How to verify the medical software product idea?
By Ewa Grudzińska
n the previous post I wrote about difficulties beginnings in medical software development. I focused on how to find a thread of understanding between IT and medicine representatives. But in this publication, I would like to raise the issue of the analysis of the idea, which is an attempt to assess if it has a chance of success. There are many business tools that can help – I will describe them later. To begin with, however, a few words of introduction.
If you are here, it means that you have probably already decided to deal with the subject of medical software. If you are starting your adventure with medical software and don’t know if your product idea is a hit, this post is for you.
Taking into account the current market trends, it seems a good idea to invest in the IT healthcare industry. Before we go to the next point I would like to mention what kind of software development is creating in the medical industry. First of all, we have to distinguish the differences between medical software development and healthcare software development.
Medical software has the potential to impact patient health, so it must be carefully designed and tested. This type of software typically requires a deep understanding of medical science and may be regulated by the Regulations for specific countries such as the: FDA (USA), MDR (UK), or MDD (Europe). The most common examples of medical software are electronic health records (EHRs), medical imaging software, and clinical decision support systems.
Healthcare software development refers to the software used to support the delivery of healthcare services. It can be used for a variety of purposes, such as scheduling appointments, managing patient records, and billing insurance companies. Examples of healthcare software include patient portal software, telemedicine software, and pharmacy management software. As you see the differences between both type of software development in the medical industry is huge. So it is good to know, which specific software is used.
An aging population and the increasing life expectancy of the inhabitants of developed countries mean that we increasingly need medical assistance and spend more on healthcare. A report prepared by Statista in 2018 on e-health shows that spending on digital health industry is still growing: in 2010 it amounted to 1.2 billion dollars, and in 2018 it was 14.6 billion dollars.
The percentage of digitized medical records is also increasing. According to data by HiMSS Europe (2018) , 73% of survey results are digitally archived in the surveyed sites. Therefore, as the number of digital data increases, the natural next step seems to be their further digital processing. But where to start and how to verify your idea?
Specify the vision and audience of your medical product
Creating a product vision is quite a creative task. It is good to prepare it in a team, preferably in an interdisciplinary team. This will allow different points of view of the same product to be taken into account. Think about exactly what your product is supposed to be. Who is it addressed to, what are the customer segments? Are they doctors, healthcare managers or patients? What are the needs of the customers to whom the project is addressed? What are its distinguishing features from the competition? Once we have answered these questions, it will be easier for us to plan ahead. For example, both an orthopedic surgeon and an X-ray machine manufacturing company may be a recipient of automatic bone fracture detection software for X-ray images. For both groups, different features of this product may be important and the sales model and communication with these customers will look different.
Identify opportunities in the medical market
Conducting market research is a complicated, lengthy and cost-intensive process, but it is worth doing at the beginning. Take into account information such as the size of a given market sector, development trends in that sector, product demand, market competition, customer preferences and opinions.
Even if we have a very limited budget, there are many ready-made studies that we can use for free to get the data we are interested in. The Internet is a mine of knowledge and it is worth using its resources. There is a plenty of sources that can provide information about the medical software industry, ex.: Deloitte reports, HIMSS Analytics, publicly available data from national health systems, reports commissioned by medical market leaders, data of NGOs dealing with particular diseases.
What resources do you need to develop a medical product?
Thinking about the resources needed and at least a preliminary answer to the question of whether we can provide them is another thing to think about at the beginning. It is worth answering here the question of what we will need to deliver the values we have defined in the product vision. It is necessary to take into account intellectual resources (competences, know-how), human resources (employees, partners), financial resources, as well as appropriate hardware, software and necessary medical data. Don’t forget to plan what you will need for clinical software verification.
Formal and legal aspects of your medical software idea
Medical software is a specific branch of software also due to the requirements and it is worth to get acquainted with them thoroughly. All medical devices introduced to the European market must meet the requirements of the Act on Medical Devices (from 26 May 2020 the Act will be replaced by the Regulation on Medical Devices), so as to ensure that they are safe for the patient. Medical devices that may expose the patient to danger must meet more stringent requirements than those that do not cause harmful effects. All devices must also be registered with the appropriate authority in each country.
The ISO EN 13485 standard, which is a standardised manual, details the standards we must satisfy for a specific product in order to be in compliance with the medical device regulation. There is also a number of detailed standards that specify the requirements for particular groups of medical devices. For example, the 62304 standard focuses on creating medical software and related processes.
Product Idea & Business Model Canvas
There are many ready-made tools that can help in creating a business model, probably the most widely used one, but the most proven one is the Business Model Canvas, which, step by step, allows you to analyze subsequent fragments of the model.
Below, you will find a sample template with instructions on how to fill it in. It is a model that we use in our work.
Click to enlarge image
To sum up, this post is not a ready recipe for success, but analyzing the above points and answering questions it is worth to delve into the topic and think about the described aspects in as much detail as possible. The more things you see now, the less of them will surprise you in the future when your product idea become real.
Contact us if you have any questions!
 HiMSS Europe (2018) https://europe.himssanalytics.org/
See the previous post: Minimum Viable Product (MVP) in IT healthcare – how to guide