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Regulatory Aspects of Due Diligence

MERGERS AND ACQUISITIONS

Illustration by Getty Images
In the financial world, due diligence is an essential part of all merger and acquisition (M&A) activities. All aspects of the target company's finances are reviewed with a goal of identifying any risks associated with the firm's solvency or its assets. In the medical device industry, these assessments must also have the added dimension of a technical and regulatory review to ensure that asset valuations are valid. A medical device company may be highly financially successful, but some portion of that success could be based on inappropriate regulatory or compliance decisions.

Regulatory characteristics can have a tremendous effect on the overall due diligence effort. Various aspects can reduce the value of a product line or of an entire organization, as follows:

  • Incomplete or limited approvals for products.
  • Inconsistent labeling claims.
  • Inadequate complaint handling systems.
  • Design control procedures that are not followed.
  • Uncontrolled production activities.

Such deficiencies can also result in compliance actions occurring months or years after the acquisition is complete. The best way to deal with such problems is to understand the company that is being acquired by performing due diligence.

Approach

Due diligence reviews can arise frequently and without warning. Time­lines are often demanding and the day-to-day responsibilities of internal personnel at both the acquiring and selling organizations continue despite the due diligence process.

Frequently, one of the most difficult decisions is determining how much effort to commit to various aspects of due diligence. Complicating factors are sometimes found in seemingly simple acquisitions. Large or complex situations may require many hundreds of hours to fully evaluate all relevant factors. Often, these hours are simply unavailable, and the effort must proceed according to a plan that prioritizes by relative risk. Audit planning tools, availability of experienced internal and external personnel, and a clear understanding by management of the outputs and the due diligence effort will help maximize the results.

At the outset a plan must take into account the business goals of the review. It must also observe available resources, timing, and availability of key personnel. Review teams may have limited access to documents, facilities, or personnel, which can affect both the scheduling of the review and its scope. In some cases, the two parties may agree to share documentation on restricted-access Web sites to enable specific users to remotely access documents they need. This can make document review much easier, especially if facilities and personnel are in multiple locations. In other cases, business and legal considerations may require reviewers to evaluate documents at one or more individual sites. In all cases, there are common considerations that management should keep in mind.

Goals of the Due Diligence Process. Identification and, if possible, estimation of risk are the primary goals of the effort. This is not the time to craft formal solutions.

Timeline and Resource Allocation. Both parties should agree on realistic timelines. Adequate resources for both the audit team and the potential acquired company staff should be identified. Access to people, documents, and facilities should be specified.

The Digits*
350
The number of medical device M&A transactions during the first nine months of 2007
17
The number of deals in 2007 that exceeded $1 billion in transaction value
*Tracked by HT Capital Advisors
Selection of Reviewers. Compliance auditors may be used, but do not assume due diligence can be done in the same manner as routine compliance auditing. External consultants with appropriate experience can be considered, especially if qualified internal resources are unavailable.

Prioritization. Frequently, time constraints do not allow in-depth reviews of every product or even every facility. Factors that are commonly prioritized include sales volumes of products, regulatory risk profile of devices, and complexity of devices. Determining whether a particular technology is considered a platform technology that can be used for additional product development is important.

End Result of the Due Diligence Process. Regulatory, business, and legal personnel involved in the process must agree on the type of report to ensure that the necessary information is generated for each functional area. In the postacquisition phase, this report can provide important information for business integration efforts.

Key Management Actions

At the outset of any due diligence effort, upper management must provide clear objectives.

Prioritize Product Lines for Review. It may be impossible to review every product line, particularly when a large organization is being acquired. Therefore, judgments must be made. Generally, the highest-risk or highest-value products should be reviewed, rather than low-priority products. Making these decisions early in the process also helps with subsequent planning such as allocation of personnel.

Establish a Timeline for Completion. Overall timing is driven by business considerations. If large organizations with multiple facilities are involved, the timing for individual site visits and coordination with all necessary participants can be a complex task. However, even if both organizations are relatively small, establishing a realistic schedule benefits all parties.

Allocate Appropriate Resources. Once it is clear what tasks need to be accomplished and when, personnel with the appropriate backgrounds can be identified and a team assembled. The acquiring company may also want to call on external resources for special assessments if its own personnel are unavailable. Other resources such as data management assistance should also be included as needed.

Coordinate Access to Facilities, Documentation, and Personnel with the Target Company. Regardless of a due diligence team's skills, it cannot function effectively without cooperation from the target company. Both sides must make a commitment to make the process work. Information and documentation consistent with existing agreements must be made available. Personnel from the selling company should also be available to explain information as necessary. However, members of the acquiring company's due diligence team must also
keep in mind that their counterparts at the target company have their own primary
job functions.

Assembling the Regulatory Due Diligence Team

Most due diligence efforts are both brief and intense. Business needs require clear lines of communication, effective preparation, rapid assessments, and reports that address management's specific needs. Time constraints can be a significant challenge. The acquiring company usually has its own aggressive timeline. The selling company also faces constraints such as accommodating external auditors and maintaining day-to-day operations. Due diligence team members with multidisciplinary expertise can help to maintain schedules and to make the best use of all parties' valuable time.

One key factor that must be kept in mind by all team members is that a due diligence effort is intended to gather information that management can use to assess risk. It is not a regulatory compliance audit.

The Due Diligence Approach

Cooperation is the key element for a successful due diligence effort. Business, legal, and time constraints can strain the cooperative spirit, and parties should try to understand these factors. Confidentiality regarding the prospective transaction and discussion of proprietary technology and methodology needs to occur in an effective manner. Upper management should establish clear ground rules; otherwise, the review effort could stall. Of course, the review team for the acquiring company should be respectful and professional.

Confidentiality is a paramount consideration in any due diligence effort. Upper management needs to establish a process that preserves confidentiality while permitting the due diligence effort to proceed in an efficient manner. Frequently, during the planning stages, trade-offs must be made between involving greater numbers of people in interviews versus limiting those involved to a smaller core group. These can be difficult choices, and they require weighing the benefits of more information against the risks of increasing the number of people aware of the possible acquisition.

Checklists can be used by organizations to guide the audit process. Even though such documents can be useful to ensure that key points are not forgotten, they can also limit the audit scope to specific items. During a due diligence review, resources are frequently reallocated dynamically, depending on both interim results and business needs.

Cross-functional expertise for members of the review team is a great asset. If one individual can review the same information from both a technical and submission compliance perspective, new insights may be gained and time can be saved. Also, the regulatory review cannot take place in isolation from other due diligence activities. Good communication from the business, legal, and regulatory teams is essential to keep the effort focused and on time.

Key Regulatory Aspects

There are common themes for many due diligence efforts in the medical device industry. These themes mostly relate to the regulatory side of medical device acquisitions.

FDA Compliance Status. Evaluating the compliance status of the organization being acquired is often the first regulatory due diligence task that upper management considers. It is a key task that almost always requires team members to visit the manufacturing site and review the operation first hand.

Although it is a positive finding if FDA has never issued a warning letter or a Form-483 to the manufacturing operation, it does not mean that major near-term operations reviews are
unnecessary. For example, perhaps the most recent FDA inspection reviewed a relatively simple product development effort and since that inspection, a far more complex product has been developed. Was the design control process appropriate for that more complex design effort? Was the process followed and were all steps documented as specified in the procedures?

Other Considerations
During the course of the due diligence process, other factors not directly related to the regulatory assessment may arise. The condition of production facilities, capacity or efficiency of production equipment, or even the quantities of current inventory are a few examples of these types of concerns. In most situations, experts would address these subjects as they arise, so that the regulatory effort can stay on track.
Frequently, some or all aspects of the design process are outsourced to contract service providers. In these cases, the vendor selection process should be reviewed. More importantly, the components of the design history file prepared by the contractor should be reviewed to determine whether they conform to either the contractor or company procedures, as specified in the design plan.

Such reviews provide executive management with information on the systems currently in place at the company being acquired. They enable management with initial judgments on the process of integrating the two companies. But other systems must also be evaluated. Historically, complaint handling and medical device reporting (MDR) systems generate substantial regulatory compliance costs long after the acquisition is completed. When involved in a due diligence effort for an implantable or other high-risk device, it is important to review a representative sample of complaint files and MDRs to confirm that adequate procedures are in place and that those procedures are followed.

The value of cross-functional teams is significant. A team member can examine a process and evaluate parameters such as device history records and in-process testing, as well as more technically demanding areas including product and process validation.

Product Approvals and Clearances. As a result of an acquisition, one or more technologies or products are transferred to the purchasing company. If marketed products are involved, many business concerns such as sales volume, reimbursement status, and distribution channels are carefully reviewed outside of the regulatory review. In addition, there are important regulatory considerations that should be examined. Has the target company's change control system appropriately evaluated product modifications? Have special 510(k)s or premarket approval (PMA) supplements been filed where appropriate? Audit team members with understandings of both the submissions process and the change control process in design controls are particularly suited to this evaluation.

Labeling Review. Careful reviews of cleared or approved indications for use and a comparison to current advertising and promotional materials will help executive management better understand how to integrate the acquired products into the combined company's portfolio. It is vital to confirm that the current claims made in promotional materials are consistent with the indications for use specified in 510(k)s, PMAs, or CE marking technical files. Unless tightly controlled, there can be indication creep. That is, over time, functionalities identified by users may be incorporated into promotional materials and user manuals without appropriate regulatory review. The due diligence review should confirm that all intended uses mentioned in the promotional material are cleared or approved.

Review of Investigational Products. Products that are still in the development process present special challenges during the due diligence review. Often, these are the products that drive the acquisition effort. However, enthusiasm over initial encouraging results must be tempered by a careful review of the development effort. Complex products such as implantable devices must first undergo biocompatibility testing. Were the appropriate tests conducted? Given subsequent design or materials changes, are they still valid?

Many other types of preclinical testing for both safety and efficacy may be necessary, depending on the type of device. There should be a rationale present in the design history file for conducting particular tests. In addition, such testing should be conducted in appropriate facilities under controlled conditions and following relevant FDA guidance documents and applicable international standards.

If clinical trial data must be generated for regulatory purposes, the clinical research documentation should be reviewed to ensure appropriate regulatory compliance, including institutional review board and ethics committee approvals, as well as device adverse-event processing. Such a review should also attempt to confirm stated results for both safety and effectiveness and to determine whether the data support marketing applications. These tasks require reviewers well-versed in both regulatory and clinical research.

It is especially important when reviewing significant-risk investigations conducted under investigational device exemptions (IDEs) to examine FDA communications. The acquiring firm should understand the detail of those discussions and FDA's data expectations. It is possible to perform extensive reviews of clinical data and case report forms such as those normally conducted in a GCP audit. However, such a detailed review is frequently beyond the scope and time limits of due diligence
review.

Finally, if multinational clinical trials are generating data in support of an FDA market application, it is vital to confirm that FDA has agreed to accept the international data. Differences in standards of care, study populations, concomitant medications, and even surgical methodology can affect the weight of international data.

International Matters. Most device companies, even those that are quite small, look outside the United States for a considerable portion of sales volume. A regulatory due diligence effort should review the status of marketing authorizations in major markets. Have products been CE marked? If so, what notified body was involved? Who serves as the authorized representative? What actions do the notified body require on completion of the acquisition?

Some notified bodies require considerably more information than others if ownership of a medical device manufacturer changes. For other international markets, are product approvals held directly by the device manufacturer or are they held by local distributors? If distributors hold the approvals, the contractual relationship between the parent company and the distributor becomes a critical issue.

Due diligence efforts also need to recognize the less tangible, but significant effects of interpersonal relationships between distributors and the parent company. Of course, management will need to use its own judgment to anticipate the effects of ownership change on the distribution relationship.

Assessment of Risk

All observations included in a due diligence report must be associated with an explanation of risk. This is not the usual goal for a more traditional compliance audit. Due diligence observations that reveal high-risk situations can influence the value of the transaction. Therefore, these assessments need to be carefully considered and clearly stated so that the information contributes to upper management's understanding.

This assessment is perhaps the most difficult task in this process. There is no universal standard for assessing such risks. Due diligence team members need to draw upon their experience to make these judgments and communicate them to management in a clear manner.

Reporting to Management

The end result of the due diligence effort is a report to management that lists findings and evaluates risks. It is vital that, from the beginning, members of the due diligence team have a clear understanding of the data that are needed by upper management and that they remain focused on those needs throughout the course of the effort. One useful technique is to have upper management and the leaders of the assessment effort agree in advance on an outline for the final report. Such an outline should list key areas of interest and include brief descriptions of the necessary data and specific questions that must be addressed. Due diligence team members responsible for sections of the report can then refer to this template and better direct their efforts. Another option, especially for organizations that expect frequent M&A efforts, is to prepare a more formal procedure describing how such an effort should be conducted.

Conclusion

Financial, business, technical, and market factors all contribute to the value of any potential acquisition in the medical device industry. Regulatory and compliance factors can also significantly affect value and influence future product development efforts. Regulatory input is a vital component of the due diligence process. Upper management must provide adequate resources in the form of personnel, time, and administrative systems to facilitate such a review. Finally, setting a positive and productive tone during the due diligence process can help to promote the effective integration of both organizations in the postacquisition phase and help to maximize the value of the acquisition.

Barry Sall is a principal consultant specializing in medical devices at Parexel Consulting (Waltham, MA). He is also a member of MD&DI's editorial advisory board. Sall can be contacted at barry.sall@parexel.com.

Copyright ©2008 Medical Device & Diagnostic Industry

Device Could Crack Case on Pulmonary Diseases

R&D DIGEST

An assay (inset) re-creates respiratory crackling (outer area) often
associated with lung disease to enhance further studies.
A lung-on-a-chip that re-creates respiratory crackles might help doctors understand whether the crackling is a contributor to lung damage or just a symptom of a disease. Lung crackles, which can be heard inside a patient's chest using a stethoscope, are associated with a number of pulmonary diseases including asthma, pneumonia, and congestive heart failure.

Researchers at the University of Michigan (Ann Arbor) developed the device to find out how small fluid plugs form in the lungs. When thick liquid plugs clog the airway, crackling is the sound heard as a person breathes. It's difficult to study these crackles in humans and animals, and it's not possible [to replicate them] in typical cell culture systems such as culture dishes, says Shuichi Takayama, associate professor in the university's department of biomedical engineering.

The chip is currently being used to study the potential causes of lung diseases. Although the chip could eventually be used to test therapeutics, Takayama points out that that would be a complex process. “The lung-on-a-chip by itself would be a relatively specialized assay system in the current stage, because it's relatively complicated,” he says.

The plastic wafer is about the size of a large postage stamp. The chip is made of two rubber sheets with its two grooved sides attached together and a sheet of polyester in between the sides. The airway channel, which is 200 μm, is lined with airway cells. It is located adjacent to a blood vessel channel that supplies the cells with liquid nutrients.

Shuichi Takayama says the lung-on-a-chip will enable studies such as smoking effects.

In a microchannel lined with human airway cells, the biomedical engineers re-created crackles that are produced by liquid plugs when they rupture. “We created a small airway on a chip where we could readily see the cells and control the liquid plugs that form and rupture, and then systematically re-created the different physiological conditions to see how cells would respond,” says Takayama.

The researchers used the chip to observe how breathing occurs in fetuses, healthy children, and adults. They recreated the liquid flow over airway cells and saw no damage to the cells. “But when we have liquid plugs with little surfactant moving through the little airways, like what happens in many diseases, we see a lot of cellular-level injuries,” says Takayama. These injuries are caused by fluid mechanical stresses that are exerted on the cell. The chip could also measure the damage that the lung crackles cause on surrounding cells.

In addition to observing crackles and their relation to lung diseases, the researchers could make the chip smoke to see how bad a smoking habit is for the microfluidic lung. “This is the only microfluidic chip that ‘breathes' and that one can ‘listen' to,” Takayama adds.

In the future, Takayama would like to integrate biochemical analysis capabilities into the device. He stresses that although the chip has potential in drug testing or other therapeutics, he doesn't foresee its use in a high-throughput-screening type of system.

“In the long term, we do think about things like incorporating other micro­engineered body parts together to make animals on a chip or minihuman types of things, but that's kind of far off.”

The researchers' work on the lung-on-a-chip was published in a November edition of the Proceedings of the National Academy of Sciences.

Copyright ©2008 Medical Device & Diagnostic Industry

Will CMS Reimbursement Spur the Artificial Heart Market?

Countermanding a policy that has existed for more than two decades, earlier this month the Centers for Medicare and Medicaid Services (CMS; Baltimore) announced a proposed policy to provide Medicare reimbursement coverage for artificial heart devices.

The CMS announcement marks the reversal of a decision dating back to 1986, by which the agency had explicitly ruled out such coverage. The proposal also started the clock running on a 30-day public comment period. A final ruling on CMS coverage of artificial heart devices for Medicare beneficiaries who are enrolled in FDA-approved studies will be made by May 1.

 
Weems
 
CMS's Weems: Relaxing policy.

Kerry Weems, acting CMS administrator, observed that the revised policy “relaxes a long-standing noncoverage policy, gives access to our beneficiaries, and promotes evidence development through FDA-approved studies of this advanced technology.”

Explaining its policy reversal, CMS said that there is now sufficient scientific evidence on the use of artificial hearts to allow coverage in carefully controlled clinical environments, which will enable the agency to provide faster and more effective rulings through informed decision making.

The CMS decision was not a total surprise. The announcement was largely the result of a process begun last spring and initiated by SynCardia Systems Inc. (Tucson, AZ), manufacturer of the CardioWest total artificial heart. The company formally petitioned the agency for a review of its 1986 noncoverage decision and, in August 2007, CMS agreed to reopen the matter.

 
Cardio West
 
The CardioWest total artificial heart by SynCardia Systems.

If CMS approves national coverage for artificial hearts, as is widely expected, SynCardia Systems would be a major beneficiary, along with Abiomed Inc. (Danvers, MA), manufacturer of the AbioCor artificial heart.

Rodger Ford, president and CEO of SynCardia Systems, noted that “many smaller insurers use CMS reimbursement decisions as their benchmark for coverage.” Because of its potential impact beyond the Medicare program, Ford called the CMS decision “an historic step toward making the artificial heart available to most Americans.”

Michael R. Minogue, chairman, president, and CEO of Abiomed, said, “This proposed decision is a positive development for the advancement of our AbioCor program in the United States. This decision by CMS provides momentum towards making the technology available for chronic patients who require biventricular support and have no other treatment options.”

 
Minogue
 
Abiomed's Minogue: Technology momentum.

According to SynCardia, the CardioWest device is covered by half of the leading insurance companies. The AbioCor artificial heart is currently approved for reimbursement by Cigna, Humana, and HealthNet.

While both companies are major players in the artificial heart market, they are not competitors in the true sense of the term, since their respective devices are intended for very different patient populations.

CardioWest received FDA approval as a Class III device in October 2004. It also has CE mark approval for distribution in Europe. AbioCor received the much more restrictive humanitarian device exemption (HDE) from FDA in September 2006. HDE classification limits the use of the device to 4000 patients in the United States. CMS notes that evidence for each of the two devices will be considered separately, and the agency will establish somewhat different criteria for evaluating clinical outcomes.

 
AbioCor
 
The AbioCor artificial heart by Abiomed.

Although initially designed as a permanent device, CardioWest is considered a temporary, yet total artificial heart. FDA has approved the device as a bridge to transplant. Patients in the intended-use population are typically in severe biventricular Class IV heart failure, and must meet the requirements for a heart transplant recipient. The optimum clinical outcomes would be successful implantation of the CardoWest device, survival to a successful transplant, and continued survival thereafter without negative effects from such adverse events as device failure, infections, excessive bleeding, or neurological consequences.

In contrast, FDA has approved the AbioCor device for destination therapy—that is, for patients who are not suitable candidates for heart transplantation, are near death from end-stage biventricular Class IV heart failure, and have exhausted all other treatment options. Optimal outcomes with the AbioCor artificial heart are successful implantation of the device, increased survival, discharge home, and no negative effects or adverse events. Since the average survival rate for these patients is 4.5 months, prolonged life is the primary measure of clinical outcomes.

 
Mackstaller
 
SynCardia's Mackstaller: Getting small.

The CardioWest device has been implanted in more than 700 patients, accounting for more than 120 patient years of life on the device with a 79% rate of successful bridge-to-transplant—reportedly the highest success rate of any such device on the market worldwide. SynCardia has 22 certified CardioWest implant centers worldwide, with nine additional hospitals currently undergoing the certification process.

SynCardia is actively advancing its technology to create next-generation products. “We're currently working on the development of a smaller version of the CardioWest device,” says J. David Mackstaller, SynCardia's vice president for sales and marketing. “There is a tremendous need for an artificial heart that can accommodate the pediatric population as well as women and often smaller framed Asian patients.”

Abiomed also has a smaller artificial heart in development—the AbioCor II, which CEO Minogue describes as “a second-generation device that is approximately 30% smaller than AbioMed I, and is anticipated to have a life expectancy approaching five years.” AbioMed currently has four U.S. hospitals enlisted for clinical trials, and hopes to increase the number of centers to 10 in the near future.

 
Ford
 
SynCardia's Ford: Boosting independence.

SynCardia's Ford says that securing eventual FDA approval of the company's smaller and more portable artificial heart drivers will result in a tremendous boost in the application range, patient appeal, and market reach of the device. In the United States, the CardioWest device is currently limited to use in hospital settings. The company's Companion universal driver system is approved for limited use under the terms of FDA's investigational device exemption (IDE), while its smaller, Portable driver is not approved and cannot be used in the United States. “Both of these drivers are already available in Europe, which enables patients to go virtually anywhere and live a much fuller and more independent lifestyle,” says Ford. A 4-lb driver for the CardioWest heart is presently in development.

Both companies say it is difficult to project market valuation figures. SynCardia estimates that candidates for the CardioWest device include up to 10,000 U.S. patients plus an additional 20,000 patients worldwide. At an average implant cost of $106,000, such a patient population could potentially yield a global market of $3.18 billion. For its part, Abiomed, with its AbioCor artificial heart device typically costing $250,000 and limited to 4000 U.S. implants per year, could create a market valuation of $1 billion.

 
Simpson
 
Stifel's Simpson: Recognizing achievement.

CMS's proposed coverage decision doesn't provide much help for those seeking to figure out the future of the market for artificial heart technologies. According to Gregory Simpson, principal and medtech analyst with Stifel, Nicolaus and Company Inc. (St. Louis), “The expected CMS decision to cover artificial hearts is not that surprising, and is in keeping with the agency's reimbursement coverage of advanced devices in the heart assist and related areas.” Simpson, who covers Abiomed, thinks the decision will not have any significant near-term impact on the company. “I only see them implanting a few devices each quarter for the immediate future. Yet, the CMS decision recognizes the ongoing development of artificial hearts as a significant technological achievement which benefits any medtech company in this space. And, moving forward, if the next-generation AbioCor II performs as expected and is able to achieve a device life of five years, the company would then be in a position to see a significant increase in demand.”

Neither SynCardia nor Abiomed sees a national coverage decision by CMS as a factor that would motivate other companies to enter the artificial heart market. “The start-up and development costs might prove prohibitive, considering both the limited size and the considerable risks associated with the market,” says SynCardia's Mackstaller.

“There are many companies developing destination therapy pumps for chronic patients,” says Abiomed's Minogue. “However, we are not aware of any other company developing a fully implantable heart with no wires piercing the skin.”

Other medtech firms developing ventricular assist devices and related cardiac products include Arrow International Inc. (Reading, PA), a division of Teleflex Medical (Research Triangle Park, NC); Cardiac Assist Inc. (Pittsburgh); MicroMed Cardiovascular Inc. (Houston); Thoratec Corp. (Pleasanton, CA); and World Heart Corp. (Oakland, CA).

A favorable CMS decision on national coverage of artificial hearts is likely to encourage or even accelerate new product development at the two major players, Abiomed and SynCardia. Future developments seem destined to expand the utility of artificial heart technologies among a wider patient population worldwide. But even with the potential for a ready and expanding market—and reimbursement coverage—most industry analysts doubt there will be a rush of other medtech companies entering this complex market.

© 2008 Canon Communications LLC

Return to MX: Issues Update.

Are You In Control of Your Software Analysis?

FROM THE EDITORS

After quietly implementing a new method for analyzing software, FDA's Software Forensic Laboratory was able to find some problems in a couple of high-profile devices that were recalled for adverse events. Called static code analysis, the technique is commonly used in the automotive and aeronautical industries and has been around for about 10 years. Simply put, it reads the lines of code without running the program. It is designed to check for errors that might keep the code from running correctly. It has been used extensively in aeronautics, and it is seen as essential in that safety-critical industry. Sounds ideal for the medical industry, right? Or, maybe not. It is costly and labor intensive—both of which can be impediments for the medical device industry.

FDA consulted with other federal agencies that deal with software integrity issues—including the Department of Defense, FBI, National Institute of Standards and Technology, and NASA—before it started using this technique, which was outlined in a single paragraph in the 2006 CDRH annual report. The agency determined that such analysis would be particularly valuable in understanding the root causes of adverse events due to software failures. Whether this a good investment of FDA's regulatory enforcement budget remains to be seen.

Often, the result of this analysis is an itemized list of coding errors that is sent back to the manufacturers. The list can contain any error, from minor misspellings or typos to major errors. But the list does not prioritize the code errors, and OEMs are expected to respond to all items.

FDA says it is currently reviewing only software that presents “an imminent public health threat.” According to MedSun, the FDA laboratory has used the new method with success to analyze software in several high-profile compliance cases. It is clear that the agency is expecting to find errors in the software that the manufacturers themselves have overlooked.

However, FDA has also said that it expects manufacturers to “increasingly” use such tools during their product development process. FDA generally avoids prescribing specific methods to industry. Does this expectation mean that FDA is advising manufacturers on how to design their software?

Some designers are already using this technique in the development of their software. Full Spectrum Software (FSS; Framingham, MA) uses both static and runtime analysis. “This is a part of our quality system, and the results are clearly and demonstrably beneficial,” says Andrew Dallas, president of FSS. “We provide a service called product hardening, which allows us to improve overall product stability and reliability.” The components include not only static and runtime analysis, but also manual code review.”

As a design tool, it is important to recognize that static analysis does not just find insignificant errors. These processes actually find coding errors created by the software engineers, explains Dallas. “The types of errors we can find are much more profound than spelling errors,” he says. “Consider a product that is designed to run for 12 hours and is acquiring patient information during that time. If a programmer has failed to initialize a variable, the value within that variable can be any value.”

He says that a major error can occur if the code uses that variable to make a decision: “If x is zero, shut down.” Static and runtime analyses can find such errors as well as others that are potentially even more serious. “Really the only downsides of the hardening process are cost and time,” he says. “These downsides, however, are quickly recouped in reduced maintenance costs.”

Static analysis can be a good tool when used at the design stage. And if you do, it may keep you from ending up in FDA's forensic laboratory after an adverse event. FDA expects manufacturers to adopt this method of analysis, but it has not specified a timeline.

Perhaps FDA's decision to do such analysis will also have some unintended consequences. It would be a tragedy if manufacturers cut back on validation activity in favor of waiting to simply respond to FDA's itemized list of coding errors.

Sherrie Conroy for the Editors

New Studies Defend Medical Device Pricing Practices

The findings of two new studies call into question the necessity and likely effectiveness of proposed legislation targeting the pricing practices of medical device manufacturers. The studies, both funded by industry association AdvaMed (Washington, DC), defend current medical device pricing procedures as being effective and necessary in promoting optimal patient care at a reasonable price.

Disputing Price Transparency Efforts

 
Hahn
 
Study author Hahn: Misguided legislation.

One of the studies—titled Is Greater Price Transparency Needed in the Medical Device Industry?—was released February 19 by author firm Criterion Economics (Washington, DC). It specifically targets the Transparency in Medical Device Pricing Act (S 2221), which was cointroduced last October by Senators Arlen Specter (R–PA) and Charles Grassley (R–IA). If the bill becomes law, it would require medtech manufacturers seeking payment under Medicare and related programs to issue quarterly reports on the average and median sales prices for all of their implantable medical devices used in inpatient and outpatient procedures. Manufacturers that fail to report or misrepresent pricing data would be subject to fines up to $100,000.

Advocates of the legislation contend that greater price transparency would serve as a way to empower patients and bring down healthcare costs. However, the authors of the new study, Robert W. Hahn and Hal J. Singer, concluded that the pending legislation is unlikely to have the intended beneficial effect.

“We found that mandatory price disclosure, as proposed in S 2221, is unlikely to benefit patients or hospitals and, worse, will likely increase costs,” said Hahn, who serves as executive director of Reg-Markets Center (Washington, DC) and is a senior fellow at the American Enterprise Institute (Washington, DC). Singer is president of Criterion Economics (Washington, DC).

In developing the report—available at www.criterioneconomics.com/docs/Hahn_Singer_Disclosure_final_12-7.pdf—Hahn and Singer reviewed previous government attempts to impose price disclosure rules in a number of other industries. In doing so, they identified conditions that must be satisfied if mandatory price disclosures are to result in large benefits to consumers or other purchasers.

Subsequently, in examining the specific characteristics of the medical device industry, the authors determined that the conditions required for price disclosures to have a favorable effect are not met in the context of the overall healthcare system. For example, the study concluded that medical device pricing disclosures under S 2221 would not provide current price information since the data would be at least three months old. Furthermore, the structure of the healthcare industry would not ensure that hospitals pass cost-savings on to consumers.

In addition, the report found that the medical device industry meets certain conditions that are likely to result in large cost increases as the result of pricing disclosure. For example, the report noted that there is a high degree of concentration among manufacturers of certain medical devices.

Most segments of the medical device industry are characterized by a significant degree of seller concentration. For example, the vast majority of drug-eluting heart stents in the United States are currently sold by only two firms: Boston Scientific and Johnson & Johnson. Similarly, the ICD industry is represented by just three firms: Medtronic, Boston Scientific, and St. Jude Medical. The U.S. orthopedic joint replacement industry, which had approximately 14 firms compete for total sales of $5.1 billion in 2006, appears at first glance to be less concentrated. A closer examination reveals, however, that five firms account for approximately 90% of all sales. Furthermore, medical device industries are likely to remain highly concentrated because they are protected by significant technological barriers to entry [p. 25].

 
Ludwig
 
Ludwig: Part of the solution, not problem.

Likewise, the report notes that there are few, if any, substitutes for many medical devices. Also, many medical device manufacturers do not already know their rivals' prices, the study noted.

Competition as a Control

Meanwhile, a second study—released just days earlier by AdvaMed—reports that the highly competitive nature of the medical device industry has limited the rate at which medical device prices are increasing. The association points to the study as further proof of the role that medical technology plays in managing—rather than exacerbating—rising healthcare costs .

“The report's findings are significant in light of recent comments by some suggesting policies to limit the diffusion of and access to advanced medical technology in response to cost pressures,” said Edward J. Ludwig, AdvaMed board chairman and chairman, president, and CEO of Becton Dickinson (Franklin Lakes, NJ). “Simply put, medical technology is part of the solution to managing healthcare expenses, and limiting patient access to life-saving, life-enhancing technologies compromises patient health and may actually increase costs.”

Between 1989 and 2004, spending on medical devices and in vitro diagnostics remained relatively constant as a proportion of total national health expenditures, according to the study. During the same period, medical device prices grew far more slowly than the medical consumer price index or the overall consumer price index.

 
Mussallem
 
Mussallem: The benefits of competition.

“The innovative and competitive nature of the medical technology sector benefits patients by providing continual improvements in care,” said Michael A. Mussallem, chairman and CEO of Edwards Lifesciences (Irvine, CA) and AdvaMed's board chairman–elect. “This study shows that there is also an economic benefit of competition due to the relatively slow rate of growth in overall industry prices.”

 
Ubl
 
AdvaMed's Ubl: Economic and medical value.

In 2004, the latest year studied, national spending on medical devices and in vitro diagnostics totaled $112 billion, or 6% of total national health expenditures. During the 15-year study period, medical device spending as a share of total expenditures never rose above 6.1% and never fell below 5.4%.

Over the full study period, medical device spending increased at an average annual rate of 8.1%, compared with a 7.4% annual growth rate for overall national health expenditures. But despite the faster growth rate of medical device spending, medical device price increases have been modest at an average annual rate of 1.2%. During the same period, the medical consumer price index grew at an annual rate of 5%, and the overall consumer price index grew at a rate of 2.8%.

“The report's findings are clear: the highly competitive medical device marketplace is working and delivering tremendous value both in patient care and in economic terms,” said Stephen J. Ubl, president and CEO of AdvaMed. “Policies that stifle innovation, interfere in the marketplace, or limit access to care threaten that success.”

The study, available here, was written by Roland Guy King and Gerald F. Donahoe. King is an independent consulting actuary and an industry leader in public sector health financing programs. Prior to 1995, he served as chief actuary for the Health Care Financing Administration for 16 years. Donahoe is a retired economist who worked as a statistician at the Bureau of the Census from 1962 to 1971 and with the Bureau of Economic Analysis at the U.S. Department of Commerce from 1971 to 1997.

© 2008 Canon Communications LLC

Return to MX: Issues Update.

Material Selection: The Right Resin for Your Design

Material selection affects a number of product-specific characteristics. Therefore, early and accurate resin choices are crucial to successfully launching a product. (Photo by Hubert Schriebl)
Choosing the right resin for a molding application is a pivotal decision for device manufacturers. And there are several matters that a device designer must consider before finalizing the resin. Material selection is driven by a combination of factors including part design, molding techniques, project requirements, cost targets, and secondary operations. These considerations are overlaid by economic, environmental, and compliance and regulatory issues.

This article discusses the various factors that drive resin selection for medical devices. And the best way to illustrate the principle of resin selection is to look at real devices. Within this article, several medical products are presented to demonstrate both resin and processing choices. Examples include an automated external defibrillator (AED) unit, orthopedic surgical instruments, an orthopedic ankle clamp, a surgical case and tray-delivery system, an ambulance defibrillator unit, and a keyboard-surround application.

The Factors

Let's start with the part itself. Part price is obviously affected by resin cost. But it is also affected by cycle time, required press tonnage, inserts, and secondary operations, all of which are influenced by resin selection.

Resin properties influence part performance. For example, adding filler can increase part stiffness. A gain in one property, however, often coincides with a loss in another. Adding the filler affects tensile elongation. Therefore if both impact and deflection are high on the list of requirements, the application may not pass all necessary specifications. Every resin property required for an application influences material selection in varying degrees.

Beyond part requirements, processing must be considered when selecting a resin. Special processes, like gas assist or structural foam, must be well thought out. The same is true for opportunities that call for more than one resin, as in overmolding applications.

Then there are the factors outside of the list of requirements. A tried-and-true resin that has been used previously for other applications may be more desirable to a designer. A trusted resin supplier that has just introduced a new material might also influence the decision-making process.

And keep in mind that computer modeling, such as CAD and CAE, doesn't drive material selection. All the software programs for part design, mold design, mold filling, and finite element analysis assume the selected resin is sufficient to fulfill all requirements for the application.

Critical Timing. Material selection affects a number of product-specific characteristics. Therefore, early and accurate resin choices are crucial to successfully launching a product. The outcome of a project is a direct result of the engineering approach used at the beginning of product development. An active (front-end) versus reactive (back-end) approach in terms of effort saves time and money on both a short-term and a long-term basis. In studies comparing the effect of both approaches over a complete product development cycle (planning, design, prototyping, and mass production), the reactive approach has been shown to make higher demands of time and money. And perhaps more importantly, the effort differential continues to exist throughout the product's life.

Such higher product costs can affect both the initial launch and later manufacturing. It can cause a delayed launch, resulting in the loss of a strategic time advantage over a competitor. Ultimately, it might mean missing the window of opportunity to be first to market and capturing market share.

First Steps. Vital to a well-substantiated material selection process is the establishment of a complete list of requirements for the product. This list should include a price target, assurance of resin availability for the first choice, and a backup of alternative resins or grades for later cospecification. The list must be generated in the early planning stage and must be as complete as possible. Generating this list is usually the most difficult and underestimated task in a whole project. If even one requirement is not recognized early enough, the whole project could be jeopardized.

Figure 1. (click to enlarge) A comparison of amorphous and semicrystalline
polymers, with the higher-performing materials toward the peak. Courtesy of Solvay Advanced Polymers.
Start by picking the right resin family. The polymer performance pyramid in Figure 1 breaks down some resin options into both amorphous and semicrystalline categories. Amorphous resins have a random polymer structure in both molten and solid phases. Semicrystalline resins are characterized by randomly oriented molecules at molten phase that become densely packed crystalites in solid phase. These structures are formed by small regions of crystalites connected by random polymer molecules.

Figure 1 also shows the performance properties of commodity polymers, engineering polymers, high-performance polymers, and ultrapolymers. Performance characteristics can vary based on the material's properties. Performance might be determined by the material's modulus of elasticity, its heat deflection temperature, its likelihood of exposure to chemicals or UV light, or its behavior in a high-humidity environment. In addition, the material may be exposed to a broad range of operating temperatures and the application still has to work properly. Often, more than one condition has to be achieved. For example, many medical applications have requirements for steam sterilization, chemical resistance, and high-heat resistance (to withstand numerous autoclave cycles).

Numerous factors must be considered when selecting a family of resins. These include but are not limited to the following:

  • Melt flow, a characteristic for viscosity at low shear rates and flow length.
  • Fillers (glass and mineral), which significantly affect performance properties.
  • Surface requirements, like gloss, color, and texture.
  • Modulus, elongation, and tensile strength for mechanical requirements.
  • Economic restrictions, including target price, resin availability, colorability, and moldability.
  • Regulations that the application must comply with, such as Blue Angel, RoHS, FDA, or ISO 10993, to name only a few.
  • Global compliance requirements on different continents or in different markets (NAFTA, EU, Japan, etc.).

On top of all this, it is important to check for UV exposure, sterilization, radiation, and flammability specifications, which can have significant influence on the number of resin families available for initial selection.

Consider the long-term property requirements for the application based on fatigue, load, and temperature. These aspects are influenced by molecular weight distribution. Often specifications for drop, load, deflection, or cyclic tests must be passed before product launch into the market. A thorough check for chemical exposure may also be necessary under field use conditions or during a repetitive cleaning procedure. Long-term color stability may also need to be tested.

Material Databases and Software

Software tools like material databases (Prospector, MatWeb, Omnexus, Campus, Material Data Center, etc.) can help you select the right material based on the list of requirements. But be prepared, the contents can be overwhelming. For example, MatWeb lists more than 65,000 materials; Prospector, more than 70,000 from more than 600 suppliers. And the numbers change daily. It is nearly impossible to stay current with the databases, because grades are continually added, modified, or deleted.

The most difficult part of using databases is sifting through the data under the constraint of a tight time-to-market requirement.

Another challenge is making one-to-one comparisons among different databases. The material data from the manufacturer dictates the format in which the data are presented. Data can be published according to ISO or ASTM specifications, or even as a result of tests developed and defined by the manufacturer. Most databases contain a mixture of data formats from the above listed specifications that are not necessarily comparable.

CAE tools for finite-element analysis (FEA) and filling simulation can also be helpful. FEA programs include Cosmos, Ansys, and LS-Dyna, among others. For mold filling simulation, Moldflow and Moldex 3D are a couple of options. The benefit of using FEA in terms of resin selection is that it offers the ability to simulate near-real-life scenarios. The process could prevent overengineering from a material perspective. It is often a challenge, however, to gain the necessary input data, such as underload and temperature. The influence of chemicals on a product over time is also difficult to estimate.

Part Design and Process

Part design is driven by many elements, such as wall thickness, size, and complexity, as well as the structural and mechanical requirements. The selected process, either bonding or painting of the parts, and cleaning procedures also play a role in how the part is designed.

Similar to the thigh-bone-is-connected-to-the-hip-bone scenario, wall thickness determines cycle time and part weight; part size affects molding costs and required press tonnage; and rib structures and wall thickness distribution influence part complexity. In turn, the selected process influences many of these variables. Cost targets can be met or missed based on process selection.

There are many processes available to designers today, including:

  • Injection molding.
  • Structural foam.
  • Gas counterpressure.
  • Gas-assist injection molding (external and internal).
  • Two-shot molding.
  • In-mold decorating.
  • Overmolding.
  • Insert molding.
  • High-temperature molding.

Often manufacturers will combine these processes to minimize costs, improve part performance, and add functionality to the device.

Other aspects to consider in material selection include secondary operations and parts consolidation. Is the part converting from metal to plastic? Does the part combine functions through consolidated parts? Can the material selection reduce cycle time, as well as costs for secondary operations? Does the application require brand identification by means of two-color aesthetics? What about noise and vibration dampening or shock absorption? Does the molded part need painting, powder coating, or metallizing? If so, adhesion will be critical.

Material and process selection should be based on the parts lists of requirements.

Conclusion

Successful material selection is based on early consideration of the application's requirements. As needed, CAE tools, FEA, and mold-filling simulation software will help to solidify a design and the associated resin selection. A defined cost target is critical to protect against developing an application out of its prescribed cost range.

The importance of choosing both the right molding technique and the right resin cannot be emphasized enough. An inappropriate combination of the two will ultimately result in higher-than-expected costs, a more difficult-to-manufacture product, or a product that doesn't meet all the objectives.

Ultimately, material selection must occur at the start of a project in order to proceed with the product development schedule realistically. If that can't happen, for whatever reason, develop a backup material option in case certain requirements are at risk of not being met or all requirements are not yet defined. Clearly this is a risky path, and such a reactive engineering approach is definitely not the recommended route. To save both time and money, remember that when to choose is as important as what to choose.

Michael Hansen is senior technical development engineer for Mack Molding Co. (Arlington, VT). He can be contacted at michael.hansen@mack.com.

Copyright ©2008 Medical Device & Diagnostic Industry

Life Sciences Venture Capital Investments Hit Record Levels in 2007

In 2007, the medical device and biotechnology industries attracted $9.1 billion in venture capital investment across 862 deals. According to the PricewaterhouseCoopers–National Venture Capital Association MoneyTree Report, based on data from Thomson Financial, these figures represent an all-time record for annual venture capital investment in the combined life sciences, as well as a notable increase over 2006 investments of $7.6 billion across 786 deals.1

Although medical devices and biotechnology both experienced double-digit gains over the prior year, the most significant growth was seen in the medical device industry. In 2007, venture capital investments in medical device companies rose 40% over 2006 figures.

 
 
Slone
 
 
NVCA's Slone: Above the bubble.
 

“In 2007, the number of deals for medical devices in total dollars was at an all-time high and reached 57% above the bubble peak of 2000,” says Kelly Slone, director of the National Venture Capital Association Medical Industry Group ( Arlington, VA). During 2007, says Slone, medical device companies were involved in 385 deals with an investment total of $3.9 billion.

For the year, life sciences firms—medical device and biotechnology companies combined—accounted for 31% of all venture capital invested, also an all-time high.

Across all industries, venture capitalists invested $29.4 billion in 3813 deals in 2007, marking the highest annual investment total since 2001. The 2007 total represents a 10.8% increase in dollars and a 5% increase in deal volume over 2006 figures.

 
 
Heesen
 
 
NVCA's Heesen: Rational investment patterns.

“The annual increase in venture capital investment in 2007 was extremely rational, as the industry is now investing in a mix of sectors that is much more capital intensive than it has been in the past,” said Mark Heesen, president of the National Venture Capital Association. “And despite the capital needs of industries such as clean technology and life sciences, we only saw a single-digit increase in deal volume, which suggests that a fair amount of discipline is being applied to investment decisions.”

Across all industries, first-time financings reached their highest levels since 2001, with 1267 companies receiving $7.2 billion in venture capital in 2007. Industries receiving the most dollars in first-time financings in 2007 were software (with 250 deals valued at $1.14 billion), industrial-energy (with 141 deals for $1.08 billion), and biotechnology (with 134 deals for $982 million).

In 2007, 114 medical device companies received first-time financing, representing a slight decrease compared with the 118 medtech companies receiving first-time financing in 2006. However, the aggregate amount invested in first-time medtech financings in 2007 was $838 million, a 43% increase over the $587 million invested in first-time medtech financings in 2006.

Not surprisingly, a similar trend was seen in the number and size of investments being made in seed and start-up medical device companies. In 2007, $223 million was invested across 46 seed and start-up medical device financings. In 2006, $164 million was invested across 44 deals. So although the number of such deals grew by less than 5%, the total invested in seed and start-up medical device endeavors grew by nearly 36%.


Reference

1. "The PricewaterhouseCoopers–National Venture Capital Association MoneyTree Report" (New York City: PricewaterhouseCoopers, 2008); available from Internet: www.pwcmoneytree.com/MTPublic/ns/moneytree/filesource/exhibits/National_MoneyTree_full_year_Q4_2007_Final.pdf.

© 2008 Canon Communications LLC

Return to MX: Issues Update.

Ethnographic Research and the Problem of Validity

DESIGN RESEARCH

Ethnographic research, such as observing the setup of a catheter, often leads to
ideation. But it can also lead to significant device design.
In 2001, William Reese and I wrote an article about the use of ethnographic research for the development of new medical devices.1 In that article, we described what ethnographic research is and why it is a useful tool for identifying user wants and needs for medical devices. The article looked at the limitations of device users' descriptions of what they do and what they need, and it explored how ethnographic research can transcend those limitations. It also discussed how ethnographic research differs from conventional market research in employing direct, real-world observation of device use.

That article examined how ethnographic interviews, which take place in the environment of device use, can yield richer and more-accurate information than interviews conducted at a neutral site (and usually conducted long after the behavior of interest has taken place). Finally, it described some of the characteristics of ethnographic research, such as spending significant amounts of time in the environment of use, working to develop rapport with informants, and carefully considering the context in which procedures take place.

The use of ethnographic research has since become much more common in medical device development. However, its relative ubiquity raises an important issue: How can ethnographic research achieve validity? By validity, I mean the degree to which the research findings accurately describe the real-world facts that they purport to describe.

The issue of validity does not always apply to ethnographic research, at least not to all research to which the term ethnographic is applied. Much so-called ethnographic research—perhaps most of it—is designed simply to generate ideas, that is, to stimulate creativity. Inevitably, when members of device-design teams go into the field and see directly how their devices and other devices are used, it generates insight and stimulates new ideas. This is certainly a reasonable and productive purpose for field research.

However, there is another, perhaps more ambitious, purpose to which ethnographic research can be applied—to guide business decisions regarding new product development, e.g., to determine what new devices are needed, what characteristics new devices should have, and so on. What “guiding business decisions” amounts to, of course, is providing information to determine how millions, or tens of millions, or even hundreds of millions of R&D dollars can be most productively spent.

Observing activities such as the note-taking process can reveal crucial steps in a user's methods.
Much of what people do is largely unconscious, and, ironically, this is more true as one becomes more skilled. For example, novice surgeons may be conscious of the position of their hands at a particular point in tying sutures. Experienced surgeons are more likely to be thinking about the next step of the procedure or even where they are going to have lunch. Also, it is well known that people tend to answer questions in ways that reflect positively on themselves or that tell the questioner what he or she appears to want to hear, often at the expense of strict accuracy.

There is plenty of room for observational research of device users that does not purport to yield a true picture of reality, but rather simply provides interesting and useful fodder for ideation. However, when the research is intended to be used to guide device-development decision making, particularly in the medical area, it is crucial that the validity of the research be carefully addressed.

Achieving Validity

In certain fields, including the medical device industry, ethnography is see as qualitative research, whereas validity associated with medical devices is usually based on quantitative research (clinical trials, etc.). If we take clinical trials or even usability testing for validation research (e.g., to address FDA's design control requirements), then there are conventions for how to achieve validity. For example, based on prototype-testing data and sound statistical principles, it is possible to predict with some accuracy how many incidents or errors can be expected once the relevant device is introduced. It is also possible to estimate the number of uses can be estimated.

However, this formal, statistical approach to validity is not typically, if ever, possible with ethnographic research. Sample sizes tend to be modest and, by definition, ethnographic research does not entail systematic variation of independent variables (i.e., experimentation in the formal sense). This does not mean, though, that validity cannot be achieved. Ethnographic researchers use several methods to address the validity of their research findings. A sampling of these methods is discussed below.

Carefully Choosing the Sample, Based on Prior Knowledge. As with any research, validity is enhanced to the extent that the research sample accurately reflects the population of interest. Achieving this goal is particularly challenging with small sample sizes (10–20 sites is a typical sample size for ethnographic research). However, sample selection can become much more sophisticated when prior research can provide guidance for which variables make a difference. For example, for in-hospital research within the United States, the type of hospital (e.g., large teaching versus small community) often makes a big difference, but geographic region (e.g., East Coast versus West Coast) makes little difference. On the other hand, the differences from one adjacent country to the next in Europe can be vast. It follows, then, that in constructing the sample, geographic region can be ignored within the United States, but not in Europe.

Measurements of equipment, light, and noise found in an operating room setup can be used to foster device design ideas.
A common mistake that can yield disastrous results is to stack the sample with so-called thought leaders who are dramatically more sophisticated than typical users of a given device. In fact, it is often more important to understand the needs of less-sophisticated device users, because a device that they can use easily will also be usable by more-sophisticated users.

Using Measurement Whenever Possible. While in the field, a researcher can go beyond his or her judgment and intuition by taking careful measurements. Measurement of sound frequency and amplitude, ambient light levels, surface heights, shapes and sizes of capital equipment, and so on can provide a solid, factual basis for making certain types of device decisions.

Engaging in Cyclical Hypothesis Testing. Well-trained ethnographic researchers do not simply take what they see at face value, but also engage in a cyclical form of hypothesis testing to squeeze out error in the data. This involves forming hypotheses about motivations, relationships, patterns, etc., and testing those hypotheses by additional observations or by saying or doing certain things and determining what results from the test. In other words, true ethnographic research requires a skeptical stance toward the data that goes beyond simple observation. This is one of the most important factors to achieving validity and one of the ways that ethnographic research, as conducted by trained researchers, differs from much of what goes by the same name.

During ethnographic catheter research, it is important to observe the physician's preferred kit layout.
Using Video as a Tool to Obtain Objective Data. It is difficult to obtain accurate quantitative data while in the field. Taking the development of a new surgical instrument as an example, it is logically useful to have good data about how instruments are actually used in surgery. Data would include the specific instruments that are used, temporal patterns of use, personnel who use the instruments, the number of times instruments are exchanged, which instruments are used simultaneously, etc. Such data are difficult or impossible to obtain in real time in the field. However, if procedures are videotaped, objective data can be obtained about such issues by careful evaluation at a later time.

Also, events that happen too quickly or too slowly to be easily seen with the naked eye can be carefully studied with slow- and fast-motion video playback. Therefore, video can be used to uncover the details of multistep procedures that take place in very short periods of time and to make detailed measurements of timing. It can also help researchers obtain precise counts of particular events (e.g., the number of sutures that are tied, the number of times instruments are picked up or reinserted, etc.).

Using Converging Methods. Confidence in findings can be increased by looking for consistency between the answers to questions asked in different ways, between verbal and behavioral data, or between different types of behavioral data. At the very least, a researcher should be able to segregate those findings that are known with confidence from those that are not by finding different ways to elicit answers to the same questions.

Looking for Consistency between Sites. Even with small sample sizes, a high level of confidence can be obtained when consistent patterns are found. For example, suppose that there is a question about whether a particular procedure is performed with the lights on or off. It seems reasonable to take the a priori probability of each alternative to be 50%. If so, we can use the binomial theorem to obtain the following probabilities that one finding or the other (i.e., lights on or off) is due to chance (i.e., not real) when the findings are consistent from site to site:

  • 1 site: 50.0%
  • 2 sites: 25.0%
  • 3 sites: 12.5%
  • 4 sites: 6.3%
  • 5 sites: 1.6%

This is the same simple probability logic that allows us to conclude that the chances of flipping heads five times in a row are 0.016. Therefore, for those observations that yield consistent results—if we can assume that the sample is reasonably representative—then even as few as five sites can yield statistical significance (conventionally, when the chances of a given finding being a random artifact are less than 5%).

Finding Face Validity. Sometimes, a finding, although surprising at first, makes so much intuitive sense upon reflection that it provides confidence that it is representative of the typical site. This is what is meant by face validity. Face validity can sometimes lead one astray, but often a highly experienced ethnographic researcher can accurately predict after the first observation which findings will be virtually universal. For example, it is common to find time-saving shortcuts or workarounds that a device's design team did not predict, but that, once seen, make a great deal of sense. It is logical that other device users would have developed similar practices.

For experienced medical device ethnographers, then, ethnography is more than just field research. Anyone can ask a question. Anyone can write down the answer. Anyone can be in the use environment. However, if important design decisions are to be made based on the data, mere experience and observation are never enough. Such decisions require research methods, such as those described above, that increase confidence in the validity of the findings.

Conclusion

In effect, the term ethnographic research is used to describe two very different forms of research. The first type, by far the most common, is really just an alternative term for field research, any research that entails real-world observation as opposed to (or in addition to) various forms of testing, on the one hand, or interviews or surveys, on the other. This type of research certainly has its place. It can give the device-design team a general feel for what takes place in the real world, and it can be a very useful tool for generating ideas, with the expectation that some other form of research will be necessary to determine whether the ideas, thus generated, have merit vis-à-vis users.

Using video to record a physician's use of the catheter enables researchers to catch nuanced data that might otherwise be missed.
The problem, though, is that the widespread application of the term ethnographic to such research has left the impression in many circles that ethnographic research can only be used to generate ideas, as opposed to being used as a real decision-making tool.

This article makes the case that there is another type of ethnographic research (not to be confused with the first type) that can be used to guide business decisions. However, conducting such research is difficult, time-consuming, and, frankly, expensive, in comparison with the idea-
generation type of ethnographic research. It is important to note that when it comes to decisions that involve users, ethnographic research, despite its difficulties, has the great advantage of not being exclusively based upon what people say.

Quantitative survey research tends to be the preferred tool when decision makers want objective data about what device users want and need. Such research yields good, hard numbers to support an objective approach to decision making. However, the drawback with such quantitative market research is that the data are only as good as the accuracy of answers to survey questions. There is enormous evidence that the answers to questions are not always accurate, for a variety of reasons.

In other words, the apparent precision and accuracy of quantitative survey research may be misleading, depending on the specific questions that are asked. For some questions, it is better to observe than to ask the user for the answer. The central point of this article is that observational research does not have to be exclusively qualitative. It can be done in such a way that it yields valid data, although validity is achieved through methods that are different from typical quantitative market research. Ethnographic research is unlikely to supplant quantitative market research or even qualitative market research any time soon, if ever, in medical device research. However, it can be an important supplement to other forms of research and can provide a deeper understanding of the wants and needs of device users.

Stephen Wilcox is the founder and a principal of Design Science (Philadelphia). He can be reached at sbw@dscience.com.


Reference

1. Stephen B Wilcox and William J Reese, “Ethnographic Methods for New Product Development,” Medical Device & Diagnostic Industry 23, no. 9 (2001): 68–76.

Copyright ©2008 Medical Device & Diagnostic Industry

Supreme Court Upholds Preemption Protection for PMA Devices

 
Hawkins
 
Hawkins: Ensuring patient access.

On February 20, the U.S. Supreme Court handed Medtronic Inc. (Minneapolis) a resounding victory in a much-watched and long-fought product liability dispute. In issuing their landmark decision, the justices established a new level of legal protection for medical devices cleared to market via the premarket approval (PMA) path.

In an 8–1 decision in the case of Riegel v. Medtronic Inc., the justices ruled that the preemption provision of the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act overrides most state-law claims seeking damages for injuries caused by medical devices approved by FDA under the PMA process. In a brief press release in response to the decision, Bill Hawkins, Medtronic's president and CEO, stated, “This is a very important decision, which ensures that patients continue to have appropriate access to innovative, life-saving medical devices. The decision recognizes the rights and interests of the vast majority of patients who benefit from a medical device.”

While the decision was widely lauded by the medical device community, many consumer advocate groups have expressed outrage over the decision, which they view as significantly limiting the legal recourse of patients injured by medical devices. Justice Ruth Bader Ginsburg, the lone dissenter among the justices, contended that “it is difficult to believe that Congress would, without comment, remove all means of judicial recourse for large numbers of consumers injured by defective medical devices.”

 
Ginsburg
 
Justice Ginsburg: The lone dissenter.

However, legal experts familiar with the case argue that the ruling—although momentous—may not have as great of an impact on patients as many opponents contend.

Distinguishing PMA from 510(k)

Victoria Davis Lockard, a partner in the law firm of Alston & Bird LLP (Atlanta), says the Riegel decision represents a watershed event for the medical device industry. “Not only will it limit the number of lawsuits, but it will allow for more certainty and consistency in the standards by which these devices are judged to be safe,” she says.

 
Lockard
 
Lockard: Supporting certainty and consistency.

At its core, the Court's opinion confirms that the federal PMA process preempts state-law tort claims—a protection not afforded to devices that undergo the less-rigorous 510(k) path to market. James Isbester, founder of Isbester & Thackray LLP (Berkeley, CA), notes that this distinction is key. “As the Supreme Court notes, the PMA process is comparatively rare,” he says. “In 2005, FDA granted more than 3000 510(k) approvals, but only 32 PMAs. Riegel will apply to only a tiny percentage of the products on the market. So at first blush, one might regard Riegel as a ‘so what' decision. That is probably a mistake.

“Although PMA devices may be only a small portion of the market, they are the bedrock products,” Isbester adds. “Without one product undergoing the PMA process, hundreds of subsequent products could not take advantage of 510(k). Riegel clearly reduces one of the big risks associated with the introduction of a new medical technology and, therefore, increases the incentive to innovate in this area.”

 
Isbester
 
Isbester: Few but significant.

Isbester points out that the PMA process will remain expensive, uncertain, and time-consuming. “But maybe with Riegel, it becomes just a little more attractive to manufacturers of medical devices wanting to chart their own path to marketing approval,” he says.

Preserving FDA Authority

Stephen J. Ubl, president and CEO of industry association AdvaMed (Washington, DC), noted that the ruling reaffirmed what two previous lower court rulings in this case had already made clear: that the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act expressly provide for FDA's ultimate regulatory authority over medical devices. “FDA—and not a patchwork of state regulations or multiple jury verdicts—should determine the safety and effectiveness of medical technology,” Ubl said. “We are pleased today's ruling will allow FDA to continue its science-based approach to approvals and prevents the inconsistencies in standards and delayed patient access to products that would occur if juries or others were to impose additional regulatory hurdles.”

 
Ubl
 
AdvaMed's Ubl: Economic and medical value.

Similarly, in issuing the majority opinion of the court, Justice Antonin Scalia noted that permitting state-law claims that companies ought to have done more to ensure device safety would be disruptive to the federal system for approving devices. “A jury . . . sees only the cost of a more dangerous design, and is not concerned with its benefits,” Scalia wrote. “The patients who reaped those benefits are not represented in court.”

 
Scalia
 
Justice Scalia: Weighing risks and benefits.

Scalia's contentions echoed the long-standing position of the medical device industry. Prior to the justices' ruling, AdvaMed—in conjunction with Medmarc Insurance Group, the Medical Device Manufacturers Association, and international attorney organization DRI—filed an amicus brief with the Supreme Court. The brief argued that FDA should continue to be the sole regulator of medical devices and that allowing a state-law liability approach to assessing safety and effectiveness would lead to reduced patient access to essential medical technologies.

“FDA is the party best suited to balance the risks and rewards of medical technology innovations,” says Kevin M. Quinley, senior vice president for Medmarc Insurance Group (Chantilly, VA). “For all its imperfections, the agency is in the best position to assess those tradeoffs.”

Not Out of the Woods

 
Quinley
 
Quinley: Retaining FDA's authority.

Based on the Riegel ruling, Caryn M. Silverman, a partner in the New York office of the law firm of Sedgwick, Detert, Moran & Arnold LLP, expects to see device manufacturers sued in pending cases involving PMA devices to immediately file summary judgment motions seeking dismissal of those lawsuits. “The Riegel decision should support the dismissal of many pending claims in those suits,” she says.

Despite the favorable ruling in Riegel, Lockard notes that the medical device industry is not yet in the clear when it comes to preemption for PMAs. “The reaction by some members of Congress has been immediate, and we will certainly see legislative efforts to respond to the decision,” she says.

Indeed, immediately following the ruling, Senator Edward M. Kennedy (D–MA) issued a statement that read, “In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices,” he says. “Congress obviously needs to correct the court's decision. Otherwise, FDA approval will become a green light for shoddy practices by manufacturers.”

However, many medtech industry observers have been quick to dispute the generalizations being made by politicians and public health advocate organizations in protesting the Riegel decision.

 
Silverman
 
Silverman: Other manufacturers taking note.

“To say that this decision conveys blanket immunity to device manufacturers is a gross overstatement,” Lockard says. “The decision applies only to those Class III devices that went through FDA's premarket approval process. The decision also allows for exceptions where state requirements mirror the federal requirements or where a company failed to comply with FDA specifications and labeling rules.”

Business as Usual

Indeed, despite the significant amount of attention the Riegel decision has garnered, the ruling will likely do little to affect public health or the day-to-day practices of medical device firms. “It's easy to get caught up in hyperbole,” Quinley says. “But the Riegel decision does not represent a sea change in issues such as insurance pricing, market dynamics, or access to redress for injured patients.”

 
Magretten
 
Magratten: Weighing the options.

Lockard agrees. “The decision does not preclude lawsuits against manufacturers who failed to comply with FDA's specifications and labeling rules during the process,” she says. “Thus, the next battleground in medical device product liability litigation will be a fight over whether the company complied with FDA requirements imposed on the product.”

Quinley adds, “It's important to remember that Riegel will only affect a small slice of the universe of medical device product liability claims. Most medical device claims flow from non-PMA devices, and injured patients can still file suit against manufacturers of those products on any basis they like. And even for a PMA product, injured patients can still sue for manufacturing defects. Further, they can still pursue claims against a doctor who used a device inappropriately.”

Quinley notes that physician device misuse played a huge role in Riegel. Charles Riegel, now deceased, sued Medtronic for injuries he suffered when a balloon catheter manufactured by the company burst during angioplasty. Contrary to the catheter's warning label, Riegel's physician inflated the device beyond its specified rate burst pressure. Moreover, the catheter was contraindicated for use in patients who, like Riegel, had diffusely diseased and heavily calcified coronary arteries.

 
Hermann
 
Herrmann: 510(k) benefits.

“It seems like a pretty clear-cut case of medical malpractice,” Quinley says. “But the doctor was never sued because the deep pockets were perceived to be at the device manufacturer level.”

Just as Riegel does not signal an end to claims against manufacturers, it's also unlikely to have a drastic effect on the path by which most medical devices are cleared to market. Although PMA devices will come to market under an added level of legal protection not available to 510(k) devices, the 510(k) will continue to be an attractive regulatory path.

“In the occasional case where a manufacturer could elect one path or the other, it will have to balance the potential long-term protections of preemption under the PMA process against the immediate and substantial costs and delays of the PMA process,” says Brooks Magratten, a partner in the law firm of Vetter & White (Providence, RI). “For a new manufacturer, short-term considerations may prevail.”

“The 510(k) route is much less expensive to pursue and much quicker—so it leaves more of a product's patent life available after the device is approved,” adds Mark Herrmann, a product liability defense partner in the Chicago office of law firm Jones Day. “Manufacturers will probably continue to use the 510(k) route even though that route does not offer the benefit of preemption.”

Quinley agrees that the business imperative of getting to market faster via 510(k) clearance is likely to override the enhanced legal protection afforded to PMA devices. “To choose the PMA path for that reason would be the risk-management tail wagging the business dog,” he says.

© 2008 Canon Communications LLC

Return to MX: Issues Update.

Bringing Medical Devices Home

DEVICE DESIGN

This glucose monitor mimics high-tech consumer products. The effect is sophisticated and discrete.
Certain macrotrends in the healthcare and medical device industries have created an environment in which it is critical that products do a better job of supporting patients' needs. In general, the population is aging. People are living longer and therefore require more care. But hospitals and physicians struggle to balance profitability with care excellence. The average length of stay for a patient decreased consistently throughout the 1990s. The shift in care has moved from the hospital to the home and from clinicians to family caregivers and the patients themselves.1

Advances in technology have been able to support this trend. With the miniaturization and ruggedization of key hardware components such as pumps, processors, and displays, devices have become far more portable, and small enough to be hand carried, worn on the body, or transported on a wheelchair.

Patients themselves have also changed in recent years. Because patients (and their family caregivers) are able to access information via the Internet, they are becoming more knowledgeable about the care options—including devices, therapies, and interventions—they may receive to address their condition. Patients are also participating in virtual and real-world communities, and so are more empowered, invested, and active in the decisions related to their care.2

The Challenges

Because of these macrotrends in healthcare, medical devices (both critical and noncritical) are used more often in the home and are used in different ways from in the hospital. It is useful to explore these thematic differences before discussing how medical products need to be designed specifically for home use.

Variable Use Environments. Home-use environments include both the physical spaces in which devices can be found and where devices may be placed in relation to the patient. For discharged patients, especially those who are mobile, the environments of use are extremely varied. A personal oxygen device may be jostled as it is transported in a car, or it may be temporarily left in the car (with the window rolled up on a hot summer day) while the patient runs an errand. Broad variations in lighting, noise level, humidity, temperature, vibration, and stability need to be factored into development.

Differing Goals, Concerns, and Expertise of the Communities of Use. Communities of use refers to the people who interact directly and regularly with a device or who influence how the device is used. Communities of use typically include patients, family caregivers, nurses, physicians, and device suppliers and manufacturers. Each community of use has different goals for medical products in general, including specific goals for devices that are to be used by patients in the home. Understanding the goals, concerns, and levels of expertise of these communities is key to developing successful products.

Range of Clinical Scenarios and Patient Life-styles. A home-use medical device may be expected to support a broad range of etiologies (the causes or origins of the disease state), symptoms, therapies, data requirements, and patient life-styles. For example, an enteral feeding pump may be set to deliver continuous nutrition to one patient during a 10-hour period. For another patient, however, a 30-minute bolus of formula may be clinically appropriate. A pulse oximeter would provide varied readouts based on factors such as whether a patient is wearing nail polish one day versus the next.

Emotional Needs of Patients. Traditionally there has been limited focus on designing medical products that address the emotional needs of patients. Clinical requirements and the capabilities of the product have been the deciding factors while selecting products for patients. Patients had been given prescriptions and had little decision-making power regarding which product they used. As patients become more informed, however, their needs have become a more important factor in determining which products they end up including in their care.

Creating Positive Experiences

Designing medical products for the home, given all the challenges, may seem like an insurmountable task. However, if we think about the ways in which people connect with products to have a positive experience, it is possible to target areas of development that benefit from specific research and design techniques.

People connect to a product in three ways: through its usefulness, through its usability, and through people's affinity for the product. Product developers have traditionally focused on usefulness and usability as the ways in which people can connect with products. Methods for achieving usefulness and usability are well established, but can be challenging to implement when designing medical products for the home.

Usefulness. Usefulness is defined as the reason someone seeks a product or service. These reasons are simply so they can live better, achieve their goals, or be more productive. Observational or ethnographic techniques and open-ended discussions help developers discover what people need, or what would be useful to them. Validation methods such as scenario board development and directional testing can help determine whether concepts in development are delivering the promise of usefulness.

Usability. Usability refers to whether someone is able to use the product to an effective end, as the product is intended. Task analysis (analyzing the information and controls a user needs to successfully complete tasks) and usability testing (evaluating how well people understand what a product does and how well they make it do what it is supposed to) are two tools for understanding a product's usability. These methods, along with others such as heuristic evaluations and secondary physical and cognitive human factors data, are well proven in providing guidance to ensure a product's usability.

Figure 1. (click to enlarge) Designing for affinities requires a formal, iterative process that integrates research and design.
Affinity. Affinity in product design is the emotional connection some individuals may have for a product. Perhaps they are drawn to its aesthetics or identify with the product and the message it conveys. In contrast to usefulness and usability, affinity is about want or unexplained desire. Specific narrative, projective, and associative research methods enable investigations into what leads to positive brand affinities with products. Specific approaches can be used to design for affinities based on the core values people would like the products in their lives to embody. The device should project the appropriate character, tone, or personality (see Figure 1).

Medical products are, by necessity, becoming more like consumer products. They need to be useful and usable, but they also need to build affinity with patients. Pharmaceutical companies are already responding to these trends with direct-to-patient advertising. This strategy is based on connecting emotionally with patients and playing off their new sense of empowerment. By doing so, a patient may be more likely to request a certain brand of drug from their physician.

To develop successful products for the home environment, we must consider the products' usefulness, usability, and affinity throughout the development process. What makes this integrated, iterative, multidisciplinary approach successful is strong collaboration between research (methods), design (creativity), and engineering (execution).

Successful Development

Specific product development techniques can be used to address a patient's need for usefulness, usability, and affinity for home medical devices. The best way to understand these techniques is to examine the design process and its influence on how products fit into patients' lives and support clinician needs.

Understanding Behaviors and Needs. Generative research borrows ethnographic and contextual techniques (including shadowing, narrative tours, and observations of use) and includes focused interviews (with open-ended and directed questions). The results define the needs, tasks, activities, and patterns of product use in various communities. Generative research is the main method for understanding what would make a product most useful. The insight derived from generative research defines opportunity areas for new products or features and improvements to existing products. It provides input that guides the overall product strategy and development process, ensuring that divergent user needs are met.

Designing for Environment Fit and Mobility. The industrial design process aims to create a range of physical solutions as informed by the generative research for what would make a product useful. Through the development of multiple, varying concepts, the team is better able to identify optimal approaches that align proposed feature benefits with engineering, manufacturing, and marketing goals and constraints.

Appropriate industrial design provides products that perform effectively across different environments and can move seamlessly between them. This may result in configurable concepts that can change in size or weight depending on circumstances and still operate successfully. At other times, the industrial design must consider appropriate, informed trade-offs to arrive at a singular, unchanging design that functions successfully across varied scenarios. A home ventilator that is used at the bedside needs to have a handle placed to facilitate transport without taking up valuable space needed for other equipment such as humidifiers and oxygen reservoirs.

Designing for Ruggedness. Effective industrial design also accounts for likely misuses associated with mobility. This includes preventive design measures such as ensuring proper distribution of component weight and ergonomic carrying affordances to minimize the likelihood of drops. It also includes thoughtful implementation for all of the device's functional details. For example, a device shouldn't have tube connections that overtly protrude or include any part that might be prone to breaking. Also, using innovative materials can provide robust, wear-resistant surfaces that soften the impact of collisions.

Designing for Confidence. The design of the device must promote confidence and compliance, as well as minimize intrusion on the quality of life for patient and caregiver. Therefore, the design must present interaction points in an obvious and fail-safe manner that reduces the steps required to use the device. Hose and cable connections should be clearly differentiated as much as possible, utilizing size, shape, and color, to prevent incorrect use. Removable parts such as batteries or disposable cartridges should be designed to clearly indicate proper alignment and prevent improper loading.

Designing for Ease of Use and Learning. Ease of use directly affects the success of home healthcare devices. One aspect of ease of use is the appropriateness of information and controls to the user's tasks. If a wound-prevention mattress (used in the home to prevent pressure ulcers) enters an alarm state because there is insufficient airflow, ease of use dictates that controls for increasing airflow should be readily available with the alarm. Usability testing of various scenarios helps developers map device information and controls for user tasks.

Ease of use also relates to the readability and clarity of instructions, graphics, and icons. With therapy devices such as volumetric infusion pumps (for delivering very accurate flow rates of intravenous fluids), setup errors can result if the home caregiver inputs incorrect numeric settings, such as volume to be delivered. Often, these mistakes occur because simple elements such as decimal points may be too small to see.

Because most home caregivers do not have a clinical background, devices should be usable with little or no training. Ease of learning reduces user errors, improves patient safety, and increases user satisfaction. Borrowing from interaction models established by consumer products like televisions, cell phones, and personal computers is an effective method for increasing ease of learning. For example, a glucose meter may use soft keys, similar to those found on ATMs, for selecting options or initiating processes. Ease of learning benefits suppliers and manufacturers by reducing the costs of training and ongoing support.

Designing for Safety

A device's ease of use and ease of learning directly contribute to the overriding goal of safety. Designers need to integrate safeguards so that stopping the airflow to a ventilator-dependent patient, for example, is a two-step, intentional process. Device alarms, though stressful, can alert caregivers to problems and provide information to help resolve the alarm condition.

In addition to audio alarms, distinct visual shifts in screen color or layout can draw a caregiver's attention to scenarios in which the device is one of many medical devices in a busy room. Iterative interaction design helps developers strike the proper balance between ease of use and safety.

Evaluating Concepts

Evaluative research can narrow a wide range of potential designs into a single, viable direction for further development (a process known as directional testing). Evaluative research can also be used to refine the usability (including both physical and cognitive human factors) of a more advanced concept before it is finalized for implementation (typically called usability testing). Directional and usability tests should be conducted with both primary and secondary stakeholders in the actual environments of use. For best results, use the highest-resolution prototypes possible, although there is also a lot of value from getting input on more basic prototypes early in the development process.

Investigating Affinity

Affinity is a key aspect of how people connect with products. Designing for affinities is one of the most challenging parts of developing medical products for the home. Affinities are hard to investigate because emotions are often linked to memories and can change over time. Emotions are also delicate and tricky to communicate accurately, and people are uncomfortable revealing emotions to strangers (such as researchers). Affinities are also challenging to capture. Typical contextual research techniques of observation do not offer value because it is rare to witness meaningful emotions. Traditional interviewing techniques often fail because emotive words may mean different things to different people.

However, there are some things that people do well in relation to communicating their emotions. For example, people are comfortable telling stories about their experiences in their own terms and responding to stimuli. Specific techniques tap into these tendencies and can reveal individuals' emotional connections to products.

Encouraging participants to engage in storytelling may reveal emotional connections that do not surface with other investigational methods.
Storytelling. Storytelling is a narrative technique in which participants tell a story about an image they have selected from a collage. Participants choose the images they are most passionate about. The choice indicates emotional triggers and connections. This technique encourages recall of memories, aids in describing emotions, and focuses the participant on a single feeling, making the discussion less abstract. Storytelling explores influences beneath behaviors that are typically observed and reveals how affinities change over time.

Scenario Building. Scenario building is a technique in which participants project their ideal experiences onto abstract, open-ended scenarios. For example, a participant is encouraged to build on a cardiac care device, to say ideally how the device would behave, act, and respond. The person may describe an entity that continuously monitors heart health and that can also do anything else asked of it. This method allows participants to think beyond constraints of current technology and exposes true desires.

Figure 2. (click to enlarge) Participants respond to style boards, such as this one, and often those choices reflect their expectations of a product.
Style Boards. With style boards, designers and researchers collaborate to build frameworks of images of existing products clustered into distinct aesthetic categories (see Figure 2). Clusters are meaningful to designers (they contain obvious form, color, material, or finish elements) and represent semantic opposites to participants. Participants respond to the image boards and indicate the cluster in which they would expect to see a product concept and explain why.

Sensory Stimuli. Associative techniques, such as having participants react to texture and material samples, color swatches, word cards, or sounds, draw out stories and emotions related to all senses. These stimuli serve as a catalyst to start dialogue and enable sharing of information throughout discussions. They represent all senses and allow for subtle unarticulated preferences.

Designing for Affinity

Designing for affinity requires a formal process. Once the core values that patients would like a product to embody are understood, designers can think about how a device can best address those values. The character of the product is manifested through its industrial design (the way the product looks and what it does) and its experience design (the way the product acts and how you interact with it). Design principles define character as the signature elements and specific features, functions, attributes, behaviors, and affordances that are concrete and actionable.

Visual Language. Visual language communicates the character of the product through aesthetics (form, color, material, and finish), graphics, and defining signature elements. If a visual language is to be successful, it must systematically relate to the core values of patients and the experience they desire. For example, if a glucose meter is targeted for teenagers, it may be designed so that it presents an image of a “cool” consumer device (e.g., an MP3 player). The method addresses teenagers' need for discretion while still communicating advanced technology.

Experience Design. Part of product satisfaction comes from supporting the type of experience people want to have. For instance, if research indicates that people want to be uninhibited by their personal oxygen system, designers must ask themselves what they can do to promote a feeling of freedom. One approach might be to introduce more automation into the device such as pressure sensing so that more oxygen is delivered when the patient is active.

Alternatively, the designer may introduce single-handed or hands-free operation elements. Designing for affinities in medical products often requires careful balance between divergent goals; elements of a product's character or personality may be in conflict. For example, the development team may need to balance a friendly and approachable tone with trustworthiness, seriousness, and reliability expected in a life-sustaining device.

Conclusion

By using a multifaceted suite of methods along with an expert, multidisciplinary team, it is possible to develop medical devices for the home environment that address patient and family caregiver needs for usefulness, usability, and affinity. Developing products that connect with patients in these three ways has many benefits including increased sales via patient pull-through, word-of-mouth publicity, and brand recognition and loyalty. Most importantly, good design leads to increased patient compliance and better clinical outcomes.

Matthew Jordan is director of research and interaction design at Insight Product Development (Chicago). He can be reached at mjordan@insightpd.com.


References

1. Report to the Congress: Medicare Payment Policy Appendix D, Table D-3, “Change in Medicare Inpatient Length of Stay, 1991–2000” [online] (Washington, DC, Medicare Payment Advisory Commission, March 2003 [cited 7 January 2008]); available from Internet: www.medpac.gov/publications/congressional_reports/Mar03_AppD.pdf.

2. “E-Patients with a Disability or Chronic Disease” (Washington, DC, PEW Internet and American Life Project, October 2007 [cited 7 January 2008]); available from Internet: www.pewinternet.org/pdfs/EPatients_Chronic_Conditions_2007.pdf.

Copyright ©2008 Medical Device & Diagnostic Industry