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Sensor Combines Color and Proximity Capabilities

Both color and proximity sensors have many medical device applications. But because of the negative effects on color sensing caused by infrared (IR) light, which is required for proximity sensing, the two features have not been combined in one sensor. As a result of advanced semiconductor process techniques and optoelectronics expertise, however, TAOS Inc. has introduced what it claims is the industry's first color sensor with an on-chip IR blocking filter and proximity sensor.

When producing ambient light and color sensors, for example, the goal is often to match the human eye, which sees visible light, explains Todd Bishop, TAOS technical marketing manager, Europe. Able to respond to visible light, as well as to UV and near-infrared light, silicon sensors have typically been used for such functions. But to obtain an optimal, more-accurate color measurement, an IR filter is needed. In the past, Bishop notes, customers had to provide their own IR filters, which could be costly and mechanically difficult to incorporate. "But with the new technology, we can incorporate an IR filter onto the sensor itself, which lowers the system cost and size while offering improved accuracy," Bishop says.

Proximity sensing, however, needs to use this blocked IR light, Bishop adds. Thus, TAOS's new TCS3x72 sensor features IR sensors for proximity in addition to color sensors that block IR on the same chip's integrated circuit. To solve this apparent conflict, the IR filter is localized only to the color-sensing photodiodes. It is also able to perform ambient light sensing (ALS), which is a technology offering brightness control on device screens to optimize viewing based on lighting conditions.

To simplify design options and minimize software development, TAOS has made the TCS3x72 series pin and register compatible. Software is provided as well to optimize the TCS3x72-series ALS, enabling light color temperature sensing. In addition, software driver support and evaluation modules help to accelerate product time to market.

The new technology could be employed in a number of medical device and diagnostic applications, according to Bishop. "Color sensors could be used to measure color for safety redundancy," he says. "For example, an IV pump might need different flow rates, depending on the liquid. If the bags are color coded, a sensor can measure this and set the pump automatically." Color sensors can also be employed in pulse oximeters to simultaneously measure the rate of change of blood flow and the oxygen level.

In the future, the proximity detection features of these sensors also have the potential to be used in virtual button applications, according to Bishop. Virtual buttons create a zone that a user can touch in lieu of a mechanical button or switch. "This could be beneficial in medical applications so that hands don't have to touch a surface and spread germs on medical equipment, such as on an on/off or light switch," Bishop says.

TAOS Inc.
PLANO, TX

Medical Manufacturing Is Moving to India

The medical device industry will continue to experience turbulence in the next decade or so, and India will be among the beneficiaries, according to Professor Balram Bhargava of the All India Institute of Medical Sciences. As noted on the medtechinsider India blog, Bhargava outlined a scenario that includes a thinning medical pipeline in the west, an exodus of manufacturing operations to India, and an ad hoc alliance of China, Israel and India joining forces to develop devices for western consumption during a lecture at Judge Business School, Cambridge University. Bhargava predicted that India is "poised to lead in a decade of frugal and affordable innovation that will impact global economies."

— Norbert Sparrow

Medical Device Safety System Design: A Systematic Approach

Medical Device Safety System Design: A Systematic Approach

As technology advances, medical devices that improve disease diagnosis and the treatment of illness or injury are introduced. Many of these lifesaving medical devices perform these functions through the control and measured application of hazardous and potentially lethal energy sources such as x-rays, gamma radiation, lasers, or high-voltage
 

An IEC-compliant emergency-off button mounted on the control console.

electrical charge. Patients and healthcare providers depend on medical devices to perform safely and predictably in a variety of situations and environments. However, as medical devices become more sophisticated, they increase in complexity and their response to user inputs, environmental inputs, and component failures aren’t as predictable. Therefore, a systematic approach to device safety is essential to the successful and cost- effective development of complex medical devices.

 A well-designed safety system must implement risk controls for all of the product’s hazards. For devices that have significant risk of harm, the safety system includes elements that are fully independent of the operational elements of the system. The safety system must also have well-defined interfaces with the operational elements of the system at critical points.

Define Safety Requirements

The process of designing an effective and compliant safety system begins during the product definition phase before product requirements and architecture are defined. In addition to the normal market-driven requirements, at least two other inputs to the medical device’s specifications should be considered. First, potential hazards of the device, identified through the risk assessment process; and second, the domain-specific safety requirements mandated by national or international standards. The medical device development team must consider the intended use of the device as well as the planned product design when analyzing the product for potential hazards. The risk assessment team should include members who are knowledgeable about the typical use of the device including the skill or training of the typical users and the range of normal and atypical, but likely use cases for the device.
 
The objective of the risk management process, as defined by ISO 14971, is to identify the inherent hazards of the medical device, assess which hazards must be mitigated through safety-related systems or other means, implement appropriate risk controls, and assess the residual risk after the risk controls have been incorporated into the design. This process will help to identify the critical points within the overall system architecture that the safety system must monitor and exert control over. By addressing product risk as an integral part of the product development process, the required safety system can be developed during the product development process and effectively integrated as a part of the system architecture. When developed in this manner, the cost of developing the product is reduced as is the overall development schedule.
 
Medical Device Design:
Develop a Winning Strategy
 The initial risk analysis will identify many, but not all, requirements for the device’s safety systems. A thorough regulatory standards review is also needed as part of the upfront definition of the product to identify the mandatory safety requirements to which the device must ultimately comply. Typically, system requirements are intentionally structured to avoid explicitly defining the design approach. Regulatory requirements are different. Regulatory requirements are often prescriptive, defining exactly how the standard must be implemented. For example, 21 CFR 1040.10 describes in detail the interlocks and safety components needed for various classes of lasers. These required elements must be included in the product design and as these features are incorporated early into the design their effect on the look and feel of the product to the end user is minimized.

Address Safety in the Architecture

Once the medical device’s risk control requirements and regulatory requirements are identified, they have to be decomposed to identify where and how each requirement will be addressed in the overall system architecture. This effort must occur as part of the initial architecture design to ensure the appropriate allocation of safety functions are made while the design architecture is still fluid. Typically, safety-related requirements are addressed by the following combinations:
  • System software and firmware.
  • Dedicated safety electrical hardware such as a complex programmable logic device (CPLD) or field-programmable gate array (FPGA).
  • A dedicated safety processor and associated software.
  • Mandated electromechanical safety circuits such as the emergency off (EMO) circuit.
  • Mechanical guards and interlocks.
Each aspect of the overall system contributes to an integrated safety system.  The system software can handle complex rules analysis and decision, and the sequencing of events.  It can manage routine error handling and communicate the system state to the user. However, because of the system software’s inherent complexity, it can be difficult to verify and regression test safety-critical functions within the larger code base. Furthermore, unless the safety-related software functions are designed for deterministic behavior, the system’s response to safety event will be nondeterministic and safety-critical operations may be delayed.

Consider an Independent Safety System

A common response to the limitations of system software is to embed critical safety functions into independent hardware such as complex hardware devices, like a CPLD or a FPGA, as illustrated in Figure 1. These devices have the advantage of high reliability, deterministic response and, in the case of simpler devices, the ability to verify the operation with 100% coverage. This means that every possible combination of input conditions can be tested.
Figure 1. Product architecture with an independent safety system.
 
 Another approach used when a device needs a complicated safety system is to design the safety software to execute independently from the device’s main application, often on a separate microcontroller. By keeping the safety software as small as possible, the ability to verify the safety software is improved, and these functions are less likely to be affected by future features added to the medical device. Executing the safety software on a processor separate from the main processor helps to keep the safety software small and further reduces the possibility of the main system software interfering with the execution of the safety software.
 
Encapsulation of safety-related functions within the system software is the next best thing, allowing rigorous testing of the safety-related functions. The processor and operating system upon which the software is executing must provide a means of isolating the safety-related functions from the operational functions of the device. The architectural features used to provide this isolation must be verified to provide sufficient isolation so that a defect in the software implementing the operational functions cannot affect the operation of the safety-related functions (see Figure 2).
Figure 2. Safety software running on the same CPU.
 
There are several real-time operating systems (RTOS) that provide this capability when used with a microprocessor or microcontroller that supports a memory management unit or similar hardware support for isolating functions. Without proper isolation, all functions running on the same hardware must be treated at the highest level of criticality of any function running on the hardware. In the case of safety-related functions and operational functions running on the same hardware, without proper isolation all of the functions must be treated as safety related and verified with the same level of rigor.
 
Another advantage of a design approach that separates safety elements of the system from the operational elements is that it bounds the amount of software and hardware that must be 100% correct. Physical separation is the most definitive. The interfaces between two processors or a processor and an FPGA can be clearly defined. In many cases the safety-related functionality is small enough to allow 100% verification coverage, explicitly testing all possible states of the safety-related hardware and software.
 
The safety system may also include interlocks, monitoring a number of safety critical sensors and switches. The safety hardware, whether CPLD, FPGA or secondary microprocessor, often contains a watchdog timer for the main microprocessor and will execute a reset or shutdown sequence if the device does not receive a signal from the microprocessor within a specified time window. If a specific set of conditions is not met, the safety system will lock out device operation in a manner independent of the main microprocessor’s control.  The main microprocessor can monitor the outputs of the safety system to provide information to the user on the nature of the fault and guidance on how to clear the error, such as “laser access door open.”

Electromechanical Considerations

Some elements of the safety system cannot be implemented in software or firmware and must be implemented using electromechanical safety circuits. The design of these elements is mandated by international standards specific to the type of device and must be designed with agency-certified electromechanical components to ensure compliance. The most obvious example of this is the EMO circuit required on many medical devices. The type of hardware that can be used in an EMO circuit and the level of redundancy required is prescribed by numerous standards, depending on the hazard level and energy source. Even the location and appearance of the EMO button is mandated. If these mandated requirements are identified in the definition phase, it will be much easier to incorporate the electromechanical components into the architecture and detailed design.
 
The advantages of electromechanical safety circuits are that they are simple and robust, and their design has been proven in countless consumer and industrial applications. Where design teams often go wrong is in trying to “improve” on these safety circuits by incorporating nonagency-certified components or nonstandard design approaches. This can lead to delays in third-party evaluation or a late-stage redesign. If the safety circuit is designed according to the applicable standards however, the third-party evaluation process should be straightforward.  

Good Safety System Design

When the team is making decisions about the architecture of the safety-related systems, several characteristics should be considered in its design. The safety system should be the following:
 
  • As simple as possible to achieve the desired safety functions.
  • Functionally independent of the main control system.
  • Have well-defined interfaces with the main control system.
  • Fully verifiable as a module or modules.
  • Obvious in both design and operation.
Any system of sufficient complexity will have design flaws and unintended behaviors – medical devices are no exception. Functional independence of the core functional system and the safety system can be thought of as a firewall to limit the effect of these defects. The following are some examples of common design flaws.
 
Sneak Circuits. A sneak circuit is a designed-in signal or current path that causes an unwanted function to occur or inhibits a wanted function.1   An example is an unintended current path in a circuit that pulls a microprocessor input high under the right conditions, throwing the software into an undefined state.
 
Common Cause Failures. This includes common mode, cascading failures, and single-point failures. An example of a single-point failure is the use of redundant thermocouples connected to a common A/D convertor to control the temperature of a heater.  Failure of the A/D convertor will result in incorrect readings from both thermocouples and a potentially hazardous situation.
 
These types of design flaws can be avoided if they are considered in the hazard analysis, requirements definition, and system architecture phases of the development cycle.  The safety system should be as independent as possible from the system that it is monitoring. Software operating limits may be supplemented by fail-safe safety limits that act on the energy source through a mechanism other than the one used by the main control software. Critical safety devices such as laser beam stops may need to have separate independent means of actuation.
 
A common example of a functionally independent safety system for such a heater would consist of microprocessor-based temperature control based on the thermocouple input, in conjunction with a separate electromechanical over-temperature switch that interrupts the heater power circuit, if there is an over-temperature condition. Because this safety system is functionally independent and uses a different design approach than the main heater control loop, the potential for an unintended interaction is reduced.

Review the System Architecture

One method to evaluate how well the team is implementing the safety architecture is to review the product architecture.  Some questions to ask include:
  • Are all of the safety requirements addressed by the architecture?
  • Does the architecture describe how the safety-related functions are isolated and protected from other aspects of the system? 
  • Can the safety-related functions of an electronic design be contained on one or two pages of the system schematic, or are aspects of the safety system spread throughout the entire document?
  •  Are the software based safety functions well encapsulated, with clear inputs and outputs, or are aspects of the safety functions spread throughout the code in a way that defies easy comprehension of the way the safety system functions?

Conclusion

The safety system of the device will be reviewed by both internal and external experts and laymen.  A system that is well architected from the beginning of the development process and obvious in its function will be easier to document. Clear documentation is easier to review and flaws in the design will be more evident.  
 
The resulting design will provide clearly defined mitigations for the device’s hazards. Most importantly, the safety features of the medical device will be comprehensive and robust enough to provide users with protection against many hazards during its use in real-life situations.

References

  1. JP Rankin, “Sneak Circuit Analysis,” Nuclear Safety 14, no. 5 (1973).
David Warburton is the director of Systems Engineering at Foliage (Burlington, MA). Dan Goldman is a lead medical device system architect at the firm.
 

This Week in Devices: Pip Implant Scandal: Fix What’s Broke. Then Stop.

this week in devicesAmong stories in this edition of "This Week in Devices," EMDT's Norbert Sparrow covers further developments in l'affaire Pip—the recent breast implant scandal—and the resulting calls for more regulatory scrutiny.

 —Brian Buntz


FDA Petition to Withdraw Stryker’s Wingspan Stent

The petition says that a recent study found that the device actually increases the risk of subsequent strokes and death, rather than preventing them. The petition also says that when the device is combined with aggressive medical treatment, it provides no additional benefit and can cause significantly more harm than safer aggressive medical treatment alone.

Public Citizen says that the new study funded by the National Institutes of Health demonstrates that some of the key conditions upon which the Wingspan stent system was approved as a humanitarian device can be met. Thus, it says, there is no longer a “reasonable basis from which to conclude that the probable benefit to health from the use of the device outweighs the risk of injury or illness, taking into account the probable risks and benefits of currently available forms of treatment.”

Kessler, now a professor at the University of Washington School of Public Health, wrote to Public Citizen’s Sidney Wolfe that while FDA needs to use its regulatory authority in flexible and not dogmatic ways, it must realize that it has an equally important duty to move swiftly to make regulatory changes and announcements when device problems are uncovered.

“These compelling post-market data about the Wingspan stent provide an opportunity for FDA to show to industry, the clinical community, and most of all to patients that the agency is serious about exercising its authority by withdrawing the HDE immediately and insisting on a recall to ensure the devices on the U.S. market are both safe and effective,” Kessler is quoted as saying in a Public Citizen news release.

Public Citizen says that while several Wingspan studies were conducted after FDA approved the device, they were not adequately designed to evaluate its effectiveness compared to medical therapy alone. But they did demonstrate that the device comes with substantial risk of great harm.

It says that the well-designed NIH study that was published last September 11 in the New England Journal of Medicine showed a more than 2.5-fold increase in strokes or death caused by the Wingspan system.

Asked for comment on the petition request, Stryker officials said the company “continues to support the Wingspan stent system and Gateway PTA balloon catheter as an approved Humanitarian Use Device for improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease who have failed medical therapy.”

The company said the NIH trial did not follow the current HDE indication for use, but rather focused on studying the treatment of severe intracranial atherosclerotic disease, early in the treatment lifecycle and with an aggressive drug treatment regimen and rigorous oversight of medication compliance. It said that the Wingspan indication is for patients who are refractory to medical therapy, but the NIH trial did not require patients to be refractory to medical therapy to be enrolled.

In January, Public Citizen supplemented its petition to refute claims that clinical trials of the system lacked subject comparability. The supplement says that the petition was based on findings in a National Institutes of Neurological Disorders-funded study that stopped patient enrollment early after determining that people treated with the Wingspan system and appropriate medical treatment had a 2.5-fold higher risk of suffering a stroke or dying in the first 30 days after stent implantation that did comparable people given medical treatment alone.

Since Public Citizen filed its petition, the advocacy organization says, there have been comments from Stryker and FDA officials suggesting that FDA’s failure to ban the device was related to a lack of comparability between subjects in the National Institute’s trial and patients the system was intended to treat under its 2005 humanitarian device exemption (HDE).

“As our analysis shows,” the supplement says, “there was significant overlap in the clinical characteristics profile of subjects participating in the trial with the profile of subjects in the Wingspan HDE safety study and, more importantly, with the profile of the several hundred patients enrolled in post-approval registry studies who were treated with the Wingspan stent system in accordance with the FDA-approved HDE indication between its approval in 2005 and the timeframe of the trial.

“The Wingspan stent system was thought to be too dangerous to implant in any more subjects in the trial. It is likewise too dangerous to use in the hundreds of patients who have clinical characteristics that overlap with the clinical characteristics profiles of both the trial subjects and the population of patients eligible for treatment with this device under the FDA-approved HDE indication. Due to FDA’s unconscionable decision to delay withdrawal of the agency’s approval of the Wingspan system HDE, the continued use of this device exposes patients to an unacceptable risk of serious harm, including death.”

Public Citizen Health Research Group deputy director Michael Carome said that the only way that further use of the device can effectively and definitively be prevented is to immediately remove it from the market. “To allow any further implantation of this device would be highly unethical as well as a violation of FDA laws and regulations,” he declared.
In a statement, Stryker said:

“Stryker continues to support the Wingspan® Stent System and Gateway® PTA Balloon Catheter as an approved Humanitarian Use Device for improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease who have failed medical therapy.* The SAMMPRIS Trial did not follow the current HDE (Humanitarian Device Exemption) indication for use; it focused on studying the treatment of severe intracranial atherosclerotic disease, early in the treatment lifecycle and with an aggressive drug treatment regimen and rigorous oversight of medication compliance. Stryker’s U.S. HDE for the Wingspan® Stent System and Gateway® PTA Balloon Catheter is limited to no more than 4,000 patients per year.

“Stryker encourages physicians to provide the appropriate standard of care for patients diagnosed with ICAD by first utilizing medical therapy according to established national and local (hospital) guidelines. Among patients who are receiving medical management only, progression of stenosis may occur over time that could result in a stroke from a distal embolism or hypoperfusion. The Wingspan Stent System with Gateway PTA Balloon Catheter is for patients who are refractory to medical therapy. In the SAMMPRIS trial, it was not required for patients to be refractory to medical therapy to be enrolled.

“Stryker is committed to partnering with the NIH, FDA and study leaders to better understand and interpret the SAMMPRIS trial results.

“*U.S. HDE (Humanitarian Device Exemption) Indication for Use: The Wingspan® Stent System with Gateway® PTA Balloon Catheter is indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with ≥50% stenosis that are accessible to the system.”

510(k) Cititical Decision Points in New FDA Guidance

FDA has issued a draft guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510( k)], to identify, explain, and clarify each of the critical decision points in FDA decision-making process used to determine substantial equivalence. The guidance is not implementing significant policy changes in the 510(k) review process, FDA says, but rather is intended to enhance the predictability, consistency, and transparency of the 510(k) program by describing in detail the regulatory framework, policies, and practices underlying agency 510(k) review. It also updates agency policies for the Special 510(k) program.

Topics covered include the 510(k) decision-making process and alternative approaches to the traditional 510(k) submission. There are appendices on a proposed 510(k) decision-making flowchart, the 510(k) summary document requirements, the 510(k) process, contents of a Special 510(k) submission, sample risk analysis summary, and abbreviated 510(k) content. 
 

99 Vaginal Mesh Surveillance Orders Issued

In July, an FDA safety alert said complications are not rare from using a surgical mesh for transvaginal POP repair. “Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk,” the safety notice said.

From 2008 to 2010, the most frequent complications reported for POP repair include mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems, the agency says. Many of the complications required additional intervention, including medical or surgical treatment and hospitalization.
FDA says it has issued 88 postmarket study orders to 33 manufacturers of urogynecologic surgical mesh for POP; and 11 postmarket study orders to seven manufacturers of single-incision mini-slings used in stress-urinary incontinence (SUI). “The manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for POP and single-incision mini-sling devices for SUI,” the agency says. “Data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices.”
 

What You Should Know about Patent Reform: The Post-Grant Review Process

MD+DI: Could you explain the post-grant patent review process?
 
David Dykeman is a patent attorney and co-chair of the IP department at Greenberg Traurig LLP
David Dykeman: The second major change under patent reform is the creation of a new post-grant review process, which allows third parties to challenge a patent based on any grounds of invalidity during a nine-month window from a patent’s issue date. A goal of post-grant review is to help ensure that only high quality patents are issued, and to shift the patent challenging arena from the courts to the USPTO. Thus, this significant change could benefit the medtech industry by reducing costly and time-consuming patent litigation.
 
Of note, the new post-grant review procedure will only apply to patents issued under the new “first-inventor-to-file” system. Additionally, after the initial nine-month review period there will be another inter-parties review period available for additional challenges later in the patent’s life.
 
MD+DI: How will the post-patent review period affect medtech entrepreneurs?
 
Dykeman: The post-patent review period will affect medtech entrepreneurs in a number of ways. First, medtech companies should implement a system for monitoring patents that takes advantage of this strategically important, but time-limited nine-month window to seek review of their competitors’ patents. This will require companies to expend resources of both money and employee time to monitor the competitive patent landscape. Large companies will have more resources to monitor their competitors’ patents and will likely challenge them in post-grant review. Early stage and smaller companies may lack these resources and may not be able to oppose all of their competitors’ patents or fully take advantage of this new post-grant review. However, all companies should benefit from the theory that post-grant review will result in higher quality patents that are more deserving of patent rights remaining issued.
 
MD+DI: What is the USPTO’s prioritized examination process and should medical device startups take advantage of this option?
 
Dykeman: In addition to the new provisions introduced by the America Invents Act, the USPTO has recently introduced its own initiatives to improve and streamline the patent process, such as a prioritized examination process. This addresses the patent backlog problem, where over 700,000 patent applications are in line waiting for examination at the USPTO. What this means is that it takes a very long time for a patent to issue—on the order of three to five years for a typical application in medical technology. Recognizing this patent backlog poses a problem for companies, the USPTO implemented new procedures in the fall of 2011 that allows companies to pay an additional fee ($4800 for large entities and $2400 for small entities) in order to move to the front of the patent application line and greatly shorten the length of the examination process at the USPTO. Medical device companies -- particularly those looking for investment or licensing opportunities or those who may find it critically important to have an issued patent to enforce against a potential infringer -- may wish to consider utilizing this procedure to significantly expedite patent prosecution.
 
MD+DI: Will the patent reform law cut down on the frequency of patent lawsuits?
 
Dykeman: Another goal of patent reform was to address the problem of patent trolls who are taking patents and enforcing them against an entire industry. While this is more prevalent in the information technology industry, the medical technology industry has seen more and more patent trolls in recent years. The America Invents Act attempts to address this in a number of ways, including the introduction of new avenues for challenging patents through the USPTO instead of the courts, as well as addressing how lawsuits can be filed against multiple defendants, which is the preferred tactic of patent trolls. The jury is out as to whether these reforms will actually reduce the total number of patent suits or just increase the number of lawsuits directed against a single company rather than multiple defendants. So while the patent reform act attempted to reduce costly and time-consuming patent lawsuits, court decisions will continue to play a key role in the patent system and in patent filing strategies.
 
MD+DI: What impact has the Supreme Court and lower courts had on the patent system?
 
Dykeman: In recent years, the Supreme Court has taken a much higher interest in issuing decisions related to patents. There has been a flurry of recent court decisions that indicate a willingness of the Supreme Court to rule on patentability questions and to address perceived problems in the U.S. patent system. Some cases on the horizon are particularly important to medical technology companies, especially in the area of diagnostics. A pair of cases are working their way through the Court of Appeals for the Federal Circuit and towards the Supreme Court address the patentability of diagnostic patent claims. One of these cases is Prometheus Laboratories, Inc. v. Mayo Collaborative Services, where the Supreme Court granted a petition for certiorari and heard oral arguments on December 7, 2011. The oral arguments in the Supreme Court revealed the complexity of the patentability analysis. While it is not clear where the Supreme Court will draw the line between processes involving mere abstract ideas and those meriting patent protection, the Justices appear to recognize that there is a need to tread carefully in order to balance the competing interests of protecting capital investments in this area and the ability of physicians to care for patients. The Supreme Court is expected to issue its decision on Prometheus in the first half of 2012.
 
Another case likely to be heard by the Supreme Court is Classen Immunotherapies, Inc. v. Biogen Idec. On August 31, 2011, the Court of Appeals for the Federal Circuit issued its second decision in Classen. In a split decision, the Court of Appeals found that certain patent claims were allowable while other claims were not eligible for patent protection. This latest development in Classen suggests that specific method steps that require putting knowledge gained from a scientific principle to “practical use” will be sufficient to satisfy patentability.
 
In light of these recent cases, medtech companies should use caution in drafting claims to cover active treatment steps. For instance, enforcement challenges could arise if the person who performs these steps is different from the person or device that performs the prior diagnostic steps. The best approach is to pursue a variety of claims of differing scope to cover the full breadth of inventive methods.
 
In 2012, it is expected that the Supreme Court and Court of Appeals will continue to issue decisions that will affect the patentability of medical technology and inventions.
 
MD+DI: What strategic advice do you have for medtech entrepreneurs looking to build a patent portfolio?
 
Dykeman: Given the patent reform legislation, and the fact that the USPTO should be issuing its Notices of Rulemaking in the next few weeks containing details on how the America Invents Act will be implemented, the key is to remain vigilant as these changes are adopted.
 
MD+DI: Could you provide us with a summary of what you think is most important here for medtech companies?
 
Dykeman: A couple of themes have clearly emerged. First, companies should file patent applications early and file often to account for the “first-inventor-to-file” rules. Second, medtech companies should monitor their competitors’ patents and patent applications given the new post-grant review procedures and the ability of third parties to submit prior art to the USPTO during the examination process. The goal of all of these reforms is for the USPTO to issue higher quality patents that truly reflect the innovations of technology companies.
 
David J. Dykeman is a patent attorney and cochair of the IP department at Greenberg Traurig LLP (Boston). 

This article is the second in a series. Dykeman, who is also the author of "Patent Reform: Navigating the Changing Patent Landscape," will be sharing more insights with MD+DI related to patent reform in the near future.

Rotational Voice Coil Stage Uses Flexure Bearing

Featuring the high precision of a galvanometer and the compact size and reliability of a resonant scanner, a rotational voice coil motor stage uses a flexure bearing to create rotational translation. This translation is achieved by tilting a precision mirror, grating, or other user-supplied load within a range of ±5°. The flexure bearing is designed to provide infinite life and smooth motion free of stiction and friction. The flexure bearing can position loads with a high level of speed and repeatability in scanning microscopy, micromanufacturing, and laser processing applications. Measuring 1.0 × 1.54 × 0.61 in., the RVC-5 motorized stage has fully integrated absolute-angle-position sensor electronics and can be supplied with a servo-controlled amplifier. It can be commanded to oscillate or move to any fixed point in its angular range following a fully linear velocity-move profile.

Equipment Solutions Inc.
Sunnyvale, CA

 

Hot-Runner Technology for Injection Molding Enables Direct-Gating of Parts

A company has designed a material- and timesaving hot runner specifically for injection-molding deep-draw medical device components such as pipettes and syringe barrels. The technology enables parts that would otherwise require gating with a cold runner to be direct-gated and supports molding applications in which component quality and gate vestige are critical considerations. The Ultra SideGate accommodates single-piece mold cavities, which eliminates the surface-quality issues associated with split-cavity designs, and it limits the size of gate vestiges on finished parts to approximately 0.05 mm. Offering tip-to-tip nozzle spacing down to 55 mm and a small nozzle housing area that accepts 1-, 2-, and 4-tip configurations, the system allows molds to have a large number of cavities while maintaining a relatively small footprint. Users can access the individual nozzle tips without removing the mold from the machine.

Husky Injection Molding Systems
Bolton, ON, Canada