<\/strong> Realigning Engineering Teams for Remote Work with Minimal Disruption<\/a><\/span><\/span><\/h4>\n
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Q:\u00a0From an engineering toolset perspective, what are some of the processes you\u00a0believe\u00a0forward-thinking firms will be working to\u00a0leverage\u00a0or incorporate into their process and why?<\/span><\/i>\u00a0<\/span><\/h6>\n

Theirry Marchal, Ansys:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

As we see the healthcare community adopting in silico method with more enthusiasm both for design and regulatory approval (not\u00a0mentioning\u00a0emerging clinical applications), the software community is rushing to deliver the supporting in silico tools. We could mention\u00a0three\u00a0major avenues followed by Ansys.<\/span>\u00a0<\/span><\/p>\n

As in silico clinical trials requires\u00a0a large number of\u00a0simulations, specific Simulation Process and Data Management (SPDM) tools structuring the digital evidence following the ASME VVUQ40 standard will\u00a0greatly\u00a0facilitate\u00a0the adoption of this approach. Ansys is customizing its Minerva tool in a Minerva VVUQ 40 template for medical\u00a0device\u00a0and pharmaceutical companies.<\/span>\u00a0<\/span><\/p>\n

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<\/span>,<\/span>\u00a0and the brain are extremely complex to model and\u00a0validate:\u00a0this requires a collaboration of various actors. Ansys is\u00a0closely working\u00a0with leading academics, global healthcare companies\u00a0and startups, and clinicians to continuously update and\u00a0validate\u00a0virtual hearts, lungs<\/span>,<\/span>\u00a0and brains in collaboration with a large ecosystem.<\/span>\u00a0<\/span><\/p>\n

Although everybody recognizes the potential of digital twin and Personal Digital Avatar, the necessity of developing\u00a0quasi-instantaneous\u00a0modeling capabilities despite the complexity of the model is\u00a0a 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\u00a0initiate\u00a0the first steps towards Personal Digital Avatars.<\/span>\u00a0<\/span><\/p>\n

Ivan Ma,\u00a0Medical Device Program\u00a0Lead:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

Engineers need\u00a0tools 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\u00a0on paper<\/span>, the production of that design can pass through many hands before it is made into a real part<\/span>, thus decreasing the probability of a successful build<\/span>. \u00a0<\/span>\u00a0\u00a0<\/span>\u00a0<\/span><\/p>\n

Q:\u00a0What do you think will be some of the differentiators between a company surviving to see 2030, and those that do not?<\/span><\/i>\u00a0<\/span><\/h6>\n

Steven Meadows<\/span><\/b>, Jama Software<\/span><\/b>:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

Along the lines of what I mentioned companies should focus on in 2022 to be successful, medical device companies that embrace a\u00a0<\/span>proactive approach to quality<\/span>\u00a0<\/span>(Link here –\u00a0<\/span>https:\/\/www.jamasoftware.com\/blog\/three-ways-to-proactively-vs-reactively-incorporate-design-controls-in-medical-device-product-development\/<\/span>\u00a0)<\/span>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\u00a0<\/span>Jama Connect<\/span><\/a>\u00a0will have the upper hand in reducing risk and complying with various standards and regulations.<\/span>\u00a0<\/span><\/p>\n

New cutting-edge technologies in the medical field\u00a0\u2013\u00a0like robotics nanotechnology, AI, and wearable health tech devices\u00a0\u2013\u00a0bring 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.<\/span>\u00a0<\/span><\/p>\n

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RELATED POST:<\/strong> Improving Quality Processes for Medical Device Development<\/a><\/span><\/span><\/h4>\n
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Ryan\u00a0Moore, Jama Software:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

Defined process, building quality products that meet a specific market need<\/span>\u00a0<\/span><\/p>\n

Carleda\u00a0Wade, Jama Software:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

Truly understanding\u00a0the market needs and being willing to\u00a0allocate\u00a0resources 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 \u201cme too\u201d devices will struggle to gain market share, and even if they are able to survive it will be difficult for them to thrive.\u00a0<\/span>\u00a0<\/span><\/p>\n

Q:\u00a0Where do you see Jama Software fitting in as the product development landscape evolves, and what can our customers expect as 2022 approaches?<\/span><\/i>\u00a0<\/span><\/h6>\n

Steven Meadows, Jama Software:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

Jama Software\u00a0provides\u00a0incredible value for hundreds of medical device companies ranging from start-ups to\u00a0established\u00a0corporations. With COVID-19,\u00a0we\u2019ve\u00a0seen an uptick in customers looking for an easy-to-use product development tool that offers differentiating collaborative capabilities to keep people connected throughout\u00a0different design\u00a0stages. Jama Software continues to invest heavily in the application, and we will see improved core product capabilities as well as integrations, strengthening the tool\u2019s ability to seamlessly work alongside other systems.<\/span>\u00a0<\/span><\/p>\n

Ryan\u00a0Moore, Jama Software:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

Jama\u00a0Connect\u00a0can be used as the core toolset for requirements, testing, and review\/approvals. Jama\u00a0Software\u2019s\u00a0ability 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\u00a0Connect.\u00a0<\/span>\u00a0<\/span><\/p>\n

Carleda\u00a0Wade, Jama Software:\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

I can see Jama\u00a0Software\u00a0bringing value to not only the\u00a0start-up\u00a0but the established company in the future. As a medical device\u00a0company,\u00a0the 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\u00a0Connect\u00a0will ensure that as products are developed that all the\u00a0bases\u00a0are covered. Later, when it is time for regulatory\u00a0approval\u00a0having a tool like Jama\u00a0Connect\u00a0in place will make the regulatory submission process very simple.\u00a0<\/span>\u00a0<\/span><\/p>\n

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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<\/span><\/b><\/a>.\u00a0<\/span><\/p>\n

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