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Wireless Advances Are Afoot

Historically, medical device manufacturers that require foot controls have used a cabled unit that plugs into the console of the device being operated. Typical applications include ultrasonic diagnostic systems, surgical microscopes, medical camera systems, x-ray equipment, and ophthalmic surgery systems.

Until recently, a cabled unit has been the only available option. Although these types of units have been acceptable, many OEMs recognized that the cable presents some limitations. In a physical sense, the cable poses a tripping hazard to personnel and limits the location of the foot control relative to the location of its host medical device. In addition, the cable is the most frequent point of failure—either from excessive stress at the strain relief or due to damage from being rolled over by chairs, examination tables, or equipment carts. Finally, the cable makes it difficult to clean and store the foot control.

As a result of these issues, field experiences, and a proliferation of wireless equipment (e.g., cell phones, patient monitoring systems, computers, etc.), many medical device OEMs have wondered whether it would be possible to eliminate the cable. This article presents major factors to consider when selecting a wireless technology for a medical-grade foot control.

Nature of the Medical Device

As previously noted, the diverse potential uses for wireless controls range from relatively low-risk applications, such as medical camera systems capturing reference images, to relatively high-risk applications, such as x-ray equipment and laser-based systems. In this context, manufacturers must consider the consequences of the loss of a desired signal, as well as the consequences of the equipment being activated by a random signal (noise) rather than through the purposeful actuation of the foot control. 

These concerns are similar to those that arise when using a cabled foot control, during which time control may be lost due to a cart or exam table cutting the cable, as an example. Although the loss of a signal in an image-capturing system is an inconvenience, it has no serious consequence for a patient. In this case, a unidirectional communications protocol may be appropriate. In these protocols, a transmitter signals the receiver, but there is no communication from the receiver. Unidirectional protocols often have the benefits of less-frequent battery recharging and replacement.

Alternatively, the integrity of communications between a foot control and a C-arm x-ray system or laser-based surgical instrument may have more significant consequences for consideration. Here it may be more prudent to use a bidirectional communications system—capable of two-way communication between the foot control and the medical device receiver. Systems such as Bluetooth, ZigBee, or some other similar proprietary protocol may offer noise immunity, greater encryption possibilities (for pairing the transmitter with its receiver), and the ability to verify the integrity of the communications link in real time.

In addition, some medical device applications may require the transmission and reception of ancillary, noncontrol data. These data could include the OEM’s identification, medical device identification, and real-time state of battery condition (voltage, current, charge status, temperature, number of experienced recharge cycles, etc.). Such parameters could be important as assessed risk increases or if a surgical procedure is interrupted due to a power loss.

Power Consumption

Because foot controls are most often battery operated, factors such as the duration of a typical procedure, the number of procedures per day, the duty cycle, and required data transfer rates affect the battery type (e.g., rechargeable versus nonrechargeable). These factors also affect the size and number of cells required to satisfy the power and battery service parameters of the application. Consideration of the wireless technology’s inherent power requirements and its ability to minimize power consumption (e.g., having a sleep mode), can help OEMs come up with the most practical battery candidates. See the sidebar, "Battery Selection Considerations," for more elements that need to be considered.

A component of the wireless setup is an RF transmitter-receiver module with an integral antenna.

Potential for Interference

How well does the technology minimize or eliminate the potential for interference? While medical device design engineers can control the generation and emission of random noise from their own equipment, they have no control over its presence in a user’s environment.

For many medical applications, total elimination of potential interference is impractical. The possibility of noise—for example, electromagnetic interference (EMI) signals from sources such as similar systems, patient monitoring systems, and other electrical equipment in proximity to the medical device—must always be considered. Note the following:

?    The need for the use of two or more like systems in the same local environment may require a wireless protocol capable of pairing the foot control and its controlled medical device in real time. Such bidirectional communication ensures that foot control A for device A will not operate device B and vice versa. 
?    Infrared (IR) wireless systems are typically not recommended for use in the presence of plasma screens (due to their emission of light in the IR portion of the spectrum).
?    Improperly applied ZigBee-based system signals may be masked by selected wireless local area networks.
?    Depending on its frequency, the possibility of random noise (such as from an electrosurgical generator) may dictate use of a wireless protocol unaffected by such an EMI presence (such as a frequency-hopping or similarly robust technology).

These issues can be addressed through the programming of data frame formats in a specific form acceptable to the receiver (e.g., such as identifying the medical device manufacturer, the specific transmitter source, signal encoding, etc.), and choosing a wireless protocol that is sufficiently robust to operate reliably in the environment. 

Desired Transmission Distance

The desired transmission distance may affect both the power requirements of the wireless protocol and the risk assessment (i.e., the farther the transmission distance capability, the greater the risk of inadvertent actuation of the controlled medical device).

In addition, OEMs must be aware of possible signal loss due to barriers in the signal path. For most medical devices operated via a foot control, the transmission distance is generally well below 10 m because the user is typically in close proximity to the medical device being controlled. Nevertheless, the wireless protocol chosen should be capable of reliable operation in the target environment.

Response Time

The wireless protocols typically considered for medical foot controls have response times well within those required (e.g., less than 250 milliseconds). However, when using a sleep mode to conserve power, system wake-up time must be considered. It is important that the system wake-up time does not exceed the desired control response time.

Cost

Table I. (Click to enlarge) A comparison of wireless technologies for foot controls.

Cost is typically be driven by the technical requirements of the application and the level of acceptable risk. For example, applications having lower levels of assessed risk may be satisfied by the typically lower overall cost (batteries, support circuitry, base technology) of unidirectional wireless protocols such as IR and single-frequency technologies. Where risk aversion is high, data density is high, or real-time pairing of the transmitter-receiver is desirable, higher-cost wireless protocols may be more appropriate.

Wireless Technology Possibilities

With the apparent need and potential benefits as drivers, a number of commercially available wireless technologies can now be considered. These include the following:

?    Infrared (IR).
?    915 MHz (available in the ISM band for medical applications).
?    DECT (digitally enhanced cordless telecommunications).
?    WLAN 802.11.
?    ZigBee.
?    Bluetooth.
?    Steute RF 2.4-MED.
?    Other proprietary protocols.

Each of these has its own unique attributes, some of which are summarized in Table I. In low-risk applications, most wireless technologies may suffice depending on cost-performance requirements.

Desired Features

Note that wireless systems can also be designed as hybrids, i.e., capable of also functioning as a conventional cabled device if needed. In addition to the requirements for a conventional cabled foot control, the following are among the most common features OEMs should seek when considering a wireless human interface:

?    Ability to meet the functional control requirements.
?    Compliance with all relevant radio-frequency standards in the countries of use, e.g., IEC 60601-1 and 60601-1-2, EN 60950, EN 50371, etc.
?    Geographic acceptance (here defined as acceptance in the countries in which the OEM wishes to market its equipment).
?    Maximum operating time between battery recharging or battery replacement.
?    Ease of periodic system maintenance for recharging, battery replacement, cleaning, transmitter-receiver pairing, etc.
?    Robust construction, e.g., IP X6 to IP X8.
?    Ability to monitor battery charge status in real time.

Other Issues

Medical device OEMs considering the use of wireless controls may have many queries about the choice of a technology for their application. Many questions revolve around safety and reliability, power management, and the receiver module.

Safety and Reliability. Although interest among both OEMs and their customers has been high, early adoption of wireless foot controls has been slow due to concerns about safety and reliability. These concerns most often revolve around false signals (EMI), crosstalk between like systems, and signal loss. Current technologies (especially bidirectional, frequency-hopping protocols such as Bluetooth and Steute 2.4-MED) effectively address these issues. Their frequency-hopping characteristics have made them highly immune to outside interference. With proper formatting of their data frames, these wireless options can eliminate the possibility of crosstalk with encryption for the manufacturer, serial number, type of device, and device identity—such that the pairing of the transmitter (foot control) and receiver (medical device) eliminates communication with other like systems or interference from other wireless systems or stray EMI.

In addition, with suitable programmed software, bidirectional communication permits constant confirmation of the married pair, immediate safe actions in the event of signal loss, and real-time monitoring of the power-supply status (to visually or audibly alert the user well in advance of the need for battery charging or replacement). 

Other safety features that can be provided include recharge cycle monitors, which track the number of recharge cycles undergone, and floor sensors, which intentionally interrupt the communications link if the foot control is picked up from the floor for more than some preset time period. In addition, OEMs can also look for options that allow system shutdown in the event of power loss or loss of communications and periodic or permanent display of the battery charge status.

This is an example of a wireless foot control module for an electrosurgical generator.

Power Management and Batteries. Currently available battery chemistries, coupled with today’s wireless technologies, provide an array of combinations with which to address each specific application requirement. In addition, the use of sleep modes with acceptably fast wake-up times enables the conservation of battery power during periods of noncontrol activity. Such conservation can extend the interval between battery recharging or replacement to weeks and months.

Foot control design can be such that recharging can be accomplished simply by plugging in a medical-grade wall recharger into a sealed recharging connector. Similarly, battery replacement can be fast and easy by using a sealed battery compartment that can be quickly accessed without tools. 

As previously mentioned, several wireless technologies enable the monitoring of battery charge status, the number of experienced recharges, voltage, current, and temperature  in real-time. Such monitoring allows safe, timely actions to be taken before a power supply and system operation have been compromised.

Receiver Module. If an OEM needs to add a receiver module to a medical device to facilitate wireless operation, typical questions revolve around the location, integration, interfacing, and power.

Essentially there are two locations for the receiver: integrated within the medical device console or in an externally mounted enclosure. The choice may depend on whether the wireless control is offered as an upgrade or postsystem sale add-on, the material of construction of the medical device console (for antenna location consideration), and the wireless technology selected (line-of-sight technologies such as IR or omnidirectional radio-frequency systems such as Bluetooth, ZigBee, and Steute RF 2.4-MED). 

The receiver requires power either from the host system power supply, a medical-grade plug-in power source, or from its own batteries, if practical. When line powering of the receiver is required, it can be provided from the host medical device’s power supply directly to an internally located receiver, or via a pin on the host’s female connector, to which an externally mounted receiver is plugged in.

The outputs of the wireless receiver can be formatted for interface compatibility to communicate with the host system, whether these are discrete analog and digital signals, USB, RS-232, or RS-485. Thus the receiver outputs can mimic whatever has been provided previously via a cabled foot control.

The questions that are paramount are a function of the application and the operating characteristics desired by the OEM’s technical and marketing staff. However, the traits previously mentioned are generally among those most frequently asked for when making an informed decision and technology selection.

Benefits and Drawbacks to the OEM

As with a conventional cabled foot control, there are benefits as well as new issues to address for the OEMs opting for a wireless solution. Among the benefits are the following:

?    Ability to increase revenues. Offering wireless controls may present the opportunity to expand an OEM’s revenues by addressing customer wants and by providing an optional wireless upgrade for their installed base of devices.
?    Ability to enhance technical image. With the increasing use of wireless technology, OEMs that offer this feature can be perceived as technical innovators or leaders. 
?    Elimination of cabled foot control problems. Manufacturers can avoid problems such as the tripping hazard, cable damage, and cleaning and storage issues.

Among the new issues to address are the following:

?    Periodic recharging/replacement of batteries. This a function of the usage, battery energy density, number of batteries, use of a sleep mode, etc.
?    Need to maintain transmitter-receiver pairs. This is important for safety as well as logistical purposes if foot controls are collected in a group for cleaning or storage. 
?    Higher cost than a cabled unit. The degree of cost increase is a function of the wireless technology selected, the number of discrete actuators, the type of controls signals required (analog and digital), and other desired design features.

Conclusion

Wireless devices continue to proliferate the medical device space and device users continue to embrace wireless controllers. As a result, one can expect to see more medical device OEMs offering such foot controls, either as standard equipment or as an optional upgrade. A number of OEMs are already offering such controls for medical devices such as x-ray systems, medical cameras, electrosurgical generators, fluoroscopy systems, orthopedic surgery systems, and ophthalmic surgery equipment.

Peter Engstrom is managing director of Steute Meditech Inc. (Ridgefield, CT). Maurizio Lauria is product manager at the company.

Why Risk Analysis Matters

In more than just the obvious way, risk is a four-letter word in the business world. Companies face risk if they move forward, and they face risk if they stand still. In all stages of medical product design and manufacturing ISO 13485 and FDA regulations require risk management, but the fact remains that establishing effective risk management is more easily said than done. Nevertheless, there are some basic steps a device industry executive can take that make setting up a risk management plan a less vexing procedure.

Requirements for risk management have been well documented in the medical device, aerospace, and automotive worlds. Now, risk management criteria are being offered to the rest of the manufacturing world. This is an example of a positive export of knowledge from the medical device industry, among others. For example, last year, ISO published 31000:2009 "Risk management—Principles and Guidelines." This is “14971-lite” for any industry’s application of risk management.

For too many companies, risk analysis is a failure mode and effects analysis (FMEA) procedure conducted once and later pulled out of a file drawer for the auditors to review. This approach barely meets the requirements and unfortunately misses the mark on intent. First, it serves only to identify risks but does not manage them. Second, it misses risks beyond the of the FMEA procedure, be they design or processing risks. In addition, the scoring criteria must be relevant to the specific manufacturing operation and understood by all those preparing and using the FMEAs. Furthermore, as a snapshot in time, the analysis may not cover changes that have occurred since it was prepared.

A Flowchart Is a Useful Tool

Why does risk matter? The answer is found in newspaper headlines, stock market reports, FDA consent degrees, attorney fees, class-action lawsuits, lost business analysis, and other negative outcomes. A failure to act becomes mismanagement and leads to a great deal of risk beyond the professional and corporate risk. Senior executives have been held personally and criminally liable for their actions while running their companies. Device industry executives are mandated, therefore, by their companies, their stakeholders, and regulators to be effective risk managers.

Effective risk management for a device industry executive entails taking a broad look at all aspects of your company’s business practices. Does your process for risk identification include all sources of risk? What about your supply chain? What about your computer and communications systems, your employees, equipment and equipment capabilities, power outages, or facility shutdowns? Does it include environmental issues like earthquakes, fires, floods, tornadoes, hurricanes, and blizzards? All these elements are different risks with different problems. Proper risk identification looks for all of these potential concerns.

Are you a component supplier? If so, have your customers properly defined all of their requirements and shared those with you? Are you really certain about that? If you’re the design-owner, are you subcontracting components? If so, can your chosen supplier meet all of the requirements you have specified? Do you understand their processing procedures well enough to know what you need to be asking of them?

A high-level flowchart of a firm’s operations is a useful tool for risk identification. If you don’t have one, it is worthwhile to create it. For every box on the flowchart, the project management team should ask: What can go wrong here, how will we know if it does, and what do we do if it happens? Putting the answers to such critical questions right into the document creates a risk management tool that can be used during the entire development process. Review the flowchart often in order to ensure that it remains current. When corrections are made, add the lessons learned to the risk management chart. Remember to add all improvements made to the system through risk management to your list of corporate preventive actions. Every action taken to mitigate risk is a “preventive action” in the lingo of ISO quality standards.

With respect to all those issues, auditors will ask for evidence showing how your system is designed to identify and reduce these potential sources of risk. As noted, simply pulling an FMEA document out of your files is not sufficient evidence that you have identified all your contentious sources. Once the sources of risk have been identified, an effective plan determines the best approach to alleviating these problem areas.

Document and Carefully Respond

Managing risk begins with documentation and continues with carefully considered responses. There are many items to think about. Among the concerns are redundant facilities in different areas of the country, alternate suppliers, validated production processes, mistake-proofing (poka yoke), inspection and testing, and control plans. Additional considerations include feasibility studies, design for manufacturability, design for maintainability, design of experiments, statistical process controls, process capability studies, Six Sigma, and lean manufacturing.

No one from outside of the company can tell you what you must do to manage risks, though some consultants may be able to offer good advice. For every risk, there is a means to mitigate it if it is cost effective to do so.

What are the best guidelines for determining a good risk management strategy? Here, ISO 31000 offers some very effective guidance. It states that proper risk management should:

  • Create value. Risk management must add value, not reduce it.
  • Be an integral part of organizational processes. A firm should design risk management procedures into its business model. The process should not be an afterthought.
  • Be based on facts, not assumptions. A company must make decisions using the best available information.
  • Explicitly address uncertainty. The risk analysis must state both known and unknown factors. No risk is known in full until something happens.
  • Provide a systematic and structured approach. This is to ensure that the procedures are applied consistently.
  • Be tailored to your company’s operations and products. An off-the-shelf fix will be ineffective.
  • Take into account human factors. Humans can dramatically increase or decrease risk.
  • Help everyone in the company to understand the process by being transparent and inclusive. If the risk management plan is in a confidential folder in the CEO’s office, it loses all credibility.
  • Be dynamic, iterative, and responsive to change. Risk management is a living process. As the company, products, and process change, so do the risk factors.
  • Be capable of continual improvement. The first pass-through of the process will have flaws. Perfection follows continual use.

Determining Acceptable Risk

Now the question becomes: How much risk management is enough? The answer to that question lies in understanding that not all risks are created equal. Some risks are acceptable, some risks are not. Companies must prioritize their risk mitigation activities. Too little and a device manufacturer ends up on the wrong side of a product liability lawsuit; too much and it goes bankrupt and produces nothing. It is the obligation and liability of company executives to draw those lines.

The food industry has a highly effective risk management strategy called hazard analysis and critical control points (HACCP). The key word here is critical. Rather than attempt controlling every risk at every step, the most effective approach is to look at the processes and determine the last point at which no further control can impact that feature, attribute, or risk potential of a product. That step becomes the critical control point. It is where the strategy ensures that the potential risk is either eliminated, if possible, or at least mitigated. Although this concept originated in the food industry, it can, and should, be a key component of effective risk management processes for medical device manufacturers.

Another effective model is the one used by ISO in determining the changes made to ISO 9001 in 2008. A simple matrix was used to compare the beneficial impact of the change with the resources required to implement the change. The vertical axis of this impacts/benefits matrix determines whether the change requires a high, medium, or low amount of resources and effort in order to implement it effectively. The horizontal axis determines whether the changes offer a high, medium, or low level of benefit to the company. If the level of benefit is low and the cost is high, the changes aren’t worth it. Conversely, a high level of benefit at a low cost makes the changes worthwhile. In between is where the harder decisions must be made. This is where having facts and clearly established decision criteria make the device company executive’s job easier.

A Shield Against Lawsuits

No discussion of risk management is complete without a consideration of legal and ethical concerns. Effective risk management is your best shield from lawsuits. If you are in the industry long enough, you will have a recall and you will have a lawsuit. What you do today, before any problem occurs, will dramatically influence how your company is perceived should a liability trial occur. If you have been open and honest about trying to identify and control risks wherever encountered—and you have records of your due diligence—you can greatly reduce any award a lawyer could obtain.

Nearly every company struggles with risk management. Struggling is understandable, but it is not an excuse for ignoring proper risk management procedures. Medical device manufacturers will only get better at the process by practicing proper risk management more often. It’s important to remember that the goal is to add value, not cost.

Effective risk management saves money in at least three ways: It reduces corporate liability insurance costs, reduces failure rates, and improves your customer satisfaction (that is, retention) levels. It’s equally important to remember that these are all preventive actions. Fixing problems before they arise is always cheaper than fixing them after you have caused mistakes.

Dan Brown is the medical device industry expert for the American Society for Quality (ASQ) and is the ISO 13485 registration services manager for Eagle Registrations Inc. (Dayton, OH). More information about risk management, HACCP, and ISO standards is available at the American Society for Quality Knowledge Center.
 

Strong Public Policy Key to Health of U.S. Device Industry

David Nexon, senior executive vice president at AdvaMed, submitted testimony at the President’s Council of Advisors on Science and Technology meeting on May 21, emphasizing the importance of setting U.S. policy that helps ensure that leadership position.

“While the medical technology industry is a genuine American success story,” he said, “our world leadership is not guaranteed to continue. Without sound public policy, it is increasingly likely that the U.S. will fall behind not only in medical devices and diagnostics but in other industries based on the life sciences.”

Nexon pointed to a number of indicators that show a narrow gap between United States and foreign competitors. While the U.S. has maintained a favorable balance of trade, he said, “The surplus of exports over imports has been narrowing both in absolute terms and relative to the size of the export-import sector. In 1998, imports and exports together totaled $24.6 billion and the trade surplus was $6.6 billion—more than one-quarter of total trade. By 2009, the trade surplus had shrunk by more than half—to $3 billion, and the surplus was only 4.7% of total trade.”

He stressed the impact of federal policies on a regulated industry. “All medical technology products sold domestically are regulated by [FDA], and most must receive clearance or approval before they can be marketed and all are subject to quality systems and good manufacturing practices regulations. Further, products are monitored for adverse events once marketed to the public and are subject to recall authority. Accordingly, FDA policies are critical to the health and growth of the industry.”
The U.S. government could and should pursue policies that ensure that the United States retains its position and is poised to take advantage of  growth opportunities. As an industry made up of primarily small companies, such policies are essential. Although he stopped short of calling them recommendations, Nexon proposed a number of ideas for the council to consider. I’ve highlighted a few of them here.

Nexon said that the predictability and speed of FDA decision-making, as well as reasonable, risk-based standards of evidence to show the safety and effectiveness of medical technology products are essential. He noted, “It is not a good omen for the future of the U.S. device industry—or for American patients—that an increasing proportion of complex products appear to be undergoing clinical trials and entering the market abroad before they are introduced in the U.S.”
Regarding payment policy and health reform, Nexon pointed out that “a reliable expectation of adequate payment for products offering clinical benefit is obviously a prerequisite for stimulating investment in technological innovation.”

He also suggested that innovation should be built into government policy. “One option for ensuring that innovation is considered as policies are implemented across the government would be to create a dedicated, adequately staffed office within the White House with the specific mission of making sure that government policies are sensitive to innovation and support the president’s goals of ensuring that America leads the world in science and technology,” he said.

He proposed a couple of ideas to strengthen U.S. trade policy. First, he suggested that the Office of the United States Trade Representative “must have sufficient authority to lead negotiations involving these issues in negotiations with foreign governments to preserve and expand export opportunities for U.S. manufacturers.” Second, he encouraged the council to consider that one of the goals of regulatory agencies should be to improve U.S. international competitiveness.

To read all of Nexon's testimony and the rest of his ideas, see Nexon.pdf. As the economy recovers, the U.S. device industry will need to know that the U.S. government is doing all it can to support it.


Sherrie Conroy
[email protected]
 

Financial Recovery Is Mixed for Medtech Companies

For start-ups in the medical device industry, competition for venture capital (VC) is more intense than ever in this sluggish economy. Figures from the MoneyTree report, produced by PricewaterhouseCoopers and the National Venture Capital Association, show a drop in investments in venture-backed U.S. companies in Q1 2010.  

Compared with Q4 2009, the medical device and equipment sector saw a 29% decline in dollars in Q1 2010, with $517 million invested in 61 deals. However, the Q1 2010 investments represent an increase of 5.5% in dollars compared with Q1 2009. If 2010 investments trend like they did in 2009, investments will shoot up as the year progresses.  

A survey conducted by MassMEDIC and PRTM, “MedTech Innovation in an Era of Change,” also sheds some light on the financial health of the medical device industry. It surveyed 100 leaders from medtech companies and industry service providers that earned anywhere from $0 to >$1 billion in annual revenue.  

Respondents answered how the economy had affected their companies’ investments. Source: MassMEDIC and PRTM survey.

A mixed response was found when respondents were asked how their companies performed during the current economic downturn. While 45% of respondents reported significant or slight growth, 14% reported a flat growth rate, and 42% reported a slight or significant decline. When comparing these results with the performance of the S&P 500 companies, the survey concluded that “in general, the medtech industry has fared better than others.”  

The VC invested in medical device and equipment companies ranged from 11% to 16% of total U.S. investments between Q4 2008 and Q4 2009. Source: MoneyTree report

Based on its sample size, the survey also found that the type of medtech company played a factor in financial performance. Manufacturers of medical supplies and implantables were less affected by the weakened economy than the manufacturers of medical and diagnostic equipment. More than 40% of the respondents from diagnostic equipment manufacturers said that their companies had experienced significant decline in 2009.  

The survey revealed a potential silver lining for medical device companies going forward. When polled how expanded healthcare coverage would affect the market size for their company’s products, about 41% said they expected some sort of increase. Only about 16% expected a decrease or significant decrease.

How a 510(k) Submission Can Affect Your Patent

Dual disclosures to FDA and the U.S. Patent and Trademark Office (USPTO) that are not properly coordinated can sometimes have disastrous consequences, including the evisceration of patent rights, which could put a company at risk. When it comes to protecting the intellectual property (IP) rights of medical device companies, patents can aptly be described as the Holy Grail of IP protection. If patent infringement litigation becomes necessary, however, a successful “inequitable conduct” defense asserted by an accused infringer can effectively destroy a patent. And depending on the importance of the patent to the company’s business model, this could spell doom for the business itself.

Obtaining a patent on emerging medical technology can often determine whether a medical device company survives, thrives, or fails. Although there are many variables that come into play when attempting to enforce a patent against a competitor, the potential interrelationship between disclosures to FDA and the USPTO shows that whether a patent is ultimately deemed enforceable can turn on assertions made a decade or more prior to a lawsuit being filed.

The U.S. Court of Appeals for the Federal Circuit has ruled that a substantial equivalence assertion made to FDA can be used to support an inequitable conduct finding under certain circumstances.1 Medical device companies seeking to achieve the seemingly unrelated objectives of patent protection and FDA approval to sell a medical device should therefore be aware of potential pitfalls associated with making related disclosures to these government entities.

Medical Device Patents

It is estimated that intangible assets represent 70% or more of the total value of U.S. companies.2 The medical device sector is one in which intangible assets generally represent a relatively large proportion of total company value when compared with such industries as automobile manufacturers or home builders. One important subgroup of a company’s intangible assets is IP, which can include trademarks, copyrights, trade secrets, and perhaps most importantly for medical device manufacturers, patents. 

When a patent application is filed with the USPTO, a patent examiner evaluates the application to determine whether the invention is patentable. This process often involves an exchange between the examiner and applicant in which the examiner offers reasons why the invention may not be patentable and the applicant will respond with reasons why the invention is patentable.3 From the applicant’s perspective, this process is generally referred to as patent prosecution.

The Duty of Disclosure

During patent prosecution, the inventor, the patent attorney, and any others associated with the patent application must disclose to the USPTO any information that is “material” to patentability.4 In many instances, inventors are employees of medical device companies and will have assigned their rights in the claimed invention to their company. In such cases, any company representative involved in writing or prosecuting the application will bear the same duty of disclosure as the inventors.

Material means that a reasonable patent examiner would consider the information to be important in determining whether the invention is entitled to a patent.5 Material information sometimes includes publications, called prior art, that indicate that the applicant’s invention may not be new.6 The patent examiner conducts an independent search to uncover relevant materials. However, it is important to keep in mind that it remains incumbent upon all those involved in the patent prosecution to disclose any relevant information.

Inequitable Conduct

If a patent owner makes a patent infringement claim, the defendant may respond with a defense of inequitable conduct, which is a judicially created doctrine that can prevent a patent owner from enforcing its patent.7 The inequitable conduct doctrine is one based in fairness and it is applied by courts against parties that engage in misconduct during patent prosecution or litigation. The underlying rationale is that a patent owner who engages in misconduct should not be allowed to enforce the patent against others.

An inequitable conduct finding may result in a court determining that the case is “exceptional,” which may entitle the accused infringer to its attorney fees spent defending the infringement suit.8 Considering that the litigation costs in a patent infringement suit can exceed $5 million for each party, an award of attorney fees could prove devastating to many medical device companies, particularly start-ups that may not have the capital to absorb such a considerable liability.

A common inequitable conduct claim is based on the accusation that the applicant failed to disclose material prior art to the USPTO during patent prosecution.9 To prove such a claim, the defendant must show by clear and convincing evidence that the applicant failed to disclose known material prior art to the USPTO and intended to deceive it in failing to make the disclosure. The legal analysis, therefore, focuses on whether the applicant knew about the prior art, whether the prior art was material, and whether the applicant withheld the prior art with an intent to deceive the USPTO. Because there is rarely direct evidence of intent to deceive, this finding can be inferred from particular facts and circumstances surrounding the situation.

Once threshold levels of materiality and intent have been proven, the court will “balance the equities” to determine whether inequitable conduct has occurred and whether the patent is unenforceable.10 If a patent is deemed unenforceable due to inequitable conduct, the patent owner cannot enforce its patent against the defendant and the defendant may be able to recover its attorney fees from the patent owner. The case of Bruno Independent Living Aids Inc. v. Acorn Mobility Services Ltd. illustrates how the convergence of FDA and USPTO disclosures can lead to a finding of inequitable conduct.

The Bruno Case

On January 11, 2005, the Federal Circuit decided the case of Bruno. The case involved a patent infringement suit by one medical device company against another that eventually resulted in the patent owner conceding that its patent was invalid and paying the defendant’s attorney fees. 

Bruno Independent Living Aids Inc. manufactures stairlifts, which are mechanical devices that allow people who suffer from mobility impairments to ascend and descend staircases on a chair that moves along a fixed rail. In November 1991, Bruno filed a patent application for a stairlift. In April 1992, Bruno submitted a 510(k) premarket notification to FDA stating the following:

Substantial Equivalence: This product is similar in design and function to those manufactured and marketed by Cheney Manufacturing Inc. and American Stair-Glide Company Inc. Copies of product information from these similar products are enclosed. Information supporting an equivalency determination will be made available upon request to any person.11

Although Bruno claimed that the Cheney and American Stair-Glide stairlifts were “substantially equivalent” to Bruno’s stairlift when it was seeking FDA approval to sell its device, Bruno did not provide the USPTO with any information relating to either the Cheney or the American Stair-Glide stairlifts. Bruno’s stairlift patent was issued in July 1993.

In July 2002, Bruno sued one of its competitors, Acorn Mobility Services Ltd., for infringing its stairlift patent. During litigation, Acorn produced prior art that had not been considered by the USPTO during prosecution of the Bruno patent. Acorn argued that this prior art established that the Bruno patent was invalid; Bruno ultimately agreed with this assessment and dismissed the remaining claims against Acorn.

Acorn then asked the district court to award Acorn its attorney fees on the grounds that Bruno had committed inequitable conduct by failing to disclose the Cheney stairlift to the USPTO while at the same time freely disclosing its existence to FDA in its 510(k) submission. The district court found that Bruno had failed to provide a credible, good faith explanation for why it told the agency that its stairlift was substantially equivalent to the Cheney stairlift, yet declined to submit any information regarding the Cheney stairlift to the USPTO. The court inferred that Bruno had the necessary intent to deceive the USPTO, held that Bruno had committed inequitable conduct, and awarded Acorn $400,000 in attorney fees. 

On appeal to the Federal Circuit, Bruno argued that its substantial equivalence claim was only relevant to securing FDA approval and did not prove that Bruno knew that the Cheney stairlift was material to patentability. The court found this argument to be disingenuous considering that Bruno’s director of engineering prepared the FDA submission and was also involved in the patent prosecution (i.e., if he knew enough about the Cheney stairlift to conclude substantial equivalence, he knew enough to recognize its materiality). The court also affirmed the district court’s finding that the Cheney stairlift was material because it employed an off-center swivel similar to the offset swivel that Bruno touted as a point of novelty of its stairlift.

In short, the appellate court found that Bruno had committed inequitable conduct by failing to disclose material prior art (i.e., the Cheney stairlift) to the USPTO during patent prosecution while simultaneously claiming that the Bruno stairlift was substantially equivalent to the Cheney device in Bruno’s 510(k) submission. 

Fact-Intensive Inquiry

As Bruno shows, an inequitable conduct analysis is a fact-intensive evaluation of the circumstances involved in a particular case. It should be noted that a 510(k) submission will not necessarily affect either the enforceability of a patent or the patentability of an invention. Lower courts after Bruno have confirmed that disclosure of a competing medical device to FDA, paired with the nondisclosure of the device to the USPTO, will not in and of itself establish inequitable conduct.12

Proving materiality of the reference from a patentability standpoint remains necessary, and although the disclosure of a similar medical device to FDA may be relevant to whether there is an intent to deceive the USPTO, it is not necessarily so.
In addition, it would be inappropriate to conclude that a claim of substantial equivalence is necessarily relevant to whether a medical device is patentable. Although the courts clearly recognize the potential relevancy between dual disclosures made to these government entities, the inequitable conduct analysis cannot be divorced from the specific facts of a particular case.

Publication Pitfalls

Disclosures to FDA may also be relevant outside of the inequitable conduct context. For example, once the agency has cleared a medical device for 510(k) purposes, a 510(k) summary is published on the FDA’s Web site and the entire 510(k) submission may be made available to the public pursuant to the Freedom of Information Act. Although trade secret and other confidential information may be protected from disclosure if certain conditions are met, various aspects of these disclosures may reveal patentable features or functions of the cleared medical device. 

Under U.S. patent law, an inventor is generally provided with a one-year grace period within which to file a patent application, and describing the invention in a publication is one way to trigger the one-year grace period. A medical device company that desires patent protection in one or more foreign countries, however, must comply with each country’s patent laws, which may differ in various respects from U.S. patent law. One very important difference is that any publication of the invention before filing a patent application will bar an inventor from obtaining patent protection in many foreign jurisdictions.13 Failing to file a patent application within the one-year grace period would similarly prevent an inventor from obtaining a U.S. patent.

Of course, the extent to which patentable subject matter has been disclosed in a publication will undoubtedly be relevant. From a risk assessment standpoint, however, it seems clear that any disclosure to FDA prior to the filing of foreign or domestic patent applications could be problematic depending on the circumstances. Because serious consequences can result from the publication of disclosures made to FDA, patent applications should ideally be filed before potentially relevant FDA disclosures are submitted.

Conclusion

In the competitive environment of the medical device industry, obtaining timely FDA approval to sell a medical device may indeed be the primary concern. However, it should be understood that FDA disclosures do not exist in a vacuum and statements made to FDA may have consequences. Once FDA approval is obtained, and assuming the device proves successful in the marketplace, the concern over whether a competitor is able to compete using the same technology can quickly become critical. A properly prepared and prosecuted patent can be a very big stick to discourage competitors from selling a company’s invention.

If patent infringement litigation becomes necessary, rest assured that the accused infringer will explore whether the applicant committed inequitable conduct by failing to disclose material prior art to the USPTO. A 510(k) premarket notification may be just the thing that a defendant needs to defeat a patent infringement claim. And depending on how fundamental a patent may be to the survival of the company, a finding that the patent cannot be enforced could itself prove fatal to the entity. 

Securing and maintaining enforceable patent rights in medical devices can be a complicated proposition. In addition to the dangers posed by the inequitable conduct doctrine, a disclosure to FDA can also adversely affect patent rights if patent applications have not been filed prior to FDA disclosure. The complexity of these issues strongly suggests that coordinated consultation with legal counsel familiar with FDA and USPTO procedures is critical.

References

1.    Bruno Independent Living Aids Inc. v. Acorn Mobility Services Ltd., 394 F. 3d 1348 (2005).
2.    Global Intangible Tracker 2007, Brand Finance; available from Internet at www.brandfinance.com/docs/global_brands_survey.asp.
3.    35 USC 132 (2006).
4.    37 CFR 1.56 (2009).
5.    Star Scientific Inc. v. R.J. Reynolds Tobacco Co., 537 F. 3d 1357 (Fed. Cir. 2008).
6.    35 USC 102–103 (2006).
7.    Digital Control Inc. v. Charles Mach. Works, 437 F. 3d 1309 (Fed. Cir. 2006).
8.    35 USC 285 (2006).
9.    Larson Mfg. Co. v. Aluminart Prods. Ltd., 559 F. 3d 1317 (Fed. Cir. 2009).
10.    Monsanto Co. v. Bayer BioScience NV, 363 F. 3d 1235 (Fed. Cir. 2004).
11.    Bruno Independent Living Aids Inc. v. Acorn Mobility Services Ltd., 277 F. Supp. 2d 965 (W.D. Wis. 2003).
12.    See, e.g., Medtronic Xomed Inc. v. Gyrus ENT LLC, 440 F. Supp. 2d 1300 (M.D. Fla. 2006).
13.    See, e.g., European Patent Convention, Art. 54.

Breathing Innovation into Breast Cancer Detection

Eliminating the harmful effects of radiation is the objective of researchers from Georgia Tech, Emory University, and the University of Ulm in Germany. The team has developed a noninvasive device to detect the presence of breast cancer that doesn’t require exposing women to radiation.
 

The portable device is used to measure the biomarkers in human breath, which are volatile organic compounds that originate in the lower lungs. According to a Georgia Institute of Technology release, “Certain compounds are related to oxidative stress, the body’s response to inflammation, and are often an indication of disease.”
 

When a patient breathes into the device, it traps the compounds. Then a sensor, which is based on the methodology of combining gas chromatography with mass spectrometry, determines the chemical makeup of a substance. From there, specific patterns in the compounds are used to confirm whether disease is present.
 

“Scientists know that it’s possible to detect different chemical compounds from a person’s breath and relate them to illness,” says Charlene Bayer, principal research scientist at the Georgia Tech Research Institute. “Yet they haven’t been able to quantify results—such as determining a patient has a tumor because he or she has X amount of Y compounds in his or her breath.”
 

Allen demonstrates a device that traps specific compounds. The compounds are examined to confirm the presence or absence of cancer.

The team has had some early success with its device. In a clinical study, it analyzed the breath samples of 20 healthy women over age 40 as well as 20 women diagnosed with stage II–IV breast cancer who had not received treatment. According to the release, “The results showed that the breath analysis was able to determine whether the sample came from a cancer patient or healthy subject 78% of the time.”
 

Currently the researchers are trying to figure out which compounds are the most relevant to the detection of breast cancer. In the previously mentioned clinical study, the scientists analyzed more than 300 volatile organic compounds. Going forward, they hope to reduce the number of compounds that are necessary to test for.
 

Bayer says that the immediate results provided by the device could help increase early detection for women who not do have access to mammograms. Additionally, it could facilitate interval testing for women who are at high risk for breast cancer.
 

Other contributors to this project include Brani Vidakovic, a professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University; Sheryl G.A. Gabram, a professor of surgery in the Division of Surgical Oncology at Emory University; and University of Ulm professor Boris Mizaikoff.
 

Monitor Detects Bad VAD Acoustics

As more elderly patients live with congestive heart failure, there is a need for technology that can monitor how a ventricular assist device (VAD) will function in the home setting. Researchers at the University of Florida’s (UFL; Gainesville) College of Medicine have developed a monitor for VADs that listens to the acoustic footprint of the device to assess function and detect impending problems.
 

“We want it for reassurance that everything is functioning in good order so the patients don’t need to worry that they’re going to suffer a catastrophic equipment failure [outside the hospital],” says Charles Klodell, MD, associate professor in the department of surgery and anesthesiology at UFL’s College of Medicine.
 

Klodell likens the function of a VAD to a jet engine. “There’s a small turbine that spins and propels the blood forward, which takes over most of the function of the left ventricle of the heart,” says Klodell. “The problem is, like any mechanical thing, at some point it is going to break. And when it breaks, that’s a catastrophic problem.”
 

The concept of the device is also similar to the way in which the military uses acoustic footprints to monitor jet engines. The method detects a problem before it occurs.
 

According to Klodell, there isn’t a device on the market that is comparable to the VAD monitor developed at UFL. “Right now for VAD monitoring, we monitor the power consumption of how the device is working and download data from the controller of the VAD. We put a stethoscope on the patient’s chest and listen to the device ourselves,” says Klodell.
 

The main components of the device are an electronic stethoscope, computer, and special software. Sensors are attached to the patient’s body and feed to a computer that analyzes the sounds that come from the pump or other areas of the body. The computer, which contains a database of signatures made by different brands of heart pumps, evaluates the sounds coming from the pump to assess whether they match the signature made by a failing VAD.
 

Wilhelm Schwab, PhD, one of the device’s inventors, is currently working on reducing the device’s size, which is basically a desktop computer on a rolling stand.
 

Other enhancements to the device include filtering ambient noise. “We want to be able to reliably compare the snapshot sound of the device today with the snapshot sound of the device three months ago,” says Klodell.
 

Klodell says it is currently difficult for doctors to detect when VADs are beginning to fail. To further investigate this issue, the research team will induce pump conditions in an animal model or the lab to study and document the acoustic footprint difference.
 

The researchers are interested in working with a company to commercialize the device. For more information, contact UFL’s Office of Technology Licensing
at 352/392-8929.

RAPS Takes Regulations to China

With its healthcare sector undergoing rapid development, China needs a strong foundation of regulatory knowledge for its researchers, engineers, healthcare professionals, and even the government. The Regulatory Affairs Professionals Society (RAPS; Rockville, MD) is helping by taking its regulatory knowledge abroad.
 

To that end, RAPS has announced an agreement to provide the University of Shanghai for Science and Technology (USST) with existing online course content that is currently offered through RAPS Online University. The course material will be adapted for USST’s students. In addition, RAPS will work with the university to develop new regulatory curricula and provide advice and support to the school’s faculty.
 

“USST is the only school in China offering bachelor’s, master’s, and PhD programs in medical devices and is in an important position for educating and training regulatory professionals in China and internationally,” says Baolin Liu, MD, professor and dean of USST’s School of Medical Instrument and Food Engineering. “We had hoped to partner with RAPS, the leading international regulatory professional organization, and look forward to great success.”
 

The new joint venture will only focus on medical device regulations to start, but RAPS says that the partnership may be expanded to cover pharmaceuticals in the future. The coursework is aimed at three main audiences:

  • Potential and new regulatory professionals.
  • Scientists and engineers involved in medical technology R&D.
  • Government inspectors.
“USST is the
only school in China offering bachelor’s, masters, and PhD programs in medical devices”

“This partnership represents an important step forward for the global regulatory profession and further demonstrates the profession’s critical importance in the continued global expansion of the healthcare products sector,” says RAPS Chairman Mark Gordon. “RAPS is glad to be in a position to help connect regulatory professionals in emerging healthcare markets like China with the collective expertise of the worldwide regulatory community.”
 

RAPS had previously been in touch with contacts in Shanghai for a project along these lines, according to senior manager of communications Zachary Brousseau. A delegation from Shanghai also attended RAPS’s annual conference last year in Philadelphia. Still, such a collaboration is new ground for RAPS. Brousseau says the organization may look into similar partnerships in the future.

Patient Preferences to Shape the Diagnostic Industry

Putting the patient at the center of care is good business for the diagnostic industry, according to a report by Price­waterhouse Coopers (PwC) Health Research Institute. The report, “Healthcast: The Customization of Diagnosis, Care and Cure,” says that between now and 2020, “health systems will turn from reactive medicine to proactively understanding and supporting individuals in managing their own health.”

PwC interviewed hundreds of leaders representing governments, hospitals, insurance companies, clinicians, and life sciences firms. Interviews were conducted in more than 25 countries. In addition, 3500 consumers in seven different countries were surveyed.

According to Doug Mowen, managing director, PwC Medical Device Industry Practice Leader, the patient-centric trend is driven by the greater understanding of how genetic factors affect health status and outcomes. “As regulators accelerate the movement toward outcomes and quality-based reimbursement, the case for personalized medicine becomes even more compelling.” This puts pressure on diagnostic companies to create more personalized diagnosis and treatment options, Mowen says.

Customer demand is another factor influencing the rise of personalized medicine. The PwC report finds that patients have been empowered by the “ubiquity of wireless mobile devices,” which makes it possible to receive care anywhere.
Additionally, technologies such as smart phones, electronic medical record databases, and home health–monitoring equipment have also enabled patients to take control of their healthcare. This leads to changes in behavior and preferences, fueling the rise of mass customization. “The patient becomes the end-user with industry players focusing on providing care and treatment options best suited to the end-user’s needs and preferences,” the report finds.

Meeting patients’ needs provides diagnostic firms with a tremendous growth opportunity, Mowen says, but it requires a change in business models. “Historically, diagnosis and treatment have operated in two distinct silos. From a patient perspective, the convergence of diagnosis and treatment is inevitable.”

For example, diagnostic companies could develop tests that show which type of patients respond well to a drug and which types wouldn’t. “If a test can help avoid use of expensive prescription by someone who won’t respond to it, the marketer of a test could potentially capture a portion of this enhanced value,” Mowen says.

Diagnostic companies should also explore partnerships with pharmaceutical companies. This would enable them to link test development to drug development and launch an approved drug with a companion diagnostic. Mowen says, “compelling clinical evidence for the test and drug would be developed in tandem, supporting the value of the Dx/Rx combination from the outset.”

Lastly, the importance of demonstrating the value of a product cannot be underestimated. “Beyond partnering with pharmaceutical companies, diagnostics companies should also be looking for ways to partner with payers and the providers to share data, increase patient adherence, and improve quality care and patient outcomes,” Mowen says.