MicroGenesis Tech Soft Pvt Ltd

Financial services companies are under tremendous pressure to restructure their teams and procedures in order to respond to accelerating business conditions and to release quicker applications and services. Faster release times require the developers, QA analysts and performance engineers to work continuously. In addition, across various programmes, they fail to provide access and insight into the work of distributed teams.

Throughout the process of Application development lifecycle, deployment of code and data manually is a costly and time-consuming process. It is also subjected to errors. As per recent analysis, 50% of the distribution initiative was made up to pushing code through implementation environments to Quality assurance, then pre-production before going live. Managing the interconnected infrastructure of virtual, physical and cloud environment is a monotonous process and requires hard-work. But by bringing Application Lifecycle Management (ALM) and Agile together and with the help of the appropriate tools designing and development of software has become much convenient and efficient.

With the help of a robust Agile Application Lifecycle Management solutions (ALM Solutions) , financial firms can avail benefits that will increase efficiency of the team, help in minimising the costs and time to market and increase the return on investment (ROI). Further, Agile ALM provides an instant access to the information the teams and stakeholders need anytime and at any point of time. Further, they gain real-time visibility and engagement in the process lifecycle which ensures that the customer and business agenda are meet. It also ensures that the team is aligned and working in close coordination with each other.

Agile ALM software offers 'continuous delivery' strategy that protects the software assets, and benefits the team from increased reuse, greater requirement management, end-to-end traceability, hassle-free coding and improved test performance. Agile ALM also free enterprises from the systems and instruments with heavy weight that keep them from producing usable and improved applications. Improved software enables a new way to engage and improve customer loyalty while being able to constantly evolve as per the customer feedback and company strategies. For the same rate, clients can streamline software releases, speed up rollout and improve the time of delivery as the same price.

Organisations trying to develop Agile ALM would first need to make their tea, familiar with Agile Methodologies and then hunt for the best tool. The process selecting the right tool must be in alignment with the Requirements and objective of the organisation. It is also easier to decide which specifications are already incorporated in which artefacts and which flaws can be tracked down to individual artefacts with appropriate and reliable tooling. Therefore, all agile activities should be natively assisted by proper ALM tools and should strive toward team-based usability and coordination. An appropriate Agile ALM tool establishes effective communication among all the channels and have integrate the complete lifecycle from requirements, testing, defects, planning, resources to development and deployment into a single source of truth to support any QA and DevOps initiatives.

An enterprise can implement Application Lifecycle Management software into the Agile Framework with the help of appropriate tools. It can also be used for all sorts of process models and methodologies, such as waterfall or spiral models, even conventional ones. Agile ALM promotes creativity and companies achieve strategic advantage, reducing costs and improving organisational performance by transforming their systems.

With the growing competition within the market, customers expect quicker software system releases. Enterprises are expected to deliver software system quicker at reduced prices. With the correct tools like Application Lifecycle Management software one will fulfil these expectations. Agile ALM is a vital tool to unleash the efficiencies within the enterprises.  

Right ALM tools will facilitate the business reduced value and increase the team's potency. Agile ALM allows continuous delivery and enterprise gracefulness.  

What is Application Lifecycle Management (ALM)?

Application Lifecycle Management (ALM) provides innovative techniques associated procedures to regulate and handle the dynamics of an application lifecycle. ALM tools are all-in-one resources that span the whole history of a product lifecycle, from the abstract stage to designing, review and stimulus of specifications, specification, execution, monitoring, rollout and withdrawal, and every one different intermediate product-related processes.

What is the use of ALM tools?

Below mentioned are the capabilities of Application Lifecycle Management Software

·   Enables teams to coordinate efficiently among stakeholders

·   Requirement management

·   Quality assurance and testing

·   Compliance to internal and external process and regulations

·   End to end traceability

·   Release and deployment management

What are the benefits of ALM in a business or enterprise?

ALM solutions facilitate organisations to drive their time to promote with reduced build and preparation time and improved productivity. different edges of Application Lifecycle Management include:  

· Transparency: Application Lifecycle Management offers a lot of exposure for the corporate. This in essence, provides them bigger management over every purpose of the lifecycle of the programme. It synchronises people, systems, instruments and procedures for the assembly and support of repeatable and sure applications.

· Improves efficiency: ALM helps the corporate to develop, communicate and apply best practises in software system development. The groups WHO work on associate application can communicate a lot of. information and criteria flowed swimmingly through the cluster. This decreases the time and energy needed for growth. Work is coordinated and progress accelerated with ALM in situ. ALM removes bugs and issues that hampered the assembly of early applications.  

What are the best ALM tools available for enterprises?

1. Best of breed ALM tools

2. Integrated ALM solutions

How connecting Agile with ALM is beneficial?

Agile may be a game-changer for planning new enterprise applications. Agile suggests shorter, unvarying intervals for jobs. Any loop builds on previous app versions and finishes with a finished product. End-users at the tip of the amount can check the finished product. To incessantly develop the merchandise, the team can use the feedback.

The advantage of Agile ALM

· As requirements change through every stage of application development, teams will adapt higher and requirement management becomes better.

· Improves the team's potency  

· Offers flexibility and autonomy for developers

Unleash continuous delivery with Agile ALM tools  

Continuous integration, delivery and preparation during a explicit product improves customers trust and deliver price for purchasers. Agile and Agile ALM tools support these processes that facilitate organisation deliver higher merchandise within the market. however just in case of continuous delivery, ancient ALM cannot fulfil the strain of enterprises. ALM has to incorporate the agile methodology.

What varieties of Agile ALM Tools are employed by enterprises?

1. Web and Cloud based mostly Agile Tools

2. Collaboration and Agile Tools

3. Automation and Continuous delivery  

With the growing competition within the market, Agile ALM has become a vital component for contemporary software system delivery. They encourage resilience and continuous execution for firms. As a result, developers can focus on manufacturing high-quality merchandise with efficiency. Customers are higher at obtaining their active new merchandise. mechanically, shoppers get reviews. Through every new work cycle, feedback will with efficiency and effectively be enforced into the merchandise. With every new update, firms will fix issues and add a lot of price. this can be the profit that the new company is aiming for and shoppers predict.

Healthcare industry has seen numerous innovations with the onset of digitisation in the industry. This has helped to integrate individuals more easily with the new embedding software for medical devices that offer improved healthcare services. Medical devices are important for healthcare industry as they provide a positive effect on human life by delivering vital knowledge and insights gained by their use.

Due to numerous developments in healthcare, medical device system applications tend to get more complicated. There are many significant and regulatory factors that influence the software efficiency of the medical device, such as regulatory delays and the implementation of international standards.

Medical device software has to undergo several regulatory bodies and follow compliances and standardizations. Moreover, they also have to live up the expectations of the manufacturers. Therefore, it is extremely crucial for medical device testing to have policy in place is critical for medical devices. The policy consists of ensuring enforcement protocols and a scheduled approach to software testing to provide efficiency for the device.

Hence, for rigorous verification and validation of devices, medical device manufacturer should follow quality assurance (QA). It ensures that these medical devices are supplied with the standard quality and reliability.

Below mentioned are some important roles played by Quality assurance in Medical Devices.

1.Ensures testing in compliance with different laws such as HIPAA, PCI DSS, FDA, etc.

2.Ensures the CRMs, patient smartphone applications, tools for medical devices, and management systems for patient databases run smoothly in diverse scenarios.

3. Integration of medical devices guarantees adequate compatibility to other applications.

4.Helps in improving the utility of medical devices.

5.The consistency and efficacy of different medical instruments was assured by sufficient monitoring to deliver optimum patient treatment.

6.Checking end-to - end systems mitigates the chance of system failure.

Further to ensure successful testing of Software in Medical Devices (SiMD) and Software as a Medical devices (SaMD) effective testing strategies are implemented based on the sets of test requirements. These standards are based on different configurations of the materials, development procedures, and other important system and software functional specifications.

To maintain system reliability, different criteria have to be checked. For medical device software testing, there are different approaches. MicroGenesis team is a key player in achieving the goal of designing and executing testing across various testing types including:

1.System End to End:  We undertake wireless testing to test communication between devices and related wireless accessories. Testing the two-way data flow, interactions and functioning across the full stream of application software, devices, wired and wireless accessories.

2. Functional:  This testing is performed to test functionality of the application software, firmware, device and accessories, At the device and firmware level, this involves testing device interaction and control of processing parameters, error condition testing, range testing, verification of data logging.

3. Exploratory:  Exploratory tests are performed to test newly added features or functions based on the requirements.

4. Localization:  Through localization we provide application screenshots to support translations team, verification of text displayed in the application against translations provided, checking text clipping and cropping.

5. Smoke and Regression:  This testing checks critical functionalities prior to full-fledged release testing, testing functioning are added in prior releases features.

6. GUI verification: This testing is done to check the correctness of GUI appearance and changes to actions performed.

7. Safety and Performance: Test application performs a given action within specified time ranges and stops electrical stimulations within specified times when various stoppage conditions are initiated.

8. Installation: This testing is performed to test clean installation and upgrade to new releases and ability to revert old releases.

9. Firmware:  Under this testing of micro controller programming logic, code functioning, system test to verify device interaction during execution, sound processing device operation modes, volume, sensitivity, LED indicator behaviour, pairing and use with wireless accessories are done.

10. APIs: Testing of APIs are done to explore boundary conditions, generate sufficient parameter combinations to verify functionality and expose failures are done. We also verify API behaviour in relations to the external environment like Files, peripheral devices etc. Verification of API call sequence and check for expected results are also carried out during the testing process. During the testing, we also check if documentation is adequate and provides enough information to use the API.

Release management is a complex process that deals with major deployments in Application lifecycle management process. Its reach extends to hardware, applications, networks, code, cloud and anything that is broad and sophisticated enough to require a substantial amount of planning and support to successfully deliver it. How good you are at your release management skills depends not only on the release management process, but also on the success of the persons concerned, both initially and in the long run.

Release management is a high-impact method that deserves rock solid execution, so here some of the pro tips to ensure that release administrations are successful in Alm solutions.

1.Plan your release efficiently: The planning phase in an Alm process is the crucial and time-consuming phase from planning to retirement. A detailed release schedule would encourage the team to remain on track and ensure that requirement and specifications are properly followed.

There are several ways of handling a release plan. The Systems Development Life cycle (SDLC) in one of the most popular release management techniques.

With a high degree of reliability and consistency, the SDLC helps software engineers prepare, build, manage and replace software systems. The SDLC may be used by other project management processes in combination or in place. There are many approaches to handle a release schedule. The Systems Development Lifecycle is one of the most common release management techniques.

At this stage it is suggested to create workflow for both your team and key stakeholders, so they can follow it throughout the release. This workflow must include the overall structure of how the release is staged and what are the roles played by team member.

2. Releasing build: Once the release plan is decided, designing and building the product for release is finalized. Here the product is developed based on the requirements drafted in the release plan.

After fixing all the issues and bugs, it is time to prepare the product/software for the real-life testing. This could need many iterations. It is submitted to the testing environment for customer approval as the team builds the product. This helps the tea, to detect any glitches or difficulties in a real-world setting that can occur.

However, if the product is found to be faulty at this stage, it is sent back to stage two. This could be continued unless the release is finalised.

3. Testing for customer approval

Testing for customer approval or User Testing Approval (UAT) is when the end user of the product user gets to use the final product. It is either done online or shared with company employees.

It is considered one of the most important steps to release management as the user data collected during this testing could decide the final launch of the product.

4. Preparation for the final release

At this stage, final touches are given to the product from the date collected during the UAT. The release preparation is also reviewed by the QA team.

In this process, the QA conducts checks to ensure the build meets the acceptable standards and business requirements planned in the release plan.

Once everything goes well, the functional team plans for the final release for deployment upon approval from the application/software owner.

5. Deployment of release

This is the big day for any team when your final product will be released into the live production environment. but before sending the build for production, the deployment stage needs to educate and train about the application to the end user and the company.

MicroGenesis offers the best Application LifeCycle Management process to its clients in partnership with some well-known ALM partners. We possess experience across diverse domains such as Aerospace, Defence, Automobile, Manufacturing, Medical and IT .

Requirement management is characterised as a required phase for systems and product or software lifecycle projects to be completed. But, creating and handling requirements is a problem for IT, Systems and Project development. Organisations need to identify and fulfil customers' expectations while adhering to regulations and staying on track and under the budget.

A faulty articulated requirement could do more harm than good. Its adverse effect can lead to time-consuming rework, inadequate deliveries, and budget overruns. Much worse, a poorly implemented requirement can force a business out of compliance or even cause accident or impact lives.  

Be it a standalone or a part of the project management plan, requirement management tools elaborate on the types of requirement from different teams, artefacts etc. To strengthen the key organisational strategy, it is crucial to find a solution to improve the requirement management.  Below mentioned are the 5 key solutions to improve requirement management and achieve the desired results in termed of better-quality products at a reduced cost.

1.Structure your requirement management tool: Duplicate requirements can trigger twice the work to be carried out, leading to conflicts and confusion and increase maintenance cost. Requirements that are removed or deleted may lead to missing some functioning or cause deficiencies. Structuring your requirement can enhance understanding among teams and remove chances of duplication. Thus, structuring requirements is the first step to take control and improving quality in the ALM process.  

2. Visualise your requirements:  An ideal requirement management tool should be able to carry out image modelling that can help teams gain a better insight of the process flow and establish effective communication between the teams and multiple stakeholders. Apart from this, a requirement management tool should be able to procure timely reports, manage multiple dashboards, graphic tools, storyboards and other requirement management tools.  

3. End to end traceability and impact analysis: It is pertinent for an efficient requirement management tool to establish a connection between all the different requirement created by stakeholders. Here Requirement management tools prove to be helpful. A requirement management tool with the ability to analyse risks and trace requirement includes the ability to run tests that will help the team to ignore risks when any decision, timeline, people or requirements are changes during the tenure of the project.

4. Bridge the gap between business and development: In certain instances, the road to improve requirement management has fewer requirements. Projects always don't have the bandwidth to implement all customer requests, marketing campaigns and business ideas when they also have to keep in mind the budget constraints and task timeline. Rather than trying to manage every requirement, project and product managers must make the right decisions on the requirements that promise to bring out value to the business. This can be achieved by merging value and information from team leads and sketch the right combination of requirements.  

This relation between engineering requirements is established and maintained by Senior management, and company and consumer wishes will help ensure that Resources are successfully invested. , creation and execution may Match technical decisions with the policy of the organisation.

5. Collaboration between other tools: Effective communication of users should be established in a successful requirement management solution or tool. This requires the need to collect feedback, study, accept updates, approval and provide electronic signatures.

Conclusion

Software has become a critical component for medical devices whether the medical device manufacturers prefer to design a new product or trying to improve the functionality of an existing one. Technology for medical equipment continues to modify and extend across all kinds of medical instruments. A key focus of medical device manufacturers must be the safety of the patients.

There are several regulatory bodies who are working across the globe to continuously monitor and report on medical device related concerns. The Food and Drug Administration (FDA) calls off many medical devices due to the software design. Failure to achieve the software design control guidelines and develop enough medical device software testing procedures lead to software irregularity often needing an upgrade or suspension of the medical device. This is given utmost important because of the involvement of human lives and this can also hamper the company’s reputation.

Here, the initial step to avoid software irregularities or failure and FDA recall is to understand the important of verification and validation of a medical device software along with its design, development and usage. Verification and validation testing are important step for the development of medical devices. However, it is often ignored by the medical device manufacturers and the importance it adds to the production of medical devices is ignored.

Medical device software updates are common to upgrade through the changes and user requirement and to rectify the existing errors. When a slight improvement happens without completing the required degree of verification &validation (V&V) testing, even medical device software that has undergone v & v testing is vulnerable to failure. Therefore, when it comes to the software for medical devices (SaMD) and software in a medical devices (SiMD), minor changes can have harmful impact on the functional and clinical performance of the medical devices. Thus, dependency on software functionality and the regulatory need to ensure that the software works as desired by its manufacturers.

How different is verification from validation?

Both verification and validation differ from each other. A medical device manufacturer is checking to see if the medical device software follows product standards through the evaluation process. Throughout the life cycle of medical device software creation, testing may occur. Validation checks, on the other hand, ensure that all interface criteria and planned applications are fulfilled. Validation checks include, but are not limited to, accessibility, approval checking, and alignment of data with gold standards where available.

During the development process, Medical Device Software Testing is done by verifying the functionality of each software element (input, output, estimation, etc.) independently or jointly to ensure that it satisfies the specified requirement. In a clinical or patient-care environment, software evaluation is typically done by using the completed product to ensure that it performs as expected.

Technology for medical devices are continuously evolving. To remain competitive in the medical device industry, medical device manufactures must keep looking ways for innovation and maximize ways the success of Verification and Validation software. This will ensure timely delivery medical device software development projects.

ALM software is crucial as it covers all the essential functions such as automation, creation, new release publishing, documentation, facilitation, testing and implementation.

What exactly is Application Lifecycle Management?

ALM process are a form of facilitator that makes it easier to manage, coordinate and track the application lifecycle across different software and infrastructures explicitly designed to optimise the application. ALM's proper implementation strengthens connectivity, automates regulatory enforcement and accelerated operational advancement through productive methods of programme tracking.

1.  Requirement management and reviews

The specifications of ALM solutions are necessary to understand. The focus of most organisations today is to study the criteria of an optimal ALM Solution. It is an instrument that during the lifecycle can obtain, compute, monitor and control the specifications of an application. It has process-oriented approaches that can incur features such as monitoring, baselining, and intelligent reporting that can help project teams to communicate easily from the point of view of requirements.

Requirement Management tools may provide the documentation of each condition with a hierarchy dependent structure. It also offers different methods of estimation and sorting for requirement details. via a requirement management method, module configuration for feedback and stakeholder inputs can be created. Tracking day to day work and process-driven regulation of testing. Along with the configuration history archive, complete configuration implementation and their specifications can be handled.

2.  Project Management

ALM solution were never a part of project management software. Features offered for Application Lifecycle Management by a project management instrument are below.

· Planning: This allows you to handle the work of planning and implementation separated into phases and sub-phases with clearer workflows to execute.

· Scripting: Through project management tool, recording of each point, mission, product, version etc can be easily done.

· Collaboration: Collaboration can be accomplished by task assignments, internal correspondence, and an integrated database of diverse agencies, staff, and stakeholders.

· Evaluation: Most significantly, data that can be aligned with regulatory data and checked for compliance will be provided in the assessment of all deployed properties.

3. Management of modelling and architecture

Designing an application is not normally part of ALM, but it is very important to handle the development and simulation of the application architecture. Using UML profiles and software designed to conform with interface standards, most of the applications are designed. Packaging an application's properties and objects as Reusable Properties Standard (RAS) assets is a simple way to share assets with local or remote users. RAS repositories may be generated for this asset storage, holding all the properties to be traded.

Using a Modelling and Architecture Management Framework, the management of properties, databases, servers and UML profiles can be easily accomplished. These instruments also ensure that an application's software requirements are consistent with the process and that operational priorities are accomplished by successful tracking and monitoring.

4. Configuration and build management

App tools and source code are compiled by an application development framework. These are bundled into devices that can be checked, installed, signed, and distributed. A configuration management framework can help control and simplify the design process while allowing customizable custom design configurations to be represented by a developer.

Each build setup would be capable of specifying its own code and resources for all the versions using a similar logic. So, organisations rent coders who can use a configuration management platform to improve the configuration of the program. If a project from the command line is installed on a remote location or utilising either device, the compilation output would stay the same.

5.Testing & release management

The management of application testing and deployment can be improved with continuous integration and deployment. Via monitoring and release control devices, this approach can be done. Other functions, such as test automation and automated implementation, make these testing and release management tools essential for working on systems.

Another advantage of testing app version of software is that they keep the older versions up and running. This enhances user experience and productivity of the application without weakening the current status and application upgrade without hampering the current update.

Conclusion

Modern healthcare has seen development of software in medical technology as a software as a medical device (SaMD) and software in a medical device (SiMD). It has become a crucial part of healthcare and have entered both diagnostic and treatment areas. Technology drives enormous advances in medical technology from computers, stand-alone applications, mobile apps, and web apps.

Since software plays a significant role in the operation of medical device software development and medical device testing, the regulators of medical devices have become strict. Medical device regulators across geographies around the world need to have oversight over defective software and delegate responsibility in the event that any bugs are found in the system.

Countries around the world abide by various laws and regulations for automated testing of medical devices. India has already taken early steps to control the medical devices industry in this context. The Health and Family Welfare Ministry (MoHF&W) recently listed a special category for all medical devices. Both software for medical devices (SaMD) and software in a medical device)SiMD will come under this category with effect from 1st April 2020.

Medical device tech companies and manufacturers of wearable devices will from now on be governed under the MD rules. Manufacturers of medical devices would have to meet the licencing and registration laws and guidelines.

As per the Medical device's rules, medical device software developers and manufacturers can consider the sale and distribution of medical devices only after procuring a licence from the regional Food and Drug Administration (FDA).

With the increased degree of regulation, a key problem to be addressed is the point that any software developed for medical and wearable devices counts as 'software.' Unfortunately, the notice offers no clarification on this score; it only demands that the software be designed by its creator for particular diagnostic, preventive, monitoring, and treatment purposes. Consequently, any medical device software which fulfils the intended purpose of being used for the above reasons will qualify as a medical device.

Technology that is used in medical devices as well as mobile applications used to monitor critical parameters in real time will fall firmly within the existing regulatory structure. However, given the broad scope of the notice, applications which does not pose any medical hazards can also be protected under the MD law. This includes clinical communication and workflow applications, such as patient registration, arranging appointments and others.

The benefits of new-age technology such as artificial intelligence and machine learning in reducing operating costs and clinical efficiencies have already been acknowledged by healthcare regulators in other countries such as the US. Some areas which technology will affect include patient tracking, workplace automation and preventive care.

Application Lifecycle Management (ALM) tools in the process of completely managing the lifecycle of a software application intended to help in business management. ALM solutions are all-in-one tools that offer end-to-end application development covering the entire history of a product or software from idea to planning, requirements analysis and elicitation, design, development, testing, retirement and all other product-related processes in between.  

Top 7 benefits of Application Lifecycle Management

1. Helps businesses to prepare and organize

ALM Solutions enable stakeholders and team to start a project with an organized plan and assessment as per the requirements. ALM Software helps in managing complex projects through resource planning. There are specific tools available for different requirements which can be for traditional waterfall projects, or agile projects or both.

2. Improves employee satisfaction, efficiency and utilization

ALM solutions bring in numerous opportunities to boost the productivity of all stakeholders and teams involved in a project. ALM Solutions enables teams to follow the best practices and proven methodologies that increase productivity. A lot of time and efforts are saved as automation eliminate repetitive tasks. ALM tools also improve collaboration among teams that eliminated human error and delivery delays.

3. Enables real-time decision making

The best Application Lifecycle Management enables teams to make more informed decisions about their applications as they mature. ALM attributes like real-time planning and version control gives stakeholders an edge, they can map the future of an application quickly and decisively so that organisations can plan effectively whether they deploy traditional waterfalls or agile development projects. ALM is particularly important for informed decision-making when organisations implement interdependent projects that require complex oversight.

4. Improves speed and agility of development

In today’s evolving marketplace, keeping ahead of the crowd is a constant battle for companies. It is particularly true when it comes to software development and application creation. ALM platform gives engineering teams the ability to produce software at the speed and agility required to stay competitive. This also offers proprietary source code management to match software development priorities with organisational objectives.

5. Improves performance and compliance

ALM platform produces a high-quality software application for your development team. It promotes quality effectively through the management of source code and the collaborative effort. If production teams and reviewers are out of the knowledge loop, this can place a toll on the development process and impact the final product quality. Communication during the governance stage, which encompasses the strategy and establishes phases in software development and information technology (DevOps) operations, is particularly important.

Governance is also known as the description and design stage of requirements, in which the specifications for solutions are specified. These requirements generally cover everything from requirements relating to technology platforms to compliance regulations. Since this phase is where applications are designed based on such requirements, providing optimum solutions for customers is essential to get this phase right.

6. Help enterprises plan more efficiently

Using ALM software teams may launch projects using existing methodologies and accurate estimates. Through resource planning, it provides support in project management. Depending on the criteria, particular techniques are available, whether they are typical waterfall projects (where projects are built through a linear approach) or agile development projects (where projects are built in an iterative process).

7. Enables team collaboration

It is essential for companies, particularly those in multiple locations to have a simple and strong network and management for collaboration between different teams. ALM software ensures that everybody involved in the development process has a full and real-time track of the project’s strategies, changes, requirements and status. ALM Software helps the whole team to define what type of skill sets would be perfect for a particular process, and how to prioritize goals.

Conclusion

Healthcare system often involves interactions of patients with minor to big medical devices. Medtech industry or medical device manufacturers offer a wide range of products to monitor and cure patients. It is vital for health care organisations to achieve better patient results, decrease healthcare costs, improved efficiency and open avenues of engaging and educating patients.

Significant technological advancements are driving MedTech innovation which has led to the development of many connected software medical devices capable of producing, storing, analysing and transmitting data. Such data build a linked network of medical devices, software applications, and health systems and facilities together with the devices themselves. With the connectivity of medical devices, there appeared new changes that improved connectivity between sensors and devices which enabled health care organisations to improve patient care even in remote locations.

MedTech industry has played an important role in reducing costs, improving the quality of patient care. However, there are several obstacles that the healthcare organisations had to face with connected medical devices when creating software ecosystem for Software as a medical device (SaMD) and Software in a medical device (SiMD) for them. Some of the critical issues are shared below.

Data safety and cybersecurity

Data breach is a major concern in connected medical devices, as the increasing numbers and capability of connected medical devices add risk of data security. This threat of data breach is often ignored by medical device manufacturers as they lack an understanding of such risks, preventive measures and its aftermath. To overcome the threat of data breach, MedTech companies need to use data anonymization, encryption of the medical software, role-based access control, data access audit, preprogramed logout and elaborate user permission settings. Frequent assessment and robust testing must be done after ecosystem’s release.

2. Development cost and implementation

A well- functioning IoMT solution will reduce healthcare costs, boost workplace efficiency and increase long-term patient satisfaction. However, a healthcare organisation requires the significant time and energy of highly qualified developers who are well versed in cloud growth, big data and data anayltics technology to build a full-fledged network of medical devices. A cost saving strategy using the iterative development approach is recommended which concentrate on core functionality at first to avod excessively complicated features in order to pay off the expenditure more quickly.

3. Developing a detailed understanding of end users

As more suppliers embrace value-based care (VBC) models, take-up speed and increasing convergence of the linked medical devices. Information and Evidence Central to VBS provides insights into patients and procedures. The issues include to what degree the IT infrastructure of an organisation can manage and process the links and data and that patients and clinicians can be persuaded of the protection and system output. Medical device manufacturers need to build an in-depth understanding of end users and create market models and scenarios that demonstrate how their existing customers work. The latest tools not only improve patient outcomes but also enhance patient outcomes but also create value for key health care stakeholders.

Conclusion

Medical devices have multiple components which include software as a medical device (SaMD), software in a medical device (SiMD), hardware and other medical components. Launching a medical device in the market is difficult as they come masked with layers of regulations and strict compliance for patient’s safety.

To launch a medical device successfully in the market, several phases which need different levels of planning, scripting and collaboration between teams (internal and external), needs to be navigated successfully. The steps for developing a medical device is related to each other and their results can be stored, shared and controlled. It can also help medical device companies to understand the viability of the medical device software and bring their final product to market successfully.

The steps for the medical device development process are as follows:

1. Initial planning and risk analysis

The first step of the production of medical devices involves initial thought followed by critical elements of opportunity and risk analysis that can decide whether you can and will progress to the next level. Including:

Defining what the medical device companies will do, how revolutionary product it is for the customers. It’s about determining fit for the drug market. Is there enough competition and distinction within your proposed product to make it worthwhile to continue?

What markets are your medical device likely to be built for? What are regulatory standards you ‘re going to have to conform to, what classification is the device likely to fall into? It is critical because it will assess the likely amount of time and cost that you will incur in marketing the product.

Is there similar product in the market to the one you are already considering to create which will make it easier to receive regulatory approval and the criteria for clinical trials?

When you are convinced that the market place of your product is competitive and financially feasible, you can move on to the next level of medical device software development.

2. Conceptualization and feasibility

During this process more systematic risk analysis, a compilation of regulatory and consumer criteria takes place with initial prototyping to serve as design proof for initiating or stopping the analysis before proceeding with the next stage of the product development.

You need to start tracking consumer needs, collecting input through surveys and researching with patients and clinicians. Competitor analysis and market research will complement all of this to plan the strategy and designs.

Such customer expectations must inform the initial design and development research that facilitates conceptualization and concept proofing by prototyping of all or part of a planned product. This method has to be carried out continuously through a design, development, and review cycle.

At the end of this step, you should know the idea is viable and can be converted into a medical product. This product is developed and launched in the market to address the needs of the consumer in a way that enhances existing solutions.

3. Design and Development- Verification and validation

Now the conceptualization of the medical device is complete, the next step is about the final design and production of a product that adheres to all the criteria for regulation. In this phase, the regulatory documentation is assembled as a part of the design inputs needed.

Formal criteria for evaluating risk feed into this design step and the entire process will continue to be controlled by design management processes outlined in ISO 13485 and elsewhere. User requirements are further gathered and translated into a database. Further, Engineering design requirements are established utilizing an iterative process that leads to a complete set of designs.

Once the product is designed, the medical device testing against the EDS must be conducted and then the actual product itself must be validated against the user requirements. There needs to be continuous planning, design, review and acceptance process at this point that will build an audit-able record of the measures you have taken to minimize the risk of failure to the end-user.

If you had pre-decided to do clinical trials for your medical device, then at this stage you need to put your clinical plan into action.

4. Final validation, product launch and approval

At this stage, all the data and documents, including clinical trial reports, must be compiled ready for submission to the concerned regulatory authority for approval. This part of the process involves reviewing and auditing the documents identified by agencies such as the FDA and MHRA which is needed to launch the final medical device in different geographies.

Once the team can generate the paperwork, the faster approval can be received and your medical device can get into the market.

5. Product launch and post launch analysis

Once you have launch approval, you will have to pass your plans to the medical device manufacturers for production. Ensure that you have a “post-launch” strategy in place to collect inputs, feedback and how are you utilizing this information to the best? How does it loop into any risk management system?

Conclusion

We have mentioned only a few of the essential processes and criteria of the 5 steps, but they all demonstrate how effective these steps are to launch a successful medical device to the market. Once your medical device is in the market and used by the customers, get ready for feedback, improvements and review process. Also, make sure to implement a robust Quality assurance and medical device testing software mechanism to ensure continuous improvement of the device.

MicroGenesis is a leading software solutions provider for medical devices and applications. They provide a single-window of services in Development, Testing and Regulatory Compliance for medical software including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).

The procedure to bring medical devices in the market can be complicated, requiring a clear understanding of the medical device software, market analysis, fulfilling the regulatory compliance of the Food and Drug administration (FDA) which include myriads of regulations. 

Here are the top 10 tips in the process that medical device manufacturers should consider.

1. Understanding of the product overview

Though it seems obvious, but it is important for medical device manufacturers to have a clear understanding of what class of device has been created. Every medical device software has a different testing requirements, cost and timelines and upon completion will have a different pool of requirements for regulatory, testing, validation and aspects of clearance or approval procedure.  Every medical device has unique product specification and require different aspects of mechanical testing. Hence, a clear understanding of the medical device is necessary.

2. Project timeline and cost involved

A 360-degree understanding of the project timeline before even beginning the project is essential which includes estimates for each individual phase and not just overall project time phase. Developing Software as a medical device (SaMD) and software in a medical device (SiMD) requires working among different departments and involves various teams. Thus, defining a timeline is important for managing the resources efficiently and creating an accurate budgetary estimate. Funding also plays an important role in achieving milestones, so manufacturers need to be careful and require thorough planning to keep all project budgets in check in the beginning.

3. Creating a prototype

Before manufacturing the final product into the market, manufacturers consider creating a prototype to troubleshoot problems and improve certain features of the medical device. A prototype of medical device gives a more realistic representation of the end product. Once the team is satisfied with the prototype, it is easy to picture the real product. This working prototype can be helpful in doing basic feasibility studies. The purpose of these studies is to undermine whether you should move forward with pursuing a full-fledged project.

4. Classification of medical devices and understanding the applicable controls

The first and foremost step to market a medical device by medical device companies is to determine how the FDA has classified the medical device. Generally, medical devices are categorized into three classes (I, II, III) which is based on the degree of risk they possess on people’s lives. As the class of medical device move from class I to class II to class III, the regulatory control is subject to become strict.

5. Selection and preparation for the right premarket submission

There is no single approach to the marketplace. The medical device manufacturers should select and arrange premarket submission, required for specific products classification. Most medical devices need to have an appropriate submission type within the product classification which can be obtained from the public product classification database.

6. Adherence to applicable regulatory compliance

Fulfilling the regulatory compliance is crucial for medical devices to market as it involves lives. It also provides FDA the insight about the effectiveness and safety of the medical device. So, it becomes pertinent for medical device companies to manufacturer medical devices in accordance with the good manufacturing practises and label their devices in accordance with the labelling regulations without adulteration or misbranding.

7. Early stage deliberations

There are many costs that are overshowed by medical device manufacturers during the early process of the product. To bring a medical device into the market, considering every cost associated with manufacturing equipment, medical device testing, certifications with regulatory bodies, product registrations, clinical trials and much more is important. Before planning to build a manufacturing medical device, a robust and exhaustive plan can help in the success of the project.

8. Hire the right team

A dedicated and experienced team is important for medical device companies to market a full functional medical device to the market. Selecting a proper team or outsourcing resources can play an important role for medical device manufacturers. A capable and well managed team ensures that the medical device software meets the regulatory requirements specified in ISO 13485 and enable the release of safe software to the market. While choosing the right time, make sure they have extensive experience in testing standalone, web, mobile and embedded software for medical devices on various platform. They are capable of meeting the ever-growing demand for regression testing of medical software through test automation framework.

9. Implementing robust Testing & Quality management system

A medical device software and application testing requires several different types of testing including functional, regression, safety, performance etc. Before marketing a medical device, it is important to set up a framework of robust testing mechanism to ensure everything in the medical device is at place. Before bringing a product into the market, certain criteria under the Quality Management needs to be taken care.  the rule of 1 size fits all doesn’t apply in medical devices. There are multiple regulatory bodies who expect to follow certain regulations. These criteria for medical devices can be fulfilled by establishing a QMS to comply with their expectations.

10. Risk Management

While designing or creating a medical device, patient safety is of paramount importance. Thus, most engineers are likely to think about mitigating risks with the initiation of the device. Creating a device that can save lives and improve the quality of life for end users is a challenge and comes with a lot of responsibility. So, the medical device design should always consider the risk outlined in the ISO 14971 on risk management and plan medical devices accordingly.

Conclusion

Bringing a robust medical device to the market could be complicated and stressful for a news developer. However, by implementing a strategic planning from the beginning can eliminate changes of uncertainty and ensure a smooth process while improving chances of bringing your product to the market.

Medical device testing includes more than just validation and verification. The advanced technologies used in a medical device software testing is critical, but the end-results are more critical than mere technology implementations. Medical devices are ready to market only after screening under the guidelines laid down by the regulatory and compliance bodies across geographies.

There have been several evidences of the stringent regulatory compliance laid upon medical device companies before launching their product in the market. In the United States, there are several policies to screen even the minor components of a medical devices. According to a report by FDA about medical devices, there has been 97% increase in medical devices recall from 2003 to 2012. 11.3% of these recalls because of the faulty software frameworks supporting the medical devices.

This clearly indicates the rigorous laws; medical device companies need to follow. Medical devices are critical for human lives and even a slightest error could lead to serious health consequences. Hence, testing for software for medical device  and software as a medical device (SaMD) should be comprehensive to detect minor defects and report anomalies at the earliest. Here are 5 key areas that should be paid attention during testing.

1. Verification and validation of requirements

Verification and validation of requirements are important aspects of medical device software testing. Validation helps to understand how about the right medical products are made and verification ensures building of product in the correct way. Some of the medical devices are extremely critical to human lives and have specific requirements to be adhered. Any unsuitable adherence could lead to fatal consequences.

2. Device security and privacy

Medical device software contains important health information of patients. Hence, medical system frameworks need strong security against firewalls to prevent intrusions and data breach. Testing of medical software devices should also be tested to ensure intelligent response to critical situations.

3. Systems integration

System integration is paramount for medical software. Proper integration testing ensures workflows, information access, response system act meticulously round-the-clock to ensure robust healthcare delivery. Hence, the need for a systems integration approach to medical software is essential.

4. System dispute 

Medical device software is prone to sudden closure or halts due to dispute in resource sharing or interoperable implementations. An error in a surgical monitoring system must be taken care accurately without causing a sudden shut down of a medical device while carrying out a surgical operation. While testing such real situation must be given special attention.

5. Human assess factor

Software plays a major role in minimizing human errors. Testing teams need to pay special notice to keystroke error detection software in the medical software frameworks to remove any software error.

Conclusion

Software testing and quality assurance teams have the onus to ensure medical device software are well-planned that incorporates the above-mentioned areas in focus. Considering the strict regulatory compliance and requirements, implementing robust testing assessment framework are essential for the QA and testing teams. MicroGenesis with its wealth of experience and scale have built a comprehensive portfolio of service offerings to deliver innovative and futuristic solutions to the clients. Our partnership with leading medical device companies have enabled them to bring quality products to the market in shorter time frames and meet EN ISO 13485, EU MDR and FDA Regulatory compliance.