Modern healthcare has witnessed a proliferation of software as a medical device and software in medical devices. They have become a vital part of healthcare and have touched every area of diagnosis and treatment. Software is driving incredible advancements in medical technology right from devices, standalone applications, mobile apps and web apps. Medical software enables a device to interact with the human body and measure blood sugar levels, monitor heart rate and dispense medication. Such functionalities help to make quick and accurate diagnosis.
Medical devices previously wired to main applications are today capable of communicating wirelessly by Bluetooth or over the internet. They can exchange data with computers, tablets, smart phones and other medical devices either in real time or asynchronously.
Medical device software development has taken on a very important role with the increasing complexity and connectivity of medical devices. It is also a fact that software has been the leading cause of device failures and recalls. A medical device must be one that, fulfils its intended purpose and most importantly is safe and meets all regulatory compliance.
New regulations seek to increase medical device safety and effectiveness particularly with regard to software. The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. The software development process includes
Quality management and risk management are necessary for safe medical device software. Risk Management of software analyses changes to medical device software with respect to safety.
Risk management is the systematic approach to recognize, analyze, assess, control and monitor these product risks. ISO 14971 describes such risk management approach for medical devices and is broadly accepted as fundamental standard for medical device development.
Software Development Lifecycle (SDLC) tools facilitate the development process and also seamlessly provide compliance. However, regulations require that support and troubleshooting continue throughout the life of the software in use. Application Lifecycle Management (ALM) on the other hand continues to help you support and resolve issues you encounter with your software even after it is out of development.
An ALM gives you all the facilities you need in one integrated software solution enabling multiple teams to work on the product without the risk of negatively impacting other work. ALM allows you to work more efficiently and makes communication and collaboration much easier to achieve. It includes the following features:
Requirement and traceability management: Identify the client’s demand and build devices based on it. Clients can adapt to the changes instantly and keep full traceability to other engineering artefacts in case of any change made to a requirement.
Design and development: System engineers and software developers can easily communicate and collaborate and enable them to prototype, simulate and execute product designs for early validation.
Change management: Track and effectively manage the change requests from various sources and ensure that the change is analysed, reviewed, and confirmed before approval for implementation.
Testing and quality management: Testing is the process of product verification and validation while Quality management help decision-makers and team to ensure effective communication for test planning, test construction and execution, workflow control, tracking and metrics reporting throughout the development cycle. This helps the manufacturers to report and fix errors easily.
ALM solutions for medical devices allows you to simplify, streamline and automate development processes which reduce costs, saves time, and increase the product quality while keeping compliance with regulatory standards. This ensures the development of software faster by bringing in agility and scalability in delivery processes.
MicroGenesis with over 20+ years of ALM experience combined with its ISO 13485 certification has been providing complete medical software development services to its customers to meet regulatory compliance.
The onset of complexities in the application lifecycle and the eagerness to bring new products faster into the market calls for constant innovation that abides by the stringent regulatory compliance. This growing complexity paved the way for multiple tools and software solutions to manage the increasing complexity of application lifecycle. To stay ahead in the market organisations keep upgrading their development tools in search of the software ecosystem that best fit their purpose. As a result, the various roles, areas or department of application development start using their own tools, creating functional silos. These isolated tools fail to provide any synchronisation of data from one tool with the other and lack effective integration mechanism in their tool setup.
Managing increasing complexity and harmonizing the work of various department calls for the integration of these tools. Point-to-point integration of separate models is not enough to breakdown functional silos. Integrated ALM solutions allow organisations to collaborate, streamline and automate product development processes, reduce time and cost and increase product quality while maintaining compliance with quality standards. Application Lifecycle Management (ALM) offers the capacity to integrate, coordinate and manage all the different phases of an application development process encompassing requirement management, project management, software design and development, Quality Assurance & Testing Services, configuration management and much more.
What are the benefits of Integrated Application Lifecycle Management?
Gain a better understanding
Keeping track of the day to day activities of an application development project is a big trouble. All stakeholders including Tester, Developer, Project Manager work in a secluded manner using different tools and limited knowledge about the application development status.
To have real-time visibility into project status and progress, it is pertinent for all the stakeholders to stay connected. Integrated ALM tools unlock the hidden data and enable all the project stakeholders to get real-time updates on project reports and development through an integrated web-based unified platform thus helping them do their job much efficiently.
Effective collaboration among stakeholders
The organisation needs to form an effective collaboration between various functional teams including project manager, testers, developer by integrating numerous development tools and processes that best fit their requirements. Integrated ALM tools ensure that all stakeholders are aligned and connected through an integrated dashboard that enables real-time tracking among teams about project development and the task assigned to the teams.
Increase productivity and faster time to deliver
An integrated ALM tool brings in several opportunities to increase the productivity of all stakeholders and teams involved in several ways.
Manage changes effectively
Managing all stakeholders with the latest change in application lifecycle development and ensuring smooth application of these changes in a big challenge for organisations. Use of different tools among any discipline could lead to wasted efforts, delivery defects and lot more. The organisation needs a connected set of lifecycle tools to ensure the development teams can capture, manage and track the status of proposed changes in various phases of the lifecycle.
Successful management of Risk
Managing and tracking issues and fixing bugs that emerge during the application lifecycle is a critical task. Holistic ALM tools help teams to track and manage risks in parallel during the development of the application lifecycle. Integrated ALM tool also helps to identify, capture, analyse and mitigate risk early in the project lifecycle to ensure better quality in the production environment.
Integrating ALM tools improve the quality of a software product by reducing the number of errors caused by communication gap among stakeholders, inconsistencies between requirements, enabling robust testing, and identifying the gap between needs and expectations of users. Integration ensures that the quality of the work is validated at every state and defects are identified at the early stages of the process. Integration also ensures that the code quality and performance throughout the lifecycle processes is up to the mark.
End-to-End lifecycle traceability
Integrated ALM traces the relationship between all components to facilitate alignment with changes at any stage of the application lifecycle. Its flexible reporting features also provide traceability in a different way to fulfil the needs of different roles. It also drives collaboration between different stakeholders and forms the base of regulatory compliance.
Real-time insights in quality and development
The integrated dashboard gives a 360-degree overview of the project, productivity and quality delivering actionable insights. It ensures every team member knows about any of the changes are made during the development process and there is no last-minute surprise causing delivery delays or project failure. The information is delivered at a granular level, from coding and testing to risk management and aligning to requirements. These insights help in decision making and managing resources efficiently.
Integration – The future of ALM
In this highly competitive environment, improving the effectiveness of an organisation and speeding product launch cycle is critical to success. Businesses are increasingly looking to scale up in the market and make the most out of their investment. To increase the return on investment, the processes and tools for managing the application lifecycle need integration. Integrated ALM tool brings the best of the existing product lifecycle and integrates them into a strong process to improve the efficiency and effectiveness of the businesses.
MicroGenesis is a leading solutions provider of holistic Application Lifecycle Management (ALM) with over 20+ years of experience in handling various ALM applications. We are partnered with leading ALM based OEM’s to deliver the best ALM solutions to our customers. Our team with its expertise and knowledge has served multiple clients across various geographies and culture and has helped them scale-up in the market.
What is Digital Workforce?
The phrase “digital workforce” has been coined recently to describe an array of robotic and automated solutions for driving productivity & efficiencies in the workplace. Mostly, the digital workforce is not a physical embodiment of a digital worker but a virtual robot (software) that will function in the background. For enterprises, the introduction of Robotic Process Automation (RPA) has resulted in substantial reduction of headcount in highly manual and cost-intensive processes.
Traditionally, we’re more accustomed to hardware robots like the ones seen in a typical automotive manufacturer than software robots.Thus, it was sort of a challenge for people to understand why digital workers were being introduced and how this digital workforce would impact and what they do on a day to day basis. Hence the move was initially met with a lot of apprehension and dismay by many stakeholders. However after witnessing how the new age Digital Workers helped the employees relieve themselves of the mundane and repetitive tasks thereby giving them room to take on more challenging and innovative tasks the adoption has almost tripled since 2017. The icing on the cake was that this adoption helped improve execution time, reduce failures at optimised costs.
Each digital worker can manage one or more process or task. It can also be trained to prioritise selected tasks, handle exceptions and ‘learn by doing’. Digital workers can be configured to run from a central server or even be tagged to an individual user wherein the it runs on the user PC and they work hand in hand to accomplish the task.
Why Robotic Process Automation?
The value addition for Robotic Process Automation (RPA) is derived majorly from rule based processes that are labor intensive, standardized and with structured data. Processes that can be well-defined, involving repetitive tasks in very large volumes, like back office work, data entry, and certain help desk tasks which feed information across different systems.
These software robots can also help postpone an organization’s investment in upgrading legacy internal IT infrastructure. RPA technology can be implemented within an environment without any change in the existing systems thereby avoiding the high costs and operational impacts related to upgradation of legacy systems and / or outdated IT infrastructure. RPA functions as a person would, creating a communication bridge between IT systems operating separately.
How will it affect the current workforce?
McKinsey & Company suggested that “currently demonstrated technologies could automate 45 percent of the activities people are paid to perform and that about 60 percent of all occupations could see 30 percent or more of their constituent activities automated.”
Based on the above statistics; It is predicted that in the next 10 years RPA will replace specific tasks that an employee does than his/her actual position. Despite the impact RPA can have, human intervention may still be needed to take certain tasks to completion. Certain traits unique to humans such as problem solving, creativity, and human interaction is not yet what a robot can automate.
RPA still needs human intervention to be successfully implemented because humans can determine processes suitable for automation and monitor the performance of the robots. The technology isn’t advanced enough to operate without human intervention nor can it reproduce the higher-level thinking and actions that humans are capable of. Essentially, anxiety about RPA replacing the need for a human workforce is irrelevant.
What does the future look like?
With the advent and rise of automation technology, other transformative technologies such as natural language processing, machine and cognitive learning are also on the rise. As a result of automation a good number of employees will be liberated to pursue more creative and innovative work, which will lead to a better customer experience as part of delivering a business service through an end-to-end process. Analysts are hailing 2020 as the “breakout year” for technology adoption by a majority of large and medium scale enterprises – mostly RPA with integrating other intelligent automation technology.
Justin Watson, global robotic and intelligent automation leader at Deloitte, said: “2020 looks to be a breakout year for intelligent automation, as organisations combine robotic process automation with artificial intelligence and other technologies to enable new ways of working. By doing so, automations go beyond the routine to the innovative, from collecting and processing data to predicting, analysing and making contextual decisions.”
The Deloitte report estimates intelligent automation will provide an average cost reduction of 22% and an increase in revenue of 11% over the next three years. However, those organisations currently scaling intelligent automation say they have already achieved a 27% reduction in costs on average from their implementations to date.
The Next step for your organisation!
By the end of the next decade there will be 4 million robots executing mundane office tasks. RPA delivers competitive edge with superior automated process frameworks, scalability, resilience and flexibility. After witnessing the scalability of RPA in digital workforce, it is only obvious that the clear way forward should be to adopt RPA as an integral part of your workforce.
Realize high return on investments with MicroGenesis with:
- 100% Accuracy: Robots are error free and their super accuracy translates to seamless and rich customer experiences, perfect workflows and zero human intervention
- Total Compliance: Improves compliance with end-to-end automation and meets risk management and regulatory needs
- 80% Cost Savings: Realize cost efficiencies of over 80% since robots can take over processes within short time frames
- Amplified Efficiencies: Free up human resource for strategic and creative tasks to earn value dividends. Productivity scores increase as high as 80% with lower processing costs, faster time-to-market and focus on innovation
MicroGenesis provides higher cost efficiencies, improved compliance and seamless deliveries with a suite of solutions built to fuel your organisation towards a brighter future.
- Resilient Proven technology: Highly integrable, robust technologies that spans from desktop & workflow automation to AI, NLP and machine learning to manage cognitive actions.
- Incremental automation: Seamless RPA engagement by identifying repeatable actions and moving up the scale to deep learning for intelligent actions
- Easy Implementations: RPA can be easily be integrated to existing systems and processes with minimum intrusion and disruption of normal business operations.
- Process & function agnostic: RPA can be then applied to perfection for any organizational function across all verticals.
- Low maintenance: Once integrated, RPA incurs minimal maintenance expenses. Low upfront investment makes ensures maximized returns for RPA.
- Business let enterprise IT: RPA focuses on perfecting business workflows with clear process audit and workflow charting to implement automation