Innovation in Medtech: harnessing “big data”

Big data – from electronic health records, bio-feedback from wearables and remote monitoring systems that communicate with medical implants – is changing how medical devices are created and designed.

MassDevice.com spoke to a pair of researchers at Battelle – David Giles, senior director of medical devices and health analytics and Stephanie Kute, platform lead for the Battelle analytics and health research team – about their experiences with big data and how it’s changing the world of medical devices.

According to the brains at Battelle, big data is in everyone’s hands. Devices are getting smarter, talking to each other and recording more information about us than ever before. But with innovation come important issues about privacy and information security, and questions about how to best use and operate in a world of data and statistics.

More and more, innovations are being gleaned from analytics, Giles told us. Recently, Battelle shifted the relationship between its analytics and clinical device development departments to make use of the emerging world of big data.

“Previously we had a clinical device development group and we had an advanced analytics group, and those were separate groups that would reach out to each other occasionally. But now, we’ve found, with the changes to big data, the availability of it and what’s being required by the market, that it makes more sense to put us together. We now have a formal relationship within the structure of the organization, and now medical devices and advanced analytics are coupled,” Kute explained. “The engineers need to be coupled with the data scientists, the mathematicians and the statisticians in order to develop innovative products going forward.”

Giles said the development is important, as new products and developments are likely to be inspired by analysis of big data.

“I think it’s really a recognition that the next innovations and the next advances in healthcare are really going to be driven by the insights in analytics,” he said.

The wealth of data is helping developers focus their products towards specific subsets of patients as well, Giles and Kute said.

“Before, you didn’t have as much info about the specific patients that were part of that trial, now you have a lot more information about the particulars of the individual patients. So, you may find your device is effective within a subset of that population, and you can still move forward and have it be an effective device, just more targeted towards a certain population,” Giles said. “Now that you have this information on everybody, you can apply that treatment more specifically. You may have previously had a device that was not considered safe and effective for a general population, but has a very good success rate in a specific population, so now issues are getting treated that need to be getting treated.”

As data grows, products are able to treat a larger population through more focused treatment plans, Kute explained, allowing patients to get more specific and personally tailored treatment plans and devices.

“When you think of an average patient – think of average height; if you go to put on a shirt sized for an average person, it doesn’t fit a large portion of the population. But if you have a small, medium and large shirt it provides a better fit for the whole population,” she said.

Data is growing in part due to the exploding market for wearable tech, Kute added. Although the medical device community hasn’t picked up wearables quite as fast as the commercial electronic market, due to concerns of accuracy and just how to harness the data, Kute thinks the devices will be transformative for biomedical tech.

“I think is going to continue to develop. Being able to have biometric data monitored 24/7 across large populations, that’s definitely new sources of data. Being able to tie that together with electronic health records and device data, specifically, is something that wasn’t available before,” Kute said.

Adoption of wearables in the consumer market will boost the adoption rate in the clinical and medical industries as devices emerge, she predicted. Giles noted that devices are getting smarter, smaller, and telling us more, all due to innovations in biotech.

“The features that you can put on a medical device, now that you have access to data and you can apply specific algorithms, is completely different. If you think of an imaging device – it goes from being an imager, to being a diagnostic tool. So that translates totally differently,” Giles said. “Now you have multiple data streams you can pull together, you get to make decisions off that. And now your device, once it goes through the proper design, development and testing, can be a diagnostic device, can provide additional value to the clinician as well as the patient that wasn’t there before.”

Giles thinks this will lead to a new generation of medical devices that are smarter, and do more for us than ever before.

“I think in general, you’re going to see smarter and smarter devices. There might be algorithms built into them. I think we’re on the nascent stages of that – the level of rigor that goes into developing medical devices is very very high,” Giles said. “I think we’re at the very early stages of that. I think over the next 5-10 years you’re going to see some big advances in the smartness of devices as well.”

With more data in the hands of developers, clinicians and even patients, data privacy and security are of critical importance, Giles commented.

“The safeguards that not only Battelle puts in place, but that are required through [the Health Insurance Portability & Accountability Act] – the safeguards are very very stringent. Privacy is taken very, very seriously. The work that we do on patient data has to be anonymized, so we can’t reverse engineer the data to identify the patient. So any identifiable information has to be stripped out,” Giles said.

While the wealth of data is a boon for for developers and researchers, keeping all the information secure can come with its own pitfalls, Giles added.

“It does cause some problems, or some challenges, in that if you strip out too much information, such as information that is collected over time, or that is time sensitive, it makes it more difficult to work with the data to identify what might be the best therapies, or to answer the questions we are seeking to answer.”

Despite the occasional pitfall, Giles said that big data was changing how development happened, and improving outcomes and innovations in healthcare.

“I think that, especially for healthcare, this is a real exciting time. With the advent of patient records and the wealth of data that is collected, there’s a lot of things that in the past were impossible, but I think, with big data, technology, devices, there’s a lot that will be inevitable,” Giles said. “We’re on that path from impossible to inevitable with new advances in healthcare that will, I think, help make healthcare more targeted and precise and through that is a way that we’re going to help reduce cost and improve outcomes.”

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