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Articles from 2011 In July

This Week in Medical Devices: Advances in Imaging Tech, Taking Stock of Biotech, and Learning About Packaging

 This week in medical device news, MPMN takes a look at six advances in medical imaging technology, including hyperspectral imaging and electromagnetic acoustic imaging. For those of you curious about how the other side lives, Ed Silverman at Pharmalot has a look at the financial state of the biotech industry, and finds that companies are making more and spending less. PMPN's Daphne Allen has information on a program that provides insight into how healthcare practitioners interact with packaging. Over at MassDevice, Westby Fisher has an essay on how sometimes, it's best for doctors to do nothing when pressured to do something.

Company Manufactures Medical Sealing Components

Medical sealing components ranging from simple seals to complex parts and microminiature custom solutions are manufactured using a variety of production technologies and processes, including liquid-silicone-rubber molding. A company offers seals for medical appliances, medical pump seals, IV components, feeding devices, implant materials, O-rings for dialyzers, and other applications. Its silicone seals resist UV light, ozone, and weather; feature hydrophobic properties; and withstand temperatures ranging from –94° to 400°F. The seals exhibit dimensional stability under adverse conditions and resist long-term compression set. The company produces microminiature seals, face seals, housing seals, filter seals, custom shapes, and other components. Validation testing for cytotoxicity and bioburden testing are also offered.

Apple Rubber Products

Lancaster, NY, 800/828-7745

Horizontal Cartoning Machines Can Accommodate a Range of Carton Sizes

A company engineers automatic horizontal cartoning machines to easily adjust to narrow and wide pitches, thus accommodating a range of carton sizes at speeds of 60 or 150 cartons per minute. The compact SC-series machines also come with a variety of in-feed configurations, including a robotic option and the manufacturer’s own end-of-arm tooling. A large-capacity carton magazine includes digital handwheel adjustment for rapid size changeover. The servo-driven machines employ either intermittent or continuous motion, depending on the speed necessary, and can handle preglued cartons with straight or reverse tuck-in closure. In addition, they accommodate a glue-closing application and automatic product-feeding systems. Available options include leaflet and booklet inserters; a choice of coding technologies; and code readers for verification of leaflets, carton blanks, or filled cartons.

ESS Technologies Inc.
Blacksburg, VA, 540/961-5716

The Conversation Continues on the Device Tax

The big-item news of the day was obviously the IOM's advice to scrap the 510(k). Nevertheless, the medical device tax has been steadily on my mind this week, thanks to a number of e-mails I've received from readers (two of which can be found here: A Reader Weighs in on the the Device Tax).

I also received the a couple of e-mails from a senior R&D engineer who gave me permission to use his quotes here. Considering the politics behind the tax, he writes:

I agree with you that the tax will have a nominal effect on device makers, as it is “only” 2.3%.

What I find interesting is that we are taxing something that the healthcare dollars in turn needs to pay for. And considering how heathcare providers “mark up” various items, one could see how the tax would result in a net loss. 

In a sense, it is simply a hidden sales tax. And since a sales tax is directly proportional to the original selling price, there will be additional pressure on U.S.-made products since low cost Asian items will be marked up less than U.S. built products (hence the expected job loss).

They would have been much better off added a “Heath Care Sales Tax” right on each of our doctor bills. But then, it would not be a hidden tax.

He continues in another e-mail.

I find it ironic that we spend more on healthcare, as a percent of our GNP, than almost any country (including those with national “universal” plans).

 In fact, the U.S. government share itself exceeds many countries with nationalized healthcare.
The other part of the healthcare debate/reform I found interesting was nearly the entire focus was how to pay for it. Very little discussion (if any) was how to contain costs or even reduce them. Since costs have been going up over the last two decades at 2 or 3 times the “official” annual rate of inflation, you have to wonder what all the factors were that caused this (and why so little effort to identify and correct them!).

I agree that the politics behind healthcare reform is an interesting subject and the logic behind it is often unclear. But, it would take a strong political force to repeal the device tax. At present, the odds that it will be repealed seem fairly low. So, at this point in time, it might be more prudent to figure out what kind of strategy is best to deal with the tax.

—Brian Buntz

Best Coverage of IOM's 510(k) Report

I'll be updating this list as the day goes on, but here is the best coverage so far on the Institure of Medicine (IOM) report on FDA 510(k)s
Monday Aug 1:

Friday, July 31:

Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years (IOM) 

510(k) reform: IOM report a headache the FDA doesn't need (Mass Device)

AdvaMed Statement on IOM 510(k) Report (AdvaMed)

Controversial IOM Report Highly Critical of 510(k) Process(Forbes)

FDA defends 510(k) as debate begins (EE Times)


—Heather Thompson

Epic Fail: IOM Disappoints in 510(k)s by Not Doing Its Job

Epic Fail: IOM Disappoints in 510(k)s by Not Doing Its Job

I say long awaited because the report comes more than six months after FDA released its plans in January to implement 47 of the 55 recommendations that its 510(k) working group published in August 2010. And I say controversial because the IOM has come under fire for not including any industry members or patients on its working panel. As such, the IOM panel appeared to have stacked the deck against industry interests, which could negatively affect the medical device market.

But the IOM effectively took the wind out of the conversation, because it did not even attempt to make recommendations to fix 510(k). Instead it told FDA not to waste its resources. “The IOM finds that the current 510(k) process is flawed based on its legislative foundation,” says the report. “Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

In a public webcast, IOM panel chairman David Challoner said the panel was unanimous and that the IOM hoped to spur a conversation, not make suggestions on how to replace 510(k). I’d say making recommendations was exactly why the IOM was tasked with the 510(k) process int he first place. That it simply refused to do so is also a waste of FDA's resources.

The debate thus far over IOM’s report has been loud. Most industry experts were prepared to immediately dismiss any recommendations to the 510(k) as overregulation. But the pronouncement from the IOM took even regulators by surprise. FDA scrambled to assure industry that it wasn’t prepared to give up on 510(k). “FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs,” CDRH director Jeffrey Shuren said in a news release.

Shuren is not alone in his dissatisfaction. “The report is extremely disappointing, given the time and effort that has been dedicated to this process,” notes John Smith, a partner in law firm Hogan Lovells’ life sciences practice. “The institute’s primary conclusion that the 510(k) process should be abandoned completely ignores the considerable debate that led to its creation and the successful application of the 510(k) paradigm over 35 years.” 

Likewise, AdvaMed spokesperson Stephen J. Ubl blasted the report. “The report’s conclusions do not deserve serious consideration from the Congress or the administration,” Ubl railed in a press release. “It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven, and unspecified new legal structure. This would be a disservice to patients and the public health.”

Beyond the recommendation to scrap 510(k), the IOM did not adequately address how to do so or venture what might replace the system. “The institute fails to offer concrete recommendations as to potential alternatives, likely reflecting how difficult it will be to improve on the existing 510(k) paradigm,” says Smith.

The IOM made the following recommendations about device regulations in general:

  • FDA should develop and implement a strategy to collect, analyze, and act on postmarket performance information.
  • FDA should review its postmarket regulatory authorities for medical devices to identify existing limitations on their use and to determine how the limitations can be addressed.
  • FDA should investigate the viability of a modified de novo process as a mechanism for evaluating the safety and effectiveness of Class II devices.
  • FDA should commission an assessment to determine the effect of its regulatory process for Class II devices on facilitating or inhibiting innovation in the medical device industry.
  • FDA should develop procedures that ensure the safety and effectiveness of software used in devices, software used as devices, and software used as a tool in producing devices.

The fact remains, however, that the IOM did not do what it was asked to do—comment on seven specific questions highlighted by the 510(k) working panel. Can FDA get its money back?

Further Reading

Weekly Vitals: IOM Reviews the 510(k) Process, VCs Like Life Sciences, and More

It seemed like the medical device industry had only one thing on its mind this week: the evaluation of the 510(k) clearance process by the  Institute of Medicine (IOM).  Although the report was only released today, some industry professionals made a preemptive strike to discredit the report as biased earlier in the week. As expected, the IOM's report recommended revisions to the process: "The committee finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA's finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle," according to the report. Today, industry group AdvaMed publicly dismissed the report, according to the New York Times, and the controversy is just getting started.

IOM-related news:

And while the IOM 510(k) review dominated industry headlines this week, there were some other stories of note:

IOM Tells FDA 510(k) Too Flawed for Rehabilitation

The Institute of Medicine released its report on the 510(k) with a bigger splash than expected. Rather than make recommendations on how to fix the system, IOM simply copped out.

"The IOM finds that the current 510(k) process is flawed based on its legislative foundation," said the report. "Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. The IOM outlines its criteria for this framework in the report."

FDA was quick to try to allay industry fears that such an important part of the device approval system would be abandoned.

"We appreciate the IOM's report on the 510(k) program, and agree that the public should continue to feel confident in the medical devices on the market today," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a release."Medical devices in the U.S. have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. and has helped bring lower-risk devices to market for the patients who need them."

It seems that FDA, industry, and Congress knew what was coming and have been working to downplay the recommendations, even before the report was released.

I'll be tweeting on the meeting held by IOM this morning: @medevice_editor

—Heather Thompson

Adhesives in Diagnostics

Adhesives in Diagnostics

Porous PSAs offer uniform, isolated pore structures to control flow and movement of liquids or gases.
Component and material suppliers in the in vitro diagnostics (IVD) industry are facing pressure to develop technologies that address the demand for fast-performing, highly sensitive, accurate, and more affordable products in a short development cycle. Understanding the special needs of the IVD industry allows suppliers such as adhesive manufacturers to embrace this challenge through the development of enabling adhesive and coating technologies. This article discusses some of the design challenges related to formulating adhesives for diagnostics and how adhesives can bring added design benefits and enhanced capabilities to device manufacturers beyond simply bonding substrates together.

Pressure-sensitive adhesives (PSAs) have been used for decades in a range of diagnostic device applications. In recent years, technology has evolved to create a more customized adhesive delivering enhanced performance capabilities. Today, PSAs are not only suitable for lateral-flow devices but also for many molecular diagnostic applications, including high-throughput screening, reverse-transcription polymerase chain reaction (PCR), cell culture, and compound storage.
Device manufacturers primarily choose PSAs for their performance characteristics and because their continuous roll format enables efficient manufacturing for batch and in-line processing operations. The adhesives provide an immediate bond without the need for water, solvents, or heat that could potentially damage a device’s sensitive enzymes and reagents. Although several off-the-shelf medical-grade PSA products are currently available, OEMs will benefit most by working with a contract manufacturer that specializes in adhesive formulation and offers custom product capabilities that overcome the challenges of these specialized applications.

Inertness and Compatibility
Formulating adhesives for diagnostic applications is challenging, and adhesive manufacturers must first ensure component compatibility to the biological sample and assay. This responsibility becomes even more complex when considering the variety of available assays and how biomarkers or reagents can be combined as device designs broaden into new fields of disease detection.
When considering adhesive or component materials for any test system, formulators must ensure that the chemistry of all raw materials is inert and remains inert to the chemistries of the device and specimen. The system must be free of residual volatiles (such as solvents; )and monomers, leachable components, and reactive materials to assure  chemical compatibility.1 Processing components must also be considered. For example, most PSA systems are manufactured with a release liner to aid in processing. Silicone from the liner’s release coating can potentially be transferred from the adhesive to the IVD device, causing contamination that may affect growth in cell culturing applications.
Environmental contamination, which potentially affects compatibility, can also occur during the handling and manufacturing of the PSA system. Cleanliness during material handling and manufacturing is equally important for maintaining compatibility and component chemistry, particularly in molecular diagnostic applications. Any bacteria, yeast, or fungi that are transferred to test components can introduce biological contamination that may negatively affect results in biotech testing. Because compatibility can change as components age, accelerated and real-time aging studies are required to ensure that the adhesive properties are maintained during the shelf-life of the device.2
Controlling Thickness Tolerance
Tight tolerances for adhesive and substrate thickness control within product rolls and from lot to lot are critical for microfluidic devices and lateral flow applications. Any thickness variations can affect sample volume and test results. PSAs are a proven component in lateral-flow immunoassays that are used in many disposable IVD devices and biosensors. PSAs offer precise and accurate bond lines that improve the reproducibility of these devices, so one or more layers of PSA tape product may be used to bond, laminate, or assemble components within a test strip.
For example, in microfluidic devices and biosensors, a spacer tape defines the height of the microfluidic channels, which are formed by die- or laser-cutting, while the lid of the channel is made of another adhesive tape or a hydrophilic film.3 Adhesive thickness and tight tolerances can be monitored and maintained by integrating sophisticated vision systems and state-of-the-art online coating controls into the manufacturing equipment train to ensure product quality.
Eliminating Cold Flow
Adhesive migration, known as cold flow or creep, is one of the many design challenges adhesives manufacturers must address in IVD device design. The delicate balance of an adhesive’s viscoelastic properties for proper laminating and cutting can have serious effects on manufacturing efficiencies if the formulation is not well-suited for an application’s production processes. During conversion, a roll of adhesive may be processed in a number of ways, including high-speed laminating, slitting, sheeting, guillotining, and laser, rotary, or flatbed die-cutting. Although the PSA format offers many manufacturing efficiency benefits for high-speed conversion, the viscoelastic characteristics can also present challenges. If the adhesive is too hard, it will provide clean cuts but less-than-optimal bonds for laminating. If the adhesive is soft, it will laminate well to other component parts. However, residue may adhere to machinery blades during conversion, affecting the precision of individually cut parts. When adhesive builds up on the blades, the result can be increased cutting cycle time, reducing overall conversion throughput.4 Additional loss of productivity occurs when cutting equipment is shut down and dissembled for manual removal of adhesive buildup on the cutting blades.
Small sample volumes and quantities of biomarkers are influencing the design of devices that use small capillary channels. As a result, the viscoelastic properties of the adhesives used in device designs with large sample flows may not be suitable for smaller-channel designs. In these instances, a dual-stage UV-curable PSA is a good substitute. It cures in less than one second without the risk of damaging sensitive components. Compare that to heat activated-systems, which require pressure and dwell time for bonding. The uniqueness of this tape construction allows it to function like any other PSA for in-line processing with high-tack properties for bonding, laminating, and assembling components within an IVD device.
Once assembled, the laminated construction is briefly exposed to UV radiation, which further cross-links the adhesive and makes it more cohesive to eliminate the risk of cold-flow. The cohesive strength of the UV-cured adhesive prevents cutting blade gumming with low shrinkage. Although the cured adhesive presents increased cohesive strength, the overall system remains flexible.
Sample Wicking

Strong intermolecular attractive forces exist between molecules to create surface tension. These intermolecular forces create high surface tension in aqueous biological samples. In comparison, the surface energy of a solid substrate is low. The membranes used in IVD devices also have low surface energy and are not compatible with aqueous biological fluids. To achieve lateral flow and, ultimately, wicking of the fluid sample, the difference between the surface energy of the biological fluid, substrates, and membranes used in the diagnostic device must be overcome.5

Two approaches can improve the flow of biological fluids through a diagnostic device. One approach is to increase the surface energy of the substrate with various surface treatments. A second approach is to reduce the surface tension of the biological fluid, which can be accomplished through the incorporation of a hydrophilic PSA.
Adhesives may be formulated with a range of hydrophilic and hydrophobic capabilities to control fluid flow in a device while also providing increased design flexibility using a small biological sample. When an adhesive’s surface is hydrophilic, it reduces a fluid sample’s surface tension, improving wicking consistency and enabling rapid fluid transfer from the inlet port to a remote reactant area for fast test results. Hydrophilic PSAs may also be used as a wicking surface that allows increased separation between the sampling port and test reagents to reduce the risk of chemical interference.
Alternatively, by slowing hydrophilicity to create a hydrophobic surface, device designers can control reaction times as a sample wicks through a device. Surface treatment techniques can be applied to the adhesives or coatings used in a device’s backing material to customize the physical character to include areas with hydrophobic characteristics and reduced surface energy. Fluid wicking through devices that use this approach can be slowed over areas of low surface energy by using a single coating. This approach permits adequate time for the required reaction or complex formulation. The technique also avoids rapid fluid wicking in devices where insufficient reaction times can cause inaccurate test results. It is possible to create a series of reaction zones of various shapes and configurations on a single adhesive film.6   
Adhesives with tailorable fluid transfer properties are available in a number of forms, including PSA, heat seal, and film coatings. These forms make them an attractive material choice for lateral flow, microfluidic, microtiter plates, and point-of-care devices that require good bonding to a variety of substrates (see Table I).
Table I. Hydrophilic adhesives offer tailorable features.

Optical Transparency and Spectral Properties
PSA manufacturers are faced with a long list of chemical compatibility and physical bonding challenges when formulating products for diagnostic devices. In addition, many biological testing applications rely on diagnostic determination by using fluorescent emissions.
Careful consideration must be given to materials when selecting cover tapes for PCR, real-time PCR, microfluidic, biochip, microarray, and microwell applications. Any interference or background fluorescence from an adhesive coating or accompanying film carrier can affect the detection of optical characteristics. Sealing or cover layers must exhibit little or no spectral emission at the biomaterial detection wavelength (typically 400–800 nm). Low fluorescent film substrates include materials such as polyolefin (PMP), cyclic polyolefin (CPO), polyacrylates (PMMA), polycarbonate (PC), polystyrene (PS), and polyethylene terephthalate (PET) (see Figure 1). From an adhesive standpoint, chemistries with high levels of acrylic acid should be avoided, and low coat weights should be used.

Going with the Vertical Flow
The availability of a porous PSA technology that provides the ability to bond multiple layers while enabling the free exchange of fluids or gasses is a relatively new concept.7 The technology was originally developed for applications requiring secure containment of fluids while providing ventilation for gas exchange, such as in microtiter plates or microarrays. Now it is being considered for IVD devices where a conventional, impermeable PSA was not previously a viable component. This customizable adhesive technology offers open pores or cells of relatively uniform size and distribution to create a low-density, highly permeable structure. The pores are isolated channels that control flow and movement of aqueous-based fluids and gases. They typically range in diameter from approximately 200 to 500 µm and have 3050% porosity. They enable flow from one substrate to the next through the z-direction of the adhesive, while acting as a gasket seal in the x-y direction.8
Pore Structure: A Microscopic View
The porous adhesive’s ability to provide bonding capabilities while allowing the free transport of fluids and gases across the two surfaces of the adhesive film could create new PSA application areas in IVD. The adhesive forms instant bonds to join film substrates, membranes, pads, filter elements, or plastic parts without the need for curing or clamping during production of the finished product. The typical pore size of 200 µm is large enough to allow the passage of a whole blood sample. Alternatively, the adhesive may be laminated to a porous membrane to filter red blood cells. For example, the porous PSA can enable the construction of a stack of filtration membranes for cost-effective sample preparation. In vertical flow or combination lateral flow IVDs, the adhesive layer can provide a physical separation between materials while enabling the rapid passage of fluids through the adhesive.9
Figure 1. The effect of excitation energy on the fluorescence of various substrates.
Dissolvable Films
Assay developers are evaluating ways to reduce cost by improving assay stability and yields of expensive reagent-laden components, and aqueous-based dissolvable films. At the same time, a related technology to PSAs that uses similar coating and processing approaches is gaining attention as a viable means for incorporating reagents into diagnostic devices such as lateral flow test strips, microfluidic devices, and microplates. These films provide a means for containing, storing, transporting, and processing reagents in a simple solid-state form. The reagents are made available by simply redissolving the film in an aqueous medium. Dissolvable films can be tailored to meet the specific needs of an application and offer significant formulation flexibility for achieving physical properties such as film thickness, dissolution rate, surface characteristics (texture), and mechanical properties (film strength). 10
Conventional preparation techniques for test strips, such as spraying, coating, or striping, can result in the costly loss of reagent. They can also limit the effective distribution of active components throughout a membrane or conjugate pad. Dissolvable films are formulated as a homogeneous mixture of a film former and reagent(s), so consistent dispersion of the active component is an inherent benefit of the film technology, translating to increased yield and reduced costs for device manufacturers.11 The film is provided in a continuous reel and may be cut into any size or shape to fit the end product design. Each precisely die-cut film component is a premeasured single dose that is easier and safer to handle than aqueous solutions of reagents. Higher dose concentrations can be obtained by increasing the loadings within the film itself or by increasing the film’s overall mass and thickness. Reagent-loaded dry films do not require refrigeration or preservatives. Increased stability of the reagent when it is integrated into a film format results in less waste and requires fewer resources for device manufacturers to properly store and handle the sensitive and fragile reagents.
For diagnostic applications that require a controlled and timed reaction, dissolvable films may be incorporated as isolation barriers formulated with longer disintegration rates. Alternatively, the films may be used in multiple-layer constructions and vertical flow devices that contain or separate one or more reagents for their controlled release when exposed to an analyte within a device.

Enhancing Conductivity
PSAs provide custom bonding with added performance benefits in electrochemical sensors, such as blood glucose or lactose test strips, or biofeedback devices that incorporate an electrical current or potential for diagnosis. Electrically conductive PSAs enable small and thin effective bonds because they not only bond components together, but also provide the added functionality of supplying pathways for electrical signals. By eliminating the need for other conductive elements, electrically conductive PSAs present options for simplifying electronic component designs.
When uniformly dispersed within an adhesive, conductive particles create pathways within the adhesive matrix to make contact from one surface to another. The conductive fillers may be comprised of a number of materials, such as nickel, silver, and carbon or a combination of these materials. The adhesive matrix may be formulated from silicone, acrylic, or rubber polymers to ensure the maximum flexibility and compatibility with metal, film, and potentially low surface–energy substrates.12
Depending on the application, a number of adhesive or film formulations can be created in combination with the carbon particles, including
  • Carbon-filled adhesive matrix.
  • Carbon- and metal-filled adhesive matrix.
  • Carbon and silver compound adhesive.
  • Adhesive-embedded composites for x-y versus z-conductivity control.
  • Conductive films and laminates.

A number of factors are driving IVD manufacturers to reduce the cost of their current products and develop next-generation devices for current and new applications. As device manufacturers maneuver through shortened product development cycles, they turn to their material suppliers for the latest technologies for enhancing product performance and value.
Suppliers face many technological challenges in developing innovative new products and efficient and reliable manufacturing processes that produce high-quality products that meet or exceed regulatory requirements. Custom adhesives manufacturers are uniquely positioned to develop and implement technologies that provide reliable bonding for a multitude of IVD testing platforms, and deliver enabling technologies to address the challenges IVD manufacturers are facing today and in the future.
1.  WG Meathrel and J O’Mahoney, “Customized Adhesive and Coating Technologies Enable Drug Delivery Methods,” Pharma, September (2009): 20–23.
2.  WG Meathrel and R Malik, “Advanced Pressure-Sensitive Adhesives Enable Advent of Next-Generation IVD Products,” European Medical Device Technology 2, no. 1 (2011): 19–21.
3.  P Hilfenhause and T Meigs, “Pressure-Sensitive Adhesive Tapes for IVD Applications, 16.2” IVD Technology (2010): 33–38.
4.  E Lakitosh, “Die-Cuttable Adhesive Development,” Internal company document. Adhesives Research, Glen Rock, PA.
5.  H Hand and W Meathrel, “The Effect of Hydrophilicity on the Flow Properties of Biological Fluids in Diagnostic Devices,” IVD Technology (2001); available from Internet:
6.  W Meathrel et al., 2002, Hydrophilic diagnostic devices for use in the assaying of biological fluids, U.S. Patent 7,476,533, filed April 19, 2002, and issued Feb 25, 2004.
7.  R Malik, R and K McKinney, Porous pressure-sensitive adhesives and tapes, U.S. Patent 60/978,591, filed October 8, 2008, and issued April 9, 2009.
8.  R Malik, “Porous Adhesive Technology for Diagnostic Applications,” IVD Technology 15, no. 2 (2009): 27–32.
9.  R Malik, “Porous Pressure-Sensitive Adhesives,” European Medical Device Technology 1.2, (2010): 41–43.
10. W Meathrel and C Moritz, “Dissolvable Films and Their Potential in IVDs.” IVD Technology 13, no, 9 (2007): 53-58.
11. W. Meathrel et al., Disintegrable films for diagnostic devices, U.S. Patent 7,727,466, filed Nov. 21, 2008, and issued June 1, 2010.
12. D Hariharan, “Electrically Conductive Adhesives Charge Forward,” Design Fax 4 (2009); available from Internet:
William G. Meathrel, PhD, is senior scientist at Adhesives Research Inc. (Glen Rock, PA). Ranjit Malik, PhD, is group leader of core technology at the company.

Washington Wrap-Up: Industry, FDA Continue to Negotiate User Fees, MDUFA

Washington Wrap-Up: Industry, FDA Continue to Negotiate User Fees, MDUFA

 Medical device industry representatives told FDA that they are not in agreement with the proposed funding for device user fees. Speaking in late June at a meeting to discuss the reauthorization of MDUFA, they objected to a possible 17% increase from FY 2012 to FY 2013. According to the minutes of that meeting, the industry representatives are against “user fees comprising 40% of the device review budget.”

The representatives do not want CDRH’s budget to rely too heavily on the user fees, and held up the drug review budget, which draws 60% of its funding from user fees, as an example of a direction they don't want CDRH to go in.

The representatives indicated industry is reluctant to commit to a reauthorization of the program before the agency has clarified whether and to what degree it will change device regulations. They proposed reconvening user-fee negotiations within 15 days of the upcoming release of the recommendations by the Institute of Medicine (IOM) on revamping the 510(k) process. The representatives suggested that they could then discuss the report and its potential impact on CDRH’s resources.

“Industry further proposed that FDA would subsequently issue a plan related to each of those recommendations with a workload and resource impact analysis,” the minutes read. The representatives also requested a similar analysis on the 510(k) paradigm, 510(k) modifications, de novo guidance, third-party review program SOPs, and multiple predicate analysis. “FDA provided clarification on the multiple predicate analysis, confirming that FDA is not limiting predicates, but will be clarifying how predicates may be used in accordance with the statute,” the minutes read. “FDA indicated that this clarification is not expected to affect 510(k) workload.”

Additionally, industry asked for more information on CDRH's plans for regulating laboratory-developed tests (LDTs). “Industry is concerned that regulation of LDTs will affect FDA’s ability to meet its performance goals because of increased workload,” the minutes read.

During the meeting, industry also presented four proposals for review program enhancements, including “presubmission meetings, refuse-to-accept procedures for 510(k)s, refuse-to-file procedures for PMAs, and an independent analysis of review process management.”

Another set of minutes from a similar meeting held 10 days earlier disclosed that FDA has rejected an industry proposal for a two-year MDUFA extension, saying the agency still wants a five-year program with decisions on topics that industry identified at a meeting in May.

In their response to the proposal, FDA officials said they did not believe that the proposed two-year extension “addresses key challenges facing the program or that it meets the goal of ensuring timely access to safe and effective products,” according to the minutes. The agency representatives said they “remain interested in engaging in discussions on topics” industry had raised. They “expressed concern that industry’s… proposal had resulted in a delay in making progress towards full reauthorization of the program, which is under a tight statutory timeline.”

According to FDA, the two-year extension “would produce even greater uncertainty about long-term program stability that would exacerbate the turnover problem and reduce staff morale.”

Be sure to check this space regularly for the latest dispatches from Jim.