Medical/Healthcare Electronics Forum

Industry professionals discuss FDA regulations, cost issues, and the future of portable devices for home healthcare

CONVENED AND MODERATED BY CHRISTINA D’AIRO

In recent years, the medical/healthcare industry has seen a definite shift beyond the walls of a doctor’s office or hospital and into the home. As medical devices continue to become smaller and more integrated, there is need for more specific regulations regarding quality and cost. In this forum, we investigate some of the challenges and new technologies that designers are up against.

Electronic Products: The FDA recently introduced the Medical Device Home Use Initiative to help regulate the use of complex medical equipment in the home. Would anyone like to comment on how this has affected or may affect the design process for OEMs?

Rob Balson (Director of North American Medical Vertical Market, Arrow Electronics) : From my perspective, one of the main things that’s going to impact in design is really going to be the ergonomics of the devices themselves. They need to ensure that devices that typically have been used, perhaps in a clinical setting by professionals, can now be used in a home setting by consumers.

So, that’s going to require really a lot more ergonomic design and user friendliness, interface design changes as well as the amount of documentation that the OEM provides and the training that they provided in the past may have to be dramatically increased to ensure that the usability of the device in the field is taken care of.

Electronic Products : Are these significant changes from how the OEMs have been designing already?

Rob Balson: I think in some devices it could be. Some, I think, have accommodated it from an interface standpoint already. In some, certainly in new devices, that’s going to have to be accommodated for.

Allan Evans (Vice President, Marketing, Samplify Systems) : I think one of the key things this really does is give manufacturers of these devices a clearer path to market because there hasn’t been any definitive regulations around home healthcare, which leaves a lot of uncertainty to prospective OEMs who are trying to develop products for this market.

And by the FDA stepping in and now actually announcing a regulatory framework, this gives these manufacturers a much more deterministic path to market and takes a lot of the uncertainty out of it. And I think that this is going to greatly expand the market in the coming years.

Gijs Werner (Global Market Manager for Commercial Products, FCI) : One of the major changes that I see happening is that, in the past, the quality standard level for the home-use devices or the hospital-grade were not as advanced. There were different life expectancies and replacement times, as well as the actual quality of the components that go into those devices were different.

With this home healthcare initiative people are gravitating to, the FDA is going to bring strict regulations for home-use equipment. So that will dramatically change the standard of home-usage devices. But at the same time, it may impact a burden of cost. So, both sides will see more changes.

Electronic Products : You mentioned that there is a difference in the quality standards of the devices. Can you explain?

Ritesh Tyagi (Director of the MCU Product Marketing and the worldwide medical segment, Renesas Electronics America) : Yes. There is a difference between consumer-grade and hospital-grade equipment. Medical device manufacturers are often OK to use consumer-grade components in home care devices.

Whereas in the hospital-grade devices, they were looking at a different grade of components, which is probably industrial or a little bit higher grade. Now, since the FDA regulations for the home come into the picture, medical device manufacturers would consider a higher quality grade componentat least industrial gradein home-usage devices as well.

Electronic Products : Do you think these new regulations are going to prompt new types of materials and components?

Ritesh Tyagi: From the electronics component standpoint, I don’t think that there is an immediate need for new material development for home-usage medical devices. If manufacturers need higher quality, then semiconductor manufacturers can provide them today. But there’s another angle which may require a different kind of packaging technology. For example, with these portable devices, I think our colleague Rob mentioned the ergonomics are going to be changed, and people are looking at the usage of these devices. For example, a lot of different devices are coming in as wearable devices. How people wear those devices and how we can make them smaller and put them in smaller packages would definitely require packaging technologies from all different angles.

Rob Balson: I would tend to agree with Ritesh. I think the regulation itself and the trend towards home healthcare doesn’t necessarily, in itself, drive the need for new technologies. But I think what we’re seeing on more of a macro level within the healthcare market is certainly an increased need for communication protocols within these devices.

Certainly a drive towards lower-power portable devices which, as Ritesh was just saying, is going to drive miniaturization of the devices across the board.

Allan Evans: I think by removing the regulatory uncertainty the FDA will allow the home market to expand from being what is now a collection of niche applications to something that can be served more beneficially with merchant semiconductor solutions, instead of needing a lot of expensive and power hungry programmable devices within products targeted for the home market.

Bruce Devisser (Product Marketing Manager for Input Devices specializing in touch interface, Fujitsu Components America) : Yes, you know, one of the things that we’re seeing, along with the other general trend in consumer and industrial electronics, is medical folks designing-in more touch solutions to obviate the need for things like silicon keypads that can have holes punched in them by pens and stuff like that. And because the touch panel is right up in front, on top of the display, we’re also seeing requirements for extended chemical resistance such as for cleaners.

If this device is around the house and somebody gets it dirty, what are they going to use to clean it? It needs to be impervious to most things that the user would find in their own home. The devices also need to be more impact resistant. And I’m not speaking to implantables or to wearables, but to handheld or desktop devices. So, one of the issues about packaging a touch panel is to seal it properly to the top enclosure and give it good ingress protection against fluid elements. So that’s another thing that I see changing compared to, for example, the industrial market.

Also, current hospitalgrade equipment does use touch panels. And they’ve pretty much developed ways to harden them against treatments. But in the hospital environment, the chemicals that are available for cleaning and routinely used for cleaning or sterilization are well known.

And back on the trends, because there’s more touch going out, there has to be a lot more attention on user interface. But one of the advantages of having an interactive display on the unit is that you can tailor your built-in instructions, help screens, and so on. You can designin the intelligence so that if a user is pressing an unusual sequence to request some action, it might pop up and say ‘hey, are you sure that’s what you want to do or do you need help?’ So, some of the companies that have been producing things like blood pressure monitors have computer interfaces if the individual wants to download and keep their own records, for example. But what we see going forward is a lot more types of devices that are going to require communication to a medical facility of some sort. And one of the challenges we see there is that people are so used to wireless devices in general, there’s going to be a lot of pressure for wireless. So, that’s a cost implication. Also, do you really want to send medical data over the Internet unless it’s really well secured or do you want to go with good-old dialup service to have a one-on-one end to end?

David Webber (Director of Product Management, C&K Components) : I am going expand a little bit on what Bruce was just saying.

First is the environmental uncertainty of these devices, especially for manufacturers of clinical devices who are moving those clinical devices into a home-use environment. As Bruce said, the clinical environment is very deterministic. You know how it’s going to be cleaned. You know who’s going to be using it. You know the temperature, so on and so forth. So, we have to take into consideration that OEMs are moving into the home environment, which is an unpredictable environment. You don’t know what the temperature is going to be. You don’t know what these devices will be exposed to. We’ve all seen situations such as a pet running around to knock it over to a kid who maybe splashes something on it.

Bringing that uncertainty of environment into the design, and accommodating for that, is going to be a key.

Electronic Products: I agree, security is important as well as environment. Because, as you mentioned, once you bring something out of the home, there are so many different variables that could affect the device or its performance.

David Webber: Yes. We’re certainly seeing things such as humidity levels as a good wild card. Miniaturization is also definitely driving a lot of what’s going on in.

The one thing that’s really helping us now is that OEMs, when they’re designing, have more clarity in the selection of their products. They’re being a lot more vocal about what they’re trying to accomplish. And giving us a lot more information on the front end of the design to help them make sure that they’re selecting the right switching solution. Also, the volumes associated with home healthcare device components is really helping us drive down the costs for some of our clinical applications now that we’re getting to some more interesting volumes.

The higher level of ceiling has certainly become a big issue from everything from sweat resistance to fluids. So we’re seeing a much greater demand there, a higher actuation life and warranty periods are certainly driving that as well. Chemical resistance has become another big driving factor, particularly with alcohols. They can really dry out plastics pretty severely. So, we’ve been very careful with the selection of materials as we’ve gone into this market. It’s been a pretty dynamic change.

Electronic Products : Has keeping the costs down for these kinds of materials provided like a big obstacle to manufacturers?

David Webber: No. I think a lot of them will run in the same molds. It’s just making sure that you’ve taken that and tested them to those criteria. I think expanding our test specifications for extremes in temperature and humidity has been a big focus, as well. But, I think doing the right material selection up front is really how you make sure that you’ve met all of the criteria.

Bruce Devisser: I’d just like to add that another point about the portability of the devices that has to be considered is that they need to be more rugged. The same device may be used in point of care in a medical facilityin the field or airborne emergency vehicle or at the scene of an incident. So, that requires a great deal more design planning and research to avoid having issues down the road.

Jon Bourne (Technical Marketing Manager, AVX Tantalum Group, High Reliability and Medical Division) : Just to expand on that a little bit in terms of components. I believe that as the FDA gets in and regulates, we will see changes in requirements. Usage of these devices in various environments will require that some of these portable electronic devices that are currently considered non-high-reliability be upgraded. As the FDA continues to regulate and add on requirements, there are going to be some changes and some of these will require higher-reliability components rather than purely commercial. And again, that will drive costs up.

Electronic Products : Do you think it will be significant?

Jon Bourne : Well, I would say between commercial grade and a medical implantable grade for example, something that goes into a heart pacer or defibrillator which is life support, it could be, you know, 5X, 10X, or more, depending on the type of component.

Plus, there may be an in-between grade where a commercial product may be not quite good enough for the application, but an implantable grade may be too much. There will be some extra testing required or slightly different materials or whatever, to make the product more reliable in certain cases.

Ritesh Tyagi : The intent of the home care initiative is not to compromise the equipment quality itself. It doesn’t make any difference if the equipment cost $1,000 in a hospital and the same $1,000 in the home. I think the first initiative is how to bring the hospitalization costs down. If a patient can be treated in the home, the cost would be significantly lower compared to the hospital care.

The second initiative will be how we can make the home environment or treatment more safe, hygienic and free from any potential hazards to surrounding people. The overall design and usability of equipment should be such that patients can manage it with minimal supervision.

Jon Bourne : All I’m saying is if someone is in the hospital and one of these pieces of equipment fails for some unknown reason, it may be easier to get another one to replace it right away, especially if it’s a ventilator or something like that that.

In the home you need to assure the user that the equipment is reliable and not going to fail. In the home, it may not be able to get replaced quickly.

Ritesh Tyagi : Somebody mentioned the user interface and touch. This is one of the things that is very important to understand, and hopefully the FDA or manufacturer will take into account. For the aging population, many times they prefer electromechanical switches as opposed to touch, because that gives them a feeling that yes, things are working. ‘Did I push the right button or if it’s working?’ As an example, if you remember the kiosks at the airport, sometimes you just push the button like five times, and you don’t know whether it is working and doing the instruction or not.

But, at the same time, the electromechanical switches, by design, are error-prone with high wear and tear. There’s another technology that is emerging, which has been widely used in the cell phone and PC market, called haptic technology. This could easily be used in medical devices. Haptic technology blends the features of both touch and mechanical switch by providing feedback feeling. I think that technology is going to be very interesting for the medical application because of the aging population. People would prefer feedback where, if they touch the button, something happens. And I foresee that haptic will definitely be a key technology for home-usage medical devices.

Bruce Devisser : I’d like to add to that. We have a lot of experience providing products or helping to design products with touch interface that provide the user with some kind of feedback. One of the most important things that we’ve found for devices intended for elderly people to use is to provide prompting. Haptic feedback is definitely one way to do that. But being able to provide sort of an on-screen guide just by virtue of what the next step isflashing the screen about to change, or putting it in a slightly different place so it’s easily noticed.

All of these elements can be combined to make a better user interface that someone doesn’t have to hear a beep. The click they can feelthe haptic feedbackand seeing a change on the screen immediately is something that I stress to designers, especially to a lot of the young upand coming designers that don’t really have a lot of experience with user interface designed for those areas.

Electronic Products : Feedback, like haptic, is important for the user so they know that something is happening or their command has gone through, especially if they’re not in the same room as their doctor or healthcare provider.

Bruce Devisser : Yes, and whoever brought up the example of the airport kiosk, that’s one of the worst things that two specific companies have done in developing that software is they’ve made it nonreactive. They’ve failed to make the user interface a high priority.

Ritesh Tyagi : Right. And if you see in existing medical devices, the user interfaces are still old style. The medical companies don’t have expertise on the ergonomic sensibility of a user interface. So there will be a learning curve for these medical companies to design more consumer stylish user interfaces.

I think in the near term we will see some basic touch interface with haptic feedback. In addition to that, I just wanted to add another thing, which I think somebody mentioned, maybe Rob, about the communication. That will be a big wave. The moment you move this equipment from the hospital environment to the home environment, the communication link between doctor and patient and the hospital and home care facility would require a tremendous amount of data to go back and forth over the Internet.

That will raise two things. One is the faster and easier accessibility of data and interoperability of the system over different networks. The second is secure data transfer. Security of the patient information will be a big part of this initiative. If medical companies and service providers don’t ensure the security of data, then there will always be a possibility of potential lawsuits.

There would be a paradigm shift in the way the equipment had been designed in the past and now. In the past, security was mainly maintained within the hospital server. But with the home care initiative, data will flow over the Internet and would require an even higher level of security. Also, if a disposable is used in a piece of equipment, then manufacturers would need to make sure that authentic disposable is used with their home care equipment. This way, they can protect a patient with any heath complications and themselves for any legal issues. That’s why I believe this will be one of the major paradigm shifts when they go into the home environment.

Electronic Products : Security could certainly be a major concern, especially, with wireless devices. I read recently that a woman made headlines last year for being the first American to have a wireless pacemaker. And that her doctor was able to monitor it from his office while she was at home. Something like that is just one example of the possibility. But, is that really safe?

Bruce Devisser: Yes, one of the issues that’s been discussed here is with the advent of the wireless technology and people seeking to have this kind of linkage, is the use of cellular access. And I think there’s a hidden weakness in there because if there was a power loss or an interruption to the service, you know, there has to be some sort of a backup plan that is controlled electronically to prevent abnormal conditions in developing with a patient.

Electronic Products : What about any new technologies or trends that are now starting to emerge?

Rob Balson : I think as we see a lot of new technology customers, emerging customers that are developing new products, we tend to get a pretty good glimpse here at Arrow as to what some of those trends are.

And as I mentioned earlier, within the healthcare market and as we’ve talked about throughout this call, I think certainly miniaturization and all of the impacts that go along with making these products more portable such as power, size and ergonomic design.

I think more and more of these devices are becoming very highly integrated, you know, multiple functions in one device; devices that used to be two or three devices to do various measurements are now being integrated into a single device. And that’s driving increased integration at the function level, from the semiconductor level all the way up. So we’re seeing a lot of integration across the board, of multiple functions into single devices.

And as we’ve said with communications, every device in my mind that’s developed going forward will have some level of communication that is predominantly wireless. I believe that will be the trend.

Electronic Products : Can anyone expand on how tele-healthcare relates to portable technologies?

Rob Balson: The devices that we’ve been talking about are devices that will enable tele-health to expand and grow more vigorously than without them. So, I think the need for portable devices, the need for home healthcare devices, is critical to the tele-health type initiative. And I think, that tele-health, tele-medicine, home health, I think they’re all kind of thrown around as similar terms. And I think there are multiple definitions going around with each one.

Allan Evans: We do a lot of work with medical imaging companies who are looking at tele-medicine approaches as a way of being able to bring in the right expertise to perform a diagnosis no matter what the geographic location. And, particularly in medical imaging applications, it’s extremely bandwidth intensive. I mean CT machines require between 5 gigabit and 10 gigabit per second of just raw data capture. And it’s that raw data that needs to be sent, from one place to the other because of the different ways they can generate images, from different radiologists to try to get that particular view to make the diagnosis.

So, we see that really the wide area networking connections as being the bottleneck in enabling that and often times it’s easier just to go send the patient over to another clinic to get them rescanned rather than being able to send all of that data across. And it’s one of the things we address with our signal compression technology in medical imaging.

Electronic Products : Any final comments or thoughts?

Bruce Devisser: Yes, one of the things that I can see is the people who are doing medical designs still have seven to ten years in mind for product life. And the rate design turnover in the portable area seems to be increasing. And the companies that make components for these types of devices are not typically interested in carrying on a relationship with a part number for that long. So that’s one of the other challenges that’s been developing. You know, the industry itself seems more geared towards shorter lifecycles.

And the medical industry is sticking with longer lifecycles. But the reality of portable and home healthcare type of environments is that the device is not going to last that long. And it’s probably not going to be reparable. So with the product lifecycle, there could be a benefit to shortening that from a philosophical point of view of the medical industry. ■