An Essential Primer for Medical Device Makers Looking to Serve the Multi-Billion Dollar Global EHR Market with Cloud Connectivity
Part Three: Choosing the right connectivity platform and partner
In this three-part series we identify the opportunity for manufacturers to integrate their medical devices with EHR systems. Part One identified the opportunity, including market size potential. Part Two addressed three key areas impacting EHR performance (data management, workflow, compliance. In Part Three, we wrap it together by suggesting how to choose the right connectivity platform and partner.
Choosing the Right Connected Medical Device Platform: How Galen Data Can Help
The EHR market makes a strong business case for medical device cloud connectivity, but it’s nevertheless a complex undertaking. In making the decision to move forward, we advise you to consider the following:
As a manufacturer, you have two options for integrating cloud-based connectivity into your device: Build it Yourself or Partner with an Experienced Provider:
The development and implementation costs of building your own MDDS internally can run as much $500,000. Equally important, the needed resources and required expertise may divert you from your core competencies. In-house teams of engineers often lack important experience in healthcare interoperability – and how to implement device-to-EHR connectivity in a regulatory-compliant manner – making it a challenging task to get right the first time.
Working with an experienced MDDS (a Medical Device Data Systems) partner often makes much more sense from a cost and human resources perspective. With time-to-market a critical factor defining medical device success, relying on the demonstrated expertise of a cloud-connectivity partner such as Galen Data can potentially shrink commercialization timeline.
Features and Functionality
When outsourcing your cloud platform, vet a partner to ensure they can deliver:
- Customized branding integrates your product end to end
- A library of modules allowing for unique visualization and reporting
- Incorporate the algorithms your product needs with security and scalability
- Intuitive User Experience (UX) and Innovative User Interfaces (UI)
- Compliant to FDA, European MDR, and Health Canada regulations
- Adherence to HIPAA and EU General Data Protection Regulations (GDPR)
- Developed per FDA Design Controls, ISO 13485, IEC 62304, ISO 14971
- Active cyber security monitoring
- Encrypted transfer and storage of data
- Full Audit Trail for all changes
- Training and support for engineer and compliance teams
- Rapid turnaround
When contracting with an EHR system vendor, you will need to negotiate a relationship that gives you control of how medical data is collected and shared.
The more than 700 EHR vendors present a huge market potential for medical device manufacturers. But just as providers are having to adapt to a new model of care, so must device makers shift their focus. Device quality and cost can no longer be the exclusive drivers of their business. They need to position their products as healthcare delivery systems rather than stand-alone devices.
As we have discussed in this series, manufacturers must be ready to deliver connectivity and data analytics and modeling to help EHR vendors manage data, improve workflows and comply with regulatory requirements to fulfill the great promise of the Internet of Medical Things.