With the myriad of challenges facing healthcare systems, technology is proving to be a huge asset in solving those problems. Cloud connectivity is one such technology becoming an enabler of digital health. Connected medical devices have already been proven to improve clinical efficacy, reduce clinical errors, and provide cost savings to users.
There are plenty of good reasons for medical device companies to make the shift to connectivity, and potential rewards to the company for doing so. Being able to create new services and tap into new markets are just two of those possibilities But one thing medical device manufacturers often lack is the required FDA knowledge, technical expertise, or even internal resources to create these sorts of solutions. Also, building the required connectivity infrastructure, and meeting the regulations can be very costly to the company. Creating a connectivity solution from scratch can add new risks to the project, which not all companies are in a position to take on.
Connecting with a third-party partner in order to provide the connectivity platform for your medical device is a great option to mitigate some of those risks and costs. However, before you select an outside partner, there are six essential questions you should ask:
1. Is the solution compliant?
Does the connectivity platform meet regulatory requirements? The platform should also comply with international standards that are generally used for medical device design. For many medical device companies, dealing with the regulatory world can be confusing and worrisome. There is a need to familiarize with the regulations and guidelines involved, then interpret how those apply. Many aspects of FDA guidelines, for example, can be open to interpretation. It certainly helps if a third-party has already done the work of applying the regulatory requirements and getting approval for their platform.
2. Is the solution cloud-based?
Connectivity to the cloud allows the solution to be more scalable overall. It is also a more cost-effective solution due to lower underlying infrastructure costs. It also gives you more options for other services like machine learning, image/video analysis, big data computing, notifications etc., and the ability to access the system from anywhere. It is very difficult to replicate this outside of the cloud. More benefits include offloading security requirements, rapidly deploying any necessary updates, improved collaboration, and data recovery.
3. Is the solution compliant with privacy requirements?
Devices must be compliant with various laws depending on the country they’re being used in. In the U.S., devices must comply with HIPAA, which requires you to ensure that data is access controlled, that access is logged, and that only the people who need it have access to the data. You are also obliged to ensure that data is not being stolen and that you have procedures and policies in place to protect the data.
4. Is security appropriate?
This is probably the most important factor to look into. Anything going into the cloud opens up a potential security issue. This can be managed, but the solution you use needs to have the right controls and tools in place. For example, platforms should use the right encryption of data-in-transit, encryption in storage, encrypting passwords, and any kind of sensitive data. Privileges need to be managed, data needs to be backed up, and security audits need to be happening regularly. Firewalls need to be regularly updated, and the separation of data and the application needs to be addressed. The bottom line is that you have to be able to trust that a third-party provider has your back when it comes to security. No medical device company wants to deal with fall-out as a result of a data breach.
5. Does the platform provide the right features?
Most medical device companies are looking to scale. This means that what features you need today may change tomorrow. It’s important to find a platform that has the right features to fit both of those needs. A platform that grows with you is ideal as you really don’t want to have to retool later. This is an efficient approach to meeting your needs. When thinking about features you might need, think about the following:
- Machine learning or artificial intelligence
- Tools for data analysis
- Visualization widgets
- Capabilities for predictive analysis
- Configurable views for different stakeholders (doctors, administrative staff, patients, potentially family members of patients)
- A smooth user experience to get to the data you need
6. Is the solution managed?
If you have to do the management of the solution yourself, including operating servers and ensuring data is backed-up, make sure you’re aware of the number of resources (time, talent, expertise) this requires. A managed solution allows you to offload this sort of technical management. All operational aspects, such as security, privacy, monitoring, and backups get done by the third-party platform.If you’re using a third-party platform management system, be sure to consider product support. Does the platform have a good, responsive support function? If you experience any issues, you need to be sure that someone will be able to help you promptly.
If you’re looking for a platform solution for connecting your medical device, compliance and security are going to be your most major considerations, followed by the actual features and whether the solution is managed. Utilizing a third-party provider will help you manage those concerns easier.
About Abbas Dhilawala:
Abbas has over 13 years of experience developing enterprise-grade software for the medical device industry. He is well versed with technology and industry standards regulating security and privacy of data. His expertise lies in programming, cloud, cybersecurity, data storage, and regulated medical device software.
About Galen Data:
Galen Data provides a turn-key, compliant software platform for device-to-cloud connectivity and data analysis that is compliant to FDA, HIPAA, CE Mark standards.