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How Are You Preparing for the Medical Device Tax?

We're less than five months from January 1, 2013, the date the medical device tax is set to go into effect. So far, the industry has put most of its might behind efforts to repeal the tax. But as D-Day for the device tax draws nearer and efforts to advance repeal bills in the Senate seem stalled out, it might be time for medical device companies to start thinking practically about how they're going to deal with the tax. What are you doing to prepare for it?

I posted that same question on the Medical Devices Group on LinkedIn and got some interesting responses. One person said his company is "hunkering down," cutting staff and focusing on cost reduction. Others mused about the industry's ability to pass the tax on to customers. Another respondent says a strong offense is the best defense and suggested a focus on growing sales is the way to go.

What do you think?

Read our overview of the medical device tax and let me know what you're doing to prepare either in the comments or on LinkedIn.

Jamie Hartford is the associate editor of MD+DI. Follow her on Twitter @readMED.
 

3-D Microscopes Help Contact Lenses Keep Up High Volume Pace

3-D Microscopes Help Contact Lenses Keep Up High Volume Pace

Contact lenses represent one of the single largest categories of medical devices, with more than 31 million contact lens wearers in the United States alone, according to the Association of Contact Lens Manufacturers. Many of these lenses are disposable, which translates into a domestic volume of more than 1 billion lenses per year. Economically sustaining this volume requires highly efficient manufacturing and testing methods, with an emphasis on low cost and high reproducibility. At the same time, these lenses incorporate increasingly complex shapes and nanostructured surfaces to support improved vision correction, including astigmatism and bifocal function. One limiting factor in producing these shapes and surfaces has been the performance of the traditional metrology instruments used to characterize the lenses themselves, as well as the tools and processes used to create them.

 
This article demonstrates how this need is now increasingly met by the 3-D optical microscope. The noncontact, gauge-capable tool enables surface metrology with higher throughput sampling density than previously possible. This tool can characterize all three critical parameters—form, local shape such as steps or edge heights, and roughness—with high accuracy. It can also be used during R&D and process development as well as in manufacturing metrology of intraocular lens (IOL) implants. Like contact lenses, these implants are also small, polymer-based lenses with increasing shape complexity. But since they represent a permanently implanted device, comprehensive testing of form and function is even more critical than for contacts. 

Contact Lens Materials

Contact lens materials and manufacturing methods have changed considerably since the first experimental glass lenses were developed more than 100 years ago. These developments have been driven by the need to produce lenses with characteristics that improve function and wearability. These characteristics include optical clarity, chemical stability, mechanical durability, oxygen permeability, and wettability.  
 
Around 70 years ago, the development of contact lenses based on a hard plastic, polymethylmethacrylate (PMMA) was a key step forward towards mass public acceptance of contact lenses. But the major advances that drove widespread adoption of the technology were the development of hydrogel materials about 30 years ago, soon followed by silicon-containing gas permeable (GP) lenses. And in the past decade, the majority of contact lenses have switched to silicone hydrogel materials. The term hydrogel refers to a soft and flexible hydrophilic material that is hydrated during use (i.e., contains up to 70% by weight of water).
 
Although these are the basic classes of commonly used materials, each manufacturer uses a proprietary blend of monomer additives to optimize different lens properties. For example, disposable lenses sacrifice durability to maximize the other characteristics, while long-wear lenses prioritize oxygen permeability.
Image 1. 3-D optical profiling measurement of a bifocal contact lens showing the characteristic surface pattern of concentric rings of alternating optical power. This false color image was obtained with a 3D Optical Microscope. All images courtesy of Bruker Nano Surfaces Division.

Contact Lens Shape Evolution

In recent years, there has been an evolution in the shapes and surface complexity of contact lenses, enabling more comprehensive and subtle vision correction. This evolution has been driven in part by the changing age demographics of contact lens wearers. Specifically, first generation of contact lens wearers needed the lenses to correct near-sightedness as this was the  only conditionthat spherical contact lenses could correct at that time based on the spherically curved lens surfaces created by conventional lens fabrication methods. Today, the fastest growing segment of the contact lens market is in the 40+ age category. Many of these users are already long-time contact lens wearers (due to near-sightedness) who are now also affected by presbyopia (a gradual hardening of the eye’s lens, which limits the ability to accommodate—focus at short distances, for example). Since presbyopia is an age-related condition and we have a naturally graying U.S. population, the demand for bifocal contact lenses that correct for both near-sightedness and presbyopia is growing in parallel with increasing age of the baby boom generation.
 
Bifocal lenses can be designed in several different ways. The predominant methodology is to create lenses with alternating optical powers structured within a concentric circular pattern (see Image 1). Each concentric lens ring is structured for either distant or near vision, and the eye looks through both powers at the same time. The visual system automatically selects the correct power choice based on the distance to the object on which the eye is focusing, thereby providing continuous near and far vision.
 
To further complicate matters, many older patients also need correction for astigmatism, where the ocular system needs different powers of correction in different axes. Toroid-shaped lenses have long been used in eyeglasses for this purpose, in situations where the lens has two different focusing powers orthogonal to each other. But with contact lenses, preventing the lens from rotating is not as easy as with traditional eyeglasses. Two widely used methods for maintaining angular orientation in contact lenses are the double slab-off design, which uses gravity, and the prism ballast, which uses a “watermelon seed” shape. In both cases, blinking forces of the eye hold the lens in place.
Image 2. Two common IOL shapes. The curved haptics are used to secure the lens in place. The monolithic flanges are necessary to support lens deformation/movement to enable some natural focusing function.

Intraocular Lenses

IOLs are the other common type of ophthalmic “device.”  They have revolutionized the treatment for opacification, or clouding of the native lens, commonly referred to as cataracts. Unlike the contact lens, the IOL is implanted in the eye on a permanent basis. Pioneered by the world-renowned ophthalmic surgeon, Sir Harold Ridley, many people now consider the IOL to be the single most successful implant, especially given the low rate of postoperative complications (POCs). This success is, in part, a result of extensive process and quality control by IOL manufacturers. Surface roughness measurements are an important component of this testing since some complications are thought to arise from the interaction between calcium ions found in eye fluids and the material of the IOL.
 
The IOL is a clear plastic lens with two protrusions on opposite edges, called haptics (see Image 2). These integral parts of the device commonly take the form of S-shaped hook extensions or rectangular lobes, depending on where and how the lens is to be secured in the eye. Like contact lenses, IOLs have gone through several material evolutions and revolutions. In addition, the initial IOLs were hard objects fabricated from PMMA (as were contact lenses).
 
The development of soft IOLs was a huge leap forward, although for different reasons than contact lenses. Specifically, a soft IOL made of hydrophilic acrylic, hydrophobic acrylic, or silicone-based material enables the lens to be folded during insertion into the eyeball. The advantages of this less disruptive surgery are obvious. Additionally, flexible lenses can be attached to the capsule, which enables limited natural focusing, just like the original native lens.

Manufacturing Today’s Soft Lenses

Cast molding is the primary manufacturing method for producing the complex geometries and detailed shapes of today’s contacts and IOLs. Here, monomeric material is thermally cured while trapped between two molds that define the front and rear surfaces of the lenses. In the case of contacts, these are referred to as the central posterior curve and the central anterior curve.
 
To maximize product consistency while minimizing fabrication costs, the “soft” mold is molded from a reference tool commonly referred to as a master pin. This tool is typically a machined stainless steel part, created by turning with a diamond blade. Using CNC fabrication, this pin is therefore a positive model of the final lens, including all the correct shape features and nanometer-level structures required in the lens.
 
To enable volume fabrication, multiple front- and back-curve molds are then assembled in mold inserts. A polymer is injected in the mold and thermally cured. The lenses are then hydrated, where they absorb 20% to 70% water by mass. Of course, this means that the final lenses are larger than the machined dehydrated form. This factor has to be very carefully allowed for when designing and machining the master pins.
 
Image 3. An example of a bench-top 3-D Optical Microscope,
Using secondary molds for volume fabrication means that the master pins are used sparingly. However, they must eventually be replaced. This process involves making secondary molds and prototype lenses that must be tested. The lenses rarely meet the target prescription the first time. Instead, the results of these tests are used to create or modify new pins, and another batch of prototype lenses. The limitations of traditional testing methods, and to a lesser extent the hydration expansion effects, means that up to six iterations are required to create a new set of conformal master pins. In addition, during regular production, all batches of lenses must be sample tested for overall shape, nanoscale features, and surface roughness. The latter is important to avoid irritation and increased risk of infection with contacts and to eliminate their potential as initiation sites for POCs (in the case of IOLs). Lastly, batch data is often embossed on the lenses via the molding process. It is imperative that these characters are deep enough to be seen without being too deep or sharp-edged to cause irritation.
 
There are two traditional methods for testing the shape and surface details of the final lenses. Both have limitations for this application. One is a noncontact, optical method for measuring overall surfaces called Fizeau interferometry. Because this is a laser method, it cannot be used to quantify step heights greater than one quarter of the laser wavelength, which translates into step heights of 160 nm. However, many of today’s lens designs incorporate nanofeatures with greater step heights.
 
A method that can measure the aspheric profile and nanometer features of modern lenses is the stylus profilometer. This instrument provides for the motion of a fine needle under low pressure over the surface of the lens, thereby obtaining an accurate, two-dimensional profile. By measuring at two azimuthal angles, the shape of the test component is approximately understood. However, the typical soft hydrated gel lens has to be frozen prior to test with this contact method, which adds to test preparation time.

The 3-D Optical Microscope

The 3-D optical microscope is a well-proven instrument in many other applications, including quality control of medical devices such as dental implants and orthopedic surgical prosthetics. It is now being increasingly adopted (or evaluated) for the metrology needs of soft lens manufacturing. Specifically, this instrument is a high-speed, noncontact 3-D tool that can quantify the overall surface contours of a lens surface, the height and width of all surface features, as well as surface roughness, in seconds.
 
Externally, the 3-D optical microscope looks similar to a conventional optical microscope, and the lens (or pin) being tested is placed on the sample stage. A broad wavelength band high-brightness LED (HB-LED) source sends light into the objective and is split into two paths by a partially reflective mirror. One of the paths is focused on the sample surface and the other is deflected to an extremely flat internal reference surface. When these two reflections are recombined, the image contains a series of dark and light bands that are a direct function of the profile of the test surface; they are analogous to elevation contours on a topographic map. Moreover, they only appear as sharp stripes in the image where the microscope is perfectly focused on that part of the sample.
 
Image 4. A 3-D surface profile of an IOL obtained with a Contour GT 3-D Optical Microscope
In operation, the instrument’s computer steps the microscope through a full range of focus positions and captures the band contours on a digital camera, while also noting the precise focal depth at which each part of the striped image is sharpest. Onboard software then uses this data to calculate a 3-D surface map over the entire field of view (i.e., tens of thousands of surface points, or pixels) simultaneously. It is this multiplex aspect that makes the 3-D optical microscope such a versatile tool, enabling complete characterization of the entire lens or pin surface
 
The 3-D optical microscope does not have step height measurement limitations, so it can measure all types of lenses. And in the latest generation of instruments (see Image 3) which use 64-bit software and multicore processing to provide a faster and more intuitive software workflow, a high rate of data collection is accomplished. A patented dual HBLED illumination source provides increased light throughput, and hence higher speed and superior data in comparison to previous generation systems which used a single lamp source or a single LED. Images 4 and 5 show false color surface data obtained using a ContourGT.

3-D Optical Microscope in Action

The benefits of white light interferometry have been demonstrated in a recent application at a major lens manufacturing facility. The plant produces 100+ master pins per year to produce 48 different designs ranging from +6.0 to +30.0 diopters in 0.5 diopter increments. Manufacturing costs are plant specific depending upon the manufacturing region. However, an average cost per iteration is about $2,500, which includes fully loaded engineering and small batch manufacturing costs. In the past, using a 2-D stylus instrument, master pins typically required four iterations of machining and prototyping, for a total average cost of $10,000. In spite of all these iterations, in the year prior to acquiring a 3-D optical microscope, 67 of the plant’s 100+ pins required some level of rework even after being initially accepted for production. The result: 667 iterations on average were required to produce the 100+ pins per year, for a total cost close to $1.7 million dollars per year.
 
Using the 3-D optical microscope, this same plant has drastically reduced the number of iterations to a much lower, but proprietary, level. This covers a reduction in both iterations for creating new pins and rework after initial acceptance. Without revealing exact cost savings, plant management indicates that the benefits and savings associated with using the 3-D optical microscope pays for the initial capital outlay for the tool in a matter of months.
 
In another application, a leading high-volume manufacturer of contact lenses recently adopted the 3-D optical microscope to enable metrology of identification markings on its lenses for consistency of height and shape. The details of this metrology are proprietary, but the broad benefits of its use can be shared to illustrate the advantage this type of metrology can bring to a production process in the ophthalmic industry.
 
Image 5. A 3-D surface profile of an excised (used) IOL showing wear at the lens edge.
Highly polished metal tools, or mandrels, can be used to create a master mold (or wafer) for contact lenses across a broad range of optical powers for many different consumers. The lenses have identification marks imprinted onto them by the tools, which if not well controlled, can detract from wearer comfort. By monitoring the height of these identification marks using a 3-D microscope, the contact lens manufacturer improved wearability and ultimately increased its share of the contact lens market.
 
An estimate by Bruker Nano finds that if all runs of contact lens production tools were controlled using this technique, a significant   improvement to contact lens wearability and comfort could be made. This would result in ultimately improved product quality delivered into the market and reduced waste materials for manufacturing.
 
Today, using the 3-D optical microscope, a major manufacturer is already  successfully controlling the height and protrusion of identifying markings on its products, resulting in consistent wearer satisfaction and ultimately increased market share per publicly available data.  Although a precise increase in market share is hard to estimate, given the high-volume nature of this business, the benefits associated with using the 3-D optical microscope are clear.  The capital equipment investment in metrology can substantially pay for itself in saved material cost and repeat customer business for comfortable contact lens use.

Conclusion

Contact lenses and IOLs are volume-produced medical devices whose successful function critically depends on their surface characteristics. Today’s lenses correct vision problems with increasing levels of finesse, so these surface characteristics must now encompass overall contour, and surface roughness, plus the width, height, and location of nanometer-scale features. As a result, the noncontact, gauge-capable tool, the 3-D optical microscope, is fast gaining acceptance as a superior, high-speed method to measure these characteristics, because it streamlines lens production and significantly reduces manufacturing costs.
Matt Novak is marketing applications manager for Bruker Stylus and Optical Metrology Business Unit, which is part of Bruker’s Nano Surfaces division. He has 15 years of experience in the development of metrology products and systems across a range of applications, including optical inspection, optical fabrication and testing, surface characterization, and thin film filter characterization. Contact him at [email protected].
 

Making the Future of Heart Monitoring a Reality

Making the Future of Heart Monitoring a Reality

In the future, your heart metrics could be routed to your cell phone to give you real-time knowledge of your heart health. Above image based on circuit board and a heart images from Flickr. 

What this might look like for, say, a 50-year-old heart patient is that they will first opt in to have these sensors implanted and to have data from them tracked. After that, a monitoring company could continuously monitor their heart health and send an alert—to the patient and their physician—if symptoms worsen.

If a family member has a heart condition, you, as a family caregiver, could be alerted if problems arise. The monitoring company could send you regular reports that list data such as activity levels, sleep duration, as well as information such as heart rate variability and so forth. 

“It really is our vision that, as devices get smaller and smaller, the connectivity of those moves up through everyday common interfaces like a cell phone into an Internet system. And all of this is monitored by someone,” Hoff says. “If you think about OnStar in cars right now, you can get alerted if you need to add more wiper fluid or if your oil needs to get changed.”

“It really is our vision that, as devices get smaller and smaller, the connectivity of those moves up through everyday common interfaces like a cell phone into an Internet system...”

“We’ve got the technology now to do much of that [in heathcare], but we don’t have the ecosystem around it,” Hoff says. “We don’t necessarily have wellness companies and monitoring centers that want to look at this information. We’ve not yet collaborated with specialty doctors about the appropriate information to give the patients that is palatable as opposed to highly technical.”

The technical components are ready for building the future described above, Hoff says. “But the ecosystem needs to catch up.” There needs to be new regulations that lay out guidelines regarding cell phones tracking data from interbody implants. The regulations should spell out answers to questions like:

  • Who looks at the data?
  • How often do they look at the data?
  • Who gets the data and when do they get it?

Developing this future ideally would require the collaboration of the industry, physicians, and patients, Hoff says. 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz. He will be chairing the upcoming MedTech Cardio event held October 30 and 31 in Minneapolis. 

Introcan Safety IV Catheter From B. Braun Medical

A company that supplies products and services for medical device OEMs has released a new line of safety-engineered catheters designed to protect against infection. The Introcan Safety IV Catheter provides passive safety protection from needlestick injuries, a multi-access, blood-control septum to aid in the prevention of blood exposure. An integrated, stabilized platform is designed to improve catheter stability and minimize movement in the vein, which could help reduce catheter-related complications.

Bethlehem, PA

MS4425 Series Pressure Sensors From Servoflo

A provider of pressure sensors, humidity sensors, sensor-signal conditioners, and LED drivers for medical applications has released a new series of temperature-compensated, piezoresistive pressure sensors. The MS4425 series is available in pressure ranges from 0–1 psi to 0–300 psi. The gauge and absolute models have a temperature-compensated millivolt output from 0 C to 50 C with ±0.15% of span nonlinearity. The series also has long-term stability of ±0.1 mV. With a dual-in-line package, the MS4425 has 1/8-in. barbed ports, which mate with 3/32-in. ID tubing. The tubes are parallel to the printed circuit board to allow other boards to be located above the sensor. A vertical-mount model (the MS4426) is also available. The MS4425 accepts a 12 V dc supply. Typical applications include medical instruments such as infusion pumps, blood pressure equipment, and deep-vein thrombosis equipment.
 
Lexington, MA

Custom Nuts From Haydon Kerk

A manufacturer of stepper-motor-based linear actuators, rotary motors, lead screw assemblies, and linear rail and guide systems used in medical applications offers customized nut designs for high-end motion-control applications. Precision nuts made from polymers can be molded in just about any shape or with any complex feature. The standard material used in the polymer-based nuts is self-lubricating polyacetal, which offers dimensional stability, good tensile strength, and is easy to machine. The company also offers nuts produced from variety of Kerkite high-performance composite polymers and alternative plastics including polyetheretherketone(PEEK), polyester, polyamide-imides (Torlon PAI), Vespel polyimide-based resin, polyvinylidene fluoride (PVDF) , polyethylene terephthalate(Ertalyte PET-P), and customer-supplied specialty materials.

Hollis, NH
 

Medical Devices are a Big Deal in Birmingham

Click on the photo to view a slide show and gain access to a series articles on Birmingham, AL, a rising medtech star in the South.

If you've been asking, "Whats the appeal of Birmingham for medical devices?," I've got the answer. Or rather MD+DI's sister publication, QMED, has the answer. In a series on Birmingham's burgeoning medtech industry, Bob Michaels explores the University of Alabama's work in developing a diamond-based coating technology that could reduce particle generation to a minimum and vastly increase the longevity of orthopedic implants.

The technology is being used by Vista Engineering, which employs the coating on implants for treating temporomandibular joint disease (TMJD). Vista, a start up housed in a technology inclubator know as Innovation Depot, is just finishing up it's studies to use the nanodiamond coating.

Another company, Endomimetics LLC, has developed BioNanomatrix, a natural, peptide-based nanofiber stent coating material that inhibits blood-clot formation, prevents blood vessels from renarrowing, and encourages the normal arterial lining to heal.

"Birmingham may yet develop into a rising medtech star next to California, Massachusetts, and Minnesota," Michaels concludes.

Heather Thompson

Hybrid Piezoelectric Power Cell Converts and Stores Energy

A new self-charging power cell technology developed by scientists at the Georgia Institute of Technology (Georgia Tech; Atlanta) directly converts mechanical energy to chemical energy. Then, the power is stored until it is needed to generate electricity. Although the technology is supported by such military institutions as the Defense Advanced Research Projects Agency (DARPA) and the U.S. Air Force, it is not difficult to imagine that it could eventually be used in such medtech applications as miniature implantable devices and handhelds.

The new hybrid generator-storage cell utilizes mechanical energy more efficiently than systems using separate generators and batteries because it eliminates the need to convert mechanical energy to electrical energy for charging a battery. The cell is based on a piezoelectric membrane that drives lithium ions from one side of the cell to the other when the membrane is deformed by mechanical stress. By means of an electrochemical process, the lithium ions driven through the polarized membrane by the piezoelectric potential are directly stored as chemical energy. The source of mechanical energy can be as simple as shoes striking pavement, which can generate enough electricity to power a small device such as a calculator.

"People are accustomed to considering electrical generation and storage as two separate operations done in two separate units," remarks Zhong Lin Wang, a Regents professor in the School of Materials Science and Engineering at Georgia Tech. "We have put them together in a single hybrid unit to create a self-charging power cell, demonstrating a new technique for charge conversion and storage in one integrated unit."

Thus far, Wang and his team have built and tested more than 500 power cells. The generator-storage cell, he says, will be as much as five times more efficient at converting mechanical energy to chemical energy as a two-cell generator-storage system. "One day we could have a power package ready to use that takes advantage of this hybrid approach," he adds. "Almost anything that involves mechanical action could provide the strain needed for charging. People walking could be generating electricity as they move."

For more information on this technology, visit the Georgia Tech Newsroom.

This Week in Devices [8/24/12]: Edwards LifeSciences CMO to Keynote MedTech Cardio; UC San Diego Launches Medical Device Engineering Program; Bill Gates Builds a Better Toilet; Robot & Frank trailer.

This Week in Devices [8/24/12]: Edwards LifeSciences CMO to Keynote MedTech Cardio; UC San Diego Launches Medical Device Engineering Program; Bill Gates Builds a Better Toilet; Robot & Frank trailer.

Edwards LifeSciences CMO to Keynote MedTech Cardio

  • At this year's MedTech Cardio held in tandem with the MD&M Minneapolis conference, Dr. Francis Duhay, chief medical officer at Edwards Lifesciences, will give a keynote speech on the overview of the cardiovascular device industry and major market trends.
    Source: UBM 

HemoSep Protects Patients From Massive Blood Loss

  • A new device, now approved in Canada and Europe, offers protection for cardiac surgery patients by collecting blood from a surgery site and transfusing it back into a patient during surgery.
    Source: Popular Science

UC San Diego Launches Medical Device Engineering Program

  • It's back to school season and the University of California San Diego has created a cross-disciplinary program, the Master of Advanced Study Program in Medical Device Engineering, to train professional engineers to apply their skills to the medical device sector.
    Source: UCSDNews

Bill Gates Builds a Better Toilet

  • To address global sanitation issues, the Gates Foundation recently held a fair inviting designers to create a better toilet.The first place winner was a solar powered toilet that also recycles human waste into hydrogen for fuel.
    Source: Fast Company

Trailer for Robot & Frank

Watch the trailer for the new sci-fi comedy Robot & Frank, in which an elderly man finds a novel use for his home healthcare robot – petty theft.
 
 

Sen. Franken to FDA: Cut Regulatory Red Tape, Speed Up Approvals

Under the headline “Loosening a Logjam on Medtech Approvals,” the Star Tribune (Minneapolis) reports that Senator Al Franken (MN) recently invited FDA commissioner Margaret Hamburg to meet with him, Senator Amy Klobuchar, and representatives of Minnesota’s medtech industry. Franken’s message, according to the article, was to implore the commissioner to cut regulatory red tape and accelerate the medical device approval process.

Hamburg reportedly told the senators and local manufacturers that the logjam is already easing as a result of the July passage of the FDA Safety and Innovation Act. However, after the meeting, Mark DuVal, an attorney who works with companies appealing FDA decisions, commented, "While we are excited about the regulatory science initiative being undertaken by FDA and LifeScience Alley, it is likely that is five to six years away or more and there are thousands of medical device companies that must contend with the here and now. So our citizen petition [asking Hamburg to review how the agency is operating] will outline those issues we think need short-term work. We hope she will find it insightful and useful."

For more information, read the whole story here.