MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Connecting with Diabetes Patients

There's no way to sugarcoat it: Diabetes device manufacturers have fallen short of meeting patients' expectations when it comes to design aesthetics and usability. But the tide could be turning as two new high-tech, consumer-friendly diabetes devices hit the market and represent a trend toward giving the people what they want.

Demonstrating an active and informed approach to managing their health, diabetics have emerged as a particularly vocal patient population that knows what it wants from these critical devices and accessories. And it isn't afraid to speak up, either. Case in point: Amy Tenderich, founder of the popular Web site DiabetesMine, wrote a much-discussed open letter to Steve Jobs several years ago requesting that Apple propel insulin pump design into the modern era of electronics by applying its trendsetting design capabilities to life-critical devices. Likewise, a survey conducted by Cambridge Consultants last year revealed that diabetes patients were unhappy with current drug-delivery designs and their user experience.

Listening to these impassioned pleas to take a cue from consumer electronics, startup company Telcare has introduced what it claims is the world's first cellular-enabled blood glucose meter. Resembling a slightly older-model smartphone, the Telcare BGM offers patients a high-tech means of taking, transmitting, and tracking their glucose levels to optimize diabetes management. Boasting connectivity, the device transmits glucose readings determined through blood samples to a private online database. Accessible to the patient, doctor, and any other permitted parties, the data can be displayed in handy charts and help identify trends.

"As a Type 2 diabetic myself, I found the Telcare meter a refreshing change, and a significant step toward bringing consumer medical devices closer to the world of modern technology," Walt Mossberg, a Wall Street Journal technology columnist, wrote in a recent product review. "Despite some drawbacks, including a high price, I recommend [that] the Telcare be considered by diabetics who want a better substitute for paper logs, or would benefit from real-time sharing of their readings."

Also trying to cater to high-tech sensibilities and safety concerns for diabetics, Medtronic has launched the mySentry remote glucose monitor. Heralding the device as a pioneer in the category of connected-care solutions, the mySentry allows parents to remotely monitor a child's MiniMed Paradigm Real-Time Revel system. Providing parents with peace of mind, the bedside device was designed in response to several studies that indicate that the majority of severe episodes of hypoglycemia in children with Type 1 diabetes occur at night. It provides data such as real-time glucose trends, levels, and alerts.

While price appears to be an initial factor with these devices, their impact could prove to be significant over time. After all, the International Diabetes Federation estimates that the number of people with diabetes will jump from 366 million in 2011 to 552 million by 2030. So, demands from this informed patient population will likely only get louder. Luckily, well-designed connectivity solutions such as these that enable better management of diabetes and allow patients to take a more-active role in their--and their children's--health are a step in the right direction.

Battery Maintenance and Diagnostics

Isidor Buchmann, CEO and founder of Cadex Electronics Inc. (Richmond, BC, Canada), will present "Battery Maintenance and Diagnostics" at the MD&M conference program on Wednesday, February 15. Cadex offers expertise in battery chargers and analyzers.

MPMN: What are some of the biggest battery-related issues currently affecting medical devices?

Buchmann: FDA has very stringent rules to get a product to market. But once a product is on the market, the battery is basically uncontrollable; nobody checks the battery and it will fade. Medical devices have to be calibrated and checked every so often. When it comes to the battery, however, the inspector just looks at the physical size, the weight, and the model number. If nothing is noticeable on the outside, the battery passes. But the battery could be virtually dead, and that's not being measured because it's difficult to do. That's something fairly difficult for FDA to control. Information such as when users should replace a battery, how to measure capacity, and what are the signs or thresholds for when a battery should be replaced is not so clear.

MPMN: What should proper medical battery maintenance, diagnostics, and testing entail?

Buchmann: Batteries do not die overnight; they fade over time. Capacity is the leading battery health indicator and a battery is rated in capacity in terms of ampere-hours. So, a battery that is rated at five ampere-hours means that it can deliver five amperes per hour or one ampere for about five hours. The battery only delivers that capacity when it is new, however. It starts to age the first day it is "born" and immediately starts to fade whether it's used or not. That's where the problem lies--measuring capacity. Medical batteries are usually replaced when the capacity drops to about 75 or 80%. But there are no clean, quick measurements. That's probably why the battery is not held to the same control standards as other aspects of a medical device.

As some form of control, we recommend a program in which a fully charged battery would be discharged on a battery analyzer while the capacity is measured. A method that's very common in the public safety sector is labeling the battery; the label would include the service date, due date, and the measured capacity. The system is self-governing in that the user only picks a battery with a valid service date. Batteries approaching the due date are separated and serviced on a battery analyzer. If above 80%, they are relabled and returned to service. We suggest that the medical sector adopt this practice. It's clean and simple.

MPMN: What demands has the medtech trend toward miniaturization and portability placed on batteries?

Buchmann: Wireless patient monitors are considered the fastest-growing sector. They're almost like a cell phone in that the patient has to make sure that the battery is being charged regularly. But, again, the battery lives for only so many years and so many cycles. What happens if the battery dies or fails? Batteries account for about 50% of medical device failures. There should be battery maintenance and an indication of when the battery should be replaced so that the patient's health is not being jeopardized.

MPMN: Does responsibility lie with the manufacturer?

Buchmann: Well, we're not quite where we should be with battery fuel-gauge technology. Besides indicating state of change, medical devices should estimate the state of health of the battery and suggest replacement when weak. That doesn't really exist effectively yet.

MPMN: What do you hope attendees learn?

Buchmann: I hope they gain a new understanding of the importance of the battery. No matter how much inspectors and FDA insist on checking everything else, if the power source dies, then the equipment goes with it. The battery should gain more importance when it comes to overall system management.

For more information on the 2012 MD&M West Conference, visit www.mdmwestconference.com.

Bioresorbable Polymers for Medical Devices—A (Still) Emerging Field

Richard Meyst, president of Fallbrook Engineering Inc. (Escondido, CA), along with Steve Coulter, senior research associate, will present "Bioresorbable Polymers for Medical Devices--A (Still) Emerging Field" at the MD&M West conference program on Monday, February 13. Fallbrook Engineering is a design and consulting house focused on medical device design and development.

MPMN: What topics will you cover in your presentation?

Meyst: There are two main areas we are going to cover. The first area is how the selection of bioresorbable materials must conform to design controls, and a key part of that is properly specifying your requirements. Second, we want to convey a recent experience in which we found very limited options for commercial bioresorbable polymer sources.

MPMN: How does working with bioresorbable polymers differ from working with traditional materials?

Meyst: By their very nature, these materials are very sensitive to degradation. You need to consider every environment that the material is in from incoming receiving to sterilization, shipping, and storage. Additionally, these materials call for much more precise processing-method controls; designing "controlled change" into a product is no simple task. Another big difference is the raw material cost. These materials are usually very expensive compared with comparable polymers, such as nondegradable polyesters. As a result, you need to employ high-yield, low-waste molding technology. There are a limited number of molders that fully understand how to properly process bioresorbable polymers in order to achieve the desired result.

MPMN: What is the most common mistake made by medical device manufacturers when designing with bioresorbable materials?

Meyst: The thing that really stands out is trying to succeed without adequate process control, which includes considerations such as water content, temperature excursions, etc. On finished parts, OEMs need to take a close look at the effects of sterilization, the impact of residuals, and the overall effect of sterilization and storage on functional, mechanical, and chemical properties. They also need to know how long the material actually lasts. For example, the material may lose its strength in a year but may persist at the site for another year or more. Also, there's a huge difference between surface erosion and bulk erosion for implantable, resorbable polymers. Companies need to look at how the loss of strength tracks with the loss of weight. And if used for drug release, how does the nature of erosion affect dosing?

MPMN: What's next for bioresorbable materials in medical applications?

Meyst: We would like to see more polymers become available. We have found that materials that were near commercialization in the late 1990s are still not available. As a commercial process, this is a deadly spiral: If more materials do not become available, there won't be as many potential uses and applications. With less use of the material, costs remain high because of poor demand, making it still less attractive for a designer to look for new bioresorbable material applications.

MPMN: What do you hope attendees will take away from this presentation?

Meyst: Because bioresorbable polymers have been well known and well characterized for decades, we thought that solving a commercialization issue would be easy. There should have been multiple material options and multiple supply sources available. Neither of these assumptions was true at all. If you are looking at medical product designs that require these materials, pay attention to the details. You should likely allow more money and time for development than you initially estimated.

For more information on the 2012 MD&M West Conference, visit www.mdmwestconference.com.

New Developments in Medical Packaging Materials

Dhuanne Dodrill, president of Rollprint Packaging Products (Addison, IL), will present "New Developments in Medical Packaging Materials" at the MD&M West conference program on Tuesday, February 14. Rollprint specializes in flexible packaging materials, including extruded laminated film, foil, clear high-barrier composites, and pouches.

MPMN: What sorts of new developments in medical packaging materials will you highlight in your presentation?

Rollprint PackagingDodrill: Many of the recent advances in medical packaging materials have been in response to the needs of the end-users--the hospitals, nurses, and patients using the products. I will be focusing on some of the exciting new material solutions developed to address these needs.

Hospital-acquired infections (HAIs), for example, are receiving tremendous attention from both regulatory bodies and hospitals. Many of the novel devices recently introduced to prevent HAIs require a peelable sealant designed to hold concentrated alcohol. New peelable technology ideal for this purpose is now available.

Another packaging issue is that nurses consistently indicate that the ability to see the product prior to opening the package improves their efficiency. A quick visual check allows them to easily double-check product size and shape prior to opening the package. Advances in ultra-high-barrier clear materials provide solutions for even the most sensitive products.

Lower-cost packaging solutions that do not sacrifice performance are an important part of cost-savings initiatives and are, thus, in demand as well. Among the most interesting developments in this area are the improvements to the bottom webs used in thermoformable form-fill-seal applications that have uncoated Tyvek as the top web.

Finally, there are a variety of material advances that also aid hospitals in meeting their sustainability goals.

MPMN: How does addressing these market needs impact medical device manufacturing?

Dodrill: Interestingly, the solutions that address the needs of the end-users often provide a real benefit to the manufacturers as well. Packaging that allows product visibility aids in on-line fill and placement verification. Lower-cost packaging materials benefit everyone in the supply stream, as do sustainable options.

MPMN: How have green initiatives and the push for sustainability impacted medical packaging?

Dodrill: Sustainability concerns with regard to packaging have been largely driven by the medical device manufacturers. Approaches to improve sustainability include moving from double packaging to single packaging; double packaging consists of an inner package intended for the sterile field that provides a sterile barrier placed inside an outer package also capable of maintaining a sterile barrier. Additional efforts include reducing package density by moving from rigid to flexible materials, downgauging materials, and choosing materials that can be more-easily recycled. Hospitals are just beginning their sustainability journey. Amazingly, most do not yet have systems in place to recycle waste. However, encouraged by groups such as Kaiser Permanente, progress is being made.

MPMN: What do you see as being the next trends in medical packaging?

Dodrill: Packaging professionals are becoming increasingly aware of the importance of considering human factors when designing a product; good design can reduce the chance of errors. So, packages should be intuitive and easy to open, even when wearing gloves. Valuable time is lost when a nurse struggles to open a package. The packaged product should also be easy to identify. A label that meets the regulatory requirements of multiple countries often is visually overwhelming for the nurse. As a result, in-line, on-demand printing will continue to grow. Serialization and the associated identification, labeling, and tracking systems will also be a challenge that the medical industry will need to address.

MPMN: What do you hope attendees will take away from your presentation?

Dodrill: Hopefully, attendees will leave with some new ideas on how to address their packaging challenges and thoughts on design considerations.
 

For more information on the 2012 MD&M West Conference, visit www.mdmwestconference.com.

CDRH Misses User Fee, Amalgam Deadlines

In both the case of the user fees and dental amalgam, FDA did it again: It missed a promised deadline and, in doing so, demonstrated why its officials habitually avoid giving an explicit time for when they will do something. They have always known that too many things can go wrong on their way to meet a commitment. 

And lately they have come to know about a new factor that can throw a monkey wrench in the works: political interference, as in December’s highly public, first-ever reversal by an HHS secretary of an FDA approval decision for a nonprescription emergency contraceptive pill.

In the case of the agency’s missed January 15 deadline for submitting to Congress an agreement with the medical device industry on new user fees, the cause was reportedly the two sides’ inability to bridge a gap in the total amount to be paid. In the confidential negotiations, FDA supposedly wanted as much as $805 million over the next five years to pay for new staff to speed up its reviews, while industry wanted to pay only $447 million. 

According to FDA draft minutes of its December 6 meeting with industry, both sides “remain far apart regarding an appropriate level of resources to support the draft commitment letter. FDA indicated that they have conducted thorough analyses of what is needed to meet the draft commitment letter and therefore any counter-offer would not differ significantly in resource needs from what they have previously presented. Industry restated their position that the draft commitment letter should not be changed to reduce resource needs. Both sides expressed concern with how long it is taking to reach agreement on appropriate funding levels but pledged to continue to look for ways to close the gap.”

FDA would say nothing publicly about the missed deadline, but an AdvaMed spokeswoman said “progress” was still being made in the negotiations. With Congress hovering the wings to take over the matter amid election-year campaign fever, politics was an additional pressure point.

Developments regarding Mercury Dental Amalgam

In the case of smaller, more focused and presumably much easier matter of whether the 50% mercury content of dental amalgam is safe for infants under six years of age and developing fetuses, CDRH director Jeffrey Shuren let his self-imposed “by the end of the year” informal deadline for a decision pass unmet.

When asked what the new timeline goal is, FDA spokesperson Morgan Liscinski responded that there isn’t one.
FDA’s history of regulating dental amalgam is tortuous. For 32 years it refused to publicly warn about its neurotoxic risks until compelled in 2009 by federal court action to classify it. Even then, the agency’s action — declaring it as safe under Class 2 for everyone over age 6 who is not allergic to mercury — was immediately faulted by dental activists as weak and based on selective reading of the scientific literature on the topic.

Within two months of the rule’s publication in the Federal Register, two citizen petitions asked the agency to reconsider it, and a month later a World Health Organization expert group agreed in concept for a worldwide phasing down of dental amalgam. Goaded by such pressures, FDA eventually agreed to ask an advisory panel in December 2010 to examine the latest science; it voted to recommend a ban on amalgam’s use in children.

Still the agency hesitated, sending Shuren to a series of town hall meetings around the country at which he heard so much criticism of the agency’s amalgam policy that he began saying he hoped for agency action on it by the end of 2011.
Liscinsky’s comment suggests that after waiting 35 years on the amalgam safety issue, FDA sees no need to hurry now.

National counsel for Consumers for Dental Choice Charlie Brown commented:

At Jeff Shuren’s Center for Devices, politics wins. Science loses. Thirteen months ago, FDA’s own advisory panel of handpicked scientists told FDA to stop amalgam use for children and pregnant women.

“But Shuren fails to heed the scientists — even though, since September, he repeatedly announced that he intended to act on amalgam in 2011. Every day that Shuren fails to act, more children are subjected to this mercury product, which — FDA’s own rule concedes — can have ‘neurotoxic effects’ on the ‘developing neurological systems’ of children and unborn babies.”

Limited Effectiveness Reported on Hip Bearing Combinations

The researchers note that FDA has been closely monitoring reports of hip implant failure related to various bearing surfaces. In November of 2009, they started a comprehensive evaluation and synthesis of evidence of reported outcomes for approved implants. They say they systematically reviewed the evidence as part of that project to determine the short- and long-term outcomes reported by patients undergoing hip replacement and the rates of revision after using implants with various bearings.

Functional outcomes, traditionally thought of as primary effectiveness outcomes, were no different among patients receiving hip replacements with various bearings, the authors say. Given the lack of comparative effectiveness evidence, they say, there is a need for a large and high-quality randomized controlled trial of bearing surfaces in total hip replacement before any benefit claims are made. Until such a trial is conducted, national registries provide important real world data that are critical for the safety and future comparative safety and effectiveness evaluation, they add.

All Malfunctions are ‘Reportable’ to FDA

Any device malfunction, regardless its severity, is a reportable event under FDA’s Medical Device Reporting regulation for all life-supporting or life-sustaining devices. That is the official word from CDRH’s Office of Surveillance and Biometrics MDR Policy Branch. Malfunctions for other devices are not reportable unless they are likely to result in a death, serious injury or other significant adverse event experience, according to FDA spokeswoman Morgan Liscinsky. A guidance document is also available on the FDA website. that outlines the reporting criteria, she said.

This blanket reporting requirement for all life-supporting and life-sustaining device malfunctions caught the attention of Hyman, Phelps & McNamara attorney Jeffrey Shapiro after reading an October 10 warning letter to Respironics Inc.

“This citation is not adequate to support FDA’s position.”
—Jeffrey Shapiro

Writing in his firm’s blog, Shapiro says the agency uses a preamble comment from its MDR rule to justify its blanket reporting requirement. “This citation is not adequate to support FDA’s position,” he wrote. “In context, the preamble statement seems merely intended to establish an enforcement presumption that loss of therapy in a life sustaining or life supporting device is likely to cause a serious injury or death. The preamble does not appear to intend that literally every possible malfunction in such a device will be reportable even if the basic regulatory requirements for reportability are absent. (Even if that were FDA’s intent, the agency legally cannot alter the basic terms of a regulation via a preamble statement.)”

To illustrate his argument, Shapiro offered the following example: “If a red light bulb in an ‘on’ switch indicator in a ventilator is off because internal wiring has gone bad, but a white bulb next to it still works and the user can tell that the device is ‘on,’ there would be no interruption in treatment due to this malfunction and no death or serious injury could occur. Therefore, this malfunction is not reportable under the MDR regulation. Under the approach taken in FDA’s Warning Letter, however, it would appear that this malfunction would need to be reported.”

Concerning Shapiro’s example, Liscinsky said MDR policy staff recommend that firms seek an MDR reporting exemption for such a scenario.

Shapiro says it is difficult to know if the warning letter is a harbinger, not knowing whether it received a legal review before leaving the Philadelphia District Office. Just to be safe, “manufacturers of all such devices will need to keep a wary eye on FDA’s enforcement of the MDR regulation,” he cautioned. 

What the Privacy Act Teaches Us About The Device Tax

Very interesting post from Roger Ehrenberg over at MedCity News. He advises device makers to embrace the tactics opponents to the SOPA (Stop Online Privacy Act) have successfully used and apply them to battling the device tax.

Key actions that have worked for anti-privacy have been to get social and raise awareness, align with innovation, make an example, find a civil action moment, and make yourself a hero.

Most critically, however, is the question of whether these efforts will work. Ehrenberg admits it is a hard sell.

—Heather Thompson

What Medtech Entrepreneurs Need to Know about Patent Reform

What Medtech Entrepreneurs Need to Know about Patent Reform

MD+DI: Why is the U.S. patent system switching from a “first-to-invent” system to a “first-inventor-to-file” system and how will this change affect medtech startups?

David Dykeman is a patent attorney and co-chair of the IP department at Greenberg Traurig LLP

David Dykeman: The America Invents Act was signed into law on September 16, 2011, and it includes a number of key provisions on patent reform. One of the first and most important provisions is switching from a “first-to-invent” to a “first-inventor-to-file” system, which will harmonize the U.S. patent system with the rest of the world. The “first-inventor-to-file” standard grants patents to inventors who first file their applications with the U.S. Patent and Trademark Office (USPTO), whereas the previous system was based on who actually conceived of the invention first, regardless of who filed it with the USPTO first. This change takes effect March 16, 2013, and will have profound ramifications on medtech companies’ patent filing strategies. Because this change encourages inventors and medtech companies to file their patent applications quickly with the USPTO—almost at the proof-of-concept or invention-formation stage—inventors and companies will need to streamline and accelerate their invention disclosure collection and review process to adapt to this change.

MD+DI: What risks does the “first-to-file” reform pose for medical device innovators? And what is the upside?

Dykeman: There are definitely pros and cons with the new “first-inventor-to-file” system. The biggest impact is creating a race to the patent office to get applications filed quickly and often, which may lead inventors to file their technology before it is completely developed or understood. As a result, companies need to guard against filing weaker patent applications, and may need to file additional provisional applications to ensure all aspects of the technology are covered. Early stage companies lacking the capital funds to file aggressively before a product is fully developed will face another challenge under the “first-inventor-to-file” system.

“The biggest impact [“first-inventor-to-file”] is creating a race to the patent office to get applications filed quickly and often.”

Accordingly, under the new “first-inventor-to-file” system, companies should make sure their patent applications are on file before they talk to any third parties or potential investors. Having to file applications early may also impede the collaborative nature of the scientific process—especially in university and research settings where ideas are discussed among colleagues. The bottom line is there is the risk that inventors could lose their rights if they are not the first to file, as they can no longer base their patent rights on proof of originality of an invention.

One of the benefits of the “first-inventor-to-file” system is that it harmonizes the United States with other countries and will simplify the overall patent process. It will also allow for the easier resolution of inventorship disputes based on the objective standard of the first filing date, as opposed to more subjective standards under the “first-to-invent” system.
The take-away message for medical device companies is to protect innovative technology close to discovery and to file patent applications with the USPTO as soon as possible.

MD+DI: How should small medical device start-ups compete with the big players to be the first to file patents?

Start-up companies should file several provisional patent applications to secure priority claims while buying time to more fully develop their technology and applications.

Dykeman: Start-up companies should file several provisional patent applications to secure priority claims while buying time to more fully develop their technology and applications. They should also utilize provisional patent applications and the Patent Cooperation Treaty (PCT) international applications to help delay costs while still maintaining protection in the patent process.

Most importantly, every company should file applications that cover the company’s core technology. Patent applications should also cover the current technology as well as future technology innovations and alternative embodiments to prevent opportunities for competitors to design around their patents. Although patent applications should be filed quickly, they should also maintain breadth and detail; elaborating on unexpected results of the invention will help provide support to overcome obviousness rejections during prosecution in the USPTO.

David J. Dykeman is a patent attorney and cochair of the IP department at Greenberg Traurig LLP (Boston). 

This article is the first in a series. Dykeman, who is also the author of "Patent Reform: Navigating the Changing Patent Landscape," explains more implications of patent reform in an interview titled "What You Should Know about Patent Reform: The Post-Grant Review Process."

Dream Devices that Would Revolutionize Healthcare

Dream Devices that Would Revolutionize Healthcare

Image from Flickr user h.koppdelaney
Last week, we posted an article titled “Experts Pick What's Hot in Medical Device Technology,” which provided a survey of medical technologies under development that could revamp healthcare. The experts surveyed for that feature were members of our very own editorial advisory board, which represents experienced medtech professionals and consultants to the industry.

Here, we’ll take a look at their view of dream devices that could revolutionize healthcare.

Orthopedic devices with embedded electronics. “Chip-based orthopedic devices could communicate the state of the device,” says Frank Pokrop, director of regulatory affairs at CareFusion. They could report if “OK” and provide data such as normal wear and stress. In addition, this technology could issue alerts when wear, particles or stress reaches an unusual level.

Self-monitoring stents. These devices might have a limited by battery life, but, they could provide reports or alerts regarding the condition of stent, incuding feedback regarding acceptable level of openness, alerts when openness starts to change, and alerts when cholesterol and other biological material starts to accumulate in and around the stent, according to Pokrop.

Alarm technology. Stephen Wilcox, PhD, principal at Design Science (Philadelphia), dreams of “a truly integrated alarm system that takes input from all the devices in the room (e.g., the ICU or OR) and rationalizes the whole thing, so the medical professionals get a smart signal from one place.” 

Sterilization breakthroughs. “A faster sterilizer that would not only sterilize health care product and package, but leave them with a preservative that would reduce contamination and infections upon application and use,” says Wayne Rogers, an independent consultant in the healthcare industry based in Phoenix. 

Microbe image from Flickr user musicalwds

Rapid microbial identification systems. “The continued evolution of rapid microbial identification systems and their application to healthcare,” says Robert Reich, the president of LexaMed, Ltd. (Toledo, OH). “Pre-admittance identification of potential patient-harbored pathogens will allow prophylactic treatment of patents thereby reducing the potential spread of hospital-acquired infections as well reducing the risk of patient nosocomial infections. Such a system could be utilized as triage in ambulances as well as emergency rooms. It could provides a potential significant cost saving to hospitals and the healthcare system in general.”

Replacement body parts. “Inexpensive manufactured working body parts and organs (arms, legs, heart, lungs, kidneys etc) could be used in third world countries to restore mobility and health,” says Richard Lincoff, client partner/medical devices industry lead at Cognizant (Greater St. Louis area).

An injectable cure would be developed to eradicate any specific cancer identified. 

A screening device for cancer. “I envision one day a screening device for cancer,” says Steve Mozelewski, senior manager, sleep diagnostics engineering at Philips Home Healthcare Solutions at Monroeville, PA. “ For example, an individual can have their DNA scanned (right now costs about $1000) and potential cancer markers identified. Based on this, an injectable cure would be developed to eradicate any specific cancer identified,” Mozelewski, says. “ Per WHO, 7.6 million deaths in 2008 were caused by cancers, 70% of which had no behavioral or dietary cause. I would liken this technology to the development of the polio vaccine by Salk in the 1950s. Prior to that, you would watch your friends pass away with little ability to do anything. The vaccine eliminated polio as a real issue. Love to see the same with cancer. Of course, this technology could then be expanded to many other types of disease-states (moral issues aside…) I admit, this technology does not directly affect everyone or healthcare as a whole, but it would certainly be exciting and wonderful,” he adds. 

Technologies that treat as they diagnose. “In general, devices that bring greater access to healthcare and deliver therapeutics at the time of diagnosis could reduce treatment time and repeated patient visits,” says John Delucia, vice president for regulatory affairs and quality assurance for iCAD Inc. (Beavercreek, OH).

Delucia provides examples: 

  • Simple to use blood analysis sensors to provide real-time results in a typical office setting rather than waiting days for results and delaying potential treatment. 
  • Delivering radiation intraoperatively at the time cancer excision. 
  • Automated pathology devices that can detect disease states (cancer) during surgery or at biopsy where the patient can go on to treatment immediately. 
  • Less expensive diagnostic imaging devices that can be used in the field or in under-developed countries 
    tricorder
Spock holds a tricorder device.
The tricorder. “I am not a 'Treky' but we continue to move towards the realization of the mythical tricorder that can scan a patient and help diagnose what is wrong,” says Bill Evans, principal and founder of Bridge Design (San Francisco). “My dream device for medical technology hasn’t changed much since I first saw it [on Star Trek],” says Andrew Dallas, president and CTO of Full Spectrum Software. “What is truly exciting is that [tricorder] technology, forecast decades ago, is also becoming a reality. As a private pilot, I have seen how the iPad has revolutionized the cockpit. In the same way, the power of handheld devices, combined with advanced, external and implantable sensors and active devices should continue to advance patent healthcare. This includes a huge range of disease states including diabetes, pain, epilepsy, depression, heart failure and more.”

“Think about how much money is spent dealing with treating chronic disease, how much good preventative medicine is not delivered, and how noncompliant patients can be,” recommends Bill Evans of Bridge Design. To deal with the problem, Evans envisions moving towards a mobile wireless device that requires no action by a patient to report critical patient parameters back to ‘HQ’ where artificial intelligence and real people can monitor and help patients catch problems before they become costly.”

Anti-aging technology. Eliot Lazar, MD, principal of ElCon Medical (Buffalo, NY). has in mind "something that halts the aging process on demand."