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Articles from 2010 In August


Three Former Execs Named in Criminal Indictment

  • George John Schulte, 62, former CEO
  • Obinna Adhigije, also known as Larry Adighije, 50, former VP of business development
  • Trung Pham, 37, former business development manager
  • Hernan Ricaurte, 41, former contract rep

The charges include conspiracy, making false statements, receipt of illegal imports, sales of adulterated and misbranded medical devices, and other offenses. (Note that not every defendant is being charged with every crime.)


 

Hospitals Not Prepared for EHRs

The AHA polled 3,100 members. Only 12% used electronic records and only 2% would have met the requirements drafted by the federal government to win the payments.

To be eligible for financial incentives, hospitals must demonstratethat they meet 14 core objectives and five of theten menu objectives. AHA found modest increases in adoption of electronichealth records between 2008 and 2009. Larger, nonprofit, urbanhospitals made more headway than critical-access hospitals,small and medium-size hospitals, and public and rural hospitals.It also found that a very small proportion of hospitals canmeet the stage 1 meaningful-use criteria. This findingsuggests that most hospitals will have to make substantial progressto receive financial incentives over the next two years, says the report.

AHAproposes several potential policy solutions, including extendingthe efforts of the Regional Extension Centers to include smalland public institutions.

Robots Administer Anesthesia From Afar?

Once the anesthesiologist placed the ultrasound probe, a catheter placement procedure was performed. Although the study showed that teleanesthesia is possible with existing equipment, Steven Shafer of Columbia University says that there aren't enough skilled regional anesthesiologists to meet the demand. The technology is also still too young, but Shafer says that if future studies demonstrate that the technology is practical, then one highly trained anesthesiologist could perform procedures around the world in one day. However, a local anesthesiologist would also need to observe the patient for complications or to standby if the remote procedure fails.

Foldable Display Technology Is No Longer Just for Jazzy Jackets

What does this light-up apparel--worn by Kanye West at the 2008 Grammy Awards--have to do with medical devices? A lot, actually. The company behind those flashy lighted jackets could contribute to next-generation medical products through the advancement of flexible displays.

Over the years, flexible displays have captured the interest and imagination of a number of researchers and organizations. Chief among them is The FlexTech Alliance (San Jose, CA), which claims to being the sole organization in North America exclusively dedicated to "fostering the growth, profitability, and success of the electronic display and the flexible, printed electronics supply chain." To further this goal, FlexTech recently announced a partnership with Nyx Illuminated Clothing Co. (Los Angeles) to create a foldable display fabricated from a panel of multiple e-paper screens.

"To enable this unique technology to work, our engineers will develop circuitry to simultaneously drive six separate e-paper screens as one single display," says John Bell, project manager for Nyx. "The screen panels will be able to be folded up into the area of a single panel or unfolded to the full six panel area on demand."

A press release from FlexTech describes the aim of the partnership as follows: "This research will demonstrate the capability to reliably fold and unfold multiple e-paper screens, allowing broadsheet screen sizes to be condensed to a 5 x 10-in. size. The final design for this project is intended to allow much of the display production to be manufactured on a roll-to-roll process with its associated high throughput and low cost. The foldable display will go through rigorous reliability testing for shock, vibration, and dynamic flexing by folding the arrangement up to 10,000 cycles."

Nyx specializes in incorporating flexible display technology into jackets designed for clubbers, entertainers, and sales representatives that wish to draw attention and convey brand messaging. However, the company recognizes the technology's potential in other areas, hence its partnership with FlexTech. The firm is also currently working with NASA, for example, to apply its display technology to the development of wearable health monitors for astronauts, according to its Web site. Potential use for storing large amounts of information or data on a foldable or compact display could be advantageous to many medical applications and is a target application area.

Read more about flexible display technology from MPMN's archive. Are you excited about the long-awaited prospect of flexible electronics and the potential they hold for next-generation medical devices? Or are you too distracted by Nyx's signature snazzy jackets? Leave a comment and let us know what you think.

YouTube's Got the Motion

YouTube's got just about everything, from old TV shows and concert footage to funny cat videos and political messages. But now it's offering something more—the YouTube Channel Video Library featuring clips about motors and motion control technologies.

That's right: Electromate (Woodbridge, ON, Canada) has just launched the new channel, which is populated with more than 80 product videos, training webinars, and other offerings from a plethora of motion control manufacturers, including Galil Motion Control (Rocklin, CA), Advanced Motion Controls (Camarillo, CA), Maxon Motors (Fall River, MA), Harmonic Drive (Peabody, MA), Tolomatic (Hamel, MN), Macron Dynamics (Croydon, PA), Nippon Pulse (Radford, VA), Intelligent Actuator (Torrance, CA), Haydon Kerk Motion Solutions (Waterbury, CT), and Zaber Technologies (Vancouver, BC, Canada).

So tune in today to Electromate's YouTube Channel Video Library.

When Surgical Sponges Lose Their Way

says that the system is the only RFID-based method that goes beyond counting sponges to include surgical instruments.


The Basics of Medical Device Risk Management

The bar for risk management has suddenly moved higher for medical device companies. After numerous product-safety-related recalls and field actions over the past few years, FDA has dramatically increased its scrutiny of the product risk management practices, demanding adherence to the current standard, ISO 14971:2007. With the agency now examining risks in terms of the worst possible outcome, practices that had been presumed acceptable are subject to heightened scrutiny. The rate at which FDA issues warning letters citing risk management deficiencies has more than doubled since 2007. Recent warning letters have highlighted inadequate links between risk management practices and corrective and preventive actions (CAPA) that have always been the focus of FDA inspections. This shift in risk management regulatory expectations makes it imperative for medical device companies to revamp their risk management practices.

Jim Prutrow

The change on the regulatory front is only one reason for companies to reassess their practices. The use of risk management as a development tool to drive product quality often falls short of its potential. Much of the time, it is seen by development teams as a paper exercise to be completed right before launch. Poorly implemented risk management programs further fuel this misguided notion that the practice adds little value. To the contrary, a well-executed risk management program that includes product development and safety, process development, strategic planning, and project execution can serve as a powerful tool for a firm to innovate and grow.

When initiated early and employed frequently throughout the product life cycle, risk management can promote innovation, leading to a reduction in the number of customer complaints, lowered service and support costs, fewer disruptions from field actions, and improved execution against program expectations. Resources once spent on such non-value-added activities can instead be used to fuel growth and shareholder value.

To reap these benefits, the organization needs to apply risk management practices across the product life cycle. This means eliminating silos and aligning incentives between development and post-commercial organizations. For maximum impact, risk management practices must be data driven, with logical, consistent risk characterization that is well communicated across the organization.

Companies should ensure robustness in the following fundamental areas:

  • Integrated processes. Companies need to develop risk management processes with integrated links to CAPA and management review processes, systems, and procedures. Such integration allows companies to prioritize continuous improvement activities, improve customer satisfaction, and sustain long-run profitability—maximizing results while minimizing risk.
  • Robust governance. Management must also play a strong role in ensuring the proper governance of risk management processes. It’s critical that an established governing body make executive-level decisions regarding risk-benefit analyses and drive key company-wide risk control measures; doing so provides single-point accountability. This body must also establish and monitor sensible metrics to measure process effectiveness.
  • Cross-functional involvement. Risk management is not limited to the quality function. Success requires close collaboration with a variety of groups, including regulatory, medical, manufacturing, R&D, and engineering. Management must ensure that these different functions all play a part in risk-management initiatives.
  • Adequate resources and tools. Determining the right number and type of resources is also crucial. Dedicated resources, fully engaged in development and post-market risk management activities, are critical to the effective and timely identification and resolution of product risks. To ensure sustained excellence, ongoing investment in training and evolving tools and techniques is key.

Given the current regulatory climate, there is no better time for companies to revamp their risk management programs—and to realize the potential business benefits.

Sharad Narayan is a PRTM manager in the healthcare business group. Jim Prutow is a PRTM director in the healthcare business group.
 

The MX Q&A: Euan Thomson, Accuray

Euan Thomson realized Accuray faced a tall order when he joined the company as CEO in 2002. Despite Accuray’s promising radiosurgery technology and the field’s equally promising vistas, the company needed to make fundamental changes if its CyberKnife Robotic Radiosurgery System was to emerge from its R&D phase and succeed in the marketplace. One of the chief challenges was the nature of the medical equipment business, which is dominated by manufacturers with deep pockets and large reputations, Thomson says.

“From the beginning, it was very clear what needed doing,” says Thomson of the Sunnyvale, CA–based equipment manufacturer. “What needed doing” included changes in Accuray’s infrastructure and a “cultural shift” in the company’s direction. Five years after Thomson became president and CEO, the company went public in 2007 and today has a market cap of just under $400 million. Accuray’s robotic CyberKnife System noninvasively treats tumors throughout the body in real-time, delivering precise, high-dose radiation that lessens the impact on the surrounding healthy tissue, the company says. The system doesn’t require the use of head or body stabilizers. “It’s a completely bloodless outpatient procedure that patients find very attractive,” Thomson says. The CyberKnife System has been used to treat more than 80,000 patients worldwide so far, according to the company.

Under Thomson’s leadership Accuray continues to advance. In June 2010 the company announced that the Mount Vernon Cancer Center in Middlesex, England, had become the first hospital operated by the UK’s National Health Service (NHS) to acquire the system. The purchase marks the 200th installation of the CyberKnife. In that same month Accuray signed a strategic alliance with Siemens giving the healthcare products giant the global rights to sell the CyberKnife System. The two firms will also collaborate on R&D, and Siemens will buy and integrate elements of Accuray’s technology in its linear accelerators. In August Accuray received Shonin approval from Japan’s Ministry of Health, Labor, and Welfare to market the CyberKnife in that country.

Before joining Accuray Thomson served as president, CEO, and board member during various periods for Photoelectron Corp., a Massachusetts-based manufacturer of miniature x-ray systems for medical and other uses. Thomson has also held positions as a medical physicist for NHS and has worked as a consultant for Varian Oncology Systems, Radionics, and other medical device companies before going to Photoelectron. He attended the University of London, where he received a BS in physics, an MS in radiation physics, and a PhD in physics with an emphasis on stereotactic brain radiotherapy.

In this conversation with MX Thomson touches on the high standard for clinical data in Europe, long-term developmental needs versus short-term financial considerations, investor perceptions, the importance of customer feedback, and how Accuray has “broken the mold” of the usual path for medical capital equipment companies.

MX: Congratulations on the 200th installation. Are the bulk of the systems in the U.S.?
Euan Thomson: Thank you. About two-thirds are in the United States and the remaining third is fairly divided between Europe and Asia. The strongest growth is in Europe.

Why Europe?
The market in Europe is very dependent on clinical data. One of the important things to realize about Accuray as a company is that we have a great product in CyberKnife. It’s designed for a field that is still developing and uses an intense dose of radiation [to remove tumors.]

We have all the FDA market clearance we need, so we can sell the device for treatment of tumors throughout the body, but there isn’t necessarily the clinical evidence yet to support that. So one of the biggest jobs for Accuray is to develop the field of radiosurgery and to really get to clinical acceptance.

In Europe in particular it’s a fairly conservative market, and it’s got strengths and weaknesses from a company perspective. It needs clinical data, which means that it can be a fairly slow-developing market. And that’s one of the challenges: Their standard for data is very high.

On the positive side, once you have that data funding for this type of capital purchase is much more centralized than it is in the U.S. And what we found in an environment of economic turmoil is that Europe remained a fairly robust market for us.

Did your position as a former medical physicist with NHS help Accuray in getting the first CyberKnife System installed at the Mount Vernon Cancer Center?
My medical physics training gave me deep product knowledge of radiosurgery. I also worked as a consultant for several U.S. companies [and had experience in the European market] before entering the market full time. That consultancy experience gave me a solid understanding of the U.S. market pressures while arming me with a detailed understanding of the European market dynamic. The groundwork Accuray created in Europe helped us gain acceptance. As we came through tough economic times, it helped that Accuray approached the European market in the right way. My background in medical physics and my consulting experience gave me an understanding of the technology and the market worldwide, helping Accuray succeed abroad.

Speaking of the global market, earlier this month Accuray received premarket approval for the system’s use in Japan. What challenges does an Accuray, or any device firm, face in dealing with the different regulatory schemes and business cultures?
Particularly in the early days as you try to develop into a global organization, you have to have a very broad range of expertise and a very broad understanding of cultural diversity when it comes to the regulatory environment. That definitely can be a challenge if you look at your global profile.

Was there any one thing that was particularly challenging?
I think I referred to it earlier. It’s the very high academic [requirements] that are demanded in order to be successful in the medical equipment environment. That was probably the biggest hurdle we faced. It took many years to overcome that.

Our first customers were very important to us. They were academic sites. To explore the overall use of CyberKnife has been a key part of our strategy. I’m a firm believer that there are manufacturing technologies that have a short life cycle. Their business case is based on temporarily favorable reimbursement. There are few examples of products that have a good clinical grounding that succeed in the long run.

In other words, I think that the investment the company makes in really proving the clinical value of a product is really money and time well spent. It guarantees the long-term success of the product.

Because of that approach, is there tension, say, between long-term technology development needs and short-term shareholder interests?
I think there is. And particularly for a capital equipment company, as we are. Each individual unit of CyberKnife that we install does impact our quarterly finances significantly. So the perception of one delayed or accelerated shipment can really affect investors’ perspective on how the company is progressing. Whereas the reality is for a business that’s growing a new clinical field and installing high-value, high-cost products such as CyberKnife, you really have to take a medium- to long-term view.

Do you think that your shareholders understand that?
I think our existing shareholders understand that. I think it’s a hurdle we have to overcome in order to attract new shareholders. New investors have to look harder at the Accuray story than they do at other stories. Those who do really recognize the potential that the product and the company have.

If you look at the profiles of most capital equipment companies selling medical products, they’re much larger players. You’re talking about Siemens and GE and Philips. There are very few examples of successful start-ups involving equipment. To some extent, we’ve broken the mold of that. But I think, going back to the shareholders, there can still be the perception that we’re vulnerable to some of the larger players, particularly Varian, that have a dominant place in the field. Investors can be worried about potential threats from larger companies.

On that note, are you pleased with your stock performance?
Overall, we’re not pleased with the stock performance. We’re an undervalued company. And I think many of the issues relate to the type of commercial threat I discussed. What we’re finding investors are looking for, and we’re happily able to deliver, is sales performance. We have an extra level of proof that we have to go to that we can sell against these larger companies. We have a robust technology that is well protected by IP, but you need commercial position. We have done that and we continue to do that.

In the last three quarters that I can talk about, we took orders for 41 systems, and we shipped 26 systems. In the context of an installed base of 200 units, to sell 41 in 3 quarters and to have a book-to-bill ratio in excess of 1.6 shows that the CyberKnife is truly a differentiated product in the market and that we as a company have the ability to sell it. When I spent time recently with investors I saw they are definitely starting to gain confidence in the ability of the product to continue to gain rapid acceptance.

How does the pricing of the CyberKnife System affect its acceptance among healthcare providers?
We’ve been very good about maintaining a high selling price and achieving good growth margins as an organization. Historically, we have growth margins in the mid-40% to 50% range, and for a capital equipment company, if you compare us with our peers, that’s actually pretty good, considering that we don’t have the order of scale that some of the companies have in their manufacturing operations. Again, we wouldn’t be able to get the margins we do for this product if it wasn’t a well-differentiated product in the market. The funny thing I actually say to investors is we probably face 10 times more questions about differentiating the CyberKnife from competitive products when we talk to Wall Street than we do when we talk to our potential customers.

The challenge is they’re much bigger companies, and many investors already have an investment in those companies, and [those companies] have a longer track record than we do. They have a very established place, so they have to whisper what we have to shout.

Given the economic downturn, has financing become a problem for your customers?
It was, specifically in the U.S. in the depths of the recession. Again, I can only speak to the three quarters [of financial results] that I can publicly disclose. We did talk about the improving mood of capital investment. We’re finding customers at that point showing signs of having better access to capital. And we did talk about growing optimism in the U.S. sales force.

Do you have plans to introduce new models or upgrades for the CyberKnife?
This question speaks to our core strategy. We need to grow in the field of radiosurgery, and we can only do that through our customers by working closely with them, because in the end they’re the ones who treat patients. We want to gain clinical experience, for example, for treating lung cancer. If we want to do that we have to provide our users with the right technology for treating lung cancer. We decided early on that we wouldn’t follow the normal capital equipment model, which is to ‘obsolete’ over time the last-generation of product and encourage people to accelerate the replacement cycle. We decided to do an upgrade strategy based on the existing installed systems.

Your approach is to incrementally add new system features.
Right, exactly. We see the CyberKnife as a core technology. As we learn more about the clinical requirements of a new application we make product-relevant appropriate upgrades, and we roll those upgrades out to our installed base. It’s a continuous process. We track ourselves on kind of an annual basis. We aim to have significant improvements and upgrades to CyberKnife.

You’d need a topnotch sales force then.
You’re right. It needs a different approach to selling, as well. Once we’re done, once we’ve developed a track record for producing these upgrades, we start to include them in our service program. So today we sell a high-level service program that includes access to upgrades, and our customers really like what they can get. For example, in a hospital …there will be this high-level service program. The users, the doctors and technicians that are actually using the system, then decide which of the upgrades they want, and they don’t have to go back to administration or regulatory affairs and ask for an incremental budget.??As an example, in about 2005 we produced an upgrade that made it much easier to treat lung cancer. Since that time we’ve seen what amounts to exponential growth in the uses of CyberKnife for lung cancer. [This approach] has multiple advantages. It keeps customers engaged an excited about the technology. And it encourages clinical experimentation of new applications for the CyberKnife. And it enables everybody to participate in the clinical growth in the radiosurgery field.

So there’s a sort of buy-in where the customers feel like they’re part of something larger.
Absolutely. It starts with clinical innovation. The clinical innovation drives technical innovation, and those two together—clinical and technical improvements—drive sales and marketing activities for both the product and for the upgrades. If both of those get installed in hospitals, we have more clinical adoption; it’s a loop that drives the business. The acceptance level is growing, but we’re still at the very early stage of total adoption.

I’m certain most patients would opt for noninvasive tumor removal rather than go under the knife. But is there a premium for using CyberKnife that could make it prohibitive for some?
We have reimbursement for most applications of CyberKnife in most locations. We have a team that works with customers, continually making a case for improvement in reimbursement environment. We’re proud of the fact that we’ve already made the CyberKnife successful to most patients. We have teams inside the company as well that work with patients in the hospital if they have challenges in reimbursement.

How did the Siemens alliance come about?
They’re one of the big capital equipment companies that still have a direct interest in radiation treatment. They produce radiation equipment but the applications of that treatment don’t overlap with those of CyberKnife. They have some expertise that we’re trying to tap into. The relationship helps both parties. We have some very high-level intellectual property and expertise inside Accuray that can help them. And obviously they have a huge brand name and market presence that can help us. It’s a very strategic relationship. As well, they can help us to gain access to customers, and we can help them from a technology standpoint.

Does the alliance expand your distribution?
It adds to our distribution capacity. It doesn’t replace the sales team that we already have. I can give you an example that would clarify. For example, there are many cases where an entire hospital may be built or an entire new wing of a hospital cancer center may be built. The customer under those circumstances is often looking for one vendor that can supply all of its equipment. Clearly, they’re not going to come to Accuray with our one very specialized piece of equipment. They’re going to be coming to the big producers, and Siemens is one of those. And now they have the ability to include the CyberKnife as part of their equipment portfolio.

In practical terms how else does the alliance benefit Accuray?
We have a good infrastructure for managing the engineering side and equipment. It’s really more about customer access and relationships.

CyberKnife received regulatory approval in 1999, and you became president in March of 2002. Can you describe some of the highlights and lowlights of the years that brought the company to the 200th installation?
Let’s see. We received FDA-clearance to treat tumors anywhere in the body in 2001, our first clearance came in 1999 for the head and brain. The reality was when I started in 2002 we only had five beta test systems in the United States with approximately 300 patients treated in the prior year.

The recent recession has been one of the biggest challenges Accuray, like all companies, has faced. We launched our initial public offering in 2007 in the midst of a tough economic climate. Despite that challenge, Accuray has continued to evolve and hit major milestones like our recent Shonin approval in Japan, forming a strategic alliance with Siemens, and installing our latest CyberKnife product, the CyberKnife VSI System.

Most important, Accuray continues to improve patient treatment, making treatment faster, less invasive, and with fewer side effects. With more than 200 CyberKnife Systems installed, more and more patients have access to Accuray’s technology, leading to a promising future for this company.

Were there any particular lows getting to that point?

Yes. (Laughs.) There were, no doubt. It was very hard in the early years. There were few customers; the company had limited funding, a small team, and just many challenges.

Was there any time when you were particularly frustrated?
From the beginning it was very clear what needed doing. The company needed a lot of infrastructure changes and a big cultural shift from being an R&D organization to being a true commercial entity. That’s never easy. You have to make changes to an established team that’s been operating in a particular way for a long period of time. The company was about 10 years old at the time and just stuck in the R&D phase. It definitely takes you through a number of low points until you start to see growth and the transition.

When was that?
I would say it was fairly clear when I started that we would have to make significant changes over the first 18 months, and it would be at least that long before we started to see results, and that was about right. We became cash-flow positive about a year from the time I started, which was the first time in the company’s history. And we have been able to maintain the growth profile since then.

Because of its noninvasive nature, do you think CyberKnife will benefit from the effort to improve efficiency in healthcare delivery, one of the goals of healthcare reform? 
We believe so. We’re first and last a cancer-treatment company. And having broader access to healthcare throughout the population should result in earlier diagnosis of cancer and earlier treatment of cancer. And those are patients who should benefit from CyberKnife.

What do you foresee for radiosurgery generally and the CyberKnife System specifically over the next few years?
We see a future that contains continued clinical growth and acceptance for radiosurgery. We have a number of important clinical studies coming up. For example, we have ones for prostate cancer and lung cancer that we believe should significantly expand the market. Those studies are being carried out exclusively on the CyberKnife.

When will you have the results?
It’s difficult to forecast exactly when those are coming. We expect results for some applications over the next year to two years. We already have good data from some applications. This is really broadening the market as much as possible. In the end we feel there could be around 900,000 patients per year in the United States who would benefit from CyberKnife treatment.
 

Sequenom Disputes FDA Letter on Genetic Test

San Diego-based Sequenom says it is disputing a recent FDA untitled letter seeking regulatory approval or clearance of the company’s genetic test. FDA’s letter is part of a recent crackdown on so-called laboratory-developed tests (LDTs) under which the agency asserts approval authority over devices that are more commercial in nature.


According to FDA’s letter in July, it had come to the agency's attention that Sequenom was marketing without approval or clearance its SEQureDx, “a prenatal genetic diagnostic technology, intended to enable the detection and analysis of circulating cell-free fetal (ccff) nucleic acids (RNA or DNA) in a pregnant woman's blood sample for fetal gene and chromosome abnormalities." It further says that if the company does not believe the test requires clearance or approval then it should provide the agency “with the basis for that determination.”


Sequenom said in a July 27 SEC filing that it believed FDA’s letter referred to its SensiGene Fetal Rhesus D Genotyping test, “which is our first laboratory-developed test (LDT) powered by our SEQureDx technology. This test is designed to detect ccff DNA from maternal blood and examine multiple regions of the gene that are known to be the most common genetic basis of Rhesus D negative phenotypes. The test was developed and validated by our laboratory — the Sequenom Center for Molecular Medicine (Sequenom CMM). We believe that the test meets the definition of an LDT. The test is solely for use within our CLIA-certified and CAP-accredited laboratory, Sequenom CMM, and is not sold directly to the general public. Rather, samples are ordered by a physician, collected and sent to Sequenom CMM for testing, and the results are reported back to the physician.”


The company said it was preparing a response to FDA's letter and planned to discuss the matter with the agency in the near future.
 

Microneedles Capable of Connecting the (Quantum) Dots Could Aid Skin Cancer Treatment

Hollow microneedles, used to deliver quantum dots, could foster new techniques for diagnosing and treating a variety of medical conditions, including skin cancer. (Image courtesy of the Royal Society of Chemistry)

Researchers from North Carolina State University (Raleigh) have developed extremely small microneedles that can be used to deliver medically relevant nanoscale dyes to the skin. Known as quantum dots, these dyes are composed of nanoscale crystals featuring unique light-emission properties. This advance, according to the scientists, could open the door to new techniques for diagnosing and treating a variety of medical conditions, including skin cancer. A paper describing the study, "Multiphoton Microscopy of Transdermal Quantum Dot Delivery Using Two Photon Polymerization-Fabricated Polymer Microneedles," will be published in Faraday Discussions.

Microneedles are very small needles in which at least one dimension, such as length, is less than one millimeter. In these tests, the microneedles were created using two-photon polymerization, an approach pioneered by NC State and Laser Zentrum Hannover (Germany) for use in medical device applications. Two-photon polymerization allowed the NC researchers to create hollow, plastic microneedles with specific design characteristics. "Our use of this fabrication technology highlights its potential for other small-scale medical device applications," explains Roger Narayan, a lead reseracher on this project and a professor in the joint biomedical engineering department of NC State's College of Engineering and the University of North Carolina (Chapel Hill).

After creating the plastic microneedles, the researchers tested them using pig skin, which has characteristics closely resembling those of human skin. Using a water-based solution containing quantum dots, the researchers were able to capture images of the quantum dots entering the skin using multiphoton microscopy. These images show the mechanism by which the quantum dots enter the layers of skin, allowing the researchers to verify the effectiveness of the microneedles as a delivery mechanism for these nanoscale dyes.

"We were able to fabricate hollow, plastic microneedles using a laser-based rapid prototyping approach and found that we could deliver a solution containing quantum dots using these microneedles," Narayan says. "The motivation for the study was to see whether we could use microneedles to deliver quantum dots into the skin. Our findings are significant, in part, because this technology will potentially enable researchers to deliver quantum dots, suspended in solution, to deeper layers of skin. That could be useful for the diagnosis and treatment of skin cancers, among other conditions."

The study is also significant because it shows that a laser-based rapid prototyping approach allows for the creation of microneedles of varying lengths and shapes. This will allow medical device manufacturers to create microneedles that are customized for treatment of specific conditions.

For more information on Narayan's work with microneedles, see the Medtech Pulse blog "Microneedles Incorporating Antimicrobial Agents Could Be the Wave of the Future."