Medical device development with its regulatory requirements is often viewed unsuited for Agile methods. There does seem to be a natural tension between commonplace Agile practices and regulatory compliance requirements in MedTech. However, these challenges can be overcome, unlocking Agile’s potential to bring important benefits to the development of medical devices. This webinar highlights key…
Roche is adapting codeBeamer ALM for its Application Lifecycle Management processes including requirements, test, risk, and defect management. Mirko Klingauf, a Systems Engineer at Roche Diagnostics in Switzerland, is tasked with the implementation. In this webinar, Mirko talks about the implementation of ISO 14971:2019 – Application of Risk Management for Medical Devices in codeBeamer ALM…
Unifying the numerous complex stages of product development is a vital challenge for innovators of medical technology. An integrated approach to MedTech product delivery is the key to navigating traceability, risk management, and quality control in a way that supports regulatory compliance and high product quality. Watch this Experts Talk webinar recording from 27 Nov…
Developers of medical devices and other medical technology are in a difficult spot. Not only are they operating at the cutting edge of technology innovation, an inherently risky business. But they must also meet regulatory compliance requirements of various local or international standards. To top it off, they have juggle those aspects while outpacing competitors…
Watch this on-demand recording of Intland Software’s Roundtable Discussion on 26 Sep 2018 featuring experts representing innovative medical device companies. Titled Agile in Medical Technology, this discussion covers the challenges and benefits of applying Agile practices in the development of cutting-edge medical technology. The discussion is moderated by Kelly Weyrauch of Agile Quality Systems. Agile software…
As new technologies are expected to bring disruptive change to many industries, 2018 is set to be an exciting year in both automotive and medical innovation. In this webinar, we’ll analyze continued trends in automotive and medical development, and how technologies such as Big Data, Artificial Intelligence, and blockchain are expected to impact these industries…
Intland Software hosted its first-ever conference for medical device and pharma product developers on 27 September 2017. Professionals gathered in Stuttgart to exchange ideas and to discuss medical and pharmaceutical technology challenges and solutions in an increasingly digital, value-based healthcare market. In the footsteps of our user conference earlier this year (which featured talks by…
This on-demand webinar recording is part of Intland Software’s Agile Training Course conducted through the summer of 2017. To access all four recordings of this session, sign up for the course! For years, Agile was considered an inadequate method for safety-critical development where a structured, organized, and fully documented lifecycle is necessary for compliance. The promised advantages…
The increasingly rigorous requirements of safety-critical regulations pose a challenge to companies developing products for the automotive, medical device, railway, nuclear, financial, pharmaceutical etc. industries worldwide. Achieving compliance with a single standard can be difficult enough. But in the case of special products such as Fritz Stephan’s mobile emergency care units, several standards of multiple…
With integrated, value-based healthcare moving health awareness and care “upstream” to prevent hospital care, medical devices are becoming more and more integrated in the lives of patients. That is, in our everyday lives, since digital healthcare technology is used even before (and specifically to prevent that) we become patients. The group of products regulated by…
With increasing market pressure to develop complex, high quality medical products as fast as possible, compliance with medical devices regulations and standards is becoming more and more of a challenge. Medical device developers worldwide are facing the problem of maintaining and enhancing product safety, reliability, and compliance with standards such as IEC 62304 (lifecycle processes)…
When prompted with the question “What are the biggest challenges you are facing?”, 66% of senior management respondents to Emergo’s 2016 medical industry survey answered that changing regulatory requirements are affecting their companies the most. Somewhat related, the challenges of developing new products came in second with 45%. The importance of adhering to standards in…
The rapid advancement of innovative technology today is propelling fundamental changes in several, if not all, industries. Due to the speed of current breakthroughs, this process is now widely referred to as the Fourth Industrial Revolution. As one of the world’s largest industries, the healthcare sector is greatly affected by this technology-driven transformation that is…
Due to traceability and compliance issues, managing complex medical device development projects is a challenge. In this on-demand webinar recording, adesso and Intland Software experts provide insights into efficient project management practice.Watch this webinar recording, prepared in collaboration with expert IT service provider adesso, to learn how to avoid traps and pitfalls, and how to…
There is hardly any aspect of our lives that disruptive and transformative technology is not affecting. Home automation, self-driving cars, IoT-connected kitchen appliances, smart bikes and similar products have gone from breaking news to being around us wherever we go. As humans increasingly accept technology as a part of their everyday lives, “digital healthcare” (the…
A recent quarterly report by Stericycle ExpertSOLUTIONS about Q2 2016 shows a rapid increase in product recalls in a variety of markets. Recalls can be associated with a growing number of reported consumer injuries in the first two quarters of 2016, already surpassing the total number of reported injuries in 2015. Recalls have impacted all…
Since 2011, medical devices have become increasingly sophisticated, and as the level of sophistication has increased, so has the time needed by the FDA to assess complex 510(k) medical device submissions (the majority of which are class 2 devices). Most recently in 2015, the typical FDA approval process had grown to between 9-12 months. In…
Intland Software’s recently published case study with Medtronic investigates how the world’s leading medical technology company was able to overcome their most pressing challenges using our integrated Application Lifecycle Management platform, codeBeamer ALM. While an interesting story, it primarily sheds light on the technical details of how this medical tech giant was able to make this…
Development teams working on safety-critical end products (such as automotive embedded products, airborne flight equipment, railway equipment, and so on) really understand the importance of quality. One small fault in the product could cause catastrophic events, and in the case of major issues, the costs of the resulting recalls could affect the profitability of the…
Innovation in the Medical Device Development industry is hampered by complex standards and regulations and once the medical device prototype is developed and tested, it then faces a long approval process. Traceability is essential for ensuring compliance with medical device standards and regulations but this often overshadows its most important function as an enabler for…
The medical device manufacturing industry is among the world’s fastest growing industry sectors. According to research, the majority of companies operating in this market are optimistic about the future of the industry in 2016. And for good reason: the medical electronics and healthcare IT market hit the $100 billion mark by the end of 2015, and…
The reliance on embedded software is increasing as medical devices are achieving higher and higher levels of sophistication. Despite widespread discussions of the benefits that adopting Agile could bring to software development companies, some medical device developers still hesitate to make the transition from Waterfall to Agile. While the advantages of Agile seem obvious, developers are…
A lot of companies working in industries that are highly regulated by standards and guidelines (safety-critical industries, such as the medical, automotive and aviation sectors) still rely on the Waterfall/V-model development method when creating software for their end products. While this doesn’t allow them to take advantage of more modern Agile methods, they choose to…
Building software to be used in safety-critical environments (for example, software embedded in medical devices, automotive or aviation systems, railway software, etc) is different to “ordinary” software development. As human lives may be dependent on these systems, it is imperative that they operate reliably, without the risk of malfunction, over extended periods of time, under…
Most companies that choose to replace their set of single-point tools with an integrated ALM solution do so because they are facing certain well-defined problems. Common issues are the lack of process transparency, burdensome methods to ensure traceability, and difficult collaboration between teams and team members. Like many other companies, DATATRAK found a way to…
Software is increasingly used in all kinds of physical devices to expand the functionality of (or even completely replace) hardware components. This has been a trend in recent years across various industries, and is also the case with medical devices. Software enables the sophistication of even relatively simple devices such as insulin pumps, bringing new…
Risk management is especially important for safety critical industries such as healthcare (with the design and manufacturing of medical devices), aviation & aircrafts, transportation, as well as the automotive industry due to the risks associated with the design of cars. Increasing complexity of such safety critical products increases risk for manufacturers as serious injuries or death could…
