George Whitesides: Paper Lab-on-Chip

There's been some buzz lately about a TED Talk that George Whitesides, a Harvard chemistry professor, gave about a novel idea for a cheap, mass-producible diagnostic lab-on-chip.

I've written a numerous times about lab-on-chip devices, most of which involve various microchannels and reservoirs etched into a credit-card size piece of plastic. Whitesides, however, accomplishes the same goal using something similar to your everyday coffee filter.

You'll need to watch the TED Talk so Dr. Whitesides can explain the concept, but basically, you place a specific reagent on one end of the channel (the "solute"), and at the other end, apply the sample to be tested (saliva, urine, blood, etc.). The sample (the "solvent") moves up the channel through capillary action and when it hits the solute, will react with it and turn a certain color that can indicate a positive/negative result, or indicate the severity of a disease. If a doctor is unable to make a diagnosis on site, a picture can be taken and emailed to a physician.

I absolutely love this concept. Though Whitesides is a chemist by profession, such a unique idea is really what engineering is all about. He can reduce the solution to something that is simple, fast, and affordable.

In addition to his TED Talk, you might want to check out coverage from CNN and Popular Science. Also be sure to check out a post I wrote in November about a UC Irvine professor's novel solution for producing lab-on-chip devices.

TED Talks Offer a Brief Glimpse Into the Future of Medicine

The TED Conference is probably my favorite conference that I've never attended. What is so unique about it is wide range of ideas shared. While the title of this post only mentions medicine, TED also includes musical performances, talks on science, society, and anything innovative. The talks are no more than 20 minutes and are geared towards anyone who's interested.

Today, I watched a TED Talk on regenerative medicine given by a surgeon at Wake Forest University. Not only did it effectively sum up one of my courses I took on tissue engineering, but it also contained many pictures and video clips to show off the new body parts at work. Absolutely fascinating!

The TED website has many other talks that you can watch for free. Here's some that I've watched that pertain especially to biomedical engineering:

"Anthony Atala on growing new organs" - Dr. Atala of Wake Forest Institute for Regenerative Medicine explains the breakthroughs his team has made in creating replacement organs, and gives a brief explanation on how it's done.

"Catherine Mohr: Surgery's past, present and robotic future" - Dr. Mohr explains the evolution of surgery and how robotics make surgical procedures faster and safer (see previous post about Intuitive Surgical for an example).

"Robert Fischell on medical inventing" - This talk was actually an acceptance speech given by Dr. Fischell for the TED Prize, a prize given to a leader and visionary in his/her field. Dr. Fischell is a legendary medical device inventor, and in this video, he makes three wishes related to the field of medicine.

"Dean Kamen previews a new prosthetic arm" - The inventor of the Segway previews an advanced prosthetic arm he's been developing. (Also see related post on prosthetic limbs).

"Mark Humayun: Restoring Sight to the Blind" - I couldn't post a medical device entry without a clip from the very first TEDx conference at my alma mater, appropriately called TEDxUSC. In this TED Talk, Dr. Humayun explains how he is developing a retinal prosthesis to help the blind see (See related posts here and here)

If you're near a location that will be hosting a TEDx event, I highly recommend that you attend. These speakers all have amazing talks on a variety of interesting subjects. My favorite one involves David Blaine and a lot of water.

Top 10 Medical Advances of the Decade

ABC News, in collaboration with MedPage Today and the American Association for the History of Medicine, has published a list of what they consider to be the top medical breakthroughs of the past 10 years.

I wish I could find a similar list from 1999. It would've been interesting to see how medicine has changed since then.

Only a few of them are directly related to medical devices (see #8 and #10), but these discoveries open up many different applications for medical devices for the next decade. I believe that when the 2019 version of this article is printed, medical devices, bionics, and regenerative medicine will have a greater presence in this list. I also believe that drug therapies will be phased out as genome and stem cell related discoveries will cure diseases that drugs could only treat the symptoms.

The Top 10 Medical Advances of the Decade:

1. Human Genome Discoveries Reach the Bedside
2. Doctors and Patients Harness Information Technology
3. Anti-Smoking Laws and Campaigns Reduce Public Smoking
4. Heart Disease Deaths Drop by 40 Percent
5. Stem Cell Research: Laboratory Breakthroughs and Some Clinical Advances
6. Targeted Therapies for Cancer Expand With New Drugs
7. Combination Drug Therapy Extends HIV Survival
8. Minimally Invasive Techniques Revolutionize Surgery
9. Study Finds Heart, Cancer Risk With Hormone Replacement Therapy
10. Scientists Peer Into Mind With Functional MRI

Learn More: The Top 10 Medical Advances of the Decade [via ABC News]

National Geographic Special: Bionics

National Geographic Magazine just published an amazing piece about the technological advancements in bionics and medical devices. The online feature includes the article from the January 2010 issue of NGM, a photo gallery of the various protheses and their users, and my favorite: an interactive graphic showing the human body and the various prostheses being developed, with in-depth descriptions of the bionic skin project, the artificial limb, and USC's artificial retina.

Be sure to check out the feature and pick up a copy of National Geographic Magazine. This feature is the cover story for the issue, titled Merging Man and Machine.

Learn More: Bionics [via National Geographic Magazine]

Research Roundup

Merry Christmas all!

Here are a few interesting discoveries relevant to biomedical engineering that you might find intriguing:

• The Daily Mail highlights a treatment to cure blindness using stem cells from a patient's good eye. The procedure only works for those who have properly functioning stem cells in one eye, but the results show a successful movement towards regenerative medicine.
• MIT has developed special gold nanoparticles that attach to tumors and convert infrared radiation to heat that destroy tumors without harming the surrounding tissue. They claim higher precision than physical removal and chemotherapy.
• The University of California, Santa Barbara (UCSB) has developed synthetic red blood cells that closely mimic the physical and functional properties of erythrocytes. Their goal is to create an effective drug delivery agent, however, synthetic blood will also prove useful during blood shortages or in places like the battlefront.

Amputee Controls Robotic Arm With Thoughts

Prosthetic limbs are fairly common among amputees today, but the functionality they offer is limited. Most are mainly flesh-colored devices with a metal hook at the end to add a bit of usefulness.

Technological advancements (and some movie magic) in the past 20 or so years have greatly changed the development of prosthetic limbs. What once only belonged to a futuristic cyborg resembling California's governor is now becoming a reality for amputees.

I'd like to suggest the development of artificial, robotic limbs can be divided into three stages. The first, mimicking the kinetics of limb movement, is doing fairly well. With the advancement of actuators, materials, and integrated circuits, scientists and engineers can create a fairly good endoskeleton that can perform many of the movements of a real arm/hand. True, there is still an endless number of movement combinations that can be worked out, but as a whole, I think the mechanics of the arm are working well.

The second stage, the one that this entry's title alludes to, involves interfacing the arm with the brain. An Italian amputee participating in a study was recently able to control his robotic arm using his thoughts much like we control our limbs. During the one-month study, electrodes were connected to him, and he eventually gained to ability to move his fingers, make a fist, grab an object, even flip the bird. This is a huge advancement given the fact that in our bodies, nerves control each of the individual muscles involved in hand movement. As the article on Discovery.com mentions, scientists now need to research how long the electrodes can stay implanted in the body without an immune response. They also need to miniaturize the technology so the processing unit that joins the electrodes and the arm can fit into a feasible prosthetic device.

What is the third stage? It's implementing the sense of touch in the prosthetic arm. Once the user is able to control the movements of the prosthesis with his mind, the prosthesis will need to give him feedback, such as the amount of force he is applying, the temperature and texture of the surface the fingers and contacting, and of potentially hazardous extremes. One of the researchers working on this is a former professor of mine, Gerald Loeb, from the University of Southern California. Professor Loeb and his lab have created a device that mimics human skin in terms of sensation, inspired by a feature on our own hands called fingerprints.

I think advancements in prosthetic limbs are probably one of the most visible applications of biomedical engineering. Pretty much everyone know about cyborgs from popular media, and I think a lot of people would be amazed to see similar technology become a reality for amputees.

Learn More: Amputee 'Feels' Fingers For First Time With Robotic Hand [via Discovery.com]

Lab-on-Chips made from children's toy

I'll be honest. I didn't know what Shrinky Dinks were until this past summer. I used them for their intended purpose, to "shrink" colorful works of art drawn on flexible plastic sheets into shiny, rigid works of art.

Never would I have thought to use them to scale channels and reservoirs down to a size suitable for microfluidics!

Michelle Khine, an associate professor at UC Irvine, came up with the idea. And her solution didn't stem from a problem with physics or the engineering process. It was simply because her lab couldn't immediately afford the specialized machines used to create the molds.

I took a class on microfluidic devices during my senior year and wrote a paper about them (see related post here). I actually got to watch a microfludic device get fabricated, and I found it's fairly complicated. It basically involves printing a series of masks and "etching" the mold out using light radiation. It requires a fair amount of precision as you are forming the actual micro-channels. The shrinky dink method, however, produces a mold in a matter of minutes.

While there are issues to work out, researchers say there are advantages to this process. It's much cheaper, faster, and works on printed metal patterns, opening up an infinite number of applications.

I really enjoy reading about engineering solutions like the one Professor Khine came up with. It's straightforward to implement, and it's thinking outside the box. Reminds me of that old joke about NASA spending millions of dollars developing a pen that writes in space while Russian cosmonauts used pencils. Only this time we look far less stupid.

Learn More: A children’s toy inspires a cheap, easy production method for high-tech diagnostic chips [via MIT Technology Review]

Website Downtime

Hi everyone, sorry for the extended downtime I had. I've been busy with a bunch of things and have not had time to focus on blogging. I have some more free time now so I'll start up blogging again within the next couple days! There's a lot of cool stuff out there I want to write about, so stay tuned!

iPhone Light-Therapy Application

I'm a proud iPhone user. I've had my iPhone 3G for a little over a year and are amazed at the ever-increasing applications for the iPhone.

One that struck me today (as well as Engadget) was a new application called the BlueWave/RedWave. It claims to utilize the LED in the iPhone screen to administer light-therapy. The application claims to have features such as "exacting nanometers" to adjust the specific wavelength of the light emitted. Depending on the color/wavelength of light emitted, such therapy can supposedly cure a number of symptoms ranging from acne to depression.

I think the application is good in concept. The developer has a number of studies on his website citing the benefits of light therapy. Light therapy certainly has some promise, but my biggest concern is that the iPhone hardware was not meant for such use and is not medical-caliber. I think the developer has good intentions, but makes too many bogus claims about his application specifically. There is no such thing as "exacting nanometers" unless he is referring to specific wavelengths of light (which are measured in nanometers). For such a device, you cannot trust the wavelength emitted (not specified in the application) because smartphone screens are not held to specific calibration standards that other light-emitting devices, such as spectrophotometers, are held to. Depending on the brightness of the LED and the color LCD that it shines through, the wavelength can vary significantly.

I'm not going to mock this application like Engadget did and call it the "worst iPhone application. ever", but I will say that it lacks specific backing and research. It would be like me reading claims about acupuncture benefits and then grabbing my home sewing kit for a pokefest. Who knows? His application might deliver benefits, but it needs a little more research.

On the more serious note, I think it's a great thing that the iPhone is being used for such a wide range of medical applications, no matter how far-fetched they might seem. Gene Roddenberry had such a vision when he came up with the famous Tricorder from Star Trek. He probably didn't realize how far technology would come by 2009 and even make his visionary Tricorder seem somewhat last-century

Learn More:

pocketpaindoctor.com - the application's website

Light therapy [Wikipedia]

Seeing With Your Tongue

Here's a unique solution to help blind people see: an electrode that stimulates nerves in the tongue depending on the brightness of an image.

Very much like USC's artificial retina project I wrote about a couple weeks ago, this device, known as the BrainPort, uses a glasses-mounted camera and an image processor to transform an image into a black and white array of pixels. The array is sent to an electrode, but instead of stimulating the retina, it stimulates the tongue using a "lollipop".

There's a learning curve involved since you're using your sense of "taste" rather than "sight", but the device has its advantages because it's non-invasive, the nerve fibers in the tongue are densely packed and closer to the surface, and saliva is a good conductor.

Learn More: Tasting the Light: Device Lets Blind "See" with Their Tongues [via Scientific American]

Vacation, Part 2

I'm going to be vacationing in Branson, Missouri from August 13-20. During that time, I'll try to blog occasionally, but depending on how relaxed I feel and/or how my internet connection is in Branson, it's not guaranteed.

Blogging will resume as normal on August 21.

Wireless Pacemaker Can Notify Physician

Pacemakers are a fairly common medical device. Companies such as St. Jude and Medtronic are continuing to miniaturize the pacemaker and extend its life between replacements.

A woman in New York recently had the world's first wireless pacemaker installed. This pacemaker sends a report to a monitoring service once a day for a physician to access.

Says Dr. Steven Greenberg from St. Francis' Arrhythmia and Pacemaker Center, "If there is anything abnormal, and we have a very intricate system set up, it will literally call the physician responsible at two in the morning if need be."

Monitoring systems and pacemakers are two essential devices for maintaining cardiac health in patients with arrhythmia, however, incorporating wireless technology into the pacemaker itself is a first. Not only can monitoring systems check the vitals of the patient, but can monitor the status of the device itself, whose proper functioning is also extremely important to the life of the patient.

Learn More: New York Woman Gets World's First Wireless Pacemaker [via DailyTech.com]

On Hiatus

DeviceLine will be on hiatus from Sunday, August 2 through Sunday, August 9 as I will be away on vacation in the mountains.

Looking further ahead, posting will be sporadic from August 13-20 as I will be away on vacation. I'll try to post at least a couple times during the week if my schedule permits.

Medical Device Principles: Batteries and Power

While medical device technology continues to grow more and more advanced, one component that seems to be lagging behind is battery technology. As you know, batteries are what makes all of our electronic devices portable. One of the specs I look at when researching a notebook computer, cell phone, or mp3 player is the battery life. With current technology, you can increase the battery life easily, but at the expense of size, as more power requires a larger battery. Recently, Apple switched their MacBook notebook line to an internal, non-replaceable battery so that a larger battery can be placed inside the notebook.

With medical devices, especially implants, battery and power is extremely crucial. A company can develop the world's most advanced implant that can prevent many problems, but if the battery needs to be replaced often, then much of the advantage is lost. This is even more important to senior citizens, whose risk of complications under general anesthesia increase with age.

The power system utilized can vary from device to device, however, how can medical devices as a whole be made to deliver results without needing their batteries replaced frequently? Here are a few technologies, current, future, and even fictional, that may be the answer:

• Conventional: a battery is attached to the device itself. It is very low-maintenance, however, as mentioned above, minor surgery must be performed to replace the battery. This system is most suitable for implants with low power applications.
• RF: this system uses an implanted receiver with control circuitry powered by an external source. Power is sent from an external source (e.g. belt-worn battery pack) wirelessly to the receiver using RF energy. This system eliminates the need to replace an internal battery, however, the external power source must be worn in close proximity to the receiver in order to receive power.
• RF + rechargeable: the newest type of system utilizes the battery feature of a conventional system with the wireless telemetry of an RF system to recharge the battery. The external power source is worn for a few hours every few weeks to recharge the battery. The battery must eventually be replaced, however, rechargeable systems last longer than conventional systems.
• Biomechanical: also known as "power-walking", there have been a few research projects that utilize the movement of our limbs while walking to generate electricity. It's only enough electricity to power small handheld devices like a cell phone or GPS, but it might be enough to power a medical implant. One company called Lightning Packs develops electricity-generating backpacks that use the body's vertical movement, similar to how a pedometer works. The latest is a study from the University of Michigan, Simon Fraser University in Canada, and the University of Pittsburgh that uses an electricity-generating knee brace.
• Nuclear: in the late Michael Crichton novel, The Terminal Man, the main character, a man suffering from violent epilepsy, has electrodes implanted in his brain to control the seizures. The electrodes are powered by a plutonium pack in his shoulder, which theoretically, would last his entire lifetime and would be removed after his death. This system would eliminate the need for any maintenance, however, as the world is still a little hesitant to embrace nuclear energy to power our cities, plutonium to power our implants will probably be left to the pages of fiction for a while. (In case you were wondering, the main character's computer "takes over" his personality and he goes crazy in the end. Read it. The book is amazing and Michael Crichton was a genius!)

Music Drives Lab-on-Chip

In college, I wrote a research paper about the development of Lab-on-chip technologies. Lab-on-chip is exactly what it sounds like. It combines all the functions of a medical laboratory and conducts tests on samples of blood, urine, or any biological fluid, on a device the size of a credit card.

Not to get too technical, but basically the volume of fluid collected is small enough that it takes on special properties that allow it to be moved, heated, and manipulated faster, cheaper, and more accurately. (E-mail me if you'd like to read my paper).

Typically, small amounts of electricity or air are required to move the samples around the lab-on-chip device. The electrical connections and air hoses can take up significant space and eliminate the advantages of a small device (see the above image of a lab-on-chip). However, a study from the University of Michigan showed that "music" can move these samples. It's actually tones at specific frequencies and amplitudes that drive the samples. The channels in the device are of varying lengths and widths, therefore, different frequencies can move samples in different channels because of the varying air pressures the sound waves produce.

Lab-on-chip devices are amazing. The goal is that these devices will be used for many different tests in the physician's office or even at home. Such devices would even be great in poor, undeveloped countries where resources and trained personnel are limited. If this sound-based engine or a similar technology really works, lab-on-chip devices will truly be portable!

Learn More: In New U-M Lab-On-A-Chip Device, Music Is The Engine [via Medical News Today]

FOCUS on...Visual Prostheses (Part 2)

In Part 1, we looked into how vision is achieved and how damage to the retina by two common diseases impairs one's vision. While there aren't any cures for such diseases, implants are being developed to help those with age-related macular degeneration (AMD) and retinitis pigmentosa (RP) live easier lives.

One of the most well-known and well-developed projects comes from the Department of Ophthalmology and the Department of Biomedical Engineering at my alma mater, the University of Southern California. Led by Dr. Mark Humayun and Dr. James Weiland, with teams from USC, Caltech, UC Santa Cruz, and the National Science Foundation, with Second Sight Medical Products, Inc., the 10-year old project consists of a glasses-mounted camera, an implanted wireless receiver, and a small electrode array attached to the back of the retina. The camera captures an image and converts it into an electric signal, which is sent to the receiver implanted inside the eye. The receiver sends the signal to the electrode array, which emits electrical pulses perceived by the user as small points of light.

Current research includes developing an intraocular camera which would be placed into the space that the (now-useless) lens occupies. Users of the current glasses-mounted camera must move their heads to scan an object. An intraocular camera will allow users to move their eyes to scan an object in a more natural manner. Another ongoing project is increasing the number of electrodes on the array. The first model (Argus I) had 16 electrodes, allowing the user to basically see only a 4x4 field of pixels. The latest model has 60 electrodes, allowing the user to see much greater detail.

Other notable approaches include the Implantable Miniature Telescope (IMT), developed by Dr. Isaac Lipshitz with VisionCare. The IMT takes one's central field of vision and enlarges it up to 3x. In this way, the image is not focused on the damaged part of the retina but is projected over other healthy parts of the retina, which reduces the blind spot that those with AMD suffer from.

Another unique approach is the Artifical Silicon Retina, developed by Drs. Alan and Vincent Chow. The ASR is implanted in the sub-retinal space in the eye and the unique composition of the device converts light into electrical current without the need of any external devices, basically mimicking the function of photoreceptors. However, it is shown that the device is not theoretically practical for neural stimulation. Moreover, Optobionics, the company that developed the ASR, ceased operations in May 2007.

Visual prostheses are exciting devices with numerous engineering challenges to overcome. The physiology of the eye only allows for an implant no larger than 5mm. The curvature of the eye presents challenges in developing electrode arrays with equal retinal stimulation. And as with almost any implant, there are issues of power and telemetry requirements. However, there is so much devoted to researching visual prostheses that we will undoubtedly have some amazing "bionic eyes" in the near future.

Learn More:

Wikipedia entry on visual prostheses

U.S. Department of Energy webpage on the Artificial Retina Project (USC project)

FOCUS on...Visual Prostheses (Part 1)

"FOCUS on..." will be a periodic DeviceLine feature in which a specific part of the body or disease will be highlighted. Basic anatomy and physiology or pathology will be covered, followed by current research and companies that are developing devices."

We've come a long ways in helping visually-impaired people to see. Maybe not as far as Star Trek's Geordi LaForge, who even in early part of his career had far superior vision than most of his crewmates even with his VISOR, but technological advancements have given blind people opportunities for greater independence. In the near future, Braille could very well become less common as prostheses are being developed to allow people to see the real world around them.

Overview of Vision: Vision is accomplished by a coordination of motor and sensory systems in the eye. Ocular muscles move your eye to the desired target. Light reflected off this target enters the eye. The amount of light that enters is adjusted by the pupil, which changes in shape to allow more or less light to enter. The cornea refracts the light, while the lens also refracts the light and focuses the light more precisely through the eye. The image is then projected in an inverted fashion onto the retina, which contain specialized cells called photoreceptors. These photoreceptors are responsible for changing light into electrical signals that are sent to the brain.

Diseases of the Eye: Patients who use visual prostheses are usually diagnosed with age-related macular degeneration (AMD) or retinitis pigmentosa (RP). Both are related to damage to the retina.

AMD is the leading cause of blindness in western countries and is typically caused by abnormal deposits called drusen between the retina and the blood vessels in the back of the eye. The result is a slow, increasing loss of one's center of vision. Those with AMD never go totally blind, however, their perception is greatly impaired, as shown in the photo on the right. There is currently no cure, and laser treatment is the only current option available.

RP is a genetic eye condition that is the leading cause of inherited blindness. RP results in slow degradation of the photoreceptors in the retina, and can lead to total blindness. Those who suffer from RP typically begin to lose their peripheral vision, giving them tunnel vision that gets smaller and smaller over time (shown on left). There's currently no cure for RP.

While both AMD and RP currently don't have any cures, there are treatments being developed in the form of implantable prosthetic devices.

Tomorrow in Part 2, we'll look into some of the devices being developed for treatment of AMD and RP and the companies behind them, as well as engineering challenges for future devices.

Company Spotlight: Intuitive Surgical

Today we highlight a Sunnyvale, CA-based company called Intuitive Surgical. Founded in 1995, Intuitive Surgical's flagship product is the da Vinci surgical system.

The da Vinci system uses robotics and the latest 3-D visualization technology to simplify many minimally-invasive surgical procedures. The system consists of a surgeon's console, a patient-side cart, a vision system, and a number of proprietary surgical instruments controlled by the surgeon on the console.

So far, the da Vinci system has been successfully used in urologic, laproscopic, gynecologic, and throracoscopic surgical procedures.

This product definitely extends the boundaries of traditional surgery. Large movements by the surgeon are translated to much smaller movements at the site of surgery, which allows for more precise techniques and is also more forgiving at unexpected movements by the surgeon's hands. While Intuitive's focus is not pure "robotic surgery", robot-assisted surgical units such as the da Vinci system certainly makes the surgeon's job a little less stressful.

Learn more: http://www.intuitivesurgical.com/index.aspx

Implantable Device for Cancer Monitoring

Dr. Michael Cima, Ph.D., a professor of Material Science and Engineering at the Massachusetts Institute of Technology (MIT) has developed an implantable device which can continually monitor the progress of cancer in the body.

Currently, the process of monitoring the growth and treatment of a tumor involves a biopsy. Biopsies are accurate, however, they can only give the condition of a tumor at a certain point in time and must be repeated multiple times to track the progress.

Dr. Cima's device utilizes nanoparticles that will clump a certain way, depending on the target molecules that enter through a polycarbonate membrane. The clumping can be detected using MRI, a much less invasive test.

The current in vivo version of the device tests for cancerous biomarkers (specifically the levels of the human hormone chorionic gonadotropin, however, the device can be modified to test for pH changes, oxygen levels, and the effectiveness of chemotherapy agents.

Learn more: http://www.physorg.com/news167335574.html [via PhysOrg.com]

The Medical Device Industry

I thought it would be appropriate for DeviceLine's first entry to discuss briefly about the medical device industry in general.

My direct experience in the industry is very limited, but from what I've learned, the area of research in which medical devices typically are born out of (usually the discipline of biomedical engineering), came primarily from an application of electrical engineering to the field of medicine. Most programs are not much older than 40 years old. With that said, as the field of electrical engineering has changed much since the 1970's, especially with the development of the integrated circuit and digital electronics.

Medical devices have also undergone a dramatic change too, becoming increasingly smaller and smaller. However, with the developments in genetic engineering, will medical devices completely disappear?

I think medical devices won't be going anywhere for a while and that the industry will continue to grow and demand will continue to increase.

First off, genetic engineering can never replace medical tools. Surgical tools, imaging modalities, and diagnostic devices are such tools that will always utilize electronics. I think as the baby boomer generation grows, there will be a greater demand for these tools in the office and in the home.

Also, genetic engineering is still too new of a technology. I'm really excited about the developments in tissue engineering, however, there are still too many hurdles that genetic engineering has to overcome. Many are concerned about the ethical issues related to stem cell research. Many of the products so far have proven more costly and not superior than their medical device counterparts, something consumers are hesitant to invest in this economy. Finally, as very new technology that involves living tissue, genetic and tissue engineering may have some unique FDA regulations to clear.

Do I want genetic and tissue engineering to one day replace implantable medical devices? Yes! And I think they will someday. Until then, medical devices will play the role of enhancing the lives of its users. For now, we'll have to live with creating "six million dollar men" before we create "frankensteins".