By Laurel Petriello

Image of aerosol delivery devices.This month’s Market Analysis discusses aerosol delivery devices with executives from three leading product manufacturers, including Lisa Cambridge, MSHS, RRT, director of medical science and pharmaceutical alliances for PARI Respiratory Equipment Inc, Midlothian, Va; Bill Seitz, vice president of sales and marketing for Monaghan Medical Corporation, Plattsburgh, NY; and Brian Sharpe, director of sales for MedQuip Inc, Bluffton, SC. The respondents discuss product trends and new developments, the movement toward home care, best practices for product efficiency, and providing for the neonatal and pediatric patient market.

RT: What are the latest trends and developments in aerosol delivery products?

Lisa Cambridge: New inhaler devices are continually introduced to the market. Many of these are drug-device combinations—meaning they are integrated with the drug product—including dry powder inhalers (DPIs), nebulizers, conventional metered dose inhalers (MDIs), and soft-mist metered dose inhalers. The trend in aerosol delivery is shifting to smaller delivery devices that offer patients portability and the ability to take treatments on the go. Ease of use and speed of treatment are other important features to help in efficient delivery and help improve patient adherence to inhaled drug therapy.

Bill Seitz: With the vast changes in health care, it’s become critical for medical device companies to focus on the “complete value proposition,” rather than simply designing and releasing another product. For companies like Monaghan Medical Corporation, which has a long-standing reputation for focusing on research and development, these higher expectations among health care providers are a welcome challenge.

Today’s market demands that companies provide more evidence-based, total “cost-of-care” value, rather than simply a low price. We are pleased to see providers focusing more on total cost and long-term outcomes for their patients. Particularly in light of the new health care reimbursement laws, which significantly impact respiratory care services, most stakeholders are focusing on products, programs, and services that ensure patients are treated effectively, and remain healthy, in order to reduce readmissions. I believe the companies and providers that most effectively adjust to these evidence-based factors and new health care laws will thrive in this environment.

Brian Sharpe: There have been several inhalation drugs introduced over the course of the last few years by manufacturers competing over this segment. These meter dose inhalers—Advair, Symbicort, Spiriva, Combivent, etc—are being used in conjunction with nebulizers to better support and manage patients.

RT: How have products changed in the last few years?

Image of Lisa Cambridge.Cambridge: Aerosol delivery products that offer patients the ability to take their treatments on the go, in addition to providing feedback on the correct way to self-administer inhaled drugs, are important considerations in the trend toward home health care. A focus on products that provide reminders to take treatments or prompt patients when to replace aerosol delivery equipment will help patients effectively manage their respiratory disease at home.

With nebulizers, portable devices are especially important for those who may need frequent medication dosing. Unlike traditional nebulizer/compressor systems that require an AC power source, these devices are battery-operated so patients do not need to stay home for aerosol therapy. Quality of life is preserved because they can still participate in daily activities outside of the home.

Sharpe: More choices, segmented between adult and pediatric products, continue to fuel more competition, though fulfilled with fewer providers as the industry has evolved, requiring HME (home medical equipment) providers to become accredited. Competitive bidding, associated costs, and regulations have also contributed to an attrition of providers.

RT: How are aerosol delivery products responding to the health care trend toward home care?

Seitz: Home care considerations are a very important element when designing products. As noted above, changing reimbursement laws are having a profound impact on hospital and respiratory care services, and the role of home care services will be a major factor. For example, the growing COPD patient population will require an increasing amount of respiratory care services, such as aerosol delivery or airway clearance treatments. The type of programs, products, and education these COPD patients receive will impact long-term outcomes, readmission rates, and their hospital’s bottom line.

Sharpe: Better availability of products through retail drugstores, DMEs (durable medical equipment providers), and even online merchants. [Also], products have improved in quality and durability. They are more consumer friendly in both ease of use and portability. Instructional training videos are readily available for both clinicians and patients, which also encourages patient compliance.

RT: Tell us about your company’s most recent aerosol delivery products and why they are innovative.

Cambridge: PARI’s aerosol delivery products are both innovative and clinically proven. They have been used most often by major pharmaceutical companies in pivotal safety and efficacy trials for nebulized drugs.

The PARI SINUS is designed to target drug delivery to the sinus cavities using a novel pulsating airflow technology. The paranasal sinuses are nonventilated organs [where], until now, [it has] been difficult to deliver prescribed medication using conventional aerosol delivery systems. The PARI SINUS pulsating aerosol delivery system has proven it’s capable of delivering medications to the paranasal sinuses, resulting in the reduction of symptoms in sinusitis and chronic rhinosinusitis (CRS).

With a rechargeable battery option, the PARI TREK S Compact Compressor System with LC Sprint Reusable Nebulizer offers portability and a fast, efficient treatment. The TREK S enables patients to take their treatments anywhere and may improve adherence to therapy, especially in active patient populations.

All nebulizer devices should be replaced on a regular basis to maintain optimal performance. If used beyond the manufacturer’s recommended time, nebulizer materials may potentially degrade and affect delivery efficiency. PARI introduced the Timestrip, a simple, yet effective way to improve patient adherence with nebulizer replacement. Timestrip is an easy to use visual indicator that reminds patients to replace their PARI nebulizer every 6 months, which will help maintain fast nebulizer treatments and performance.

Seitz: Our last two major product releases, the AeroEclipse II Breath Actuated Nebulizer (BAN) and the most recent Aerobika Oscillating Positive Expiratory Pressure (OPEP), are both very innovative and unique.

The AeroEclipse II Breath Actuated Nebulizer revolutionized aerosol delivery by only creating aerosol in response to the patient’s inspiratory maneuver. This on-demand therapy means less medication waste, higher drug delivery efficiency, and safer clinician working environments. The AeroEclipse II BAN device has become common among hospitals across America, and has substantial evidence, including several cost-savings studies.

We just released the Aerobika Oscillating Positive Expiratory Pressure device, which is an innovative design that allows for effective airway clearance treatments with a device that’s easy to clean and use in conjunction with aerosol treatments. A recent crossover study that utilized hyperpolarized helium magnetic resonance imaging indicated, after 4 weeks’ use of Aerobika Oscillating PEP therapy, noticeable improvement including reduced dyspnea, increased gas distribution to previously unventilated areas, and reduced hyperinflation.

Image of Bill Seitz.In addition, our AeroChamber Plus Flow-Vu Anti-static Valved Holding Chamber was recognized in 2010 as one of the “top 10 innovations over the past 25 years” at AANMA’s 15th annual Allergy & Asthma Day Capitol Hill event. Needless to say, we are extremely pleased with these results and excited about the opportunities.

Sharpe: Our most recent designed Compressor Nebulizer System not only outperforms the competition, it creates a sense of style beyond any product in the market. We strive to increase positive clinical outcomes while understanding that today’s medical equipment can have many different molded designs erasing the hospital appearance of yesterday’s equipment. Products today are designed to improve patient compliance.

RT: Do you have any advice for respiratory therapists on how their patients can gain the most benefit from their aerosol products?

Cambridge: When treating patients on aerosol therapy, there are many factors to consider. Choosing an effective aerosol device is an important consideration for patients who require aerosol therapy. Effective inhaled drug delivery is a complex function of device-related factors such as delivery efficiency and patient-related factors such as proper technique and breathing patterns, all of which may potentially influence how well your patients respond to their prescribed therapy. For a drug to reach the lungs, it has to be in the respirable range and patients need to use the delivery device correctly to achieve symptom control while minimizing adverse side effects. Proper inhaler technique is not intuitive. If a patient cannot master the use of one type of delivery device such as a metered dose inhaler, switching to another device is warranted.

For nebulizer delivery, there is a lack of standardized guidelines to measure or report technical information for inhaled delivery devices. Clinicians may find it challenging to objectively compare their efficiency. The medication package insert includes information about which devices were used in the pivotal clinical trials. This information is important since different types of nebulizers exhibit different characteristics, including how much drug is actually delivered to the lungs. Variability in nebulizer performance may not be as significant in delivering bronchodilator medications, but may have a major impact for delivery of other medications, such as inhaled antibiotics, potentially affecting therapeutic response.

Finally, long treatment times and an increased frequency of treatments can decrease patient adherence with their prescribed regimen. Today, clinicians can offer patients more efficient devices that deliver medications in significantly shorter periods of time, thereby increasing adherence to the treatment regimen.

Seitz: The best advice I can provide respiratory therapists is to remember the important professional role you play in a patient’s life and ultimate outcome. A well-trained, caring respiratory therapist is better equipped than anyone to provide education and training on aerosol delivery devices. We suggest using educational tools available to assist their efforts, such as patient-oriented product instructions, video aids, and demonstration devices. The concise and caring education that respiratory therapists provide their patients can last a lifetime.

In addition, respiratory therapists can maximize their patient’s aerosol device outcomes by selecting products that offer evidence, simplicity, and proven outcomes. In this era of health care, it’s more important than ever to look at total value and ensure positive outcomes as much as possible.

Sharpe: Change filters. Clean, replace neb cups and filters on a regular basis. Follow the manufacturer’s maintenance and replacement guide. Ensure proper education at the beginning to increase positive patient outcomes.

RT: Does your company carry aerosol delivery products for use with infants and children? And if so, how do your products differ for the pediatric population compared to adults?

Cambridge: Children pose a particular challenge in delivering aerosol treatments. Pediatric patients are often uncooperative and cry during therapy, which can significantly decrease dosing to the lungs. PARI’s Bubbles the Fish II Pediatric Aerosol Mask is intended to help remove the scary aspect of treatment and improve acceptance to therapy.

Clinicians should also take note of the delivery efficiency of device interfaces such as masks. Just because something is cute in appearance doesn’t mean that it is efficient. Previous studies have concluded that the use of the blow-by technique to administer nebulizer medications is ineffective in delivering therapeutic doses to the lungs of pediatric patients. To the contrary, newly published evidence suggests that blow-by therapy may provide adequate aerosol delivery when using specific nebulizer/mask interfaces. Smaldone and Mansour report that blow-by technique with the PARI LC Sprint Nebulizer and Bubbles the Fish Mask delivered substantial amounts of budesonide even at distances of 4 cm from a pediatric face model. These amounts were found to be significantly higher than the other nebulizer systems tested when the facemask was placed directly on the face. With the proper nebulizer/mask interface, these results suggest that blow-by is an effective option for uncooperative children.

Seitz: Monaghan Medical Corp has focused on developing specific pediatric products for many years. In fact, our aerosol research laboratory has invented specific testing applications that allow us to mimic pediatric aerosol delivery under the unique respiratory characteristics of children. As RTs who have worked in pediatrics settings are well aware, there are many respiratory differences between children and adults. We believe it is critical to create aerosol delivery devices specifically designed to address these unique differences. For example, our AeroChamber Plus Flow-Vu Anti-static Valved Holding Chamber incorporates a ComfortSeal Mask, one way valve system, and Flow-Vu indicator that are specific to pediatrics. These features allow children to receive the “right sized” particles through the chamber but not exhale into it.

Sharpe: Yes, an integral objective in pediatrics is to provide unsurpassed clinical delivery with design and appearance that reduce stress and anxiety, ensuring both parent and child an effective easy treatment.

RT: What is the impact of the Affordable Care Act’s 2.3% medical device tax on the market?

Cambridge: The US aerosol delivery market has increasingly faced greater challenges due to increased cost control measures, including declining reimbursement from government and third-party payors. As a result, the market has experienced significant price erosion. There is industry concern that the 2.3% medical device tax will adversely affect product innovation and ultimately patient care, as the tax will place additional strain on businesses that already operate in a progressively price-sensitive market. For PARI, product development will remain consistent with that of a market leader and innovator while adapting to changing market conditions.

Seitz: The Affordable Care Act’s medical device tax has obviously been a concern and is considered a financial burden for most medical device companies. However, Monaghan Medical Corporation is not altering our long-term plans as a result of this program and will continue our mission of creating the world’s premier aerosol delivery devices.

RT: What’s next for the aerosol delivery market? What is your company working on?

Image of Brian Sharpe.Sharpe: Design implementation and increased portability with smaller units. Our primary concern and objective is focusing on the advancement of respiratory health care. We will continue to strive and address the growing concerns of COPD with the best compressor nebulizer systems available. It is alarming that COPD is now known to be the third leading cause of death in America today. Recent studies indicate that in 2009, 40.3 million Americans were diagnosed with asthma or COPD (chronic bronchitis and emphysema). Of these, 25.1 million had asthma and 15.1 million had COPD. These numbers are increasing and are expected to increase to 43.9 million by 2016; as these numbers continue to climb, MedQuip will stand poised to assist both patients and providers in addressing their medical device needs. RT

Laurel Petriello is associate editor for RT. For further information, contact [email protected].