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Articles from 2013 In August


A Preview of MedTech Polymers

This year’s PlasTec Texas Expo and Conference will be held October 14–15, 2013. The event will be comprised of two industry conferences (MedTech Polymers and Powder Bulk Solids) as well as the Houston Seminar Series and a Tech Theater. In addition, the event will feature more than 50 presentations ranging in structure from interactive case studies and technology breakdown sessions, to panel debates and keynote presentations. This slideshow provides a preview on what to expect at both the expo and conference.

This year’s PlasTec Texas Expo and Conference will be held October 14–15, 2013. The event will be comprised of two industry conferences (MedTech Polymers and Powder Bulk Solids) as well as the Houston Seminar Series and a Tech Theater. In addition, the event will feature more than 50 presentations ranging in structure from interactive case studies and technology breakdown sessions, to panel debates and keynote presentations. This slideshow provides a preview on what to expect at both the expo and conference.

What Medtronic's New Direction Means for Medtech

Earlier this summer, Medtronic announced the acquisition of Cardiocom, a chronic disease management company, for $200 million. The company described the acquisition as part of its broader vision for the future. However, some analysts believe that this purchase could indicate difficult times for the medical device industry, and Medtronic's own faith in its traditional medtech business. Omar Ishrak, CEO of Medtronic, stated that its involvement as a hospital-consultant and disease-management specialist is evidence of an evolution that will help the company improve its reach into the healthcare ecosystem. Armed with the Cardiocom acquisition, the first part of this initiative will focus on patients suffering from heart failure. "The necessity for change is unmistakable," Ishrak noted during a conference call. "The good news for Medtronic is that, in this time of uncertainty, there will be a premium placed on those who can innovate." Deutsche Bank analyst Kristen Stewart points out that the underlying message behind Medtronic's action is a push to continue to offer value in face of an environment that is increasingly focused on slashing costs. The current environment no longer rewards incremental innovation with tidy sums. In addition, physicians--representing much of Medtronic's traditional customer base--is no longer nearly as powerful in making purchasing decisions. Instead, increasingly, hospitals themselves have become empowered to make those choices. Stewart argues that Medtronic's new direction is a "a significant departure" that could indicate "challenging times ahead for device manufacturers." Other big device companies are likely to follow in Medtronic's footsteps and diversify their business, which would represent a turning point for the industry, which had been moving in the opposite direction in recent years. Consider, for instance, that big companies like Covidien has recently sold off non medical device units to focus squarely on that business. For medical device manufacturers, focusing on FDA approval and new technologies may not be enough. Instead, Ishrak believes that leaders of medical device firms must focus on a patient's overall health with a broad continuum of care. According to analysts at Deutsche Bank, this evolving business model could indicate challenges faced across the industry. "The challenge for a company like Medtronic is that the products are typically a substantial portion of the costs and in many cases hospital efforts to reduce costs are focused on just gaining greater price or standardizing to use less or lower cost products," notes Kristen Stewart, an analyst at the German bank. These concerns have been seen at other medical device manufacturers too. Earlier this year, Qmed explored how Intuitive Surgical's poor results in the second quarter affected medical device exchange-traded funds. On July 9th of this year, shares of Intuitive Surgical dropped down almost 18% following Q2 results. While da Vinci's poor results were partially a result of several ongoing concerns about the cost-effectiveness and safety of its da Vinci robotic surgical system, the company's lackluster performance was able to drag down a variety of financial instruments. Following the release of its Q2 results, the iShares Dow Jones US Medical Devices ETF dropped 1.6%. Another instrument, SPDR S&P Health Care Equipment ETF, dropped 0.9%. Since Intuitive Surgical comprises only 2.3% of the SPDR S&P Health Care Equipment ETF, this represents a significant drop. In part, these ETF drops could indicate issues with the overall medical device industry. These issues include international pricing pressures, competition from emerging markets, the 2.3% medical device tax and soft spending at healthcare facilities. That being said, the medical device industry in the United States has weathered the recession better than many other industries. As long as medtech leaders look for new, innovative ways to improve patient outcomes and quality of life, the medical device industry will still have room to grow.

Medical Device Jobs: The Ultimate Medtech Career Guide

Medical Device Jobs: The Ultimate Medtech Career Guide

The medical device industry offers lots of opportunity for employees. In the United States alone, more than 7000 medical device companies employ more than 400,000 workers who earn salaries that are more than 40% higher than the national average, according to an AdvaMed report. 

Looking for a job in medtech? Attend the MEDevice San Diego Conference September 26–27, 2013 for valuable networking opportunities.

But landing a job with a device company can be challenging. To help you out, MD+DI has put together a roundup of career advice for medtech job seekers. Whether you're looking for a job, asking for a raise, or trying to decide which career path to take, you'll find the answers to your questions here.

Job Search

How to Land a Job in Medtech

The Most Common Resume Mistakes Medtech Job Seekers Make

Tips for Medtech Job Seekers

Which Medtech Jobs are in Demand?

Where to Move to Land a Job in Medtech

Which States are Home to the Most Medtech Jobs?

Medical Device Job Advice from Reddit

 
Compensation

Medtech Salaries By the Numbers

Medtech Salary Stats

2012 Medical Device Industry Salary Survey Analysis

Salary Calculator

 
Career Path

Medtech Salaries by Position

The Highest-Paid Engineering Positions in Medtech

Which Medtech Jobs are Paying Well?

Should You Work for a Medtech Start-Up or an Established Firm?

Should You Consider a Job in Regulatory Affairs?

My First Job Was Boring: Confessions of a Medical Device Software Engineer

Jamie Hartford, managing editor, MD+DI
jamie.hartford@ubm.com

[image courtesy of PONSULAK/FREEDIGITALPHOTOS.NET]
 

Stroke-Detection Startup Gets Boost from European Investors

Jan Medical (Mountain View, CA) landed Series B funding from Brainlab, a German-based investor. Armed with the additional funds, the company will continue its pursuit of FDA approval for its ischemic stroke system. The device can also be used to detect concussions. While the company didn't disclose the total investment amount, it's believed to be above $3.15 million.

According to the company, new funding for the Nautilus NeuroWave is valuable in today's market. Since venture funding for diagnostics and medical devices has been depressed, the latest cash infusion is good news for the company. The stroke / concussion-detection device, dubbed Nautilus NeuroWave, can detect abnormalities in a patient's brain faster than existing technologies. In particular, the device can detect cerebral abnormalities with a higher level of precision than traditional imaging systems.

The novel device currently has an Investigational Device Exemption (IDE) in the United States. In many cases, the Nautilus NeuroWave can diagnose the health of a patient's brain in only a few seconds.

While ischemic strokes are treatable with current medical technologies, there is only a small window where treatment is effective. However, most modern brain imaging techniques are ineffective at detecting an ischemic stroke. While there are advanced imaging options, these are not widely available and can take more time than a traditional CT scan.

"Patient outcomes will be enhanced, as healthcare providers will have clinically relevant and timely information to treat their patients faster, at lower cost and with less risk," notes Paul Lovi, president and CEO of Jan Medical.

St. Jude's Renal Denervation Tech Cleared in Europe

St. Jude Medical landed CE Mark approval of its EnligHTN Renal Denervation System. The device is designed to treat patients suffering from uncontrolled, drug-resistant hypertension.

Armed with an advanced generator that can deliver simultaneous ablations through the use of a multi-electrode catheter, the device can reduce total ablation times by four-fifths compared to first-generation systems. This represents a reduction in ablation times from 24 minutes down to four minutes.

Renal denervation is an ablation procedure that utilizes catheters to treat hypertension. By delivering radiofrequency energy through an ablation catheter, the device can create miniature scars along a patient's renal nerves.

Since renal nerves play a role in controlling blood pressure, creating these lesions can reduce both systolic and diastolic blood pressure in hypertensive patients. The device features a non-occlusive, unique basket design. This gives physicians the ability to deliver predictable treatments while allowing continuous kidney blood flow. The device, featuring four catheter electrodes, delivers 60-second ablations. Under most usage conditions, these ablations are performed twice in each of a patient's renal arteries.

"The next generation EnligHTN system offers physicians our proven multi-electrode catheter with a new intuitive, faster generator that quickly and effectively delivers consistent ablations with a significant reduction in procedure time," noted Frank J. Callaghan, president of Cardiovascular and Ablation Technologies at St. Jude Medical.

Advamed Calls CDRH ‘Inconsistent with ISO’ in New Guidance

Advamed Calls CDRH ‘Inconsistent with ISO’ in New Guidance

By: Jim Dickinson

AdvaMed says that a CDRH draft guidance on using international standard ISO-10993 on biological evaluation of medical devices is inconsistent with agency acceptance of the principles in ISO-10993-1:2009. For example, Advamed says the draft guidance puts a strong emphasis on biological test selection, with minimal guidance on the earlier standard’s three-step process for biological evaluation.

According to AdvaMed, the draft guidance implies that FDA favors biological testing rather than using the principles established in ISO 10993-1:2009 to prompt necessary testing using a risk-based approach for evaluating biological safety of medical devices. “Ignoring such a fundamental change to a key international standard is a major oversight that needs to be addressed,” Advamed's statement says.
 
Comments from the 510(k) Coalition, a lobby group of medical device companies, say that in addressing biological evaluation of new medical devices, FDA must balance the need for appropriate biological evaluation to identify real life risks with the need for timely patient access to new medical devices. “An inappropriate standard has the real potential of slowing medical innovation, limiting patient access to better devices, and consuming valuable agency and industry resources,” AdvaMed says.
 
The coalition urges that FDA implement least burdensome principles, ensure that the draft guidance is not prematurely implemented, provide a logical implementation timeframe, ensure a reasonable probability of actual exposure before testing is required, ensure that one is not obligated to test materials already approved by FDA or routinely used in medical devices, revise the definition of “material” to make it consistent with general usage of the term, ensure that the agency maintains the 510(k) regulatory pathway, address risk/benefit questions, and link the document into the modifications requirements and guidances, among other things.
 
In separate comments on the draft, three experts from the ISO Technical Committee 194 that writes the ISO 10993 series of standards caution that the specific approach taken in the document “does not adequately capture the letter or the intent of the current versions of ISO 10993-1 and ISO 14971. Rather, the draft guidance continues and in some ways extends the earlier approaches … where there is undue emphasis on adherence to a predetermined list of tests to be carried out, and insufficient attention to rigorous expert evaluation of biological risks and focus on the significant risks identified in a risk management-based evaluation.”
 
In its comments to the docket, the Medical Device Manufacturers Association (MDMA) voices support for the comments from the 510(k) Coalition and reiterates several of its key concepts.
 
Merck recommends that FDA strengthen the draft guidance by including specific recommendations for scenarios where chronic in vivo testing may be considered to clarify the likely length of testing as it relates to device contact duration.
Roche says the guidance appears to focus mainly on requirements for additional in vivo studies beyond those proposed by ISO 10993-1 and it might be better to focus on studies that may be eliminated from the testing program consistent with industry efforts to reduce animal use.
 
Johnson & Johnson says it generally agrees with the draft guidance and believes some areas of it would benefit from more complete harmonization with ISO 10993-1 and the entire ISO 10993 series of standards. It also voices support for the comments from AdvaMed and the 510(k) Coalition.
 
Finally, People for the Ethical Treatment of Animals says the draft guidance fails to incorporate support for use of non-animal methods and other refinements in many of its recommendations. It says,“We urge FDA to strengthen its stance on use of non-animal methods and other humane practices in the final guidance document so as to reduce confusion in industry regarding FDA’s acceptance of procedures that replace the use of animals in procedures, lessen the pain and suffering they endure, or reduce the number of animals required.”  

FDA Considers Sex-Specific Medical Devices

On average, women will use medical devices more than men during their lifetimes. Based on this, FDA regulators are looking for effective ways to create gender-specific medical devices for women. In early August, FDA regulators shared news of an initiative to develop gendered medical devices. In a congressional report required through Section 907 of the FDA Safety and Innovation Act, officials explored how women and other demographics help support the approval of medical devices through clinical trials. To gain a better understanding of how women impact clinical trials for medical devices, regulators explored 37 premarket approval applications in 2011. Based on these results, FDA regulators note that sponsors provide and analyze clinical data about women in many unique ways.

In particular, the report highlighted a workshop by the Center for Devices and Radiological Health. This workshop was designed to explore how the health of women (HoW) is linked to medical device use.

The HoW initiative includes three broad goals. One goal includes the development of innovative clinical studies, technology and innovative strategies. Another goals hopes to address unmet needs and identified gaps through the use of targeted resources. Finally, officials hope to improve communication between providers and women.

By improving the quality and consistency of healthcare-related communication, officials hope to find new ways to ensure the safety and efficacy of medical devices used by women. To make this happen, hundreds of representatives from advocacy groups, federal agencies, healthcare, academia and industry joined together to brainstorm effective ways to find solutions to clinical research needs.

This initiative was based on draft guidance released on December of 2011 (and also noted in the 907 report by FDA regulators). In the draft, officials at CDRH outlined expectations for sex-specific enrollment in data analysis, clinical studies and the dispersal of study-related information. Officials hope that the final guidance can provide a solid framework for guiding the analysis and communication of device clinical studies that involve women.

In addition, the HoW program by CDRH hopes to complement this initiative through the development of partnerships with other key players. Officials believe that communication information about gender differences to the medical device industry, clinical investigators and health care professionals can improve patient outcomes.

Taken as a whole, officials believe that laying this groundwork out can ensure that women are considered in device innovation and research agendas. By guiding the clinical community and industry to focus on women, officials believe that providers will be in a better position to understand how gender-specific treatment options can impact patient outcomes.

Officials will release an Action Plan in 2014.

Types of Miniature Liquid Valves

It is possible to choose several types of liquid valves. Each has advantages as well as disadvantages. In general, a two-way valve is selected for applications that require the stopping and starting of flow. A three-way valve is useful where it is necessary to select one liquid or another, or to mix two liquids.

Meet with valve suppliers at MD&M Chicago, September 10–12, 2013.

In poppet solenoid valves, the liquid flows around the plunger, spring, and the internals of the body of the valve. It is therefore a valve that has a high internal volume and is not well swept, meaning there could be significant carryover. Poppet valves are good at handling crystals, and they seal at high pressures. When made from the right grades of stainless steel, the valves can be highly resistant to bleach and other chemicals. When an application calls for no carryover, it is best to choose an isolation valve.

Diaphragm isolation valves often look like a poppet valve, but instead of the fluid flowing through the body, spring, and actuator, a diaphragm is placed such that the poppet pushes on one side while the fluid is on the other side, thereby isolating the fluid. The valves thus have very low carryover, and the components on the nonliquid side of the valve do not have to be chemically compatible with the fluid. The valves can have very small internal volumes and typically do not handle high pressures well. They also tend to have slow response times because the diaphragm, which has low inertia, has to be moved. Diaphragms are typically made out of Teflon, EPDM, or FKM.

Another kind of isolation valve is the rocker isolation valve. In this type of valve construction, a solenoid acts on a rocker assembly that pivots, sealing first one seat and then the other seat. It has more internal volume than a diaphragm isolation valve but less than a poppet valve. It is typically less well swept than a diaphragm isolation valve. The valve is small, so the design is more compact, which is an advantage in some situations. However, the valves tend to have lower pressure ratings compared with poppet valves and tend to have more carryover than diaphragm isolation valves.

Pinch valves allow no contact between the valve and the fluid. Tubing containing the fluid is placed in a channel in the valve, and the valve pinches the tubing to stop flow. The valves are inexpensive and have no carryover. However, over time the tubing begins to shed particles which can clog the system or contaminate the fluid. Time fatigue can cause the tubing to restrict flow. The tubing does not open completely when the valve opens. The tubing also wears out quickly, which means that pinch valves have higher maintenance costs.

Donald S. McNeil, BA., MBA, is senior product manager for Parker Hannifin Corp.’s Precision Fluidics Division. He has more than 25 years of experience developing laboratory instruments for clinical diagnostics and analytical chemistry. Previous positions include product management at Beckman Coulter, Bio-Rad Laboratories and Veeco Instruments. E-mail him at dmcneil@parker.com. 

How to Select the Correct Miniature Liquid Valve

How to Select the Correct Miniature Liquid Valve

Miniature liquid valves direct fluid flow in clinical diagnostic, analytical chemistry, and agent-detection applications. Selecting the right valve to control the flow of the various media is not always a simple process. Instruments used for clinical diagnostics might involve in vitro systems found in hospital labs that automate testing blood and other bodily fluids for different diseases or automate testing DNA, RNA, and proteins for biomarkers. Analytical chemistry equipment often automates the analysis of different cells’ characteristics.

In selecting the right miniature liquid valve for these kinds of applications, many factors, including the valve’s internal volume, the carryover, the kind of fluid to be pumped through the equipment, the valve’s leak rate, and the overall system pressure, should be considered. A good way to get a better handle on the selection process is to take a closer look at these requirements.

Internal Volume

A key consideration for a miniature liquid valve is its internal volume, which can range from a few microliters to hundreds of microliters. Most liquid valve manufacturers list the internal volumes for their valves.

Meet with valve suppliers at MD&M Chicago, September 10–12, 2013.

There are two reasons to look for a minimal internal volume in a liquid valve. The first is to reduce the cost of individual tests. For example, designers continuously search for ways to reduce the amount of expensive reagents used during a test. Having a reduced internal valve volume may allow for reduced reagent consumption. Secondly, internal volume can affect carryover, which occurs when a portion of a sample left in the valve contaminates the next liquid running through it. Poor carryover performance can result in questionable or inaccurate test results or require that the valve be washed for longer periods to clean it out, causing delays before the next sample can be run. This loss of throughput reduces the effectiveness of a laboratory instrument.

Although carryover can be worse in valves that have larger internal volumes, it is not always the case. The key to avoiding carryover is to ensure that the fluid path through the valve is very well swept. Swept refers to how well the fluid flows through the valve based on valve design (e.g., it does not contain pockets for the fluid to get stuck in and slowly leach out later).

Carryover is a function of the valve design, the flow rate of the liquid through the valve, and of the chemicals being pumped. Some liquids are more viscous than others, and it is possible to have a valve with a higher internal volume that is very well swept and has a lower carryover than another valve with a smaller volume that is poorly swept. When a valve is poorly swept, a smaller internal volume might have a higher carryover.

It is common to test for carryover by comparing valves from different suppliers in the same setup to see which performs best. Carryover is not a concern in applications for which a valve is always running the same kind of fluid or where mixing fluids is not an issue, e.g., if the valve delivers the same reagent all the time.

Material Compatibility

Another critical consideration is whether the valve is compatible with the fluid that will flow through it. Valves typically encounter common fluids such as solvents, acids, bases, bleach, and saline solutions. In general, a miniature liquid solenoid valve is made up of components such as a valve body, an elastomer seal, a spring, and a solenoid actuator, all of which must be compatible with the fluids with which it will come into contact.

If the valve that is not compatible it can fail prematurely or contaminate the fluid. For example, a fluid such as methanol can destroy a fluoroelasomer (FKM) seal. In this case, it is better to select a valve with a seal made from ethylene propylene diene monomer (EPDM).

In addition to choosing a valve with a compatible seal, it is critical to choose a valve with wetted parts (all parts that come into contact with the fluid) that are compatible with the fluid (see Table I). For example, valves with Teflon diaphragms can be damaged by media that contain particulates, whereas stainless-steel valves can be highly resistant to corrosive materials such as bleach. As long as the valve and its internal parts are compatible with the media, the valve is classified as “inert.”

Table I. This chart for Parker Hannifin’s Series 3 miniature inert valve shows the compatibility of various chemicals with different valve seals and wetted parts.

Valve Leakage

Another factor to consider is a valve’s leak rate. There are two leak rates that are important to consider when selecting a liquid valve: internal and external leakage. Internal leakage occurs when a valve does not completely close. This can cause test samples to be contaminated or cause equipment to consume more fluid than needed. Many manufacturers publish the leak rates for their valves.

Most valves are rated bubble tight. Under this designation, the valve is tested with air at a certain pressure and with the valve closed. The valve is considered leakproof when no air bubbles leak past the valve seat. The test is a good indicator that the valve will close securely because the small molecules of a gas are much harder to seal against than the significantly larger molecules of a liquid. The test thus proves that no liquid will make its way out of the valve.

The main factor affecting internal leakage of a valve is the system pressure. The higher the pressure, the more difficult it is to seal against it. For low-pressure applications, rocker isolation valves often work well. For high-pressure applications, a poppet valve does a much better job (see the sidebar "Type of Miniature Liquid Valves"). Using the operating pressure specification found in the manufacturer’s catalog helps in deciding which valve will work best.

When a valve leaks externally, it might indicate that the valve is damaged, was installed incorrectly, or the connections to the valve are not secure. Additionally, some valve designs are simply better at eliminating external leakage.

External leakage must be avoided because when a valve is handling caustic material, fluid dripping from the valve could damage the equipment or invalidate test results. An important example can be found in a bleach valve. Should bleach leak out of the valve and into the system, it can destroy critical components. Noxious fumes can also be a safety concern for operators or patients near the device.

Controlling bleach is important in applications such as clinical diagnostics. For example, in vitro diagnostics machines pump blood and body fluids. Periodically, the whole system needs to be shut down and the samples removed (see Figure 1). Bleach is pumped through all the fluid circuits to clean out any proteins or other matter. Next, the system is flushed with water to remove the bleach. A special grade of stainless steel and materials that are highly resistant to bleach can improve the effectiveness and stability of the valve.

Figure 1. This image shows a typical flow diagram of a bleach wash system. The three way valve is used as a diverter to select either bleach or water. The two-way valves on the manifold assembly turn on and off to deliver the liquid selected.

In terms of risk mitigation, when pumping a fluid such as bleach, it is better to select a poppet valve over a diaphragm valve because the diaphragm is a thin membrane of rubber that, over time, can fatigue enough to leak externally.

To reduce external leakage, it is best to mount the valve by way of a manifold. The manifold provides a flat surface on which to mount the valve and has internal passageways, instead of a bunch of tubing, that connect the valve to the system. Manifold mounting allows a higher packing density of all the system’s valves and simplifies the fluidic design.

The second best approach to attaching the valve is by way of threaded connections. The connection most likely to leak externally is tubing pushed onto a barbed fitting.

Pressure and Flow

Another basic consideration is the fluid flow through the valve. Generally, system pressures typically range from about 10 to 30 psi and are generated from devices such as a pump. When selecting a liquid valve, it is important to consider what orifice size will meet a designer’s target flow rate at the particular operating pressure. To evaluate the flow rate, consult the valve’s flow curve.

Fluidic design is fairly complex. The flow rate required at different points in the system must be known, and the correct orifice size can be selected accordingly after looking at the flow curve. The orifice size determines the flow capacity of a valve, but often it does not provide the exact flow rate required by an application. However, the flow rate can be controlled by timing the opening and closing of the valve to supply only the desired volume of fluid required. The exact valve timing can be programmed into the system controller.

Fluid Particulates

Particulates in the fluid can restrict the flow of a valve or prevent it from opening or closing fully. For example, crystallized salts could get stuck in the valve, or the media could contain debris. Different valves are better suited to handling particulates than others. For example, a type of poppet valve pushes a metal plunger with a hard seal material down on the seat using a return spring force. It easily breaks up crystals that may form in the valve. Diaphragm isolation valves and rocker valves are not as good with particulates because they have a soft diaphragm that particulates can deform or damage, causing the valve to leak internally.

Other Considerations

The electrical voltage required to actuate a miniature liquid valves must also be considered. The typical voltages used in the systems under discussion are 12 or 24 V dc. Selection here is just a matter of choosing the appropriate voltage for the system.

In addition, reliability is critical. Over the life of a system, a valve might open and close hundreds of thousands to millions of times. To ensure a valve will operate reliably, look for one with a reliability rating of millions of cycles. The valve design is a major factor of how reliable it will be. Valves without sliding metal-to-metal surfaces are best because they minimize wear on the moving parts, thereby increasing the life of the valve.

In conclusion, selecting the right miniature liquid valve involves a number of decisions to match the correct valve type and compatible materials to the needs of the application. The various advantages and disadvantages of the types of liquid valves should be considered in selecting the right valve for a particular fluidic system.

Donald S. McNeil, BA., MBA, is senior product manager for Parker Hannifin Corp.’s Precision Fluidics Division. He has more than 25 years of experience developing laboratory instruments for clinical diagnostics and analytical chemistry. Previous positions include product management at Beckman Coulter, Bio-Rad Laboratories and Veeco Instruments. E-mail him at dmcneil@parker.com.

How BD Uses Human Factors to Design Drug-Delivery Systems

How BD Uses Human Factors to Design Drug-Delivery Systems

Improving the administration and compliance of drug delivery is a common lifecycle strategy employed to enhance short- and long-term product adoption in the biotechnology and pharmaceutical industries. With increased competition in the industry and heightened regulatory requirements for end-user safety, significant advances in product improvements have been achieved in the injectable market, for both healthcare professionals and patients. Injection devices that facilitate preparation, ease administration, and ensure safety are increasingly prevalent in the marketplace.

The BD Physioject Disposable Autoinjector offers users a 360° view of the drug injection process and features a one-touch injection button.

While self-injection devices use proven technologies that enable commercialization within one to three years, differentiating these systems in a competitive marketplace requires considerable insight into the disease state, market trends, and potential patient profile. Despite the operational burden associated with introducing a new self-injection device into the pharmaceutical market, many companies now use human factors engineering to retain or enhance market success.

The home healthcare market, for example, has become an area of increasing focus for the pharmaceutical industry, with growth in the United States of approximately 8% year over year and an annual market spend in excess of $2.6 billion in 2012.1 Interest in self-administration injection systems also continues to grow in outpatient care with the introduction of new injectable therapies for the treatment of diabetes, rheumatoid arthritis, infertility, multiple sclerosis, and many other diseases that affect large populations. Self-administration injection systems offer convenience by allowing patients to administer physician-prescribed medications in their preferred setting.

When selecting a system for drug delivery, it is imperative that the end user can use the system successfully. A patient-centric model can help maximize the opportunity for such success. The working philosophy of human factors engineering is now being used throughout the pharmaceutical industry through an interdisciplinary approach that evaluates patient dynamics and focuses on improving the safety, efficiency, and robustness of the delivery system. This approach examines where “a body of knowledge about human abilities, human limitations, and other human characteristics that are relevant to design” can be used when designing a drug-delivery system. 2

In response to increasing request for human factors studies in the approval of medical systems in the United States and EU, CDRH in 2011 issued a draft guidance on the consideration of human factors in medical device development and testing. The guidance provides recommendations for medical device design optimization through human factors analysis, testing, and validation. The intent is to improve the quality of the device user interface such that errors that occur during use of the device are either eliminated or reduced.3

As a result of the recent guidance, designers and manufacturers of medical devices are now accountable for assessing and mitigating user error. Coupled with IEC 62366:2007 and AAMI’s HE75, there are now clear guidelines to provide direction for applying best practices for human factors and usability engineering in product design, for assessing and controlling use error, and for developing the evidence needed to support regulatory review of the product.4, 5 In addition, these guidelines hold medical device developers and manufacturers accountable for considering user needs to ensure that design features are likely to lead to correct use of the device. Failure to consider human factors and usability can now result in costly delays caused either by designing a suboptimal product or by lengthening the process of obtaining regulatory approval to market the product.5

Traditionally, human factors engineering addresses individualized aspects of development for each self-injection device, including the following:

  • Task analysis and design.
  • Device evaluation and usability.
  • Patient acceptance, compliance, and concurrence.
  • Anticipated training and education requirements.
  • System resilience and failure.

To achieve this, human factors scientists and engineers study the disease, patient, and desired outcome across multiple domains, including cognitive and organizational psychology, industrial and systems engineering, human performance, and economic theory—including formative usability testing that starts with the exploratory stage of the device and continues through all stages of conceptual design. Validation testing performed with real users is conducted as the final stage of the process.

FDA, however, recommends that validation testing be performed in a simulated user environment that challenges all key aspects of a product’s design and that reflects the level of product-use training end-users are likely to receive. To meet these standards, many pharmaceutical manufacturers and drug-delivery system companies will need to reposition product design and engineering platforms to focus more on the relationship between the patient and the delivery system.

There are, however, a number of limitations to the utility of human factors engineering in the development of medical devices, particularly self-injection devices. These are often directly related to the targeted patient profile, with many similar limitations to the overall clinical trial design and conduct. While field-based survey methods are extremely useful because they are conducted in the patients’ natural environment, there are various limitations including:

  • Patient recruitment, training, and study monitoring.
  • Longer study periods to accommodate redesign.
  • Patient attrition.
  • Inability to anticipate pain on injection reactions.
  • Limited patent protection on redesigned devices.

The Importance of Human Factors Engineering at BD

Becton, Dickinson, and Co. (BD) has more than 100 years of experience developing medical technologies to address healthcare problems and has established a patient-centric culture that flows through to the current product design approach. Our product development teams have realized that while home healthcare can offer patients new levels of treatment conveniences, there must be a greater focus on understanding the design and utility of the system and the human factors that influence its overall usability. BD proactively and independently designs studies to ensure the highest quality human factors research is a component of the final product our partners put into the hands of patients.

The goal of each product development team at BD is to develop drug-delivery systems that make it safer and easier for patients to take medication the right way every time. Considering the device-user interface, human factors engineering has become an integral part of medical device development and, consequently, for combination products, such as disposable pens, autoinjectors, and patch pumps. As a result, BD is now in the unique position to integrate new patient-focused characteristics to successfully prove the safety and efficacy of the systems released on the market.

Human Factors in Action

In developing or modifying a self-injection system, the engineers at BD undertake extensive patient-focused research designed to uncover unmet patient needs¬—identifying human factors concerns that directly impact usability. A key part of this development process involves subjecting the device to several rounds of usability testing, putting the representative system into the hands of the target user.

The BD Physioject Disposable Autoinjector is a recent example of a commercialized self-injection drug-delivery device where human factors engineering played a key role in the product’s success. Designed for use in the treatment of chronic diseases such as rheumatoid arthritis, multiple sclerosis, and osteoporosis, the BD Physioject pen is a single-use, disposable autoinjector that incorporates a BD Hypak Glass Prefillable Syringe to perform fixed dose automatic injections.

To design the BD Physioject Disposable Autoinjector System , BD conducted multiple human factors studies and clinical studies to assess all aspects of performance safety, efficiency, patient acceptance, and ease of use, including pain perception compared with prefilled syringes.5 The studies provided essential insights regarding the overall user-product interface and highlighted that patients had a strong and positive response to both the product design and the user experience.

As a result of human factors testing, the BD Physioject Disposable Autoinjector System provides multiple features designed to aide in patient safety and ease of use, allowing the patient to control the start of the injection once the autoinjector is placed on the skin and the cap is removed. Specific design features included in the BD Physioject Disposable Autoinjector System include the following:

  • Ergonomic design that is easy to handle and use, especially in patients with limited dexterity.
  • A 360° view of the drug and injection process, allowing the patient to confirm full dose delivery.
  • A simple, one-touch injection button for activation.
  • A hidden needle before and during injection to reduce needle-stick anxiety.
  • A protected needle before and after injection to reduce the risk of needle stick injury.

The BD Physioject Disposable Autoinjector System can also be customized to further meet patient-specific or disease-state-specific requirements.

As a result of the advances in patient adherence and compliance, as well as overall acceptability and effectiveness of autoinjection drug-delivery devices, drug-delivery system manufacturers now work in close partnership with pharmaceutical companies to maintain a high standard of product development through human factors testing. This partnership enables the design and execution of testing protocols that identify the widest possible range of issues that may affect the user experience at an earlier stage of drug development. When submitted to regulatory and health authorities as part of the overall approval process, data on human factors testing may facilitate product registration.

Although there are still logistical solutions to further address, human factors engineering provides a patient-centric model for the development of new and innovative strategies to meet the changing needs of the pharmaceutical industry. Medical technology companies can now design drug-delivery devices that meet the physical and emotional needs of the general population of care providers, patients, and other users—ensuring increased patient usability and therapeutic compliance. Human factors engineering plays a pivotal role in ensuring the patient remains central to the development process through usability, verification, and ongoing validation testing.


References

1. Declining Medicine Use and Costs: For Better or Worse? A Review of the Use of Medicines in the United States in 2012, [online] (Parsippany, NJ: IMS Institute for Healthcare Informatics, May 2013); available from Internet: http://static.correofarmaceutico.com/docs/2013/05/20/usareport.pdf.

2. A Chapanis, “To Communicate the Human Factors Message, You Have to Know What the Message Is and How to Communicate It,” Bulletin of the Human Factors Society 34 (1991): 1–4.

3. FDA, “Draft Guidance for Industry and Food and Drug Administration Staff —Applying Human Factors and Usability Engineering to Optimize Medical System Design” (Washington, DC: CDRH, Office of Device Evaluation, 2011).

4. IEC 2366:2007, “Medical Devices—Application of Usability Engineering to Medical Devices” (Geneva: International Electrotechnical Comission, 2007).

5. ANSI/AAMI HE75:2009, “Human Factors Engineering—Design of Medical Devices” (Arlington, VA: Association for the Advancement of Medical Instrumentation, 2009).

6. Supplement Approval—Rebif Rebidose, [online] (Washington, DC: FDA, 2012); available from Internet: www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103780Orig1s5121ltr.pdf.

7. C Berteau et al. “Evaluation of Performance, Safety, Subject Acceptance, and Compliance of a Disposable Autoinjector for Subcutaneous Injections in Healthy Volunteers,” Patient Prefer Adherence 4 (2010): 379–388.

Raza Ahmed is worldwide director of medical affairs for the BD Medical – Pharmaceutical Systems at BD (Franklin Lakes, NJ). Reach him at Raza_Ahmed@bd.com.