Healthcare costs around the world are on the rise. According to the Organisation for Economic Co-operation and Development (OEDC), health expenditure over the next 15 years is set to reach 10.2% of GDP by 2030. But without timely action, a sizeable portion of this expenditure is likely to be wasted — in the US alone, $700bn in healthcare spending is squandered yearly. By embracing medical device interoperability, healthcare authorities can reverse this trend and invest more in patient care.
But before exploring this further, it makes sense to define medical device interoperability. Put simply, medical device interoperability is the ability to exchange data across devices, products, technologies and systems.
Better patient outcomes
Connectivity matters more than ever in a world where devices ‘speak’ to each other all the time. But just as importantly, Healthcare interoperability can also improve patient care, reduce errors and encourage innovation.
A true story provides a good illustration. Several years ago a patient was admitted to hospital, treated and released. It turned out that the patient was prescribed a treatment in hospital that contraindicated for a comorbid condition. If the patient had stayed on this treatment, he would have almost certainly died. Fortunately, in this case, the healthcare system had developed an interface for their hospitals that allowed reports to be pushed directly to a physician’s electronic medical record (EMR). This meant that the patient’s physician was able to receive a report from the hospital the day the patient was discharged and was able to stop the medication.
It goes to show how important accurate data is for medical assessments. And with medical errors contributing to 9.5% of deaths in the US alone, this has become a pressing issue. Interoperability solutions can reduce the risk by giving clinicians access to data at the point of care.
A boost to innovation
Lastly, there is a direct connection between healthcare interoperability and innovation. Better access to patient data can aid in more accurate treatments. With access to connected medical devices, clinicians can also prevent unnecessary hospital admissions and ensure care is delivered at the right time and place.
It’s clear that interoperability brings huge benefits to healthcare. So what factors should be taken into account when developing medical devices for this market?
Classification is key
The first factor to consider is classification. Manufacturers must follow distinct processes to classify their products as interoperable medical devices. The system established by the US Food and Drug Administration (FDA) is typical. It makes clear that the intended use of a medical device needs to be clarified in an “intended purpose” document. But that’s not all. Every market has its own product definition, so manufacturers must also ensure that the intended purpose of a product aligns with these requirements.
Interoperability should be a priority
Standards relating to interoperability must also be followed. Let’s say a company is designing a connected medical device that transfers patient-driven data into a physician’s electronic medical records (EMR) system. The data would need to be received using healthcare data interoperability standards like HLZ v2 or FHIR otherwise the product would not be fit for purpose.
Implementing product updates
Interoperable medical devices can also throw up unforeseen challenges for manufacturers. There may be a necessity to upgrade software or patch security vulnerabilities, which is why flexibility should be baked into any product.
As long as the changes do not alter the intended purpose of the product there shouldn’t be any need for re-certification. For example, a business may choose to update a library that operates a piece of software without changing the interface. In this instance, the product would not need to be recertified unless there was a significant change to the solution.
With Star’s experience bringing innovative medical devices to market, we can help you handle these challenges. Star’s HealthTech technology consulting team can determine what approach best suits your short and long-term goals. Whatever approach you choose to take, Star consultancy services are ready to give you guidance and a strong roadmap for building connected medical devices.
