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Healthcare Reform Could Give Hospitals More Pricing Leverage

One program, called the Acute Care Episode demonstration project, measures patient outcomes to ensure that patient care doesn't suffer when doctors try to save money. Baptist Health System (San Antonio), is part of the project and negotiated price cuts for orthopedics products through competitive bidding. The project also involved Medicare combining payments to doctors and hospitals, which allowed doctors and patients to share hospital savings. The healthcare system said it has saved about $2 million since the program started a year ago. 

Medical Device Innovation Lags Behind Other Industries, Report Says

Although they deliver a wealth of products that save lives and improve the quality of life, medical device and pharmaceutical companies are trailing other industries in terms of innovation, according to a new report.

The Innovation Index released jointly by consulting firm Strategos and stock research company wRatings states that, despite increasing R&D spending by 2% while most other industries reduced R&D spending by 4%, the medical device and pharmaceutical industries lag significantly in this area behind the food and beverage and consumer electronics markets, for example. This could, the report speculates, factor into the low ROI recently experienced by some life sciences companies.

"These are indeed some of the best inventors in the world," the report states. "Unfortunately, their innovation performance lags significantly behind other industries that have appeared in the Strategos/wRatings Innovation Index, highlighting the point that innovation is more than technology invention."

Potential problem areas cited by the report include the life science industry's tendency to keep its eyes on the prize, so to speak. By concentrating on developing the next blockbuster product, companies may be missing or bypassing solid smaller opportunities. Furthermore, the authors note that the most useful products in the food and beverage industry are frequently the most simplistic. In contrast, the most useful drug or device products are often the most complicated.

"Healthcare is on the brink of profound change driven by the inescapable forces of new regulations, demographics, consumerism, and costs of new technology," the report concludes. "In the face of these changes, there will be a great shift in the competitive landscape.  Pumping money into R&D is not the only lever for success. In fact, R&D spending has no correlation with the primary measures of corporate success."

Should life sciences companies examine the possibility of a new business model? How important is R&D in life sciences? Read the full report and sound off in the comments section below.


Caution: V&V May Be Hazardous to Software Quality

With the continued uncertainty regarding how much additional information FDA will ultimately require for the 510(k) and PMA application processes, some companies are responding by dramatically increasing the level of detail and the volume of their technical documentation. This trend is particularly evident in software engineering design documentation and in verification and validation (V&V) documentation.

Federal regulations for medical devices require that OEMs provide the following:

?    Design input and output requirements documentation.
?    Design verification performed and documented to confirm that design outputs meet design input requirements.
?    Design validation performed and documented to ensure that the medical device meets user needs for intended use.

The House That Software Built

Industry has recently seen a major rise in the level of detail in the software design and V&V documentation, at least in part due to uncertainty regarding the amount of information FDA requires. I have seen companies attempt to make V&V documentation detailed to the point that anyone can execute the test protocols. This may be motivated by a desire to employ low-cost testers instead of experienced software quality assurance (SQA) engineers. The problem with this approach is that by the time SQA engineers have documented a sufficiently detailed test protocol that anyone can execute, they have spent so much time doing so that they could have run the protocol themselves. There is absolutely no time or cost savings earned with this approach.

Creating excessively detailed design and test documentation is problematic. Even small feature changes are costly to implement, because the V&V documentation must then be changed. The resulting changes cascade so that all related documents must be modified. This is significant rework. In some cases, even desirable features are not added because the resulting document changes are prohibitive from a cost or scheduling perspective.

An alarming practice is having SQA engineers spend 90% of their time on a project developing and maintaining V&V documents. For detailed V&V documentation to be ready for execution by the end of the project, SQA engineers must begin writing the documents immediately after the functional and design specifications are complete. By the time the documentation is complete, the software is also complete, leaving actual software testing to occur at the very end of the software project.

This obsession with creating such detailed V&V documentation may lead some medical device software managers to forget a basic tenet of software development best practices. Specifically, software quality can most efficiently be achieved by building software incrementally, on a solid foundation of thoroughly tested software.

In software development, a milestone is a point during development at which the state of the software is formally tested. Each time, the software must be thoroughly tested and debugged before moving on to the next milestone. Often the milestone includes logically grouped sets of features that must be completed before some additional features can be started. Building on a solid foundation is an apt metaphor. Just as a well-built house must be constructed on a solid foundation, each milestone represents a portion of that foundation. Conducting software testing after the system is complete leaves little time to execute that testing. It leads to poor quality software that can only be mitigated by extending the project deadline to allow for intense testing and the subsequent rework.

Correcting software bugs at this stage of product development could require entire sections of the software to be completely rewritten and retested. Returning to the foundation metaphor, if the first layer of a foundation crumbles under the weight of the successive layers, the whole foundation must be torn down and rebuilt.

While the software development team is coding the first set of base features, the QA team should be planning test strategy, not writing protocols. Once the first round of coding is complete (the first milestone), QA should begin executing software tests, including some ad hoc testing. It is a common misconception that ad hoc testing is random testing. During ad hoc software testing, experienced SQA engineers quickly run tests of their own choosing based on their knowledge of the software, best practices in SQA, and their own creativity. There is no requirement that ad hoc testing be thoroughly documented, and no FDA guideline states that every test must be documented. A common question that is raised regarding ad hoc testing is “if it's not thoroughly documented, how do you know what you tested?” A better question to ask is “have our most experienced SQA engineers performed sufficient ad hoc testing?”

FDA Wants What It Wants: No More, No Less

FDA regulations require that OEMs demonstrate through documentation the activities that were performed to verify that requirements were met as well as the activities that were performed to confirm that the software conforms to user need and intended use (see the sidebar “FDA and Software”).

“A conclusion that software is validated is highly dependent upon comprehensive software testing, inspections, analyses, and other verification tasks performed at each stage of the software development life cycle.”
—General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Documented tests describe a logical series of steps with known inputs and an expected result. One shortcoming with this approach is that users do not always follow a logical series of steps. Users can interact with software in unpredictable ways due to distractions, mistakes, or misunderstandings of system work flow. Additionally, there can be interactions between software modules that cannot be predicted during test case planning. So although documented testing is the correct approach for confirming that requirements are fulfilled, it is not suited for uncovering defects that users could encounter.

Therefore, an appropriate amount of ad hoc testing is consistent with FDA guidelines. The key is finding the balance between documentation and testing. Sufficient time and resources must be devoted to writing the V&V documentation as the software is being coded so that the tests are ready for execution when coding is complete. But the need to generate documentation should not prevent ad hoc software testing from occurring as milestones are reached.

Detailed V&V documentation is not a substitute for well-executed software testing and a proper SQA process. Conversely, extensive software testing does not alleviate the requirement to produce and execute sufficiently detailed V&V documentation. It is the SQA team's responsibility to calculate the time needed to develop V&V documentation. The appropriate level of detail depends on clinical and safety considerations, as well as on the project’s size and complexity. However, conducting intense software testing prior to developing the V&V documentation gives the SQA team valuable experience in using the software. Therefore, the time estimates for developing the V&V documentation and execution become much easier to calculate. Additionally, the time required to write the V&V documentation is reduced.

It is unreasonable to expect V&V documentation to trace every possible path through today’s software. Modern software is simply far too complex. This is why SQA engineers often employ sophisticated test methods, e.g., automated testing, to reach high levels of software quality. In addition, the software development team must also employ detailed code inspections, static analysis, and run-time analysis tools where appropriate as part of the formal development and test process.

Although the V&V documentation must be sufficiently detailed to satisfy FDA’s guidelines, these guidelines exist to ensure product safety and efficacy. FDA never intended the requirements to be so burdensome as to limit testing of the medical device software. V&V is not software testing. Verification testing ensures specified requirements have been fulfilled. Validation testing ensures that particular requirements for a specific intended use can be consistently fulfilled.
When considering software engineering documentation, it may be useful to address functional specifications, design documentation, and V&V documentation with the following question: “What is the purpose of this document, and is it sufficiently detailed to achieve that purpose?”

Although there is no formula for determining the optimum balance between testing and V&V, it may be safe to say that if the SQA team is spending 95% of its time on a project writing and updating documentation, then not enough software testing is being executed. Some projects require more documentation than others for reasons that may have to do with overall system complexity, clinical safety, or any number of other reasons. However, the same general rule applies.


Even if FDA were to change its guidelines on engineering documentation, its goal is, and always will be, to ensure the highest quality software possible relative to patient safety and efficacy of products. Documentation, even perfectly detailed documentation, is not a substitute for good SQA practices. If a quality management system is so documentation heavy that SQA engineers are spending the majority of their time documenting and doing very little testing, it is time to review the system.

Documentation must be sufficient to meet the clinical and safety requirements of a product and FDA guidelines. But software testing must also be sufficient to meet best practices in software development. Finding the correct balance is the key to achieving both goals.

No Need for a Lead—A Possible ICD Breakthrough

According to the company's Web site, the lack of a lead simplifies surgery by eliminating the need for imaging equipment.

A study of the device, published by the New England Journal of Medicine, analyzed two short-term trials in which the S-ICD was implanted in patients. TThe researchers found that the device "successfully and consistently detected and converted episodes of ventricular fibrillation that were induced during electrophysiological testing. It also successfully detected and treated all 12 episodes of spontaneous, sustained ventricular tachyarrhythmia."

There are some limitations to the S-ICD system. For example, it is not appropriate for patients who require both a pacemaker and a defibrillator.

Carbon Composite Material Could Function as Ersatz Nerve Bundles

An artificially colored scanning electron microscope image shows a channel with a carbon nanotube bundle (yellow-green) protruding from it, above the surface of the glass (blue).

Employing a technique for processing carbon nanobubes, researchers at the Oak Ridge National Laboratory (Oak Ridge, TN) are laying the groundwork for a material that could one day mimick the human nervous system, enabling the development of bionic devices.

"We make this material in a way similar to what you may have done in high school when making a glass capillary over a Bunsen burner," remarks Ilia Ivanov, a researcher at the Center for Nanophase Materials Sciences Division. "There, you would take the glass tube, heat it up, and pull, or draw, as soon as the glass became soft."

Ivanov and John Simpson of the Measurement Science and Systems Engineering Division are doing something similar, except they use thousands of glass tubes filled with carbon nanotube powder. After several draw cycles, they can make fibers just four times thicker than a human hair containing 19,600 submicron channels, each of which is filled with conducting carbon. Because each carbon nanotube-containing channel is electrically insulated from its neighbors by glass, it can be used as an individual communication channel.

While these nanostructures have electrical and other properties that make them attractive for use as artificial neural bundles in prosthetic devices, the challenge has been to make bundles with enough fibers to match that of a real neuron bundle. With current technology, the weight alone of the wires required to match the density of receptors at even the fingertips would make it impossible to rely on the use of these nanostructures. Now, by adapting conventional glass-fiber-drawing technology to process carbon nanotubes into multichannel assemblies, researchers believe they are on a path that could lead to a breakthrough.

"Our goal is to use our discovery to mimic nature's design using artificial sensors to effectively restore a person's ability to sense objects and temperatures," Ivanov says. "The human hand has a density of receptors at the fingertips of about 2,500 per square centimeter and about 17,000 tactile receptors in the hand," he adds. "So in terms of density of channels, we are already in the range needed for 17,000 receptors in the hand."

Ultimately, Ivanov says, the goal is to duplicate the function of a living system by combining the existing technology of glass-fiber drawing with the multifunctionality of submicron-scale carbon nanotubes.

More information on this research can be obtained from the Oak Ridge National Laboratory.

Infusion Pumps in the Hot Seat at FDA

On April 30, FDA sent a letter to Baxter Healthcare Corp. ordering the company to recall and destroy all of its Colleague Volumetric infusion pumps currently in use in the United States. This action, the agency said, was based on a “long-standing failure to correct many serious problems with the pumps.” FDA believes there may be as many as 200,000 of those pumps currently in use. FDA has also ordered the company to provide refunds to customers or replace the pumps at no cost to customers to help defray the cost of replacement.
FDA says it has been working with Baxter since 1999 to correct numerous device flaws and that since that time, the pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors, and other issues.
On April 8, 2010, Baxter submitted a proposed correction schedule to FDA that stated that Baxter did not plan to begin the latest round of corrections to the adulterated and misbranded pumps until May 2012. The proposal also stated that Baxter does not anticipate completion of the proposed corrections until 2013. FDA says that on that schedule, a device with known safety concerns would remain in use on patients needing specialized care until 2013. FDA says it found this proposal unacceptable.
Infusion pumps, including the Baxter Colleague models, have been the source of persistent safety problems, the agency says. The adverse events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, according to FDA data. And problems with infusion pumps are not confined to one manufacturer or one type of device.
In response, FDA announced a new initiative to address safety problems associated with infusion pumps. As part of its initiative, FDA is moving to establish additional premarket requirements manufacturers will be expected to meet, in part through static testing in FDA’s facilities before device submissions. FDA is also holding a May public workshop on infusion pump design, and the agency is raising public awareness of the issue among healthcare workers and patients.
FDA recently created a draft guidance called, “Total Product Life Cycle: Infusion Pumps—­Premarket Notification [510(k)] Submissions.” The agency says it had received more than 56,000 reports of adverse events related to infusion pumps between January 1, 2005, and December 31, 2009. It noted that many of the pump problems appeared to be linked to faulty design, including software error messages, human factors, broken components, and battery failure.
The guidance includes tips for manufacturers submitting 510(k)s. For example, it says that companies should consider performing a use hazard analysis, which identifies any hazards particular to their infusion pumps. The agency also recommends that a clinical evaluation be conducted that evaluates device performance and human factors.
It’s important to get the problems with infusion pumps resolved, but this problem also reminds us that it’s time to be more diligent than ever in terms of safety and efficacy. The 510(k) review process is in the spotlight, and problems like this one will only fuel calls for an overhaul.
Sherrie Conroy for the Editors

Sil-Pro Expands Cleanroom and Molding Capabilities

Sil-Pro's new 3500-sq-ft Class 10,000 cleanroom will be used to mold components for medical device applications.

Sil-Pro (Delano, MN) has added a 3500-sq-ft Class 10,000 cleanroom, which will incorporate new molding operations to serve the growing requirements of the medical device industry.

"Sil Pro's growth since its beginning in 1999 has been very rapid," remarks Brian Higgins, the company's VP of sales and marketing. "Our growth rate each of the last four years has averaged 27%. Our new cleanroom facilities are designed to accommodate this growth rate and more. Four new LIM presses will be added in the new space by year-end ranging from 40 to 90 tn. Additional equipment is also being installed to provide value-added operations such as slitting, bonding, and pad printing."

Another example of the company's growth is that its engineers and process planners recently designed and built a high-volume automated molding system for a customer requiring an output capacity of 2 million components a week. The components are for use in a disposable device used in insulin delivery systems.

With 115 employees, the ISO 9001:2000-certified manufacturer provides liquid silicone molding and gum stock molding. In addition, it bonds silicone parts to plastics, metal, and other silicone parts using medical-grade adhesives. Its services include medical device assembly and packaging.

"Sil-Pro's unique facilities and processes, together with our partner relationships with customers, drives this growth," Higgins says. "By teaming with customer design engineers during the product development process, we work through design iterations utilizing our CAD design capabilities and medical device experience. We refine the design and an appropriate manufacturing process that includes in-house mold design and build, highly automated manufacturing, assembly, and quality verification."

St. Jude Criticized for Marketing Claims

Some surgeons use ablation devices to treat atrial fibrillation by burning really small amounts of heart tissue. However, none of the manufacturers have FDA approval to market the devices for this use. St. Jude says that Epicor is "designed to safely, effectively, and reproducibly create a classic box lesion in a single step." In other words, atrial fibrillation treatment is not spelled out, but the terms in the statement refer to a burn pattern that surgeons create when using the devices for this unapproved use.

A St. Jude spokeswoman said that the company "is working diligently to address the points raised in the warning letter and to resolve the FDA's concerns."

This Week In Brief: May 11, 2010

MedPlast (Tempe, AZ), a provider of custom-molded thermoplastic, rubber, silicone, and elastomer components and molds for use in the medical device industry, among others, has announced that it has achieved ISO 13485 certification at all five of its locations across the country. This achievement comes on the heels of several cleanroom and tool room expansions last year.

Contract medical device manufacturer Metro Mold & Design Inc. (Rogers, MN) has added a four-axis, high-speed machining cell to a Class 8 cleanroom environment in order to support medical implant and component requirements. The clean environment will reduce the risk of contamination while machining PEEK implants and other parts made from exotic plastics, according to the company.

As part of its continuing expansion efforts, Sil-Pro (Delano, MN) has dedicated a 3500-sq-ft Class 10,000 cleanroom to molding operations serving the medical device industry. The company plans to add four liquid injection molding presses ranging from 40 to 90 tn to the space by the end of the year in addition to equipment for slitting, bonding, pad-printing, and other value-added operations.

Okuma America Corp. (Charlotte, NC), a developer of CNC and machining technologies,  has announced that MP Systems Inc. (East Granby, CT), a supplier of high-pressure coolant systems, has joined the Partners in THINC organization. As a member of the group, MP Systems seeks to help customers in the medical device manufacturing industry, among others, optimize CNC machine tool performance and maximize overall productivity.


Want to Make Cheap Devices? Get Inspired by Everyday Objects

A salad spinner served as inspiration for a novel low-cost centrifuge.

A pair of undergraduate researchers at Rice University (Houston) are putting a new spin on medical device design. As the basis for a student project, students Lila Kerr and Lauren Theis employed a salad spinner as the core component of a low-cost, rudimentary centrifuge. Such creative thinking helps to pave the way for future cost-effective devices with the potential to improve healthcare in developing countries.

As part of an Introduction to Bioengineering and World Health course, the students were tasked to develop a portable, low-cost, no-power method for diagnosing anemia. By combining the salad spinner with plastic lids, yogurt containers, and a hot-glue gun, the students were able to design and assemble the centrifuge for less than $30. 

Once engineered, the centrifuge performed its designated function in tests. The students put capillary tubes containing 15 µl of blood into the device and manually spun them, ultimately achieving separation of the blood into heavier red blood cells and lighter plasma. Effectively separating the blood allows for diagnosis of malnutrition, tuberculosis, malaria, and HIV/AIDS. 

This creative device inspired by an ordinary kitchen tool is a great example of design innovation. Along the same lines, MPMN noted the similar ingenious engineering approach to microfluidics taken last year by Michelle Khine, who used the children's toy Shrinky Dinks to accomplish her design goal.

While engineers are making progress daily in the lab, it seems as though the playroom and kitchen can also serve as settings for inspired medical device design. Sometimes the solutions to high-tech problems can be surprisingly low tech and simple.