Thousands of startups are reshaping healthcare with groundbreaking digital medical devices and software that are improving healthcare quality. When developing a medical device, it’s important for companies to find the best medical software development company for their needs. But with so many companies out there: what’s the best way to choose? This blog post will provide eight parameters that will help you crystallize your requirements and identify the best software company for your product.
1) Experience in Medical Development
While there are many software development agencies and freelancers out there, developing a medical device is unique and unlike any other type of development. Medical software requires complying with strict regulations, being upheld to high security standards and getting approved by the FDA and CE. Therefore, it’s important to find a company that has experience and know-how in medical software development. Otherwise, you might find yourself having to go back to the drawing board when you think you’re at the finish line. This is costly and wasteful.
2) ISO-13485 Compliance
Choose a company that is ISO-13485 certified and can manage and execute the process accordingly.ISO-13485 defines the design and development standard of medical devices. To comply with ISO-13485, your medical development provider should work with you on a number of aspects, including PDR (Product and Development Review), SRS (software requirements specification), SDD (software design description), risk analysis, CDR (critical design review), STD (software test description), STR (software test results), traceability, documentation and more. Make sure you choose a company that knows how to manage this process.
3) Familiarity with Privacy Regulations
Healthcare devices are subject to strict privacy regulations like HIPAA and GDPR, which protect patients’ data. It’s important to make sure your software development company knows how to develop a product that complies with these standards. For example, how to protect patient data in the database and how to implement authentication.
A good company will also be able to advise you in the design process to ensure these regulations are kept. Like consulting you about not showing unnecessary patient information on a public-facing screen.This will prevent a lot of discomfort when engaging with the healthcare system.
4) Experience in Cyber Security
Cyber Security is important both for regulatory needs and also to protect your device and the patients and personnel who will be using it. Data encryption, risk analysis, and vulnerability scanning are a must – to name a few.
In addition, the FDA has recently added a compulsory penetration test (PT) report that needs to be submitted with the software. Therefore, it’s important to choose a company that knows how to:
- Develop a product that will pass a penetration test with minimal rejects
- Work with a PT supplier to run the test
- Be able to fix the code according to the PT results
- Submit the PT report to the FDA
For patient protection and to avoid data breaches, choose a company that has expertise in developing secure software from cyber attacks
5) FHIR Compliance
FHIR (Fast Healthcare Interoperability Resources) is a standard for individual healthcare platforms, applications, providers, and systems to communicate with each other and exchange information quickly and efficiently.
By developing in compliance with the FHIR standard, you will ensure better and faster market penetration of your device. So find a company that knows how to develop for FHIR without fear.
6) Speed and Agility
Thousands of startups are competing on the market, pushing ahead to get approved and trying to get their devices implemented in hospitals, clinics and doctors’ offices. Choose a company that works efficiently that is familiar with the industry standards, and that developer in a scrum model. Scrum will enable you to constantly be in the know about the features that are being developed, so you can influence them in real-time, and not when development is over. This will ensure you don’t waste time that could have helped you move forward to regulatory approval and market penetration.
Don’t be surprised at the end of the development process. Work with a company that is transparent with you throughout the process. Track tasks and development on tools like Jira, ClickUp or others, hold weekly or monthly meetings, and stay in the know throughout the entire process.
8) End-to-end Industry Knowledge
While most medical software development companies focus solely on development, some gems are familiar with the submission process, know how to design and can take on regulation monitoring as well. Such companies can save you a lot of time and energy instead of running back and forth between multiple suppliers. They can also provide consultation about risk management, cybersecurity, privacy, and more.
Choosing the right development company can be an intimidating process, but the right company will be able to guide you through the development, and provide a top-notch product that complies with all standards and passes regulatory requirements with flying colors. Take the guidelines above into consideration when choosing your company, and we hope to see you in the market soon!
About Medi Software
Medi Software is Israel’s leading provider of software development, regulation, and cybersecurity services for the healthcare industry. With over 100 successful projects under our belt, we have the experience and expertise to bring your product all the way to FDA and CE approval. Lets Talk!