Software as a Medical Devices: Definition & Scope of Regulations

Software Challenges For Connected Medical Devices – How To Solve Them?

Since the past 40 years, the number of technology innovations both within and around medical devices have increased dramatically. Especially, the past 20 years have witnessed an acceleration in the sector, thanks to the Internet of Things and rise of its other corresponding parts like wireless connectivity, cloud computing, and AI, etc. These advancements have transformed the healthcare processes.

Even after 20 years, these leading-edge technologies are continuing to source a seismic shift in the process of healthcare administration and delivery.

And now, mobile applications have also seeped in and have become an important part of these highly demanded, technology-based medical and non-medical purposes.

These Apps or Software which are a medical device on their own – Software as a Medical Device – have grown to become an inherent part of the users’ life. The applications of SaMD are not just limited to diagnosis but have also made their place in the monitoring and treatment process. In fact it is SaMD that has led to the evolution of healthcare 1.0 to healthcare 3.0.

Seeing the growing inclusion of  SaMD in the everyday healthcare, The International Medical Device Regulators Forum have described the concept and SaMD risk categories in detail for the medical app development industry to follow.

* SaMD is not the only compliance that healthcare industry stakeholders – mHealth applications entrepreneurs and device manufacturers should follow. There are other compliances as well, such as FDA, HIPAA, HL7, and FCPA. We have touched upon these compliances in much detail in our mHealthcare App Development Guide

In this article, we are going to throw some light on what is SaMD, the regulations that it entails, and what mHealth app types which are categorized as Software as a Medical Device.

What is Software as A Medical Device?

What You Need to Know About Software as a Medical Device • dicentra

The terminology – Software as a Medical Device stands for any software that is intended for use for one or multiple medical purposes and which performs these purposes without being integrated into a hardware medical device.

Here’s how IMDRAF defines SaMD – 

‘The term “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.’

How to know if your mobile app is a SaMD

What Is Software As a Medical Device (SAMD) | Perforce

  • SaMD is a medical device and includes some in-vitro diagnostic (IVD) medical device.
  • SaMD is able to run on general purpose (non-medical) computing platforms.
  • Software does not meet the definition of SaMD if its intended purpose is to drive hardware medical device.
  • SaMD may be used with other products such as medical devices.
  • SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software.

Factors to Consider for SaMD Characterization

There are two ways through which SaMDs are characterized:

A. Information provided by SaMD

  • To diagnose or treat patients
  • To inform clinical management
  • To drive clinical management

B. Healthcare Condition

  • Critical condition
  • Serious condition
  • Non-serious condition

On the basis of these characterizations, SaMDs are divided into four categories.

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Category Wise Examples of SaMD

Building Your First SaMD/Clinical Research Application – Small Planet

Category IV:

  • SaMDs which perform diagnostic image analysis for enabling treatment decisions when patients suffer an acute stroke
  • SaMDs which calculate the fractal dimension of a lesion and builds a structural map which reveals different growth patterns for providing diagnosis or identification if the lesion is benign or malignant.
  • SaMDs combining data from the immunoassays to the screen for mutable pathogens outbreak that can be highly communicable.

Category III:

  • SaMD which makes use of phone’s microphone for detecting interrupted breathing during sleep.
  • SaMD used for providing information by clicking pictures, monitoring growth or other data to supplement other information that a healthcare provider uses for diagnosing if a skin lesion is benign or malignant.

Category II:

  • SaMDs that analyzes heart rate
  • SaMD which use individuals’ health record data for predicting the risks of heart disease or stroke and create prevention strategies.
  • SaMD which integrate and analyze multiple tests to offer recommendations for diagnosis in certain clinical indications.

Category I:

  • SaMD which gather data from symptom diaries for providing information to gauge  occurrence of an asthma episode.
  • SaMD analyzing images, movement of the eye for guiding next diagnostic action for astigmatism.
  • SaMD which store historic blood pressure information for health care providers to review.
  • SaMD using data of hearing sensitivity, speech in noise, and asking users to answer questionnaires about common listening situations for self-assessing hearing loss.

What Can SaMD Manufacturers do to Ensure Regulations?

SaMD- Need for Regulation. | NovoJuris

SaMD companies should have a good Quality Management System incorporated into the development process to ensure compliance with any regulation. The chosen QMS platform should be capable of compliance with regulatory requirements like the FDA 21 CFR Part 820 and ISO 13485:2016.

Any misstep in the direction can lead to severe consequences with your application getting banned being only the tipping point. Noting the cruciality, it is advised that you should partner with a custom healthcare software development company who works alongside medical practitioners who understand these regulations and compliances to their entirety.

FAQs About SaMD 

Q. What are examples of software that are not Software as a Medical Device?

  1. Apps that hardware medical devices need for performing its role.
  2. Apps which are dependent on the medical device data.
  3. Apps that enable communication and streamlining of clinical workflow, like ones for scheduling visits, video or voice calling, etc

The app examples are not limited to these. There are a number of other app types which do not fall under the definition of SaMDs.

Q. What can Software as a Medical Device actually do?

SaMD applications are those which act as a stand-alone health application that gives users the insight into their physical health by making diagnosis, doing X-ray processing, or calculating insulin doses.

Q. What is IEC 62304?

IEC 62304 is a standard that specifies the life cycle requirements needed for the creation of Software as a Medical Device and Software within medical devices. When used along with ISO 13485, it offers a framework that is important for safe designing and maintenance of medical device software.

Q. Describe your QMS process for medical device software development

We have our own internal QMS for working with medical device and pharmaceutical clients, to ensure our own quality. We do not get audited by clients, third parties, or regulators.

Stage 1 : Initiate Project: Conduct a kick-off teleconference with Client to:

Review the project plan and timeline

Finalize key sources of information

Define the project team

Stage 2 : Review Documentation: Evaluate and examine all relevant documents including existing product information, nonclinical data/plans, and regulatory documentation.  The sources of this information are:

Non-clinical data, regulatory correspondence, product technical specifications, references to predicate devices, proposed product claims and intended/indications for use, etc.

Stage 3: Determine Regulatory Pathway Using information from above section, Develop an FDA regulatory path determining whether 510(k) or de novo is most appropriate (a PMA regulatory strategy is more complex and will require a higher budget).  The goal will be to advise Client on the optimal approach to FDA.

Alignment of Lean Principles During Software Development

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The first time I heard of lean manufacturing was in the context of Toyota in my business operation class. Everyone, like me, who read into lean principle, was completely fascinated by the concept of reducing waste and increasing productivity through an intentional design.

Over time, the lean manufacturing method worked and the lean principles of product development flow was adopted by a number of industries, even outside manufacturing, which included software development.

Lean development principle is an agile approach which was developed on lean manufacturing principles. The same, that is being used by Toyota as a lean development methodology for managing and optimizing the process of vehicle production for minimizing waste and increasing customer value.

I know what you must be thinking. If the lean principles originated around vehicle manufacturing, how does software development fit in?

The connection between lean agile methodology and software development was first introduced in 2003 in a book named “Lean Software Development: An Agile Toolkit” by Tom and Mary Poppendieck.

In the book, Poppendiecks interpreted how the lean principles could be applied into the software development process. Both software development and manufacturing processes follow repeatable structures and rely on high quality standards. They also depend heavily on teamwork to get things done.

The question, however, is how it can be done. In this article, we are going to look into how we align our software development process with lean software principles.

Table Of Content

  1. What are the Strengths and Weakness of Lean Agile Software Development?
  2. The 7 Principles Of Lean Software Development
  3. Tools Used in Software Development Process
  4. Aligning The 7 Lean Principles Into Our Software Development Projects:
  5. Phase Wise Application of the 2 Principles
  6. Overcoming The Challenges of Using Lean Principles
  7. Conclusion

If you still are not sure about what are the lean principles in the software development process, then let me help you out with the meaning.  Lean software development is a collection of principles that is used for software development to reduce the programming effort. Lean principles got their start in manufacturing, as a way to optimize the production line to minimize waste and maximize value to the customer.

  • Repeatable processes
  • Team collaboration
  • Uniform standards

What are the Strengths and Weakness of Lean Agile Software Development?

What are your Strengths and Weakness? How to Deal with them?

The strengths of lean product development principles include:

  • A streamlined approach allowing functionalities to be delivered in a limited time
  • Elimination of unnecessary activities which can lower the cost
  • Empowerment of the development team, helping them make decisions that can boost their morale.
  • The flexibility of the project to frequently adapt the project and customize it according to the customer’s requirement.

The weaknesses of lean software development methodology include:

  • It depends greatly on the involved team, making it less scalable compared to other frameworks
  • It relies on stringent documentation. Failure on this part can lead to heavy development mistakes.
  • Planning is necessary before the project is started. Before kicking off the project, you should be aware of the project vision, roadmap, release plan, and iteration plan.
  • Professional teams are required to maintain workflow coordination and make quick decisions while working.

The 7 Principles Of Lean Software Development

There are seven key principles of the lean software development approach working with the aim of fastening delivery and bringing high value to the end-users:

  • Eliminate Waste
  • Create Knowledge
  • Build Quality In
  • Fast Delivery
  • Empower Your Team
  • Delay in Making Decisions
  • Optimize the whole

To fulfill these objectives cum principles, we make use of tools such as:

Tools Used in Software Development Process

5s System – It is designed to improve efficiency and productivity through a systematic approach and following its five S’s that stands for Sort, Set, Shine, Standardize, and Sustain.

Inventory management – We follow the practice where we lower the number of operations that are in progress in one go through the application of theory or constraints or queuing theory.

Kaizen – This lean development tool helps in promoting improvement in quality, technology, processes, productivity, and safety. It is most helpful in developing a safe and tech culture.

Kaizen - Wikipedia

Kanban – It is a pull project management system, where we limit tasks that are getting completed simultaneously. This helps us in preventing the overload of the development process.

Kanban Tool - Kanban Boards for Business | Kanban Software

Value stream mapping – It is a visualization method, where we visualize the development cycle – from client request to deployment. This helps us in demonstrating and helping optimize the time spent on holding and on actual processing.

Let us now look at how we align the seven principles of lean manufacturing with our software development cycle in our role as a leading lean software development company.

Aligning The 7 Lean Principles Into Our Software Development Projects:

Lean Software Development Guide - Lean Principles, Waste and Process

1.  Eliminate Waste

7 Wastes of lean – How to eliminate all non-value-added activities? | Spica International

The foremost principle of lean product development that we adopt is elimination of everything which does not bring any value to the end-users. We start by identifying value of the product we have to build.

It makes it easy to identify the waste like unnecessary code, unclear goals, additional features, and extra processes, etc.

Wastes is one of the biggest digital transformation challenges. In our experience, can be found in a number of domains:

  • Waste of work-in-progress i.e. the partial work. This can be lowered by putting limitations in work-in-progress, through the mode of Kanban.
  • Waste of overproduction waste. These emerge when the feedback cycles get too lengthy and a series of extra features are demanded.
  • Processes waste. These are eliminated by our software development company through pair programming approaches and better collaborations.
  • Handsoff waste. We solve the issue by not keeping our team functioning as silos. We work as a close knit cross-functioning team which helps in enhancing efficiency.
  • Software defects. Waste tends to seep in when the quality is not made a part of the software development firm process with different balance and checks.

2.  Create Knowledge

The Expert's Guide To Create A Self-Service Knowledge Base

Software development process, in itself, is one that is heavily knowledge generating one. Anteelo from the beginning has been an extremely knowledge focused company. This is one of the main reasons how we have been able to incorporate blockchain and AI technology in the projects before any other software application development company in the industry.

We align the principle with our development process by implementing some key methods like: code reviews, performing training, code comments, project documentation, pair programming, and sharing sessions, etc.

3.  Build Quality In

Build Quality In: The Key to Continuous Delivery in Kanban - Blog | Planview

Our software development team ensures that the focus is always on delivering high-quality products. We always keep enhancing our development process to eliminate the project from the first step to the end product.

There are various lean agile software development approaches that we apply to better the product quality:

  • Pair programming – to lower the miscommunication waste and maximum output.
  • Testing criteria – offering the engineers a system ensuring that it meets the requirement.
  • Incremental development – bettering the quality through timely, consistent feedback.
  • Lesser wait states – to protect the quality and streamline efficiency while lowering the gap in knowledge.
  • Automation – using assets like AI and machine learning to lower and eventually eliminate the errors in development processes.

4.  Fast Delivery

Isometric Super Businessman Flying Fast to Delivery Parcel to Customer by ojogabonitoo

The agile development basics focuses heavily on the fast delivery of software processes. Lean agile principles, being a part of the approach also put focus on fast delivery. It simply means that the project team would have to deliver the modules according to the milestone plans.

Achieving fast app development time becomes easier when there is a stable workflow that helps teams in understanding the value of the process and thus facilitate fast results.

5.  Empower Your Team

How To Empower Your Team: It's All About Leaning In, Not Stepping Away

This one lean principle is what we follow regardless of the team and project. Our team that focuses on software development for startups understands that when you work together you have to respect each other. And when things go south or not according to plan, the focus should be kept on checking for gaps in the work process that might have led to conflicts and challenges.

Ever since our inception, we have been focusing on the creation of a favorable work environment where we lead by example. To better the morale, we also enable creative freedom to our teams giving them the choice to identify the best approach for any task.

6.  Delay in Making Decisions

10 brain reasons for delaying a decision - Money Women and Brains

We know what you are thinking – delay in decision-making has to be a bad idea.

But when we follow the lean-agile principles, we believe that deciding late is not equal to becoming irresponsible. In fact, it encourages the team to keep their options open for a long period of time so that they can gather data which can help in taking important decisions.

The result of this is that our project never suffers from negative impacts which emerges because of bad decision making.

7.  Optimize the Whole

Optimize the whole

We go for the optimization of the complete development process, which is not just limited to the sub-processes. We work with the understanding that if we add value to a specific set of processes, the end product will end up getting affected, and the end-results would be sub-optimized.

To handle sub-optimization, we encourage operating with good work capacities. We optimize the entire process which enables identification of value flows for the entire team that, in turn, promises valuable and timely delivery.

Overcoming The Challenges of Using Lean Principles

Although the article, up until this point, has been inclined towards how lean software methodology makes it beneficial for a smooth software development process, there are some challenges that are prevalent which have to be solved.

  • The team members have to be self-directed and be able to work as a cohesive unit.
  • There can be instances where the requirements might keep increasing without a finalization in sight. These have to be managed with delicacy upon talking to the clients.
  • Lean method is heavily focused on continuous improvement. The timelines for implementations are also generally long. This, in turn, can increase the timeline when you are able to reap the benefits.

Conclusion

Since lean agile methodology presents a customer oriented, adaptable, and flexible system, there is no hard and fast rule to follow the procedures or methodologies. But one can always take note of the given information so that there is no problem while developing a software.

It is always advisable to search for an expert, (who are focused on improving and enhancing their skills) while employing a team to build your application. The best way to do that is to either partner with software developers that are well-adapted with the technology and client’s needs, or you can opt for top companies in your area like top software development companies in USA or software development company in California, if you live in the US. But make sure you choose the best to get quality results.

Custom Software Development Supremacy- Explained

Custom Software Development Trends and Methodologies | Flexsin Blog

Understanding a clever and cost reducing way that businesses adopt to scale and solve problems in direct ways using custom software development. To be or not to be, that is the question businesses face when it comes to choosing between customized software and standard software. In some respects, the question could be the difference between the haves and have nots. Being a successful custom software development company ourselves and pushed to innovate cutting edge solutions on a habitual basis, we know first-hand what to do when.

If organizations are to transform digitally, then the installed software would have to compliment the needs equally. If you are in the middle of such a dilemma, by the end of this article you would gain clarity on the subject. Hence, we begin by answering the question, what is custom software?

What is a Customized Software? 

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The software that comes pre-packaged with features is referred to as Commercial Off The Shelf or COTS. The vendor that develops it owns the responsibility of updating its versions. Enterprises slash users subscribe to it by paying a licensing fee. It is designed keeping in mind the most universal needs of the mass market. Microsoft Windows is an example of COTS. It offers the apparatus for each user to carry daily-life computational tasks without having to think twice.

On the other hand, a software that you develop, or ask a third-party to customize for you is called customized software. Since it is created unique to the needs of a particular user, it is also termed as bespoke software. Made on order, it weighs high on features that are relevant to the organization. Custom software applications are cut to fit the ongoing and upcoming business requirements.

Tasks that a standard software will take ages to complete can be accomplished in a whisker of time with custom software apps. Think of it this way, COTS is a public utility vehicle that takes the combined choices of travelers’ into consideration and drives at a speed fast enough to pacify those onboard. While custom software is that private car that you can modify as per wish and break the speed limits with.

Now that you understand what is custom software, let’s find out about its development procedure followed by a full cycle app development company.

Does Custom Software Development Process Differ from Standard?

Not at all. The software development life cycle is almost identical in each case. You traverse the same stages of basic information collection, coding, testing out the software for inconsistencies, finally moving over to deployment.

There is an unprecedented urgency in enterprises to transform digitally for sustenance. Each is looking to differentiate itself and be seen and as an innovator. Be it an in-house project, or one that is outsourced to a company like Anteelo, custom development of software involves the following stages:

Application customization

Application Customization Services (ACS) - Flexile

You would either purchase a COTS software and re-program it to requirements or build a bespoke solution. No matter what you choose, it will begin at this stage of code creation.

Application modernization

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Maturing with time, stakeholders realize that their value chains must improve and be just as impressive as their product suite. The deployed custom software will have to be modernized with features as new technologies emerge.

Application management

Why does your business need Application Management Services?

It is similar to after-sales support but one that you either do internally or let the third-party that designed the software for you do it. These envelope everything from installing the software to ensuring its 24/7 availability.

Why Choose Custom Software Development?

The reason why custom software is preferred is due to the changing market trends that makes the business transformation either costly or time consuming. Custom software application development helps businesses in building an intuitive and user-friendly software product tailored to their business requirements. It also handles various types of organizational challenges like process complexities, employee struggles, and meet the preference of customers.

Some points are discussed below for opting custom made software:-

Flexibility

Free Flexible Clip Art with No Background - ClipartKey

One of the crucial benefits of custom software companies is its flexibility. Any change required might be easily acknowledged so your platform is always updated with the ongoing patterns. A significant degree of flexibility offers effectiveness in the working process. Competitive processes are simple to automate so that the framework automatically leads the users and there is no requirement for human intervention.

Better integration

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Custom programming application improvement organizations give a scope of choices to incorporating various sorts of APIs. The vast majority of the bundled programming are not viable with different programs thus incorporating another product to improve its capacities are impractical. It is this explanation; numerous organizations lean towards custom software applications over canned programming.

Future innovation

The cloud will be the centre of future innovation - Talent Germany

Having your own types of custom software will empower you to explore and welcome on board creative ideas quicker and without relying upon other innovation merchants to do it for you. This can help in more noteworthy market ability as your brand would be perceived as a forerunner instead of a late adopter for innovations that user’s long for.

App security

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The internet has an intricate dangerous environment and application security is a grave concern for modern organizations, regardless of the size. An application on the Internet is exposed to security breaches. Each organization takes measures to shield their customized software application development products against exploitation by hackers, the current circumstance is still the worst. By engaging in a presumed custom application advancement organization, organizations can take added measures to keep their information from hackers and displeased workers.

Cost reduction

Cost-reduction tactics for small businesses - Commercial Associates

At times the business do not need all the functions offered by a format yet they had to pay. On account to create custom software, you pick what you need and pay just for it. Additionally, there is something intriguing and that is off-the-shelf solutions ordinarily require monthly or yearly licensing expenses. There are already many payments in the process that if you calculate, then it will be much more costly. If you pick a custom solution, you’ll pay more at first but later on you do not have to put much effort. You can say that custom software development cost is a one-time investment.

What are the Benefits of Custom Software Development? 

It is not a good rationale to buy an inferior product, and subsequently, modify it for installation. Why wouldn’t you just create the whole thing on your own! The following advantages of custom software will help you make up your mind. The benefits can also be read as ways how custom app development can increase app development:

Vendor independent 

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Custom design software and you shall be free from the clutches of vendors who upgrade their product based on user reception and trends than your needs. In doing so, your business circumvents fee surges caused in the name of licensing and maintenance. Then there is the possibility of the vendor ceasing operations leaving your IT department to shreds and affecting business continuity.

You would although need to hire subject matter experts to cope with a proprietary solution. But again, there is no saying how much indirect benefit you would derive from them such as mentioned in the next point.

Create white-label products

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The resources you devote to creating a bespoke internal solution could be monetized by licensing it to similar businesses or allowing them to use it as a White Label product by making a one-time payment. A White Label product is one that you build and sell to a second organization, conferring them the right to use it under their brand name. The only catch here is to define the terms of use. Although white label solutions are not always deemed to be effective for long-term, they can be a good option, nonetheless for entrepreneurs who are just starting their journey.

High-End integration

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Investment in COTS software becomes a catch-22 situation when you discover you have to program extensions into the system to make it worth your while. Diverting the same expenditure towards custom software applications that integrate effortlessly with other software (because you made it so) saves you much-needed energy.

Performance

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Custom software development provides for more stable and efficient IT operations as the software does all (perhaps more) that is asked of it to deliver value-adding results.

Scalability 

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Nobody knows better than you the future of your venture. It becomes a self-fulfilling prophecy that you would, during the course of customized software application development, come up with something that is scalable and relatable to the needs of your company.

Optimized business process

Business Process Innovation | InfoStages Advisors

Every association has its own plan of action and in-house processes. It is hard for businesses to change their process to suit a specific application, no matter how effective and powerful it could be. Software should be planned and developed in a way to such an extent that it can align with the business model. Custom development assists with improving your business processes instead of replacing them.

Compatibility

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Most organizations have a design model in which the output generated by a specific process (software application or module) works as an input for another process. A smooth flow of data is essential while streamlining business. Utilizing different packaged programming for various processes can disrupt data flow. Building custom software can resolve numerous kinds of issues concerning the flow of data between progressive processes.

Data security

What Is Data Security?

A significant concern for some B2B and B2C organizations, data access, and security concerns influence many end-users in the market today. Supporting costly security protocols can make you pass added expenses to the services you offer to your customers. With custom development you have the ability to choose which data security technology or protocol is appropriate for your business and coordinate that in your software.

Cost effectiveness

Cost-Effectiveness Analysis | POLARIS | ADP-Policy | CDC

With custom development you can plan and stage the development process. You’re not needed to contribute an enormous amount of money first on to receive the rewards of automation. Based on your financial plan and funds accessibility, you can begin automating single processes flows in a coordinated and planned way over the long run to make development affordable software development services.

Adaptability

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Organizational processes change with time, and as the market dynamics change, it gets important to adjust to new processes and innovations to maintain your marketing stronghold. Customized software can be effortlessly changed – New cycles and innovations can be incorporated into your current programming as and when showcasing patterns change, so you can stay side by side of your rivals.

How to Decide Whether You Need a Bespoke Solution or Not?

By tradition, companies prefer to purchase COTS software provided it helps them meet up to 80% of the following business requirements.

  • Either allow the functioning of or automate entirely B2B transactions and processes unique to the business
  • Take care of proprietary information and safeguard confidential data
  • Suffice for ad-hoc privacy issues that might arise
  • Enable integration with software already deployed by the company
  • Reduce the cost of operations and increase return on investment
  • Accord a certain level of competitive advantage to the brand

There are companies that may be fine if the software delivers 60% efficiency than 80%. The vacuum that exists they fill on their own. But that is a risky proposition, leaving things up to chance and making superficial efforts to transform digitally.

A big reason startups cover ground on legacy businesses faster than others, is because they do not hesitate to innovate. And if that means bringing in new digital solutions, so be it.

[Further Read: How We Solve the Digital Transformation Challenges Pulling Your Business Down]

Get The Requirements Ready 

Once you set your mind for custom development of software the next step is identifying collaborators to help you with project development internally. These include program sponsors, high-level stakeholders, sometimes your customers, and other miscellaneous partners.

This step is all about conveying the workforce your plans to transform digitally post which a detailed draft must be prepared listing down your Key Performance Indicators (KPI). KPIs must bear in mind:

  • To flatten out any statutory and or theoretically unachievable targets and be realistic
  • Define the role the proposed software will play in business development
  • Not to leave room for assumptions in that the end-to-end capabilities of the software are discussed with project stakeholders
  • The introduction of the software must not intervene with pre-existing COTS software
  • There must be ample proof of concept in the market to base and validate your theory on
  • The source-code used should not violate intellectual property rights and must be either open-sourced or written from scratch
  • The allocated limit of budget and time should be respected
  • If needed there can be partial diversions/pivots from the originally agreed course of action

Development Methodologies You Can Use 

You can pick any of the following software development methodologies:

Waterfall model 

Envisaged in the 1970s, the Waterfall Model is rigid in its implementation and benefits those with a crystal clear understanding of requirements. The expectation setting is followed by rigorous project documentation. It is sequential in nature meaning one stage of the project must be finished before beginning the next. It includes the following phases:

  • Define scope
  • Re-assess the scope
  • Design
  • Implement
  • Test
  • Deploy
  • Maintain

Not that this model is out of fashion, but development teams that want to mix things up and be prepared for last-hour changes to plans, don’t like the Waterfall Model much. It is built for those who like working under ironclad rules.

Agile development

Agile Advantages For Software Development | DevCom

Agile is the exact opposite of waterfall, in fact it was introduced to do away with the rigid, inflexible redundancies of the waterfall model. It prioritizes business unit collaboration over documentation. Teams that go Agile, do so to wrap up coding in design sprints that are time bound mini-projects to accomplish software development faster. Customer satisfaction is the priority here, everything else takes the backseat. Here at Anteelo, we trust Agile more than other methodologies as a custom software development company. Based on experience, we can help you decide between Agile and Waterfall models easily.

Scrum

This is a nuanced approach between older models like the Waterfall and newer ones like Agile. It facilitates regular team interaction but with a relative degree of self-discipline.that team members must impose on themselves. Sprint retrospectives in scrum development last an average of two weeks during which the primary objective of software development is fragmented into smaller, more achievable goals. Developers stick to the daily briefs that are a product of demo feedback. The development is quick and results steady.

Lean 

A philosophy, methodology, or a mindset, call it what you will, it brings out tremendous productivity from teams in custom software companies. Whereas other entries in this list were specifically meant to bolster software development practices, Lean methodology was adopted from the manufacturing sector.

Agile is accomodative of flexibility, but it offers no actionable course to extend the same ideology towards business wings outside of Information Technology. Lean proposes the no-nonsense approach, nullifying wasteful practices, encouraging knowledge sharing, experimentation, innovation and faster turn-around times.

Feature driven development (FDD)

Why (and How) You Should Use Feature-Driven Development | Lucidchart Blog

Custom software design and development can be taken up via Feature Driven Development as well. FDD has been a precursor to the now omnipresent, Agile and Lean approaches. It follows a five-step development model. In the first step you take your plans to the whiteboard and lay out an overall strategy. The next step is defining the specifications of the software followed by planning around each feature holistically. Designing and building each feature make up for the last two stages respectively.

Make up Your Mind

We hope this clears the air around custom development of software. Be it on-demand, or standard solutions, Anteelo  has a track record of achievements in both categories. Our report card in the subject boasts nothing short of an ‘A’ with top industry review journals giving us a 10/10 on numerous occasions. Signing off with a saying dear to all at Anteelo.

If you are looking to develop an app that would be up to date with all the latest technologies of the current time, you should partner with a software app development company that is well-adept with the changing market needs, or you can opt for developers in your area like software development company in USA or Florida if you live in US. But make sure you choose the best to get quality results.

Steps For Effective Software Product Development in 2021

All the major elements of software product development - NewGenApps - The Technology Company with Integrity Uncategorized % %

There are a lot of things that should be spontaneous in life, like office parties, weekend trips, even tattoos but software development is not one of them! Stages of software development should be efficiently and effectively planned. If you want to develop a great software product, you need to have a proper plan and process in place. Benjamin Franklin so aptly put it – “If you fail to plan, you are planning to fail.”

Let us take you over the sequence of steps that are required for proficient software product design and development. The full cycle of product development involves several steps where the ending of one step is the beginning of another!

Table of Content:

  • SDLC for Product Development
  • SDLC stages: What are the stages of software development life- cycle?
  • How an MVP approach can make the software development process more effective?
  • Steps to lower the software development time and cost
  • Why does Anteelo trust agile methodologies?
  • The Path to Success

SDLC for Product Development

Software Development Life Cycle (SDLC) is a process for developing high quality software to meet customer expectations. SDLC includes a structure with a detailed plan to strategize, build, and maintain the product development.

Each stage of the product item advancement life cycle has its procedures and deliverables that get into the following stage. Throughout the software development process, every product begins with a thought. Then it goes through exploration, improvement, and testing, to the last service.

SDLC stages: What are the stages of software development life cycle?

As discussed above, the process of software development is a step by step method that needs to be dealt with in an efficient and effective manner.  Let’s learn about SDLC methodologies and stages in detail:

1. Idea and Concept:

Difference Between Idea and Concept | Difference Between

It all starts with an out-of-the-box idea and validating your application idea, but it is suggestable that right from the very beginning, document everything! Don’t keep your software product development ideas just inside your head. Any concept should be carefully thought out and brainstormed in order to be executed. Here are a few things that you can probe upon:

  • Define your goals
  • List out the features your software will have
  • Research other software products
  • Figure out how your product will stand out
  • Discuss the target audience
  • Sketch out what the software product will look like
  • You can be analytical and put together a user story

These simple steps will help your software product development life cycle in ways that you can’t even fathom and make the process smooth right from the start! This also defines a clear agenda that you have regarding the product.

2. Planning and Feasibility Analysis:

The Components of a Feasibility Study

Feasibility analysis, an important part of the app discovery process, will help you determine not only the technical but also the economic aspects impacting your software product development process. You need to keep a few things in mind while planning the roadmap of your product like time, resources, essential tasks, estimates, and ROI etc. An adequate amount of analysis and planning helps in foreseeing the risks that can occur during the software product design process. It will also help you in being ready with risk mitigation strategies.

3. Proof of Concept:

How Proof-of-Concept (POC) App Development Helps in Building Error-free Software Products - Aalpha India - Bangalore

Once you are through with your second step, you can go ahead and start with a proof of concept (POC). POC is one of the most important steps that software development services need to follow. This stage comes into existence way before the software development process starts. It will help you in validating your idea and you would know if the software product development steps are actually working for your business or not. It will not only confirm technical feasibility and possible expectations but also determine the potential blocks and the scope to accomplish them.

4. Design:

Logo design process: how professionals do it -

A good design is the one that doesn’t scream ‘look at me’ rather it shouts out ‘look at this product’. Software design is an integral stage of software development. Once the POC is successful, the design team conceptualizes a detailed software architecture hitting the bull’s eye when it comes to the features of the software. Product design strategy is about striking the right balance between user needs and business goals and not losing sight of either one during the SDLC.

The product design of your software will include prototypes and the final mockups, making sure that they are very customer centric. So the wireframes, standards, workflows and end goals should be defined keeping user interaction and final output in mind.

5. Proof of Value:

Proof of Value (POV) dives deeper into what the product means to your business. It helps you determine if your goals are achievable or not! Through the POV process you can easily take a single case from beginning to the end and inspect all the elements and understand the gaps on the way.

A POV basically provides a better understanding of the predicted value that the products will bring in and measure success.

6. Development and Coding:

Coding Standards and Development: A General Overview

Once we have all the key elements like the POV, design document and the functional requirement specification document, we can start with coding and development. It is all about giving life to your product! The software product development engineering team has to make sure that their coding process is accurate since it is potentially the riskiest step of the SDLC. Once the complete architecture that includes database, application programming interface and planned functionality of the solution is built, we can move towards the testing stage.

7. Quality Checking and Testing:

Pin by Kairos Technologies Inc on Software Testing | Software testing, Testing techniques, What is software

Now that your team is developing the software, quality checking and testing is one of the most important development process steps. I would highly recommend you to test, track and fix bugs simultaneously. However, once the product is developed successfully, you must have a final in-depth test as well.

You can start with these simple mobile app testing steps:

  • Releasing the product to a small group of beta testers
  • Using UX tools to keep a track of how the users are interacting to your product

You need to be 100% sure that you are not distributing buggy software to customers; this can ruin your reputation and result in loss of revenue. Testing plays a huge role in the software development procedure. I cannot emphasize it enough!

8. Deployment and Implementation:

Ready' for Implementation, 'Done' for Deployment!!

Once you are done with software development process steps like designing, coding and testing of your application, now is the time of actual installation of the crafted product. The application is now moved to production including data and components transfer. However, during the next releases, only some specific changes will be deployed. At this stage, end-users and system analysts can see, use and experiment the ready application.

9. Marketing Strategies:

12 Advanced Marketing Strategies for Amazon Sellers

Simultaneously the marketing team will keep coming up with a multi-platform approach to turn the spotlight towards your product. Out of the box strategies that will focus on telling the product’s unique story, understanding the competitive analysis, investing in digital marketing, creating social media and SEO master plans will enhance the product’s value.

10. Maintenance, Upgrades and Enhancement:

Application Maintenance | IT Company | Riyam Computer Services

You think that you have accomplished all the SDLC methodologies, well think again! The software development steps are not over yet. The final stage includes maintenance, operations and regular updates. Since this process starts post-launch, keep in mind that the customer needs are evolving every single day, which makes this step extremely essential.

The product will be upgraded, maintained, polished, redesigned and enhanced according to the feedback of the customers and the rapid development in the IT sector. I believe that this is the perfect time to vigorously modify the application’s functionalities to upgrade its performance. This way, you will be able to meet the actual needs of your target audience.

How an MVP approach can make the software development process more effective?

The full-form of MVP is – minimum viable product. The MVP will help you gain the users perspective. How? Below are some important pointers for you to keep in mind:

  • It is a ready to launch version of your software product with the sufficient amount of features that are enough for the initial users.
  • Once the feedback is received from the initial users, only then the final product is designed with all the elements.
  • The MVP process is cost effective since it saves time and accelerates the development process.

Building an MVP is not the only important task but testing its viability is just as important too. A software development company may think that the product can satisfy the needs of the customers but until and unless the MVP test is run, it cannot be said for sure.

Steps to lower the software development time and cost:

Step-1: Turn to outsourcing

More Companies Turn to Outsourcing As a Foundation for Innovation - Gorilla Logic

Outsourcing the software development process results in 40% decrease of the actual cost. You should consider your outsourcing options because:

  • Initial in-house cost cutting will save you a lot of money in the form of on-shore salaries, benefits, taxes, marketing and management costs, etc.
  • Zero pay out on software architecture.
  • You’ll be able to choose designers and developers on the basis of technical knowledge, relevant experience and lower budget criteria.

We suggest you do your due diligence and award yourself with a software product development strategy company that is capable of meeting the quality requirements and completing your product successfully.

Step-2: Leave no room for assumptions

Employee turnover: 9 reasons good employees leave | CIO

You should not be ambiguous about what you want when it comes to product development! If the requirements are not clear your product can turn into a disaster because of haphazard design, unplanned functionality and the lack of distinctness.

Documenting each and every requirement and expectation regarding your product will help you eliminate the room for vagueness. This will reduce the overall software development costs and save time for you, helping you focus on other important business problems and solutions.

Step-3: Testing is the key element

React Testing Library: The Modern Way to Test React Components | by Dilantha Prasanjith | Bits and Pieces

Make sure that the testing team is involved in every step of the way. Successful software developers reveal that they started testing for red flags, errors or bugs right from the design phase.

If the errors are found at a later stage, the intensity of rework increases! The quality check team will not only save the cost and time by reducing the chances for mid-project redesigning but also avoid sub-optimal application quality. By making software testing your ‘mantra’ you will throw light on potential risks and surface functionality conflicts.

Step-4: Prioritize the ‘must have’ features and eradicate the ‘nice to have’ features

I’m sure that we all buy gadgets and do not use about 50% of the features, same is the case with software products! They have a lot of unessential functions that your target audience will never use. Such features increase the development time and maintenance cost, so make sure your product has the most viable features.

I advise you to start with a smaller chunk of money and create a basic product. Once it turns out to be profitable, you can always expand the functionalities of the product. This step will save your time and cost. Also, carry out a proper market research to determine and forecast what your clients are embracing about your product.

Popular Software Development Methodologies

A team picks a specific set of tools and procedures for design, testing, management, and other software development processes. These choices rely on the aim that stands before the team and the objectives of the product that is to be built. Here are the most well-known software development models that an experienced teams use:

Waterfall Model

JIRA Waterfall Model - Javatpoint

This model presumes that each stage is finished before the beginning of the next one. For instance, QA engineers begin testing solely after programming is totally done.

V-shaped Model

V-Shaped Model (Sami, 2012). | Download Scientific Diagram

It is a lot like the waterfall model with a slight contrast- that is the testing occurs simultaneously with the other major stride for software development process.

Incremental model

Incremental Model (Software Engineering) - javatpoint

This model is split into builds. It implies that the product is developed with discrete squares/parts. In other terms, it means that the product is built like an enigma.

Rapid App Development Model

Rapid application development - Wikiwand

In this model, the project development is split among small teams who work simultaneously.

Agile Model

Agile Model (Software Engineering) - javatpoint

It is a sort of incremental model where each delivery is focused on better software quality. This methodology is broadly spread amongst teams and customers as it displays consistent process and fast results. Time taken to each build can be measured by weeks rather than by months.

Why does Anteelo trust agile methodologies?

The agile software development process and its most popular methodology – scrum, give you an interactive and dynamic experience. Agile methodologies will give you the power to collaborate with customers, interact with individuals and stay in constant touch with the team working on your project and produce sustainable, profitable and successful products.

It is all about accelerating the process, making it more efficient, and responding to the real needs of your customers, even if it does not align with your initial plan. Agile does help you to go with the flow and move in one direction with the understanding that you’ll change course along the way because of the constantly evolving technology and requirements. Also, this is the reason why the agile approach is really effective when it comes to startups.

The Path to Success

The most important outcome of following the above SDLC phases is that it will give fluency to the project execution process. Understand that the SDLC can be structured to the needs of a particular project in order to deliver the best product possible.

Anteelo offers custom software application development processes. The Anteelo product development team accomplishes in understanding your product, designing and developing it, testing it, and finally constantly evolving it. We align lean principles in our software development process.

Lean development principles is an agile approach which was developed on lean manufacturing principles. We assist in discovering, designing, engineering and scaling up your product. We excel in customer satisfaction, cost effectiveness, and efficient workflows.

If you are searching for a reliable custom software development company that involves the latest technologies of the current time, then you should opt expert agencies or companies in your area like software development company USA, if you live in the US. But make sure you choose the best to get quality results.

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