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Adopting Static Analysis Tools

SOFTWARE VALIDATION


(click to enlarge)
The results page of a static analysis tool. In this example, the tool found 1400 uninitialized variables in less than 20 minutes.

Recently the FDA software forensics lab announced that it was using a set of five static analysis tools to test the software in medical devices that had been recalled due to adverse events.

In an interview with The Gray Sheet, Brian Fitzgerald, the deputy director of the forensics lab, said, “We're hoping that by quietly talking about static analysis tools, by encouraging static tool vendors to contact medical device manufacturers, and by medical device manufacturers staying on top of their technology, we can introduce this up-to-date vision that we have.”

To improve software quality, firms may want to consider static analysis tools. However, device companies must first understand the capabilities of static analysis and run-time analysis tools and how to effectively integrate them into a software development environment.

Static Analysis and Run-Time Analysis

Static analysis tools read the source code and identify certain classes of errors without actually running the code. They have evolved from simple syntax checkers to powerful tools that algorithmically examine code for errors and defects, even in large code bases. A software development team can use these tools to detect and fix errors early in the software development process. Run-time analysis tools are incorporated into the build process and identify errors while the code is running.

Each type of tool has advantages and limitations. It is best to use both static analysis and run-time analysis tools in conjunction. The two types of tools are complementary in that each looks for specific types of errors that the other doesn't.

However, static analysis tools have not historically been widely used by software developers. Such reticence is primarily because of the high cost of entry for some tools. Some of the more sophisticated options cost $20,000 or more. And although some tools are available under free (or nearly free) open-source licenses, the time and effort required to configure such systems has also restricted broader adoption.

Getting Started: Identifying Meaningful Errors

For medical device software, static analysis tools can be employed from day one. However, in the early stages of software development, static analysis tools generate more false positives (errors that are not true errors) because the code is just starting to be developed. The results improve as the body of analyzed code grows larger. Early and frequent use of static analysis can help team leaders identify whether certain developers consistently write code that produces certain types of errors. Such information can help the software team correct poor coding practices early in the process before they negatively affect the overall quality of the code. In addition, a software team leader can begin to tag certain errors as irrelevant so that more meaningful errors are easier to see.

What are meaningful errors? A static analysis tool vendor recently announced availability of new concurrency defect detection capabilities in its tool for C/C++ and Java. This technology introduces static defect detection of race conditions, one of the most difficult-to-find concurrency errors that occurs in multithreaded applications. A race condition is an undesirable situation that occurs when a software system attempts to perform two or more operations at the same time, but the nature of the system requires that the operations be done in sequence.

Race condition defects have been responsible for some notorious failures of device software. For example, race conditions in the software of the Therac-25 radiation therapy machine were cited as contributing to the death of five patients. In that case, the software was performing the two competing operations in a random fashion, a defect that was virtually impossible to find manually because the software performed the operations in a different order each time it executed.

Race conditions are just one example of defects that are difficult to find without an automated tool. Other errors are situations in which engineers have failed to initialize variables properly, have written redundant code, divided by zero, allowed memory leaks, or failed to implement memory-freeing techniques and calls properly. Another error is having incomplete states that can result in unpredictable behavior.

Run-time analysis tools complement the static analysis tools by tracking and reporting problems such as unhandled exceptions or failures in the code, out-of-bounds parameters that are being passed to functions within the code, and report memory errors such as freeing the same block of memory twice. Such errors can be difficult to detect using only manual techniques such as formal code reviews.

Integrating Static Analysis into Software Development

It should be noted that static analysis tools are software development test tools, not software quality assurance test tools. A software team leader can use the results to focus quality efforts, but the error-correction warnings are meant to be interpreted and corrected by developers.

One of the challenges in implementing a static analysis tool is learning to properly configure the tool to the environment and to the base of source code. Medical device companies should understand that they will see a high false-positive-to-true-error ratio, often as high as 10:1. This can be frustrating for a software team leader, who must weed through all reported errors.

Although combing through false positives is a daunting task, it is necessary. The key to success is in continuously configuring the tool.

As development proceeds, a static analysis tool must be modified. The sensitivity of the tool should be lowered gradually as the base of developed code grows. Additional flags for nonmeaningful errors can continue to be set by the software team leader. The tools can be configured to ignore certain types of errors and report only classes of errors specified by the software team leader.

In cases for which the software development effort has hopelessly stalled, static analysis and run-time tools can be employed as emergency diagnostics to find structural defects in the code. If the team has never used a static analysis tool, it is often worthwhile to bring in an expert to set up the configuration, analyze the results, and implement corrections.

When a project is stalled the best option may be to apply code hardening. Code hardening is the process of stopping the test, debugging cycle, and bringing in static and run-time analysis tools to analyze, stabilize, and prioritize development. Code hardening at this stage is expensive and time-consuming, but it is often the only way bring the project to a successful conclusion.

Costs of Software Errors


More on Static Analysis:

Software industry averages for defect-correction costs help illustrate why its important to start early.1–3 The cost of correcting a single defect during the design phase is $455, during the coding phase it is $977, and in the final test phase it is $7136. There can be hundreds and sometimes thousands of defects discovered during a typical software project.

Although there is no documented data on the cost of a software rescue mission involving code hardening, anecdotal evidence suggests that costs can reach up to half a million dollars.

Conclusion

Based on the costs of error detection and correction at various phases, the business case for investing in analysis tools is strong. From a software development process perspective, it may be challenging to select the most appropriate static analysis tools and accept the steep learning curve associated with employing them in an optimal fashion.

It may also be difficult to garner acceptance into the development team's culture. However, allocating the time required to learn and implement the tools may be well worth the effort.

Andrew Dallas is president and founder of Full Spectrum Software (Framingham, MA), which provides custom software development and testing services. He can
be contacted via e-mail at adallas@fullspectrumsoftware.com.

References

1. C Jones, Software Assessments, Benchmarks, and Best Practices, (Indianapolis: Addison-Wesley, 2000), 100–101.

2. W Humphrey, Introduction to the Personal Software Process, (Indianapolis: Addison-Wesley, 1997), 213–217.

3. B Boehm and V Basili, “Software Defect Reduction Top 10 List,” IEEE Computer 34, no. 1 (Washington DC: IEEE Computer Society, January 2001): 135–137.

Copyright ©2008 Medical Device & Diagnostic Industry

Johnson Medtech Opens Four New Cleanrooms

Johnson Medtech says its plans for an added work area should also complement the firm's manufacturing, supply chain, and logistic management capabilities.

Johnson Medtech, the medical products arm of Johnson Electric, has opened four new cleanrooms in Shajing, China. According to a spokesman for Johnson Electric, the cleanroom facilities will increase the company's medical manufacturing capacity by 1 million additional Class II and Class III medical devices and subassemblies per year to address increasing demand.

“With the demand for our design and medical device contract manufacturing services continually increasing, these new cleanrooms will help us deliver the highest-quality medical devices with the fastest time to market,” says Robert Hoctor, vice president of medical devices for Johnson Electric.

The four cleanrooms added to Johnson Medtech's facility total 14,000 m2 on three floors.

The cleanrooms encompass 14,000 m2 on three floors. One cleanroom is a Class 1000 cleanroom equipped with an air shower. The other three are Class 100,000 cleanrooms. An engineering office, a testing laboratory, and a document control room were also part of the expansion.

The firm is also set to begin construction of an additional control manufacturing area, which will provide an assembly line and plastic injection workshop. The site is intended to boost the company's design, engineering, prototyping, and testing capabilities. The added work area should also complement the firm's manufacturing, supply chain, and logistic management capabilities.

Johnson Medtech has ISO 13485–certified manufacturing facilities in the United States, China, and the UK.

Copyright ©2008 Medical Device & Diagnostic Industry

CDRH Changes Course on Dental Mercury

The deal came three months after a settlement offer from Consumers for Dental Choice. The group had been trying for 10 years to get CDRH to require labels about the neurotoxic side effects of mercury amalgams.

In a news release, attorney Charles G. Brown for the group said: “During a several-hour negotiation session, FDA agreed to change its Web site on amalgam—dramatically.” He continued, “Gone, gone, gone are all of FDA's claims that no science exists that amalgam is unsafe, or that other countries have acted for environmental reasons only, or that the 2006 scientific panel vote affirmed amalgam's safety.”

Instead—see www.fda.gov/cdrh/consumer/amalgams.html—FDA has moved to a neutral course. Its new policy statement recognizes the serious health concerns posed by mercury amalgam, in particular for children and unborn children, pregnant women, and those with mercury immuno-sensitivity or high mercury body burdens.

Brown called the agency's move “a 180-degree reversal from FDA's 30-year policy of protecting mercury fillings...To change FDA policy, we tried petitions, congressional hearings, state law fact sheets, scientific advisory committee hearings, and letters galore—to no avail. So in the great American tradition, we sued.”

This led to judicial direction to mediate, and the agreement was forged May 30 before District of Columbia federal court magistrate judge John M. Facciola.


Blog:

“The impact of the rewriting of [FDA's] position on amalgam can hardly be understated,” Brown said. “FDA's Web site will no longer be cited by the American Dental Association in public hearings. FDA shows awareness of the key issues involved. As it prepares to classify amalgam, FDA has moved to a position of neutrality. Indeed, having repeatedly raised the question of amalgam's risk to children, young women, and immuno-sensitive persons on its Web site, I find it inconceivable that FDA will not in some way protect them in its upcoming rule.”

TMJI-CDRH Battle Heads to Federal Court

TMJ Implants (TMJI) has had a contentious, protracted battle with CDRH. TMJI is contesting the center's decision to fine the firm $340,000 for late filing of 17 medical device reports. But the matter could be resolved in the courts soon.

In June, FDA formally denied a petition for stay of decision (imposing the fine) as “untimely.” TMJI filed the petition in May. The Golden, CO–based firm is now seeking redress before the 10th Circuit Court of Appeals in Denver. Hewing tightly to a CDRH brief in opposition, FDA deputy commissioner for policy Randall W. Lutter told the company that it had offered “no justification for failing to file within the 30-day time frame specified in 21 CFR 10.35(b). Moreover, you submitted an amended petition five days later...that again includes no explanation for the late filing.”

Lutter's letter recognized the pending 10th Circuit case regarding that decision and said that “we do not intend to seek payment...while this matter is being considered by the court.”

Larson Cited for QSR Violations

An FDA inspection at Larson Medical Products' Columbus, OH, manufacturing facility in March found numerous quality system violations, according to a May 7 warning letter from FDA's Cincinnati district office. The letter says the company manufactures low-temperature thermoplastics indicated for use as splinting materials. It also makes devices intended to be used for positioning and stabilizing patients undergoing radiation therapy.

Violations cited include:

  • Failure by management to ensure that an adequate and effective quality system is implemented and maintained at all levels of the organization.
  • Failure to establish procedures for quality audits. Also, failure to conduct such audits to ensure that the quality system is in compliance with requirements and to determine the effectiveness of the quality system.
  • Failure to establish and maintain procedures for implementing corrective and preventive actions and failure to document such activities.
  • Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.

The warning letter says the inspection also revealed that the devices are misbranded because the firm failed or refused to furnish required medical device reporting information.

The company was given 15 days to respond with specific steps taken to eliminate the violations.

New Tests, Labeling for Contact Lens Solutions?

FDA's Ophthalmic Devices Advisory Committee has recommended labeling changes and additional testing for contact lens cleaning solutions to prevent eye infections. Changes would include discard dates on lenses, a warning to not reuse cleaning solutions, and a recommendation to frequently change contact lens cases.

The recommendations come in the wake of incidents in 2006 and 2007 in which Bausch & Lomb's MoistureLoc solution and Advanced Medical Optics's Complete Moistureplus solution were linked to hundreds of serious eye infections.

FDA officials told the panel that 80% of contact lens problems are caused by users not following label directions. “This is a unique medical device in that patients have enormous control over the rate of infection,” said Malvina Eydelman, CDRH ophthalmic device division director.

Panelists agreed but also said companies could improve their products by testing them against more types of bacteria and fungi, especially Acanthamoeba keratitis, the parasite involved in the Advanced Medical cases. They also considered other FDA suggestions, including whether labels for lens care solutions should have a “rub and rinse” recommendation. Although many multipurpose solutions advertise “no rub” cleaning capability, which is an FDA-approved claim, many doctors still recommend rubbing and rinsing to provide additional safety. Panel members agreed that FDA guidance should include a rub and rinse recommendation.

The panel also said that FDA should consider requiring companies to add discard dates to contact lenses, a practice already followed in Europe.

Experts from the American Academy of Ophthalmology and other organizations told the committee that improving contact lens product testing and advocating universal lens-care guidelines for consumers will help prevent eye infection outbreaks. “Now is the time to tighten the safety net around contact lens products,” said academy spokesperson Elmer Tu.

FDA officials said they will consider the panel's recommendations and the possibility of updating guidance to industry.

FDA Cites Chattem for ‘Icy Hot' Problems

A February inspection at Chattem Inc.'s Chattanooga, TN, facility that manufactures Icy Hot heat-therapy patches found quality, medical device reporting (MDR), and misbranding violations. Several days after the inspection, the company recalled the patches. FDA's New Orleans district office issued a warning letter four months later.

The letter says that the company failed to establish and maintain adequate procedures for implementing corrective and preventive actions (CAPAs). It notes that the firm received some 200 complaints about the patches. Problems mentioned in the complaints included burns, skin removal, and skin irritation. Those are defined in the firm's standard operating procedures as major complaints requiring CAPA, but none were initiated.

In addition, the firm has not provided FDA with documentation showing that personnel have been adequately trained on the new complaint and CAPA procedures that emphasize thorough investigations.

The inspection also found that the company failed to submit an MDR within 30 days of receiving information that the device may have caused or contributed to a death or serious injury. The company acknowledged that it failed to submit 15 reports within 30 days of receiving such information. FDA says the firm also has not provided documentation showing that personnel have been adequately trained on MDR procedures, and that the procedures have been successfully implemented.

The company's response was inadequate, FDA says, because it failed to revise its standard operating procedure to address all regulatory requirements. The firm also did not show that personnel have been adequately trained on the recall procedure.

Chattem was told to take prompt action to correct the violations and to respond within 15 days, outlining specific steps taken with an explanation of how the firm will prevent these and similar violations from reoccurring.

Chattem's Chattanooga Problems

The company also failed to submit a written report to FDA of a labeling correction or removal to reduce a health risk posed by the device. The warning letter cited an unreported labeling change that was implemented to reduce the risk to health from burns, skin removal, and skin irritation associated with the patches. The labeling change was initiated as a response to more than 168 consumer complaints, the letter says.

The inspection further found the product to be misbranded because the labeling doesn't have adequate directions for use. Also, it does not have adequate warnings against use in certain pathological conditions or by children where its use may be dangerous to health.

FDA Cites Sandstone over Laser QSRs

Sandstone Medical Technologies (Birmingham, AL) does not have an effective and adequate quality system in place for its Class II medical laser systems, a warning letter charges. The firm imports and relabels the lasers for distribution in the United States. The firm was also cited in the letter for the following:

  • Failure to establish and maintain corrective and preventive action procedures.
  • Failure to establish and maintain complaint files and associated procedures for receiving, reviewing, and evaluating complaints.
  • Failure to establish and maintain servicing instructions and procedures.
  • Failure to establish and maintain procedures for acceptance activities.
  • Failure to submit annual reports for the laser systems.

Additionally, the warning letter cites the firm for failing to develop, maintain, and implement written medical device reporting procedures. And, it says, labels affixed to each laser do not include the month and year of manufacture, which is required by FDA regulations.

Medtronic Spine Settles Medicare Fraud Case


Medtronic's Settlement by the Numbers

2
Number of employees who
blew the whistle

5
Number of years required
in Medtronic's integrity
agreement with HHS

$75 million
Amount, plus accrued
interest, that Medtronic
paid to the government

Medtronic Spine LLC (Sunnyvale, CA), formerly known as Kyphon Inc., has settled a whistle-blower suit alleging Medicare fraud with a payment of $75 million plus accrued interest to the U.S. government. It also entered into a five-year corporate integrity agreement with HHS.

“[The] settlement demonstrates our commitment to ensure that the Medicare Trust Fund is used to pay for necessary medical care and is not depleted as a result of aggressive marketing schemes intended to increase sales of unnecessary devices or procedures,” said Gregory G. Katsas, acting assistant attorney general of the Justice Department's Civil Division.

Two company employees had charged that Kyphon improperly persuaded hospitals to bill for spinal surgery at a more costly inpatient rate. The alleged fraud involved kyphoplasty, a procedure in which spinal gaps are filled with bone cement.

Medtronic issued a statement saying that Kyphon had reached the agreement with the federal government to settle the suit before being acquired by Medtronic. It said the settlement agreement reflects the company's assertion that Kyphon and its employees had not engaged in any wrongdoing or illegal activity.

The corporate integrity agreement focuses on training about appropriate reimbursement advice to customers, and also requires maintenance and implementation of standard compliance processes. It contains measures to ensure compliance with Medicare regulations and policies in the future.

CDRH Proposes End to ‘Baseline' Reports

CDRH has proposed to stop requiring baseline reporting as part of device adverse-event reports because the information is also contained in MedWatch mandatory reporting forms.

The proposal is proceeding under a direct final rule unless an adverse public comment is received. In such a case, the proposal would move under a proposed final rule. The proposal may be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0310-nfr.pdf.

Copyright ©2008 Medical Device & Diagnostic Industry

Bishop-Wisecarver Branches Out to Shanghai

OUTSOURCING NEWS


Bishop Wisecarver manufactures guided motion components and systems, such as this wheel track.

As part of a strategy to expand its global reach, Bishop-Wisecarver Corp. (Pittsburg, CA) has opened an office in Shanghai. The new branch is a key point for giving customers in the region local services and inventory, reduced shipping costs, and faster shipping services.

The company has important business relationships with distributors in China. It says that having local sales support and technical capabilities will also improve customer service, communication, and sales cycles.

“The China market is key to our global strategy,” says Ray Harrington, vice president of business development. “We see abundant opportunity to advance Bishop-Wisecarver's presence in Asia, and the opening of the Shanghai office reinforces our commitment to current and potential partners and customers in the region.”

Jennifer Ye is heading the new branch. Ye has experience with industrial products in the areas of import, export, and domestic sales. She also has provided customer and sales support to the company's client base in China.

Bishop-Wisecarver makes guided motion components and systems for linear, rotary, and curved-track applications. Located in the San Francisco Bay area, the company is known as the manufacturer of the original DualVee bearing guide wheel.

Copyright ©2008 Medical Device & Diagnostic Industry

The Greening of Medical Product Design

PRODUCT DEVELOPMENT INSIGHT


The original product is adequate, but a redesign could save money for the OEM.
An initial design change results in a lighter handle.
A smaller wand and base in the final
version is sleeker and wastes less material.

The green writing is on the wall: it is time for medical manufacturers to conside the sustainability of their products, packaging, and production processes. In the consumer world, Wal-Mart is undergoing a major effort to adopt sustainability and even hired the ex-head of the Sierra Club as a consultant on this topic. Clorox recently announced its Green Works line of greener household cleaning products. Companies with a strong presence in the medical field like Kimberly-Clark and Philips have long been doing something about the issue.

In this author's experience, countless medical product consumers around the country have revealed their concerns about sustainability in interviews. They consistently bring up the topics of global warming or green in discussions about new products that, as recently as two years ago, would have been solely focused on efficacy and usability.

Even if you are not doing something about getting greener, your customers are. Alegent Health, a company with nine hospitals and 8600 employees, has recently named a vice president of sustainability. When faced with a choice of medical products of similar cost and efficacy, it is likely that customers will purchase the greener product, especially if manufacturers have added green to their brand attributes in a way that customers see has real meaning.

Sustainability broadly means considering the environmental effect of a product throughout its life cycle, not just in its creation and initial use. And it is a daunting topic for the uninitiated. Although RoHS and other legislation in Europe have brought some sustainability issues to the forefront, it is understandable that many medical manufacturers have been reluctant to embrace sustainability. The device industry is notoriously slow to make changes. In addition, the industry is sometimes exempted from the legislative restrictions required in the consumer marketplace and therefore less likely to pursue such change. Further, sustainability has an image of increasing costs.

The good news is that there is a lot of low-hanging sustainability fruit that can be harvested by applying common sense principles and a sustainability-conscious eye to the product lifecycle.

This article presents practical advice to designers and manufacturing engineers about how to improve the sustainability of device products. Be prepared to be surprised, as have many in the consumer world—you might just find out it makes good business sense too.

Start Here: Map The Product Lifecycle

Understanding how medical manufacturers can affect sustainability requires mapping a product's lifecycle. This includes raw material extraction; all the processing and manufacturing; actual use; and disposal, reuse, or recycling.

Creating a sustainable product is an attempt to reduce the environmental footprint at each stage with some kind of change. It is up to your company to decide what constitutes a better, or greener design. Changes do not have to be massive to have a positive effect. For instance, Philips Healthcare allows a product to be considered a Green Flagship if it achieves an improvement over its predecessor or competitor of 10%, but a review of their products with this status indicate that most achieved improvements in the 25% to 35% range.1

OEMs usually focus on improving efficacy and usability, and minimizing trauma and cost. Like these factors, sustainability can have the biggest influence at the very beginning of the product's conception. Many sustainable qualities of a product are baked in during the innovation and design stage.


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For medical products, the business model is also important. For example, a onetime-use disposable employs more resources than a re¬usable product. Of course there may be clinical, product, or sterility issues that require disposability. Keep in mind that because of such factors, the approaches to sustainability from the general consumer or industrial world do not always translate well to medical products.

Quantifying Design Alternatives

Once a specific device's lifecycle is understood, and OEM can begin identifying the places to lower its environmental impact. To determine which ideas are the best to pursue, the development team should quantify the effect of the various choices and then find what is right for the product and the company.

One way of enumerating a particular design's impact is to use software such as Life Cycle Assessment (LCA). This software draws on carefully researched databases, allowing manufacturers to estimate the effect of one type of plastic over another, the weight and material type of packaging, or shipping options Leaders in LCA software are European companies with products such as SimaPro and GaBi. (Demonstrations of these products are available via Web download.)

Although larger companies may already own such software or think nothing of purchasing it and training people on how to use it, the software may not be the right place for most device manufacturers to start.

Hans van der Wel, the Philips Healthcare's manager of Ecodesign & Sustainability helps run their Green Flagship program. He says the best method for starting out is to “keep it simple. Start with a spreadsheet based on simple indicators. We call ours Green Focal Areas [and] include qualities like the amount of materials, energy, and hazardous substances used.” Van der Wal explains, “Top management needs to be behind the initiative, and you may need to hire consultants to help at the start.” He says it took Philips ten years to get to its Green Flagships program.

Example: An RF Surgical Tool

An example product can help demonstrate how medical device designers might use the suggestions in this article. A product system includes a disposable and an energy-supplying console. The following section explores the effects of changing these system elements, which are typical to many medical products.

In evaluating the environmental effect of the various components that make up the whole product, designers will need to use real impact data. Various data sources use different units that cannot be comingled. The LCA software makes finding such data easier. It is probably the best long-term solution as a tool for companies, but does require a commitment of money and training that might slow initial efforts. The Okala Guide is inexpensive ($12) and has a useful table of impact factors that covers common materials and processes. It is used in this example. The Okala guide combined with a simple spreadsheet may be good tools to get the development team started.

To make this example easy to understand and illustrative of the kind of improvements possible, not every material or process is considered for comparison. In some places system elements are combined and given overall numbers to ease the reading of the tables.

The analysis focuses on areas where manufacturers can have the most influence and compares the effects of changing those particular parameters. In practice, when you consider the whole product, the actual impact reduction achieved might be a lower than the numbers shown here. However, on an established product an overall 20–30% reduction is relatively easy to achieve.

Product Description. A hypothetical existing RF tool for clamping and cauterizing surgical wounds is being considered for redesign. The company hopes to improve sustainability. The product is a system consisting of a disposable handpiece and an RF energy generator and controller:

The Disposable Handpiece: Consists of a plastic and metal handle with integrated mechanisms that provide mechanical advantage to the surgeon's grip during the procedure, and a wiring harness to connect to the console. The handle is currently single-use (all parts) and contained in sterile packaging. It is manufactured at one location but used in all major global markets.

RF Energy Generator and Controller: Consists of a piece of capital equipment that is a power and control source for the disposable. It is based on 5-year-old electronics and display technology, has no field upgradable features, and is intended to last 5 years in use. The console is built into its own hospital cart.

Two levels of sustainability improvement are considered: first, a few options for redesign of the disposable, and second, a redesign of the reusable energy-generating console. To begin, readers should understand the existing product's ecological footprint to accurately compare new design approaches.

Calculating the Footprint


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Everything that is used to make, use, or dispose of a product, (including materials, processes, shipping, use of energy, etc.) is scored based on its environmental effect. This is calculated using a rating called impact factor. Impact factor numbers have been gathered or researched and reduced to a standardized unit by an agency such as the makers of LCA software or compiled in resources like the Okala guide used here. This factor is based on how the particular parameter is used in the product (e.g., per pound of material, KW-hr of energy, Ton-miles of transportation, etc.) In Tables I, II, III, and IV the total effect of product aspect equals the “Amount” (in whatever units are shown) multiplied by the impact factor. Totaling the scores yields an overall product rating. In this example, units are in Okala milli¬points. Impact factor units must be the same for all contributors. Note that values from sources that do not share units cannot be mingled.

Table I. (click to enlarge) The environmental footprint of a hypothetical RF surgical tool.

The RF device example looks at the effect for the entire life of the product, which is assumed to be five years. (see Table I) During this time a typical user buys one console and uses ten disposables per week, yielding a use of 2,600 disposable per console lifetime. This means that of the roughly 212,000 impact points total shown in Table I, the 2600 disposables used over the product life contribute about 196,000 points. Disposables make a significant contribution to the overall impact, and it is important for designers to consider the overall system usage, not just individual parts, in evaluating and comparing the various redesign choices.

With this calculation in mind, consider the following possible changes to the hypothetical product.

Scenario 1—Make the Disposable Part Weigh Less (console unaffected). This scenario simply considers taking advantage of improved design optimization tools such as finite element analysis (FEA) to reduce the material needed for both the plastic and metal components (without compromising function.)

A slight weight reduction has various virtuous affects. Less material is used, which reduces environmental impact. In addition, lower material cost helps offset the increased design and validation costs of a lighter handpiece. Packaging can also get a little lighter to reduce shipping cost and impact.

Table II. (click to enlarge) In scenario 1, the disposable is redesigned to be made from a lighter material. The result is a 6% decrease in impact over the life of the product.

A modest change to the product like this, requiring no major changes to the way it is made or used, yields a small but meaningful 6% reduction in impact over the product's life (see Table II).

Scenario 2—Make Disposable Weigh Less and Enable the Wiring Harness to be Reusable 20 Times. The development team notices that almost half of the disposable's impact comes from the copper wiring in the leads that connect it to the console. In this scenario, the leads are redesigned to be sterilized and used 20 times instead of just once. The copper content remains the same, but the insulation needs to be beefed up to make the parts rugged enough to withstand re-use. Also, now they will not be packed with every disposable but instead shipped one set per box of twenty handpieces. The product and packaging are overall lighter, further reducing impact. A factor must be added for the sterilization by the hospital.

Table III. (click to enlarge) In scenario 2, the redesign continues. The disposable is made from a light weight material and designers have reworked the wiring harness leads so that they can be sterilized and used up to 20 times.

Reusing the wiring harness has a very significant affect. Now the impact is reduced 44% overall from the reference existing product (see Table III). This redesign does, however, require a change in how the product is sold (box of twenty handpieces with just one wiring harness enclosed) and in how it fits into the hospital's overall workflow. Hospitals must sterilize, manage, and inventory a wiring harness for twenty uses. But copper is also expensive, so now the cost to provide the function of twenty handpieces has decreased. Such savings could be passed on to users in exchange for the task of sterilization, without negatively affecting the manufacturer's profit per handpiece. It is a balancing act, because the cost of sterilizing at the hospital may outweigh any savings.

Although the market may not yet be ready to make such a change in how it handles wiring harnesses, the example does show what an enormous contribution such change can make to how green the system is overall. As some large hospital groups become serious about being more sustainable they may be prepared to make these kinds of changes in the near future.

Table IV (click to enlarge) Scenario 3 builds on previous revisions. It explores how redesigned electronics and a lighter material for the enclosure affect the product.

Scenario 3—Build on Scenario 2 by Redesigning Electronics and Choosing Lighter Materials for the Enclosure. Now the development team turns its attention to the console, and notices that the energy used while the machine is on (usually for a 4-hour procedure) affects every disposable. Modern electronics will not only be RoHS compliant, but also offer a more efficient package in terms of PCB size. Furthermore, new electronics consume half the energy of older electronics (due to improved sleep modes between uses during the procedure). Now that the console is smaller, it can be built into a lighter portable enclosure, rather than integrated it into a heavy cart. Such changes have a significant affect on both disposable and capital system elements, and yield an overall 52% reduction (see Table IV). Notice that if further changes are made to the console electronics to reduce copper wiring by 20–50% (perhaps by some novel pulsing technique or a change in the frequency of the RF), it would have significance to the product's impact score.

A simple spreadsheet scenario like the tables allows a team to see possibilities for redesign. This is obviously a highly generalized example. Only your technical and marketing teams know where opportunities lie for your specific product in its clinical efficacy and marketing acceptability.

The Disposable Matters More

Tables II, III, and IV show the differences between lowering the impact of the disposable and that of the reusable (console) portion. In this example, it is assumed 10 disposables are used per week per console, not an unreasonable assumption for this kind of surgical tool. As noted, this means that over a 5-year design life, 2,600 disposables are used. Therefore even a small improvement in the disposable has a magnified effect. By contrast, if the design team halves the impact of the console it hardly reduces the overall system's impact. For this reason, medical products are often significantly different from consumer products. Using less plastic in a radio will lower its overall impact. Doing so in our medical console example does not have the same results; designers must consider the effect of the whole system's use.

Although the case study shows that focusing the redesign effort on the disposable has the most affect on environment, there are still things the manufacturer can do to the reusable portion of the product that can further reduce the impact every time a disposable is used. In the example, 50% more-efficient electronics in the RF energy generator lowered the energy portion of the product's impact 2,600 times because each use of the disposable cost 50% less energy.

Other medical products can see such savings, too. For instance, a sophisticated mechanism might be used in an electrically-actuated disposable to install an implant in a difficult location in the body. The whole mechanism might be disposable. An appropriate redesign might be one that alters the point where the system breaks between the console and the disposable, moving as much of the mechanism as possible into the reusable portion. A lighter, disposable dramatically reduces the overall systems effect, but makes the console more complex. It might require some innovation to make the coupling functional and convenient for users. A design that moves the coupling outside the sterile field avoids the need to sterilize with every use. Innovation in this area may have a positive business effect for everyone involved. The disposable costs less to make, and can lead to cost savings for the user without necessarily reducing the manufacturer's revenue per procedure. The product can be legitimately marketed as cheaper and greener.

It's Debatable, and That's the Point

Readers will note that it is likely to be hotly debated within a development team whether the kinds of assumptions stated in this article are true, and whether the design goals desired can actually be achieved. In the hypothetical example, a significant portion of the impact reduction on the disposable comes from reusing the wiring 20 times, instead of disposing it after one use. But OEMs are right to question whether the change is reasonable.

Will the surgical team accept this change in their workflow? Will the hospital administration mind having to sterilize and inventory a wiring harness for twenty uses? Will a lighter console be well received in the market if customers are used to having it built into a cart?

Such investigation is critical to understanding the product's lifecycle, imagining changes, and using spreadsheets or LCA software to analyze these scenarios. Some ideas will not work for customers; some will create cost or schedule burden for the manufacturer. Airing these issues allows the development team to have a healthy debate as they choose the best way forward. Perhaps only part of the potential savings should be added to a next-generation product, saving more for the future when all the stakeholders are more comfortable with the changes.

This exercise shows how changes like lowering energy use through a better sleep mode for the console can have a greener consequence than things like using a lighter plastic on the enclosure. It's not always the obvious things that can have the most beneficial effect, and unfortunately finding the changes that have the greatest potential are not formulaic. Each product will have very different aspects that must be rethought. The product's whole life cycle matters, not just early stages like materials or manufacturing choices.

Perhaps as an industry we need to reconsider what it means to be “green.” As Wendy Jedlicka, a sustainable packaging expert, puts it, “The idea that you have to wholly embrace eco like a religion is short-sighted and frankly not sustainable. We need to get everybody doing a little bit of something to mitigate what we are doing right now; then we can keep improving.”

Bill Evans is founder and president of Bridge Design Inc. (San Francisco). He can be reached at bill@bridgedesign.com.

References

1. Philips Medical Green Flagships [online] (Amsterdam [cited 28 May, 2008]); available from Internet: www.medical.philips.com/main/company/sustainability/green_flagships.

Copyright ©2008 Medical Device & Diagnostic Industry

Despite Advances, Factories in China Still Require Oversight

OUTSOURCING NEWS


Representatives from SmartSourcing work with manufacturers in China to manage products at every stage.

David Hale of Smart Sourcing Inc. (SSI; Farmingdale, NY) says that although manufacturers in China have made significant strides in improving medical device technology and product quality, the real challenge is to identify the correct factory and manage the product at every stage.

To that end, SSI has added a new division that enables U.S. companies to outsource medical device component manufacturing and assembly to Asia. The division from SSI employs a proprietary network that aims to reduce product manufacturing costs. It has more than 80 prequalified vendors throughout China and two regional offices in Shanghai and Ningbo.

According to SSI, companies can see 30–80% cost reduction, depending on the labor. “SSI had been embedded in China for nearly a decade,” explains Hale, president of the firm. “We knew that the only way to succeed was to scrutinize and qualify the plants and personnel and have on-site presence.”

Hale says that the firm has instituted a test program of producing OEM medical components, such as injection-molded parts, printed circuit board assemblies, and subassemblies for box building. “This enabled us to confirm the manufacturing capabilities [of the China-based facilities] and, most importantly for this market, confirm the quality system that is ISO 9001 and ISO 13485 certified,” he says.

The company can accommodate Class I, II, and III cleanroom environment needs and can work with an OEM at any point from manufacturing, packaging, or assembly.

Copyright ©2008 Medical Device & Diagnostic Industry

Wound-Care Products Develop a Sweet Taste

NEWS TRENDS

(click to enlarge)
Wound-care products are expected to show growth in the global market.

Although honey-based treatments have been around for centuries, mainstream medicine has increasingly adopted wound-care products that use the natural sweetener. Good clinical results and a better understanding of the soothing and healing effect of sugars are the biggest drivers for the renewed interest in honey, according to Mary Anne Crandall.

Crandall wrote a report for Kalorama Information (New York City) that looked at the global wound-care market in general. Among the strongest trends in the $12.3 billion industry was the use of honey-based products.

“One of the biggest problems in wound care is infection,” says Crandall. “[It] interferes with healing, so finding other methods to help retard bacterial growth is the focus at this point. The honey does this because of the antibacterial properties in the substance.”

Honey produces hydrogen peroxide, which stimulates new cell and blood vessel growth. It also reduces inflammation and swelling and helps to shed dead tissue.

The type of honey used in wound-care products comes from the manuka plant (also called the Leptospermum), a shrub native to New Zealand and Australia. Derma Sciences Inc. (Princeton, NJ) received FDA approval for the first honey-based dressing in the United States last summer. The company gets manuka honey from its partner, New Zealand–based Comvita.

(click to enlarge)
The total worldwide wound-care market revenues (in $ millions) for 2002–2012.

Other companies that are using manuka honey in wound-care products include Mölnlycke Health Care (Göteborg, Sweden) and Advancis Medical Ltd. (Nottingham, UK).

Aside from the increased use of honey, one of the strongest trends in wound care is the development of products for the aging population. Other considerations focus on reimbursement issues and function. As a practitioner in Medford, OR, Crandall has seen an increased focus on tailoring the selection of a product on a per-patient basis, rather than using the same product on every patient.

Reimbursement of honey-based products has proven to be a hurdle for manufacturers. “As more of these sophisticated dressings come on the market, they do work and really provide good medicine for patients,” says Crandall. “However, insurance companies are reluctant to authorize these products just because of the cost.” As a result, companies have conducted more of their own research and development to provide the clinical information that aims to prove the superiority of their product.

Despite reimbursement issues, Crandall expects an ongoing dynamic product pipeline in the wound-care market. “I think, as a whole in the wound-care industry, there's nothing that you can say is really fantastic and works 100% of the time,” she says. “I think we're still looking for that and wanting to improve on the products that we have.”

To obtain a copy of World Wound Care Markets 2008, contact Kalorama Information at www.kaloramainformation.com.

Copyright ©2008 Medical Device & Diagnostic Industry

Parexel Helps Customers Meet Global Clinical Trial Needs

OUTSOURCING NEWS


Parexel International Corp. (Waltham, MA) is aiding its clients in managing global clinical trial requirements with a clinical logistics service. The service helps medical device companies and supports their clinical studies through centralized coordination of clinical study supplies, lab services, and ancillary supplies.

“Specialized knowledge and significant resources are required to effectively manage global clinical logistics,” says Joe Avellone, corporate vice president of operations and clinical research services at Parexel. “In this regard, companies can avoid developing their own internal systems and having to manage multiple vendors by outsourcing clinical logistics to Parexel, taking advantage of our global team of experts and our distribution infrastructure to reduce costs, improve compliance, and increase efficiencies.”

The clinical logistics services include the following:

  • Clinical trial supply management: Managing import and export requirements, labeling, distribution, and inventory control.
  • Lab services: Organizing a centralized lab system, overseeing transportation logistics for lab samples, and managing data.
  • Ancillary supply management: Distribution testing and diagnostic equipment, lab supply maintenance, and providing proper documentation.

The company has supported the supply of stents and catheters to participating clinical sites for a coronary stent study. It also works with device and diagnostic companies to develop custom services based on specific study requirements and the clinical supply chain.

Copyright ©2008 Medical Device & Diagnostic Industry

Bionic Hand Grabs MacRobert Award

NEWS TRENDS

Users have liked the i-LIMB Hand's functionality, natural movement, and the way that it grips objects.

The team responsible for developing the first commercially available bionic hand has been given the 2008 MacRobert Award for innovation in engineering.

The i-LIMB Hand, developed by Touch Bionics (Middletown, NY), is a prosthetic device made of high-strength plastic material with five individually powered digits. The firm sees the product's multiarticulating finger technology as the key to its success. Combined with advanced electronic and mechanical engineering techniques, the team was able to develop a lightweight, robust prosthetic that appeals to patients and caregivers.

“We are over the moon to have won the 2008 MacRobert Award, which is a huge honor for any engineering-oriented company,” says Touch Bionics CEO Stuart Mead.

First presented in 1969, the MacRobert Award is sponsored by the London-based Royal Academy of Engineering. It recognizes the successful development of innovative ideas in engineering.

The i-LIMB Hand was introduced to the market in 2007. Since its launch, more than 250 patients worldwide have been fitted with the device. It is the second medical device to earn the MacRobert Award in the past five years; the other was a retinal scanning device developed by Optos plc that was awarded in 2006.

Copyright ©2008 Medical Device & Diagnostic Industry

MedPlast Absorbs Two Molding Firms

K&W offers thermoplastic molding and contract manufacturing to medical OEMs, and ERPG has focused on growing its healthcare base with thermoplastic, silicone, and rubber molding services. According to MedPlast, the acquisitions enable the company to offer product design, tooling, engineering, and precision manufacturing.

“This is a tremendous opportunity for MedPlast,” says Harold Faig, CEO of MedPlast. The company's molding capabilities, combined with its engineering and manufacturing expertise, will give it an advantage over competition, Faig says.

The firm will operate five plants across the United States, employing about 800 people.

Copyright ©2008 Medical Device & Diagnostic Industry