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.
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.
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.
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!
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.
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.
Spotlight: How GynTools Chose a Software Development Company
GynTools developed Gyni™, a solution for enabling accurate self-diagnosis of Vaginitis within minutes. They were looking for a medical software development company that could quickly develop their prototypes. They needed a company that would accompany them throughout the entire process, including development, cybersecurity, information security, regulation compliance and bringing the product to FDA and CE approval.
GynTools chose Matrix Medika after reviewing a dozen suppliers. This decision was based on Medika’s vast experience in developing medical solutions in an agile manner. In addition, they were impressed with Medika’s ability to accompany them throughout the entire product lifecycle, from product requirements, the architecture, and finding a cloud solution, through web, mobile and device (firmware) development, and all the way to cyber security, regulatory and information security services – all in one place.
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!