Expert Series: Dr. Royth von Hahn on the state of the medical device field
Dr. Royth von Hahn is the head of medical and health services in the U.S. for TÜV SÜD. His background in physics, electrical engineering and as a lab subcontractor for a university made him an ideal candidate for the job.
“I joined TÜV SÜD in 2007 when they acquired my lab. Up to that time I was a subcontractor at a university operating a very specialized lab for measurements of ultrasound devices - mainly ultrasound devices,” Dr. von Hahn elaborated. “Over the years we had more and more of these subcontracts until they finally acquired the lab.”
In our discussion with Dr. von Hahn, we touched on the overall direction of the medical device field, focused on some of the newest and most exciting technologies to enter the market and how regulations must be able to keep up. Finally, Dr. von Hahn weighed on TÜV SÜD’s numerous areas of expertise to help device manufacturers and hospitals maintain compliance in this changing environment.
Active vs. non-active devices
It’s important to make the distinction between the two primary categories for medical devices globally: active devices and non-active devices. In short, an active device requires a charge, battery, or some power source, while a non-active device does not. Typically, non-active devices can include those that will interact directly with the human body, like implants, so material testing is important. Each item requires its own testing and certification protocol, with some overlaps.
For active devices, there are quality management audits and manufacturer certification measures, in addition to laboratory tests for the device itself. On the non-active side, it’s more about quality management, design certification and process compliance.
“We handle active and non-active medical devices, and the challenges for those areas are a little bit different,” Dr. von Hahn pointed out. “On the active side you have all the risks with electrical safety per se, but also those involved with software and data analysis. On the non-active side, the risks are more the result of the interaction between the human being and the device - materials, sterilization, and contamination. That involves more quality management, product design and process testing.”
Overall, there are three categories of medical services TÜV SÜD provides:
1. Quality management certification - this is the basis for a manufacturer’s market access
2. Technical evaluation of the device - another essential step for getting a device to market, including design, documentation, safety and effectiveness
3. Device testing - only applicable to active devices, wherein the group will bring the device into the lab and test it for voltage, emissions and so on
Major technologies entering the medical device market
The medical industry has been among the most active in terms of product innovation and technological advances. Dr. von Hahn listed five of the most interesting new technologies to hit the medical device market and noted what makes each one of particular importance for manufacturers and health care providers in the next three to five years.
1. Big data
This is less of a discrete technology and more of a trend - big data refers to the way certain devices can collect massive amounts of information and reveal insights and trends lost to more traditional, closed-off data collection methods. But big data, as it applies to medical devices, also brings up a few new challenges.
Medical devices collecting patient data must adhere to existing privacy laws - but placing restrictions on the amount of data collected or the context in which that data is used runs counter to the benefits of big data. Different countries or regions have different restrictions on data use. In some European countries, patient data is private data that belongs exclusively to the patients. Individuals must sign off on how their information is shared, used or contextualized.
Moreover, with greater data collection, algorithms, trend analysis and IT systems also comes the need for a larger, more experience staff in each of these areas. Then there’s the issue of where that data is stored - in some cases, there is no guarantee of where the physical data ends up. That can restrict certain patient services when patient information is required to remain within a specific region.
2. Wireless technologies
Wireless technology can open up new types of applications. The challenges are not quite as complex as the ones Big Data presents, but there are more mobile medical devices and more combinations where doctors or technicians might use a mobile device featuring an app. Smartphones are not medical devices, but they will function as such, so those devices must comply with security protocol and data housing regulations.
3. Drug-device combinations
More pharmaceutical products will require a special application and be linked to a specific medical device. For example, one use case that may be coming soon is in ultrasound technology contrast agents - small gas-filled bubbles introduced to the blood vessels that creates better imaging contrast. One idea involves filling these bubbles with a pharmaceutical agent, destroying the bubble with an ultrasound pulse, and releasing the substance in a certain area of the body.
Another use case involves coating a medical device with a pharmaceutical substance. In this case, providers need a team that can understand pharmaceuticals and medical device technology.
Nanomaterials have gotten plenty of hype, especially regarding working with materials to create specific shapes or structures. These are of significant interest regarding implant products - developments in skin grafting, bone reconstruction and other advanced types of surgery may leverage nanomaterials that must be compatible with other devices and with human biology.
“This is one area in particular where innovation changes the type of devices and also triggers new devices on the market,” Dr. von Hahn explained.
5. 3-D printing
This process will change the medical device market by enabling any kind of user to own the manufacturing process and create more unique items. Not only will non-manufacturers be able to create certain devices they were previously unable to, but they can do so in-house and for specific individuals.
That opens up a new range of regulatory questions - if a 3-D printer is located in the hospital, that facility must be held to some of the same standard normally applied to medical device manufacturers.
“With 3-D printing, you are able to do certain things that can’t be done with traditional manufacturing methods, especially in terms of available shapes - very interesting with certain types of implants,” Dr. von Hahn noted. “Another interesting thing is that you can have the device manufactured specifically to the patient based on imaging data.”
New regulation environment calls for a team of experts
Current regulations do cover some of these brand new technologies, as they fall under certain safety and manufacturing protocols. However, regulations and standards are reactive to the pace of innovation. As regulatory change and standard publishing happens far more slowly than technological innovation, manufacturers and health care players have to be prepared to meet new requirements as soon as the standards roll out. This means that what’s been the status quo for manufacturers could change quite rapidly.
Usually, standards take one to three years to emerge. However, by that time, there is usually some kind of guidance available as to what the requirements will be, allowing manufacturers and testing laboratories to produce and test a product to their best estimate of the coming standards. But in some cases, there is very little guidance. That means testing has to take on more of a risk mitigation element - all the more reason to bring in a testing group with a deep understanding of the industry.
This can get tricky. For example, some cancer-treating devices must abide by certain safety parameters. But by their nature, these devices are aimed at destroying certain kinds of tissue to treat cancer - clearly, testing the device had to allow that damage the take place, but ensure the item was still safe for use in the human body.
Dr. von Hahn and his team at TÜV SÜD cover every side of device testing, even when a new technology has little precedent or even regulatory guidelines to provide context. Additionally, regulatory changes also put more pressure on every player in the medical device market - including the testing bodies - such as IT security requirements and staff member certification. With increasing complexity on both the regulatory side and the technology side, it’s more important than ever device manufacturers and users to lean on a testing provider with the manpower, expertise and flexibility to meet those demands.
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