By 2025, it is forecasted by Fortunebusinessinsights that the global market size of medical devices will reach $612.7 bn. Undoubtedly, medical devices provide many benefits to patients and help healthcare practitioners diagnose and treat people in the most efficient way. The success of medical device market growth is caused mainly by the boost of surgical procedures and the rising number of chronic diseases. 

medical devices market size

The increasing investments in medical device development is a result of rapid technological innovations, which allow for the manufacturing of smart next-gen products for healthcare. Despite the growth in medical device manufacturing, the ease of adoption remains a problem. It especially happens because of low-security risks associated with malware attacks and various breaches to medical device software and patient sensitive data. 

Due to a great number of potential risks and threats, which arise in any type of software development, manufacturers of medical devices should consider all the pitfalls beforehand. Thus, a lot of companies decide to outsource medical device development to professional software engineers who have expertise and experience in the healthcare industry. Usually, these experts are skilled enough to prevent possible problems. However, it is crucial to be prepared for such cooperation and know the simplest rules. 

How to assess all the risks? Use the right risk management software.

What is medical device outsourcing?

According to the recent data, medical devices outsourcing market is expected to grow up to $208.36 bn. by 2026. Medical device outsourcing is delegating the development of device hardware, software, or middleware to the third party that is more qualified and experienced in healthcare devices engineering. Traditionally, the reasons for outsourcing are lower costs, higher expertise, and the ability to focus on industrial development without distracting from concentrating on the core business. 

The industry of medical devices produces millions of products that range from simple gloves for surgery to AI-powered imaging equipment. New technology adds value to the table when it comes to providing high-quality diagnostics and treatment. A lot of companies are engaged in research and development of new devices. In the conditions of frequent changes and a continually growing number of innovations, it is crucial to know the key pillars of medical device outsourcing. 

What medical device development services can you get?

Medical devices are developed both by small and large companies. The latter develop mainly devices while the former ones are focused on the development of special software. Traditionally, small companies are considered to be start-ups funded by venture capital organizations that plan to get some profit in case a company produces a promising product. However, very often the development is outsourced because professional medical device software development companies can guarantee the success of the project. 

medical device development services

So, what are the advantages of outsourcing services? By delegating medical device development to a third party, you get the following benefits: 

  • Gaining a competitive edge amongst other manufacturers by implementing the latest technology advancements.
  • Acquiring testing services, proof of concept, value chain mapping services to validate the project idea or the quality of the product.
  • Focusing on core business activities. 

What services are provided? We gathered the most frequent services offered for medical device development that very often coincide with the stages of development:

Defining requirements and designing the architecture

Architects gather all the initial requirements to build a product with high performance that complies with all the regulations. Regulatory compliance as a service is a relatively new direction in software development. It means that the outsourcing provider ensures that the product will adhere to all the policies and regulations. This service is one of the stages of medical device development when all functional and non-functional requirements are collected. During this stage, software architects consider all possible security risks and issues.  


Verifying the feasibility of the project is very critical during the first phases of medical device development. You can use any of the provided services like value chain mapping, prototyping, and proof of concept. 

Design and development

Whether you need software or a physical device, the design is all about how your product will look like and how interactive it will be with users. 

Launch and realization

When the idea is verified, the design is agreed, and the product is ready, the project team can start manufacturing the parts of the device or launching the software. 


Once the parts are ready, expert technicians can assemble them into a single system for further testing of all the functionalities. In the case of software or middleware development, the product can be seamlessly integrated with the existing systems.

Producing a small series of devices or Minimum Viable Product (MVP)

 If you need to validate the concept of your project, you can order the manufacturing of a small number of medical devices. Similarly, if you need to test how software for medical devices works, you should ask for MVP. It is a software product with a minimal set of functionalities and features aimed at testing how users will interact with the solution. 

Is it safe to outsource medical device software development?

Once you have set your medical device development plan, you might think about how it is safe to rely on offshore developers. Don’t be afraid! Below is a checklist that may come in handy for those who are about to outsource. Our experts from DICEUS have a vast experience in providing software development services for different horizontal and vertical markets. They prepared this list based on their experience in communicating and cooperating with clients from over 20 countries of the world. Below are our best practices and knowledge that we kindly share with you.

Expertise and experience

Your outsourcing experience mustn’t be a fluke. You should carefully choose an outsourcing partner based on their expertise and experience in the healthcare domain. Thus, look for those companies that have relevant competency and needed skills to accomplish your project. The first thing to pay attention to is the past experience, i.e. the similar projects completed by a potential vendor. Where to look for those? You could ask a vendor directly for some presentation of the relevant cases or search on their website. Most of the software providers have profiles on trusted ranking and listings websites like Clutch or Good Firms. 


Many projects fail because of incomplete requirements, poor communication between a customer and a vendor, inconsistency in project management, and many other reasons. How to evaluate the quality of the provided services, the final product, and the project in general? Before striking a deal, negotiate the quality issues. What you should know about it is that professional developers use special metrics and checklists to plan the project, evaluate the performance and monitor the progress. Ask a potential vendor to provide you with the metrics they use. Hence, you will make sure that the quality will be appropriately assessed, documented, and reported to you as a customer on a regular basis. 


By reaching out to the outsourcing providers, you should be aware of the fact that they work not only with you. Depending on the company’s size, they may have dozens of customers and projects, respectively. However, you must make clear how project management is organized. Scrum medical device development is one of the fastest ways to effectively build software for healthcare. In the picture below, you see that the tasks are assigned from the product backlog, then prioritized, and put to the sprint planning. Traditionally, one sprint lasts about 2 weeks, the progress is discussed at a daily scrum meeting to share the status and identify all the issues. The sprint is ended with a comprehensive review by all the stakeholders and ultimately, a sprint retrospective is held. 

agile in medical device development

Agile in medical device development is quite popular as it allows for a clear understanding of what’s going on. The customer can also track every change to timely react to it. 

Recently we developed the software part for the IoT-powered platform used for clinical trials. Check out the Shimmer case.

Tips on hiring the medical device development partner

Selecting developers or a manufacturer to produce a state-of-the-art solution for the medical devices market is hard, especially if you don’t know the basics of outsourcing. Let’s summarize what steps you should follow not to fail. 

  1. Define the initial requirements for the product very carefully. Make a detailed list of features and functionalities your product should have. Find some examples.  
  2. Think of what services you will need to get from a potential vendor. Probably, to get a fully workable solution, you will have to collaborate with multiple vendors.
  3. Consider your budget in advance. Conduct some research on the prices for medical device middleware development, software for healthcare, etc. 
  4. What risks must be taken into account once the project is being planned?

Once you collect all the requirements and understand what you need clearly, start looking for the companies with relevant expertise. The more precisely you define your expectations, the more detailed and challenges-focused proposals from potential vendors will be. 

How DICEUS can help you

DICEUS is the right place where outsourcing medical device manufacturing will be without any difficulties. We are an outsourcing partner to public and private clinics, medical centers, and hospitals. Our expert developers build solutions for personal healthcare as well. Below are areas of our expertise for healthcare:

  • Artificial Intelligence
  • IoT
  • Cloud computing
  • Big Data
  • Robotic Process Automation

DICEUS knows how outsourcing medical device manufacturing affects the financial part of your business and we are ready to share our insights. Devote 15-30 minutes of your time for free consulting on medical device software development.