Software as a Medical Device
Medical Device. Photo by Lucas Vasques on Unsplash

The medical device industry is growing all the time. As our understanding of technology continues to develop and knowledge of effective healthcare methods continues to grow, so do the medical devices that help provide patient care.

For those who develop these medical devices, it is imperative that they marry the technology to the healthcare purpose of the device so that it assists in providing the best patient care possible. In an industry where a device working properly can mean the difference between life and death, the effectiveness of these devices is paramount.

Below we will review some best practices for ensuring a medical device works as intended. These are five important issues to keep in mind during the development process so that the devices produced are up to the challenges the healthcare industry presents. Here are five factors in creating an effective medical device.

1. Understand Your End-User

The world of devices is incredibly broad: large and small devices, simple and complicated devices, devices meant to be used in all different aspects of the healthcare industry. With so many medical devices, there is no one-size-fits-all set of standards for each device.

The key for developers is to put themselves in the shoes of the end-user. This end-user could be a doctor, a nurse, an administrator, a patient, or a subsection or combination of these categories. Creating an effective medical device means identifying who is this user, identifying the pain points, and creating a device that will help meet these needs.

Market research is critical to understanding the end-user. Like any product, a medical device will only be successful if it meets an unmet need for users. One of the first steps in medical device development should involve painting a comprehensive picture of the average end-user so that at every step along the way in the development, you can check in with this fictitious user and make sure the device is meeting their needs.

2. Create a Detailed Plan

Two of the biggest questions in developing a medical device are how long will it take to develop and how much will it cost. To be an effective device that gets to users in a timely and cost-effective manner, staying on-time and on-budget is a necessity.

One way to stay on-time and on-budget is to create a development plan. The plan must describe the several steps the product will go through before it gets to market. When you know the steps, you can estimate the time and cost and create benchmarks to meet.

The steps of the plan will differ from company to company and device to device but there is a general blueprint to follow. These steps should include some variation of researching and gathering information, creating the product, testing and refining, and finally delivering to the end-users.

3. Have a Robust Quality Assurance Process

Quality assurance is vital in developing any product but with a medical device, it is even more important. These devices may be used in high-pressure situations or to monitor, prevent, cure, or otherwise help care for people’s health. Accuracy, precision, reliability, and overall quality are essential and these features all start with quality assurance.

Quality assurance must permeate the entire process of creating medical devices. A good example of the high-level quality assurance processes that must be implemented is IQ OQ PQ. As Dickson explains here IQ OQ PQ principles represent the medical device industry standard for quality assurance.

This is a quality assurance process for qualifying the equipment used to produce medical devices. Installation qualification (IQ) starts the process by verifying a piece of equipment has the proper specs to do the job right. Operations qualification (OQ) follows and confirms that the equipment will work as part of the process under simulated conditions. The last step, performance qualification (PQ), stresses the equipment to establish parameters of operation and gain an understanding of how conditions will affect the final product.

4. Keep Security Top of Mind

The unfortunate truth about any technology nowadays is that developers have to be keenly aware of security. This is especially true of any medical device that is connected to the internet.  Cyberattacks on medical devices are growing at an alarming rate, so to create an effective medical device today, the security of that device must always be front and center.

Many medical devices these days gather a host of sensitive personal health data. It is important to secure this data not only out of an obligation to patients but also because not doing so can create major HIPAA violations, running afoul of the U.S. Food and Drug Administration (FDA), or result in fines or worse for healthcare providers.

Effective medical devices in 2020 must include the latest in cybersecurity. Protecting devices from hackers is something that should be baked into every layer of the technology that makes a device work. Physical security concerns should be addressed, too, so that devices cannot be tampered with in-person either.

5. Focus on Software

The majority of medical devices in the 21st century will rely heavily on software in order to perform tasks. This can come in the form of Software in a Medical Device (SiMD) or the device itself can even just be software as is the case in Software as a Medical Device (SaMD). However, the software comes into play, it will be essential to the device’s effectiveness.

Medical device software should be user-friendly and secure which dovetails nicely with two of the previously discussed factors. It should also be easily updatable to speed up the feedback loop for the device.


Software that can be quickly and easily updated gives devices the advantage of continuous improvement. Developers can get feedback almost in real-time and make the needed updates to improve device function. This quick and continuous improvement will make devices much more effective than those of past generations.


Keeping these five factors in mind will help medical device developers create effective devices. Understanding the user, creating a plan, implementing quality assurance, and creating secure software-driven devices will all help in the process and aid in achieving the end goal: providing a medical device that will improve the healthcare landscape.



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