Medical software is becoming an increasingly common solution in healthcare, making diagnosing and treating diseases easier. Thus, many manufacturers consider outsourcing medical software development. But you might ask yourself – is it not better to just hire an in-house team instead? Let’s discuss the benefits and drawbacks of outsourcing medical software development.

Medical software – what do we mean?

Medical software is software “intended to be used alone or in combination for the purpose specified in the definition of a medical device”. What does it mean? Think of medical software as software that can be used to diagnose, treat, or alleviate a disease.

Need some examples? You probably have heard of an app which helps patients with PTSD or through post-stroke rehabilitation. Medical software can also assist healthcare practitioners, for instance, in making diagnoses through AI-based analysis of blood test results.

If you read this article, you probably already have an idea for medical software. But how do you bring your plan to life? Let’s think about what steps are ahead of you.

Creating medical software includes stages such as:

• intended use definition,

• product design (functionality, target, potential design),

• software development (programming, testing, and documenting your app),

• certification (according to MDR or FDA standards),

• marketing (promoting, selling, and reimbursing your medical device).

Every step we have listed above is crucial and can’t be omitted. You will need expertise, resources, and knowledge for each of them. Thus, you might want to consider whether or not you should outsource the process of creating your medical software (or some steps) to an external company.

So what can you do to develop your medical software? Either hire an in-house team or outsource the process to the external company.

What does it mean to outsource medical software development?

Before we discuss pros and cons of in-house vs outsourcing, let’s consider what outsourced medical software development is. Simply put, outsourcing software services means contracting activities related to developing applications or software to an external company.

You can either outsource all the development processes, including product design, software development, and support through the certification, or just commission one of the processes, such as product design. It all depends on your needs and the services of the outsourcing company.

Furthermore, there are two main paths to outsourcing development of your medical software – team extension or project-based.

• Team extension means hiring professionals from the outsourcing company to collaborate with your existing team on the development process of a medical app. In doing so, they become a part of your QMS (Quality Management System).
• Project-based means that the whole team working on your medical app is outsourced and handles the commissioned project based on your requirements. Such a team follows QMS, which was established by the outsourcing company.

And what if you don’t want to outsource? You can hire an in-house team which will be working in your company developing your app.

So, what are the advantages and disadvantages of outsourcing your medical software development? Is it better or worse compared to hiring an in-house team?

Outsourced medical software development vs in-house – which one to choose?

Both outsourcing and in-house solutions have their strengths and weaknesses. We will give you a comprehensive overview of them so that you can make the best-informed decision for your medical software.

In-house development of medical software – pros and cons

It’s commonly believed that building an internal team responsible for the technological development of a company is a decision that guarantees cheap and safe project implementation.

Many arguments are behind this opinion. In-house solutions bring some benefits to your table. What are some of them?

1. Expertise on the inside of the company
   Once you create your team, you can be sure that you have experts working on your app inside your company. Thus, they are always when and where you need them to be.
   
2. Effortless communication among team members
   It’s much easier to communicate with your team if they are hired in-house. Not only can you quickly meet with them in your office, but it’s also easier to bond.
   
3. Common organisation’s culture
   All your employees are well-familiar with your company’s culture, so you are sure your values and mission are the same.
   
4. Direct management of your employees
   You can manage your employees effortlessly as they work for you, not external companies; thus, you can easily monitor their work.
   

On the one hand, you should be aware of the weaknesses of this solution:

1. Time-consuming process
   Hiring and introducing new employees to the company can be challenging, as it takes time, resources, and effort.
2. High costs of employment
   You need to ensure not only a fixed salary and systematically allocate funds for internal, but also external training, improving the soft skills and competencies of your employees.
   
3. Need to create a new work process
   Some of your employees can be familiar with developing medical software, and some don’t. What’s more, they might have different experiences in how the development process should look like. Thus, you have to create the work process from scratch. Setting up a proper process in place and making sure everybody follows usually takes months not weeks.
   
4. Challenging human resources aspects
   You have to put effort into maintaining an appropriate work environment but also deal with the emotional aspects of having to fire someone when they turn out not to be a good fit or when you have to cut costs.
   
5. Lack of skills and knowledge
   You will hire the experts, yet there might be some aspects they have to learn and some skills they must acquire in the field of medical software development. For example, knowledge of regulations in the U.S. or EU.  

Outsourcing medical software development – advantages and disadvantages

The other option you might consider is outsourcing your medical software development to an external company.

There are many advantages to this solution, such as:

1. Having an experienced team working on your app
   Companies specialising in medical software have already created some solutions like this, meaning they know what risks should be taken into consideration and what activities should be avoided.
   
2. Ready-to-apply work process
   With their experience comes the step-by-step work process of what to do, which can be instantly introduced to your project.
   
3. Detailed Quality Management System
   In an ideal scenario, companies that design medical software have taken the time to develop QMSs that are ISO 13485 compliant. Thus, you save time by not having to create such a system from scratch.
   
4. Risk-reduction of software’s malfunction
   If the company has experience in developing similar software and follows the recommendations set out in ISO and IEC you gain certainty of achieving the desired results.
   
5. Wide choice of experts and talents
   Outsourcing software development allows you to choose from many companies operating worldwide and go with the one that provides you with the best offer tailored precisely to your needs.
   
6. Cost-effectiveness of the project
   An external company can outline the costs of creating your medical app at the beginning of your cooperation. What’s more, they will take the budget control off your shoulders.
   
7. Shorter time of developing your medical software
   Because of the company’s experience and proven plan, the development time may be shorter than if you had handled it yourself.
   
8. Best of experts working for you
   External companies hire the best of the best as they can afford a slower, more comprehensive recruitment process. What’s more, such companies launch several projects a year; thus, their specialists have experience in developing diverse medical software devices.
   
9. International specialists at your fingertips
   Speaking of experts, outsourcing allows you to hire suppliers from a different country (ideally with the best price-quality ratio), as most tasks can be carried out remotely.

Of course, outsourcing isn’t just sunshine and rainbows. There are also some downsides to it, such as:

1. Scarcity of job control
   As you outsource the work, you can’t observe everything the company’s employees do. Thus, you might fear about the quality of the job. However, you have probably chosen a company based on the good opinions of their other clients, which minimises the risk. Moreover, you can always count on regular updates from the outsourced team responsible for your medical software.
2. Lack of own experts
   Relying on the external company is easy, but on the other hand, you don’t hire experts inside your own company. Thus, you don’t gather skills, resources, and knowledge inside your organisation.
3. Intellectual Property is created externally
   When you outsource medical software development, your intellectual property is created externally. Therefore, you might want to prepare a detailed contract in which you will include information on future usage and ownership of the code.
4. The risk of hiring a non-medical service provider
   There is a risk that you will hire a company that doesn’t have experience in developing medical software that is compliant with MDR. The worst-case scenario is a lack of compliance and the need to rewrite everything from scratch. 

To sum up, working with a software development company gives you a lot of flexibility, provides you with time- and cost-efficient solutions, and allows you to use the knowledge of the top experts.

How to choose a company for outsourcing medical software development?

Outsourcing, while bringing many benefits that we have mentioned, unfortunately, can also cause problems. This happens when you find an unreliable partner. So, before you decide to cooperate, it’s worth verifying the software company you are considering working with. What should you take into account?

Experience of the company

Software houses usually share information about their past projects. You can find them on their website or social media. We encourage you to read about their implementations and learn if they have worked on a similar project to yours.

It’s also always a good practice to contact the company and ask about their experience. Maybe they will share some case studies with you?

Good reviews

Try to learn what other people think about the company you consider for cooperation. Do they have positive reviews? Have they won any prizes? 

Maybe you could look for some testimonials or (even better) contact some of the outsourcing company’s past clients to learn more about their experience with this particular company.

Compliance with international standards

In the European Union, there is a demand for medical software to be developed according to some standards, such as MDR (Medical Device Regulation) or ISO 13485.

To be more precise, if an outsourcing company develops your medical software, it will be referred to as a “critical supplier” in the MDR documentation. If this company is ISO 13485 certified, it may be considered a critical supplier without an additional audit conducted by a notified body.

We encourage you to check if the outsourcing company develops software in compliance with ISO 13485 and other standards (e.g., IEC 62304). Thanks to this, your app certification process will be easier.

Answers your business needs

If you haven’t yet written down your needs and expectations for the outsourcing company, now is the time to do so. This way, you will be able to check if the software company meets your needs in terms of availability, budget, process compliance, technological stack, and business culture.

Values and system work

Some companies write about their mission and values. So you probably should read them and learn if you have a similar way of seeing things when it comes to work ethic and developing medical software.

This way, you avoid misunderstandings. What’s more, communication runs smoothly without any downtime. If it’s possible, it’s worth meeting your potential partner face to face (or at least over a virtual coffee) before you start working together.

How to begin with outsourcing medical software development?

Well, it all usually starts with a simple conversation.

You can begin your cooperation with your chosen software development company with a quick discovery workshop (compared to the whole app development process). It will help you decide if you enjoy working with them and are a good fit for one another. If nothing else, you’ll end up with a better idea of what your app should look like, including a UX design or a prototype.

At Revolve Healthcare, we firmly believe in developing medical software that meets your needs but is also created with your patient in mind. We develop medical software in compliance with ISO 13485 and following the MDR standards.

We would be happy to discuss your project and the possibility of outsourcing your medical software. During a free discovery meeting, we can get to know each other, learn about your needs and answer any questions you may have. Contact us or learn more about our services.