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Medical device software now drives the core of digital health. AI powers diagnostics, IoT connects patients to providers, and real-time data shifts care from reactive to predictive. According to recent statistics, the global SaMD market is projected to grow from $2.77 billion in 2024 to $52.87 billion by 2033 at a compound annual growth rate (CAGR) of 38.4%. The U.S. advances rapidly with FDA pathways designed for speed, while Europe maintains a GDPR-compliant digital health infrastructure, holding a 30% global market share.

Nevertheless, the future is bright for SaMD; it has benefits and challenges. Let's dive into the meaning of medical device software development, including the steps and types.

What Is Medical Device Software Development?

Medical device software development refers to designing, creating, testing, and maintaining software that is integral to the functionality of medical devices or operates as a standalone medical device. This software must meet strict regulations for safety and accuracy, including those from the FDA, MDR, and ISO 13485. 

Who Benefits from Medical Device Software Development

Demand for medical device software spans many sectors. Let's explore the industries leading the way.

Healthcare Providers

Real-time patient data helps providers make sharper decisions and diagnoses. Automation reduces manual errors and allows staff to focus on care. AI and IoT add efficiency and enable remote, personalized treatment. This delivers faster, safer care while cutting costs.

Medical Device Manufacturers

Medical device manufacturers use software to automate quality control and ensure compliance with regulations. Real-time monitoring reduces errors and helps make proactive adjustments. Scalable updates future-proof devices, while ERP systems improve supply chains, reduce costs, and accelerate time-to-market.

Pharmaceutical Companies

Pharma firms cut trial costs via wearables, automate drug production with digital batch records, and monetize AI-powered SaMD apps that improve adherence. Real-time monitoring speeds up approvals, while AI-driven data tailors therapies and unlocks revenue from digital treatments and SaaS models, sharpening efficiency and market edge.

Telemedicine Providers

Telemedicine thrives in video conferencing and remote monitoring, particularly in underserved areas. Yet, it needs specialized software to connect with medical devices for remote diagnosis, monitoring, and treatment. Modern medical device software improves access to care, diagnostic accuracy, patient engagement, and chronic disease management while also helping reduce hospital readmissions.

Biotech Companies

Biotech companies use medical device software to process complex biological data, speed up drug discovery, and perform diagnostics. Custom tools automate tasks while ensuring compliance with FDA and HIPAA regulations, reducing risk. The result? This tech drives innovation, cuts costs, and accelerates the development of market-ready biotech products.

Clinical Research Organizations (CROs)

CROs gain efficiency and accuracy through automated data handling in device trials. Better data management and real-time monitoring improve trial quality and speed. This leads to faster market entry, reduced costs, and ensured regulatory compliance.

Research and Development Laboratories

Medical device software transforms R&D labs. Thus, teams automate tasks, use AI for sharper data analysis, and lock in compliance from day one. As a result, labs hit faster diagnostics, therapies, and disease control breakthroughs without slowdowns.

Advantages of Software Development for Medical Devices

Software is the new heartbeat of healthcare, making devices smarter, faster, and more efficient. Better outcomes and lower costs are just the beginning. Discover the full positive impact below.

Increased diagnostic accuracy

Medical device software improves diagnostic precision through advanced data analysis techniques. Algorithms detect subtle patterns humans might miss, especially in imaging and laboratory results. Machine learning models continually refine their accuracy by analyzing millions of patient cases, significantly reducing error rates.

In practice, whole-slide imaging in digital pathology achieves a diagnostic concordance of 96.5%, matching that of traditional light microscopy. AI models like GPT-4 show pooled diagnostic accuracy of 52.1%, on par with non-expert physicians but still below experts by 15.8%

Process automation

Automation eliminates repetitive tasks, reduces errors, and allows medical staff to focus on patients. The software handles everything from scheduling to medication management, reducing costs while boosting efficiency. Hospitals report significant time savings and happier staff after implementing automated systems.

Real-time patient monitoring

Connected devices track vital signs without constant staff presence. The software alerts doctors when readings breach safe thresholds for immediate intervention. This capability saves lives in ICUs and helps patients with unpredictable chronic conditions.

Integration with medical systems

Medical software integrates with hospital databases, electronic health records, and laboratory systems. This eliminates data silos and ensures all providers see complete patient information. System interoperability reduces duplicate data entry and lowers the risk of transcription errors.

For instance, integrated medical software reduces duplicate data entry by 30% and transcription errors by over 50%. Hospitals with connected EHR and lab systems report a 25% boost in care coordination and faster clinical decisions.

Regulatory compliance

Built-in audit trails, access controls, and encryption protect patient data while meeting legal medical device software standards. These safeguards prevent costly violations and data breaches that damage trust and finances.

Flexibility and scalability

Medical software adapts to changing needs through modular design and cloud deployment. Solutions scale from single clinics to hospital networks without performance loss. Providers start with core functions and expand as requirements evolve.

Remote access and telemedicine

Telemedicine breaks geographical barriers to healthcare delivery. Remote monitoring enables home recovery while maintaining professional oversight. These systems maintain care continuity during emergencies when facilities reach capacity.

Cost reduction

Software-driven automation delivers significant savings through improved efficiency. Predictive maintenance prevents equipment failures and reduces downtime. Digital transformation reduces administrative overhead, with hospitals reporting a 30% decrease in operational costs. 

Improved user experience

Intuitive interfaces cut training needs and boost adoption among medical staff. Human-centered medical device software design makes complex technology accessible to everyone. Patient apps improve treatment adherence with simple instructions and timely reminders.

Support for analytics and AI

Analytics transform medical data into actionable insights for treatment. AI identifies high-risk patients before acute episodes occur. Machine learning models continually improve with new clinical data, keeping recommendations updated with medical advances.

Key Aspects to Consider in Medical Device Software Development

Medical device software revolutionizes healthcare, but building it is no walk in the park. From regulations and compatibility to testing and ongoing maintenance, the stakes are high, and the margin for error is zero in medical device software development. Here's what matters most and saves lives.

Meeting Regulatory Standards

Regulatory compliance is non-negotiable. Developers must navigate a maze of standards from bodies like the FDA or EMA, which classify software based on risk and dictate the approval process. Whether it's a 510(k) or a PMA, getting them wrong can result in costly delays or outright rejection. Stay updated, plan for compliance from day one, and document everything—regulators love paperwork.

Ensuring Data Security and Privacy

Medical software handles sensitive patient data, which makes security a top priority. Encryption, secure authentication, and regular audits are must-haves to protect against breaches. HIPAA and GDPR aren't just guidelines—they're the law. One misstep can lead to hefty fines and a PR nightmare, so lock it down.

Designing for Usability and User-Centered Experience

If your software design for medical devices isn't user-friendly, it's a liability. Engage with doctors, nurses, or patients early and often to design interfaces that reduce errors and fit seamlessly into their workflows. Accessibility isn't optional—it's essential. A confusing UI can lead to misdiagnoses or delays, so make it intuitive and easy to use.

Ensuring Compatibility with Healthcare Systems

The software never lives in a vacuum. It must comply with EHRs, LIS, or PACS, using standards like HL7 or DICOM. Since interoperability isn't just a buzzword—it's how data flows smoothly in healthcare—build with flexibility in mind. Systems change, and your software should keep up.

Implementing Effective Risk Mitigation

Risk management is baked into medical software development. Use frameworks like ISO 14971 to identify hazards, assess risks, and implement controls to manage them. Plus, tools like FMEA help catch issues before they become disasters. In this field, an ounce of prevention is worth a pound of cure.

Thorough Testing and Quality Validation

From unit tests to clinical validation, every layer counts. Rigorous validation, covering unit, integration, system, and user acceptance testing, helps catch defects early. Include performance, security, and interoperability checks. Pay attention to documenting everything: regulators will demand proof.

Ongoing Maintenance and Software Enhancement

Launch day is just the beginning. Bugs, security patches, and new features require constant attention. Set up a robust post-market surveillance plan to catch issues early. Your software should evolve with healthcare, not fall behind.

Types of Medical Device Software

Based on hardware and regulatory integration, medical device software falls into two primary categories:

Embedded Software for Medical Systems (EMSSW)

This type of software is an integral part of medical devices, such as pacemakers, infusion pumps, and imaging machines. Embedded systems control device functions, ensuring they operate safely and effectively. It is not standalone software like desktop or mobile apps, and it cannot function without the hardware of the medical device.

Examples of Embedded Software for Medical Systems (EMSSW) are:

• Pulse oximeters.
• Smart bio-sensors.
• Glucometers.
• Electronic blood pressure sensors.
• Medical imaging devices, such as X-rays, MRIs, and CT scans.

Standalone Software as a Medical Device (SaMD)

Standalone Software as a Medical Device (SaMD) performs a medical function independently of dedicated hardware. Think algorithms spotting heart issues in ECGs or apps managing diabetes. Regulated by the FDA and EU MDR, it operates on phones, laptops, or clouds, slashing costs and supercharging care delivery.

Examples of Standalone Software as a Medical Device (SaMD):

• Patient imaging or scan analysis.
• Remote ECG-monitoring.
• MRI Viewing applications.

Steps in Medical Device Software Development

When lives depend on technology, there's no room for error. Follow the steps of medical device software development grounded in timeless principles: safety, usability, and trust.

Comprehend Regulatory Standards

Compliance encompasses global frameworks such as IEC 62304 (software lifecycle management) and ISO 13485 (quality management), as well as regional mandates, including FDA design controls in the U.S. and MDR/IVDR in the EU. Data privacy laws, such as HIPAA in the U.S. and GDPR in the EU, govern the handling of patient information. Developers must integrate these standards early, ensuring risk management, usability testing, and documentation meet audit requirements. A deep understanding of these rules prevents costly delays and ensures software reliability in clinical settings.

Conduct Market Research and Identify User Needs

Research market trends and competitors to define your software's unique value. To gather user needs, engage stakeholders, such as clinicians, patients, and administrators, through interviews or surveys. Translate these into clear use cases and functional requirements aligned with clinical workflows. 

Select an Experienced Development Partner

Choose a development partner with proven expertise in medical device software and IEC 62304 compliance. Ensure they understand relevant regulations, such as FDA or EU MDR, and can support submissions and audits. Verify their technical skills in areas such as embedded systems or AI, and confirm that they follow rigorous testing protocols. Prioritize clear communication and strong project management to meet your timeline and goals.

Development and System Integration

Adopt an iterative development approach, such as Agile, tailored to IEC 62304 to balance flexibility and traceability. Design a modular software architecture for scalability and integration with hardware or external systems, such as EHRs, using standards like HL7 or FHIR. Follow secure coding practices and document code for compliance. Integrate software with hardware or APIs, then conduct thorough verification and validation through unit, integration, and system testing to ensure safety and performance.

Deployment and Ongoing Monitoring

Prepare regulatory submissions, such as a 510(k) for the FDA or a Technical File for EU MDR, to gain market approval. Deploy the software in phases, starting with pilot testing in clinical settings to validate real-world performance, train users to ensure proper operation, and minimize errors. Implement post-market surveillance per ISO 13485 to monitor performance, collect feedback, and address adverse events. Use analytics to track usage and identify issues, such as cybersecurity threats.

Ongoing Support and Maintenance

Provide prompt bug fixes and updates to enhance functionality or security, ensuring compliance with regulations for significant changes. Offer user support through helpdesks or chatbots to resolve issues. Plan periodic upgrades to keep up with new clinical needs and technologies. Prepare for software end-of-life by managing data migration and complying with data retention rules.

How to Select the Best Medical Device Software Development Company for Your Project?

First, clearly define your project goals and requirements. List specific features like AI diagnostics or cloud integration, compliance needs (e.g., FDA, EU MDR), and budget constraints. Identify the target users, such as clinicians or patients, to guide usability expectations. This ensures you communicate precise needs to potential vendors.

Second, research companies with a proven track record in medical device software. Check portfolios for projects like remote monitoring or EHR-integrated tools. Review client feedback on platforms like Clutch or KLAS Research. Confirm their experience with regulatory approvals, such as ISO 13485 or CE marking.

Third, evaluate their regulatory expertise. Ask how they handle standards like HIPAA, IEC 62304, or FDA guidelines. Request examples of compliance documentation or successful submissions. Strong regulatory knowledge prevents delays and costly revisions.

Fourth, assess their technical capabilities. Verify expertise in your required tech stack, such as IoT, HL7/FHIR for interoperability, or secure cloud platforms like AWS. Ensure they can integrate with healthcare systems and support cross-platform development. Technical alignment reduces risks and boosts performance.

Fifth, prioritize cybersecurity expertise. Confirm they follow secure medical device software engineering practices like OWASP's S-SDLC and use encryption and authentication. Ask about their process for regular updates and vulnerability patches. Robust security protects patient data and builds trust.

Sixth, check their focus on user-centric design. Review examples of intuitive, compliant interfaces for medical devices. Ensure they conduct UX research to minimize user errors. A user-friendly design improves adoption and care outcomes.

Seventh, confirm their collaboration and transparency. Look for clear communication, detailed project plans, and methodologies such as Agile or Scrum. Request clarity on pricing, timelines, and milestones. Transparent collaboration aligns the project with your vision.

Eighth, compare costs while prioritizing value. Expect custom medical software to cost between $ 200,000 and $400,000, depending on its complexity. Ensure they offer scalable solutions and ongoing support. Choose a vendor that strikes a balance between quality and budget without compromising on standards.

Finally, shortlist 3-5 companies and request detailed proposals from them. Conduct interviews to assess their approach, certifications, and alignment with your goals. Select the partner with the best mix of expertise, reliability, and transparency. Sign a contract only after reviewing terms and ensuring mutual clarity.

The Future of Medical Device Software Development

Medical device software already stands at the cutting edge of healthcare innovation, driving massive change in how we diagnose and treat patients. Yet, with billions of dollars flowing into health tech and regulatory barriers easing, the future of medical device software development is bright for the coming years. 

AI and Machine Learning Integration

AI algorithms are already making waves in the medical device software sector. Predictive analytics and personalized treatments help spot patterns humans miss, delivering faster diagnoses and better outcomes. The tech now works across nearly every medical specialty, and the trends show it won't stop soon, only evolve.

Cybersecurity as Priority

Security doesn't leave the center stage as connected medical devices face sophisticated threats. Manufacturers now build in encryption, strong authentication, and continuous security monitoring from day one. Patient data protection matters as much as clinical functionality.

Edge Computing Implementation

Processing moves to the device itself, shortening wait times for essential procedures. The tech works even when networks fail, and it is a game-changer for implantables and wearables. Edge computing delivers real-time insights exactly when patients need them.

Interoperability Standards

The industry finally tackles its fragmentation problem with standards that work. FHIR and open APIs create true connectivity between previously siloed systems. The seamless data flow means better decisions based on complete patient records.

Sustainability and Scalability

Developers focus on energy-efficient software to extend the battery life of devices. Modular designs allow easy updates without replacing hardware. Cloud integration supports scaling for large patient populations. This reduces costs and environmental impact.

Regulatory Evolution

Regulators are finally catching up to tech innovation with more flexible frameworks. The FDA and international bodies now offer pre-certification pathways and real-world performance monitoring. Companies can innovate faster while still proving their products are safe.

Why Darly Solutions is Your Best Medical Device Software Partner?

No cookie-cutter code here. We're healthcare tech experts who solve real problems. For hospitals, clinics, and MedTech startups, we've delivered over 60 projects that handle messy data, strict compliance, and seamless integration.

Every solution is tailored, whether you're upgrading old systems or launching new ones. Our tech stack is healthcare-tested: secure, compliant, and built to last. Here's how we do it:

Our services cover:

• Custom software development for unique workflows.
• App development that works across devices.
• Cross-platform solutions to reach more patients.
• Automation services to slash admin time.
• UI/UX design that the medical staff actually uses.
• Integration services to connect legacy systems.

We build dashboards that act, not just display. Our scheduling tools cut admin work in half while keeping patients happy. Need e-prescribing or billing that's both secure and fast? We've done it reliably on a large scale.

Need experts who speak healthcare? Whether it's a whole managed IT team or project-specific help, we're here. Outsource your software development to us, and let's build tools that save time, money, and lives.

Conclusion

Medical device software development is more than code—it's about building tools that make healthcare smarter, safer, and faster. With the right partner, you get solutions that boost outcomes, cut costs, and keep you ahead of the curve. Darly Solutions brings deep healthcare expertise, proven results, and a relentless focus on real-world impact. If you're ready to transform your healthcare business, Darly Solutions is the team to trust.

Getting started with the ChatGPT 

Many of you have heard about Artificial Intelligence from OpenAI—ChatGPT. No wonder because all the social networks and the Internet, in general, are full of headlines about a newfangled tool that conquered the whole world with its capabilities. Before we give a more detailed description of this tool, let's go over the basics of this technological wonder.

To get started with the chat, you need to register in the system. The process is similar to registration in social networks and takes little time. And then, you just need to enter a request on the principle of communication with a live person. In fact, he can answer any of your questions, but keep in mind that the request must be accurate and precise. The robot will catch the context of the request and give you a text response.

The model uses a neural network architecture called a transformer, trained on a large corpus of text data. The transformer learns patterns and connections between words and phrases in the text data, which allows it to generate new connected and grammatically correct text.

ChatGPT is changing the world by making communication more accessible and efficient. Using natural language processing, it can understand language much higher than traditional methods. This means that ChatGPT-based chatbots can respond to users more naturally and human-likely.

ChatGPT areas of opportunity

OpenAi has transformed the digital world with ChatGPT. With it comes more and more opportunities for developers, marketers and designers, business owners, office workers, and others. The ability of AI chatbots to understand our language makes interacting with technology more accessible.

Let's look at ChatGPT areas where it can be most helpful:

Blogging

If you have a blog or plan to create one, this tool is handy. It helps you generate blog topics, rubrics, and texts for them. We recommend making additional edits to the generated texts to add individuality and better promotion in search engines.

Content marketing

Marketers can safely draw ideas and inspiration here with a well-formulated query to the system. This is not a panacea for all marketer's problems but a great helper for creating creative content or themes. It's essential to use GPT-generated content as a starting point and to carefully review and edit the text to ensure that it meets your standards and accurately represents your brand or message.

Chatbots

When a business needs to communicate with customers or effectively put the process of ordering goods or services—chatbots are the perfect solution to close this issue. Since chatbots and ChatGPT are identical, you'll have no problem incorporating them into your business. And the GPT tool will compose questions and answers for prospective conversations with your customer.

Trading 

It can collect market data to identify patterns and predict future market trends, analyze social media and news articles to determine market sentiment and identify potential risks in the market, which can be used to make strategic decisions to minimize losses and maximize profits.

Code writing

In addition to plain text, this chatroom can even write code for a program. Users have already tested it to write code for Angular, Python, and other developing technologies. And HTML/CSS is a piece of cake.

Incredible things that you can do with the help of ChatGPT

ChatGPT has revolutionized research and development with its idea generation, data analysis, and simulation creation capabilities. It can generate natural text that sounds like it is spoken by a human, providing personalized support in various sectors, from healthcare to customer service. In addition to these powerful features, ChatGPT offers excellent benefits for market research and automating tasks such as content creation or customer interaction on social media sites. Pretty impressive right?

The basic list of what you can create with it includes the following items: 

Text Generation

ChatGPT can generate human-like text of any complexity. It can be used to create creative works, scripts, articles, stories, poems, and other forms of text content. 

Translation to other languages

Just enter the desired text and specify a request for its translation with the specific parameters, if any, for translation.

Text Summarization

ChatGPT can summarize significant lengthy texts into shorter versions explaining the main points and thoughts. 

Ending a text

If you have a beginning of a text or a code, you can complete it in your desired direction by specifying this in the chat request. Be as specific as possible in your request, so the answer matches the expected result.

Answering questions

ChatGPT can answer questions based on the context you set, which is helpful for customer service chatbots. Also, it provides information on a wide range of topics.

So what's the bottom line: replace or implement?

In recent months, discussions about ChatGPT taking over all spheres and professions, which are somehow related to the content, have been raging on the Web. Such drastic changes will certainly not happen soon, and here's why:

• ChatGPT can be great for dealing with fundamental customer service issues and providing quick information, but more complex or sensitive issues require human involvement. Customers want a personalized experience, so real people answering their questions are still needed.

• ChatGPT can't provide a different level of empathy, judgment, and problem-solving than a human customer service representative. In addition, its responses are limited to pre-programmed scripts that need to be more flexible for different customer needs rather than people who can offer more adaptive solutions.

• ChatGPT can help improve customer service, but it will never replace the value of human interaction and expertise.
  

As AI continues to evolve, there will be an increasing need for individuals who can design, develop, and maintain these systems. AI also creates new job opportunities in data science, machine learning, and robotics. These jobs require specialized skills and knowledge that are in high demand. People may need to adapt to new roles that require more advanced skills, such as managing and maintaining AI systems.

That is why it makes sense to talk not about replacing the central employees with a chat room but introducing AI technology into the company. It should not be a substitute for specialists, but a technical addition, which will increase the work process's efficiency and help you find new ideas and rely on when making business decisions. Moreover, the chat cannot exist separately from the person because its system needs to be updated, cleaned, and worked with when necessary. There is a possibility of creating a collaboration of human and AI that significantly increases the productivity of any company.  

Summary

ChatGPT is a powerful and unique tool that can be incredibly useful in many contexts. However, as with any technology, it is essential to use it responsibly and to be critical of its limitations and potential biases. It has already brought significant benefits, such as increased efficiency and productivity, improved decision-making, and quality of life. 

In any case, we should not rely solely on the work of Artificial Intelligence. It is important to critically evaluate its results and format it to the necessary level. After all, no one has yet been able to recreate the human mind. So use this tool wisely, maximize work quality, and simplify your workflow. ChatGPT handles this perfectly.

In today's world, companies are actively seeking ways to automate and optimize their business processes with the help of software. When choosing how to implement such solutions, the question arises is whether to create custom software or buy a ready-made solution. Both approaches have their cons and pros, but each has its own application for a specific purpose. The final decision on the choice between these approaches will depend on the client's individual needs and the business goals.

Let's look at both approaches in more detail, which may help to choose favor of one of them.

Build custom software

The essence of this approach is that the company orders software product development from an IT company's specialized development team. It has a clear plan of action and a list of requirements for the future product. Also, a digital product created from scratch can fully automate specific business processes of the client company, taking into account the specifics of the industry.

Pros of the approach

Tailored to individual needs

The company will receive a solution fully customized to its unique needs and requirements. That can be registration forms, buttons, visual elements, individual blocks, custom graphics or dashboards, unique designs, and more. The company can also define the required functionality, architecture, design, and integration with other systems according to specific business processes.

Flexibility and scalability

The customer company controls the whole development process and can make changes and expansions as needed. That allows them to respond quickly to changes in business requirements and scale the system as the company grows.

Security 

Developers can implement data protection mechanisms and use advanced encryption methods to ensure high security in the finished system.

Ability to integrate

The development of a digital product from scratch provides the ability to fully integrate with the company's other systems. That allows for efficient data exchange between different systems and increases the overall efficiency of the client's company.

Ownership of intellectual property

The company has complete intellectual property rights associated with the created product. That gives the company control over it and the ability to develop and monetize it further.

Cons of the approach

High price

The development of any product usually requires a significant financial investment. A company must consider the cost of hiring experienced developers, conducting requirements analysis, designing, developing, testing, and supporting the product. That can lead to significant costs, especially for smaller companies with limited budgets. Nevertheless, a business development investment quickly pays off for the company. 

Development duration

Creating software is a lengthy process, especially for complex and large-scale projects. The time required for requirements analysis, design, development, and testing can be significant, which delays the implementation and use of the finished product in the business.

When a business needs custom development from scratch

Customized needs

If a company has unique business needs that cannot be met by ready-made solutions on the market, developing a customized digital product allows them to create a solution that fully meets the requirements and goals of the company.

Competitive advantage

A unique software solution created specifically for a company can provide more efficient and innovative functionality, an engaging user experience, or improved processes, which helps stand out in the market and attract new customers.

Long-term strategy

Instead of relying on third-party vendors and ready-made solutions, a company can create a product that it can control, develop and scale according to its needs and changes in the business.

Business process optimization

Specialized software allows companies to automate routine tasks, improve interaction between departments and increase the company's efficiency as a whole.

Buy ready-made solution

Ready-made software solution usually has a wide range of functionality that can be applied to various business tasks. That allows companies to save development time and start using the software almost immediately after purchase. When choosing a ready-made solution, a company should carefully evaluate its functionality and flexibility to ensure it meets its basic requirements.

Pros of the approach

Customizable functionality

That includes adding modules, integrating with other systems, and customizing program parameters. 

Time-saving

Digital turnkey products are already developed, tested, and ready to use. Purchasing this product saves the company's time they usually spend on requirements analysis, development, and testing solution.

Fast start-up

Ready-made digital products have already been developed and tested, allowing companies to use and benefit quickly. The company can quickly incorporate the product into its business processes and get results without waiting for development to be completed.

Low costs

Buying a ready-made digital product is usually cheaper than developing a solution from scratch. In this case, the company avoids the high costs of hiring developers, requirements analysis, and the development process, which can significantly reduce costs and improve budgetary performance.

Proven solution

Ready-made digital products are usually thoroughly tested and have a proven track record. By purchasing such a product, a company gets a proven solution that has already been used by other customers and has demonstrated its effectiveness.

Cons of the approach

Business process mismatch

The turnkey solution may not meet the company's exact needs or require additional customization and integration with existing systems. In some cases, the company may need help adapting the turnkey solution to specific business processes, which can result in a loss of time and resources.

Limited customization and integration

Ready-made digital products may offer limited customization and integration with other systems or applications to meet unique customer requirements, which may require additional modifications.

Vendor dependency

Buying a ready-made product can create dependence on the supplier of that product. The company will rely on the vendor for support, updates, and bug fixes if any are encountered. If the vendor is unable or unwilling to continue to develop and support the product, the company may find itself in a quandary.

High licensing costs

Buying a ready-made solution can incur significant licensing costs, especially if the company plans to use the product on several workstations or for a large number of users. That can impact the company's budget and reduce financial efficiency.

When a business needs to buy a ready-made digital solution

Urgency

When a company has urgent needs for a specific functional solution, buying a ready-made product can quickly meet those needs. That is especially true if there is no time or resources to develop their solution.

Limited budget

If a company has a limited budget to develop its digital solution, buying a ready-made product can be more cost-effective. It avoids the cost of development and hiring developers and reduces the risks associated with budget and development time.

No need for unique features

Buying a ready-made digital solution may be enough if a company doesn't require specific features and capabilities only available when developing its solution. If the solution offers all the features the company needs, it can avoid developing and testing its product.

Narrow specialization 

Some industries have specialized, ready-made digital solutions designed for specific vertical markets or industries. In such cases, buying such a solution specifically tailored to the needs of an enterprise may be preferable because it already meets that industry's specific requirements and standards.

Summary

Ultimately, choosing between creating custom software and buying a ready-made solution depends on a company's specific needs and goals. If a company has unique business processes or needs full software customization, custom software creation may be preferable. That will allow the company to get a solution that best meets its requirements and contributes to optimizing business processes.

However, ready-made software may be the best option if a company requires a faster, more cost-effective solution. It is essential to carefully study the market for this kind of solution to choose the one that best meets the company's needs and is flexible enough to adapt to individual requirements. It's also important to consider company resources, budget, and timeline.

Ideally, companies can combine both approaches, using ready-made solutions as a foundation and complementing them with custom development to meet unique needs. For example, a company might purchase an off-the-shelf customer relationship management (CRM) system and complete it with the custom development of a module specific to its industry or business process. That strikes a balance between efficiency and flexibility.