Medical Electronics Forum

What issues are facing the industry?

CONDUCTED AND MODERATED BY CHRISTINA NICKOLAS

As the medical electronics industry keeps on growing, today’s designers face challenges to keep products small, reduce power consumption, understand the ongoing changes in regulatory requirements, and communicate effectively among manufacturers and healthcare professionals. Representatives from various industries recently discussed issues they face and how those issues impact the design process.

Electronic Products: What trends in portable medical electronics do you see today and what is driving these trends?

Steve Coble (Engineering Manager, Optoelectronic Assembly Products, OPTEK): One of the things that we have seen in our medical applications has been a significant increase in miniaturizing. And also, we have a product line that came out with a bubble detector that has been extremely popular in the IVs and throw-away market. I see a lot of growth going on. And with the aging of the marketplace, I see smaller more-affordable-type equipment being pursued and the type of construction and manufacturing required to support that.

Richard McKay (Managing Director, Apollo Display Technologies): One of the largest markets for Apollo is the medical market—in the United States. We’re seeing a trend towards mobile medical devices and are continuing to try to reduce the power requirement and extend the life of the display in particular, the backlighting system, and not have a negative impact on display brightness itself. Our LED backlighting upgrades for displays address that trend.

Early 2005 was our first release,of a 6.5-in. display, which is very popular in the medical devices. That LED backlighting system essentially allows the customer‘s design engineer to put a product in that has a 30% to 35% decrease in power draw for the backlighting system itself.

Our style of upgrade keeps intact the manufacturer’s original mechanical specification of the display. We do not change the mechanics in most upgrades that we do. This LED upgrade extends the backlight life up to 100,000 hours from the standard 50,000 hours of your classic CCFL backlighting tubes that are out in the market historically.

Demand for portables

Pat O’Doherty (Product line director for Precision Signal Processing, Analog Devices): I think that medical equipment is going into places where previously it was either cost-prohibitive or even footprint-prohibitive to go. For example, in ultrasound, we’re seeing the portable ultrasound segment growing like crazy because there’s a demand for this equipment in the hands of first responders, for example, which would never have been the case only a few years ago.

So you’re seeing a lot of ambulances and first-responder teams going around with ultrasound equipment in their hands so that they can do more than monitor vital signs and get someone to an intensive-care facility. We’ve also seen AEDs [automatic external defibrillators] starting to appear in airlines, in office buildings, and even now on amazon.com for home use. There is a demand now for equipment that previously would never have been broadly available, and I think that’s kind of a global trend that we’re seeing that’s fueling medical electronics deployment in general and particularly, portable medical equipment.

Philippe Mattelaer (Business Development Manager, IMEC): I entirely agree with the previous speakers’ position about the need for lower-power portable devices. This is also the reason why IMEC sees the opportunity here to catch up with ultra-low-power solutions for future portable medical devices. This happens through the development of self-powered wireless sensor nodes that could transmit vital signs from patients, in a smart waymeaning sensed data converted into useful informationto the clinician.

So this ultra-low-power topic is the centerpiece of an entire research program that IMEC has set up. This involves about 200 researchers in partnership with the industry in fields such as ultra-low-power radio combined with a new generation of sensors connected to smart ultra-low-power data-processing capability and operating autonomously, On that last point, those self-powered wireless sensor network solutions, as we’ve defined them, will consume no more than 100-µW. Extending the battery life time is not always possible; but in combination with energy scavengers, we see several solutions coming up.

Dr. Robin Sarah Tichy (Technical Marketing Manager, Micro Power Electronics): I’d like to refer back to Pat’s comments. Micro Power manufactures about 80% of the battery packs that go into the AEDs that Pat referred to. And I think that the batteries have been an enabler of the proliferation of AEDs in schools and other public places. And the big breakthrough is that lithium primary batteries are available now with 5-, 7-, and even 10-year shelf lives, which means that they can sit on the wall for a very, very long period of time and wait for that one-time useand that’s very important.

And I also wanted to refer back to the ultrasound becoming more and more portable and commonly used in first-responder and point-of-care situations. Historically, we’ve seen medical equipment have just a backup battery, but with the new Li-ion technology, these medical devices are becoming more portable and so, they’re becoming more common.

Quintin DePina (Sales, Microbridge Technologies): We are seeing a wide variety of different sensors being used in medical applications. These are sensors used in equipment for surgical procedures, intensive-care units, and home care. And on the sensor front, the most complicated sensors are used for implantables. We also see sensors being used in catheters and external sensors that potentially could come into contact with blood and body fluids.

It’s been our goal here to work with the different sensor manufacturers to deliver increased accuracy while reducing the cost and the size of these different sensors.

George E. Cramer, Jr. (Vice President, Marketing & Commercial Development, Adhesives Research): And typically, the products we make are the products that would be interfacing with a lot of portable medical devices—the hardware, electronics, and the body. And one of the trends that we’re really focused on is point-of-care diagnostics.

Point-of-care diagnostics could be as simple as a glucose blood sensor that has to fit into some sort of reader system. These readers and sensors are becoming more reliable, capable of storing more information, and are more user friendly. Consequently, there are also devices evolving that could do things in the field implemented by the consumer for other kinds of diagnostic systems that would test bodily fluids. We would help, with our materials, to collect the sample that would then be plugged into an apparatus of some sort. So I think the point-of-care diagnostics area is becoming bigger and bigger and it’s being driven by things that are broader than just blood glucose, which is the obvious biosensor application.

Matthew Borne (Marketing Manager in the Power Management business at Texas Instruments): I work within the power management business here at TI, whether it’s for power modules, battery chargers, bor oost converters for LED backlighting for LCD screens. But in working with our medical team, the biggest thing is acquiring information on the patients wherever they are, and being able to access that data and act on that data.

So there is TI OMAP working on an instrument that you hang on your hip that communicates through a cellular signal back to the hospital to say something’s going on or just to report back data. Another example would battery charging and battery monitoring for the Li-ion batteries, as was mentioned before. Just to be able to take, you know, basically take the hospital with you as much as you can to be where the patient is instead of having to bring the patient to the hospital.

Electronic Products: How do regulatory requirements affect the design process and are there ways to bring products into the market faster?

Philippe Mattelaer: IMEC aims at developing research platforms and technologies that live up to 10 years ahead of time so we normally don’t have to go through much with that question. However, as we try to integrate battery technology with wireless autonomous sensors, compliance and safety around the battery technology becomes important factors.

Secondly, as we process data, such as vital signs taken from the patient, it’s important that we follow established standards. Another factor is that once we get to the fusion of all these functionalities to demonstrate the total concept, it’s very important that we listen to what the market really wants. As long as we demonstrate, follow one or more standards, people in the industry are happy with us. So definitely, I mean I would conclude that this is really an important factor especially when we try to demonstrate the technology.

Richard McKay: In comment to that question, the approvals process, as everyone knows, for medical equipment is quite lengthy and very expensive. Anything a supplier, such as Apollo, can do or a vendor can do to supply testing or regulatory information that’s already been done on the individual components being supplied to the manufacturer building the end product is going to accelerate them towards market completion on their own certified final product.

What we tend to do on all of our board-level and interfacing products for LCDs is take any pre-scans, FCC testing, and basic regulatory testing such as UL and we will readily provide that information to the end customer or the engineering consulting group that’s working on that project. Compiling and sharing that data with them and giving them as much information as possible gives them a jump-start into getting their regulatory approvals.

Quintin DePina: FDA approval is an issue, especially in the area of Class III implantable sensors where FDA approval is a must. We find, at times, that with new technology, the FDA requirements are somewhat of a barrier because there’s a higher hurdle due to the length of time getting the new technology qualified. Incremental use of new technology is impeded some, if you will, waiting for that next generation of product design.

Robin Tichy: Actually, I have a fairly specific comment, but very relevant for some of the new portable medical devices that we see coming out. And that is that there are special shipping regulations around Li-ion batteries.

So, if a medical OEM is considering say switching from a large sealed lead-acid battery to Li-ion, they need to be aware that there is a limit to how many Li-ion cells can be shipped without being shipped as hazardous material. That limit right now is 12 2.2 Ah in cells, and it’s something that can be a real challenge to overcome for some of the medical OEMs that we switching over to newer battery technology.

Electronic Products: Is this a new requirement?

Robin Tichy: It’s not new, but it’s actually in flux at the moment; today there’s a limit of 8 grams equivalent lithium content. And that is actually going to change in 2008 to a 100-Wh rating limit.

George E. Cramer, Jr.: And I guess the kinds of things that we would focus on internally as far as shortening the cycle are to make sure our design records, validation techniques, and change control systems are in place to ensure compliance so that auditing us as a vendor to medical device companies becomes more of an afterthought rather than a prerequisite to make sure we’re qualified so that we’re not in the way of them creating what they need to do in order to get submission approval.

We do, however, see some challenges in the approval process for some of the newer “combination” products that bring different technologies and designs into question. The challenges exist for the drug delivery technology provider, the device developer, the component supplier, and the regulators. For example, there is a transdermal patch that now has a battery and a microprocessor in it. The product is manufactured as a portable electronic device that will deliver a drug. Is this a drug or a device? These questions on design and dependability are complex and do take some time to resolve.

Pat O’Doherty: I think, you know, on the one hand, you’ve got the FDA with their obligation for making sure that all new technology is safe. Smart drug-delivery devices that would be an area where they would be very conservative, and we’ve seen that as well. We’ve seen products taking 7 years to get approval and so that would be at the extreme end of that spectrum.

But for a lot of the portable equipment, we’re talking about they’re not classified as breakthrough drugs or long cycle approval devices. So, you know, as you’re dealing with Class 1 and 2 equipment, you can get faster approval. And a lot of the equipment that’s starting to proliferate now does have shorter approval cycles.

So I have a mixed opinion about this. I think the FDA has a very clear mandate to maintain safety. And we, of course, have to make sure that our technology and new technology is being adopted as fast as possible. And it’s a balance. I think one of the new areas that will pose a problem is ubiquitous wireless networks because I think several of the callers have mentioned that they’re working that area. And just the idea of wireless sensors, you know, in large numbers in hospital environments with the whole issue of EMI interference and loss of signal that’s going to have to be grappled with, and it’s a difficult issue.

Philippe Mattelaer: On that last note of getting the wireless to work properly in but progressively also outside the hospital environment, I should highlight the existence of the Continua Alliance, an initiative led by Intel. This alliance targets full interoperability of medical devices in the E-health sector and mobilizes therefore companies to agree mainly on existing standards. Such an initiative, I think, exemplifies the importance of a consolidated view about interoperability in the industry as it might open up the market opportunity much faster for everyone.

Steve Coble: One of the things that we have done at OPTEK is to help speed up the design processes has been to incorporate some of the TS qualities of the automotive programs with PPAPs. PPAPs is a program that was established for automotive manufacturers in the design process. We have seen some very good success with this process. In our business, we are more of a support to the system of the customer and a partnership with the customer’s design engineer. So we put engineer-to-engineer in the design to process. We also provide design support in the way of quality and reliability data that will help move us through their system. This design process could be for the infrared or the VLED markets that we support today. We are incorporating this modified PPAP process and have, for a number of years, with great success. With this process we have reduced design time from maybe months to weeks.

Matthew Borne: I think along with what Steve said, I had some of the same experience. I remember he was talking about PPAP. TI’s Medical/High Reliability business unit directly manages similar documentation to PPAP for medical customers.

And they have, within that team, people that have been in the military industry or space industry, automotive industry for 20-plus years working with quality, whether it’s TS16949 or the military standards. This team is built to make sure that the information is taken in for the medical parts we’re releasing and makes this data available to medical customers.

And then, along with the PPAP requirements, you know, making sure that we don’t change the devices that we ship to those customers where a change in device may have negative effects, whether even just moving from fab or assembly sites, they have negative effects on their qualifications. So it’s deriving the data then making sure that data stays the same for that part as we ship it to the customer.

Steve Coble: I’d like to add one more thing. I think consistency is a key element and this is what the gentleman just said. I support him on that thought process and I think that’s what makes your program successful is that consistency from the design on through the finished goods.

Are we communicating?

Electronic Products: What is your perspective on where there might be some room for improvement and communication, on the engineer, the manufacturer, the healthcare professional, regulatory agencies and even the consumer, you know, the patient?

Richard McKay: In reference to sharing information, there can be a lot of improvements made there. There are many, many players involved, many different companies and manufacturers involved in a single medical device that’s manufactured no matter what that device may be. Each of these manufacturers needs to take ownership of their product and make the regulatory and approval data that is for their particular piece of the puzzle readily available to each of those different companies involved in the project.

I think right now some of that data is very difficult to come by and some of it is nonexistent from some of the suppliers. They do not do their own due diligence on products that they may design where they go and get these pre scans done. They understand what markets their products are really going to be used in such as the medical market and should go and try to gather some preexisting test and verification data for those clients that are manufacturing the end product.

Steve Coble: One of the things that we have seen is that communication in that design aspect is being able to meet the customer’s needs. They have in some cases, does not want to let go of enough information at first to design a product or a sensor that’s going to do everything they want the device to do. The customer will push the limits of the design but they do not give us the full parameters. That communication at the design stage is a critical—the most critical part of any product that you’re going to produce.

So I think that communications is what you are really going after and sharing that with that designer right up front. Because you can build something that will do what you think you want it to do is one concept of the design. But if you want to go beyond that design, you have to put it on paper, you have to take it forward and you have to communicate that information.

Philippe Mattelaer: I hear of several issues raised by the previous speakers with respect to communication and exchange of knowledge between the different parties involved in a product development. In that respect, I should highlight the business model that we use at the research center is based on open innovation. In other words, that means that technology partners actually share parts of the research program in a joint mode with the involvement of industrial residents. From experience we see that this process significantly facilitates the exchange of information amongst the different industrial partners.

I think in the context of complex product such as the one that we are talking about in the medical field, I think that certainly helps to have that sort of model being applied.

Robin Tichy: Micro Power Electronics designs all custom battery packs and chargers for medical OEMs, obviously with the custom work, every project is going to be different so we need to be very careful to make sure that we’re designing exactly what a given medical company will need for their product. And what we’ve implemented is new product introduction engineering process where at each stage of development, the medical OEM customer gets communication about what the design looks like and whether and how it maps to their product needs. The customer has the ability to sign off on that design as it stands before the project moves forward.

George E. Cramer, Jr.: And we do the same thing and it really does help as we develop products and eventually commercialize the technology.

Future of nanotechnology

Electronic Products: What is in the future for nanotechnology?

Robin Tichy: In the battery industry, there are already products that are commercially available that use nanotechnology, and I’ll give one example; there are battery cellslithium ion battery cellsavailable from a company called A123 based in Boston. They’ve been in the news recently for the batteries that they’re providing to Black & Decker and General Motors.

And the nanotechnology that they use enables very high current discharges for relatively extended periods of time and that’s why they’re used in power tools. But we see that’s also quite relevant for a number of different medical applications, especially orthopedic surgical power tools which basically have the same power requirements as the kinds of power tools that would be used in construction.

Richard McKay: Nanotechnology is definitely coming. I think there’s a few things that need to be overcome first and that’s perfecting these said “smart devices” that are coming out in the industry. And then focusing on miniaturizing those devices. That will come. The evolution of most all products is to miniaturize so, it will come.

Steve Coble: We’ve seen a significant drive to go to nanotechnology. We have seen it in our (VLED) backlighting applications where they want surface mount. We have seen a crossover from our military products to commercial products. We have leadless chip carriers that are isolators that are very small that can be mounted on PC boards.

And we have also seen a drive to miniaturize the IR sensors that also have the capability of withstanding the extreme temperatures. A product we have called a Pill Pack is extremely small but very durable. This type of package has seen more and more of that type of requirements in the designs or that capability in the design. So I think smaller and more robust components is an emerging market – when it comes to the circuit design.

Pat O’ Doherty:I think nanotechnology is a fairly limited definition but we’re seeing miniaturization certainly in every aspect of the medical market and that would be everywhere from imaging all the way through to patient monitoring, through smart drug delivery systems, through implanted electronics.

Everywhere you go, lower power and smaller footprint are becoming key. So if you think about a patient monitoring system which has wireless lead-connections instead of covering a patient with 12 leads in an intensive care system, it has a lot benefits for patients and for the caregivers as well; it’s much more reliable. But everything obviously has to be much lower power and much smaller in order for that system to be able to function properly.

And we previously talked about portable ultrasound, you know, we’ve got ultrasound systems which fit in people’s pockets now as opposed to being wheeled around on a cart. And this whole issue of everything getting smaller and cheaper, we would see proliferating everywhere from CAT scanners, which are your, you know, almost one of the largest pieces of equipment that you can get in a hospital, all the way down to these handheld pieces of equipment.

There is a very serious focus on making everything smaller—for a large number of reasons—not just to make the equipment smaller, but it is also to do things like to cram more channels into a given system so that that system can be more effective in providing therapy or providing imaging that is useful to a doctor.

Richard McKay: The main stumbling block in getting to the nanotechnology level is getting past the miniaturization process. They’re not going to get there until they can manufacture and perfect the devices to run on their own and eliminate the human operator factor of the equation. There’s actual papers written on this. Some of those papers are published by the CDRH (Center for Devices and Radiological Health) on these “smart devices” and also papers on the “human factor” and the risk management of having humans still operating this equipment versus fully automating the equipment.