Medical Outlook 2011

 Increased recom­mendations for home monitoring of medical conditions will lead to an increased need for portable medical devices – such as blood pressure, diabetes testing, and more.Growth in the life sciences industries will greatly depend on how the FDA responds to growing complaints that they are stifling medical technologies.

Advanced Medical Technology Association (AdvaMed) recently released a report, “FDA Impact on U.S. Medical Technology Innovation,” which garnered responses from more than 200 companies concerning their experiences in working with the FDA. Participants were also asked about their experiences working with European regulatory authorities in order to offer a comparison between aspects of the two dominant regulatory systems.

“In general, survey respondents viewed current U.S. regulatory processes for making products available to patients as unpredictable and characterized by disruptions and delays,” the results summary states. “Forty-four percent indicated that part way through the premarket regulatory process they experienced untimely changes in key personnel, including the lead reviewer and/or branch chief responsible for the product’s evaluation. Thirty-four percent of respondents also reported that appropriate FDA staff and/or physician advisors to the FDA were not present at key meetings between the FDA and the company.”

The report goes on to highlight that those factors contribute to significant delays in navigating FDA regulatory processes, with premarket process for 510(k) pathway devices (of low-to moderate risk) taking an average of 10 months from first filing to clearance. Devices requiring a clinical study for low- to moderate-risk devices before making a regulatory submission, the premarket process took an average of 31 months from first communication to being cleared to market while, in comparison, it took an average of seven months in Europe.

For higher risk devices seeking premarket approvals (on the PMA pathway), responding companies indicated that it took an average of 54 months to work with the FDA from first communication to being approved to market the device. In Europe, it took an average of 11 months.”

Beyond the time gap comparing FDA and Europe approval processes, the survey also showed that the average total cost for a low- to moderate-risk 510(k) product from concept to clearance was approximately $31 million, with $24 million spent on FDA dependent and/or related activities. For a higher-risk PMA product, the average total cost from concept to approval was approximately $94 million, with $75 million spent on stages linked to the FDA.

According to the report, these statistics result in a “significant, measurable cost to U.S. patients in the form of a device lag. Respondents reported that their devices were available to U.S. citizens, on average, nearly two full years later than patients in other countries, due to delays with the FDA and/or company decisions to pursue markets outside the U.S. before initiating time-consuming, expensive regulatory processes in their own country.”

Stephen J. Ubl, president and CEO of AdvaMed, commenting on the study that assesses the impact of device regulations on continued medical innovations says, “This report is a wake-up call for those who want to promote medical innovation and preserve American jobs. A regulatory environment that is marked by needless delays and inefficiencies makes it harder for medical innovation to thrive and companies to survive. These delays particularly hurt small companies and their ability to produce next generation technologies.”

Ubl continues that, “We (AdvaMed) support efforts such as improving reviewer and manager training, developing specific guidance for product types, improving de novo process, and developing specific metrics to improve consistency.

To read the full report, click here.

Implant Outlook
While AdvaMed’s report highlights the growing concerns and issues within the FDA’s 510(k) process, industry reports show that the medtech arena is still ripe with growth potential.

Fredonia Group Inc. released statistics for implantable medical devices, with U.S. demand expected to increase 8.3% annually to $49 billion in 2014. According to this report, development of next-generation devices based on new technologies and improved materials are the main reason for growth. “Shortcomings in existing drug therapies will also contribute to the more frequent use of implantable devices to treat and manage cardiovascular diseases, orthopedic conditions, neurological disorders, ophthalmic impairments, and other ailments,” researchers note.

The report goes on to offer that, “Demand for orthopedic implants is expected to increase 8.8% annually, to nearly $26 billion in 2014, with the market for reconstructive joint replacements gaining momentum from improved products, such as rotating platform knee replacements, as well as from the aging U.S. population and physically active lifestyle trends. The orthobiologics sector also is expected to grow during this time, as advances in biotechnology leads to the commercialization of new and improved products.”

An expected increase of 7.5% annually, to $17.6 billion in 2014, is the outlook for cardiac implant demand, with cardiac resynchronization therapy devices posting the fastest growth among pacing devices, as they greatly improve therapeutic outcomes in congestive heart failure patients, the study suggests. The report goes on to mention that the introduction of new drug-eluting stents with improved design and reduced risk of complications will boost the market for cardiac stents and stent-related implants.

“Other implantable medical devices expected to fare well in the U.S. market include simulators for neurological conditions, brachytherapy for prostate cancer, cochlear devices for restoring hearing loss, and gastric bands for obesity surgery,” the study states. “Strong growth is also projected for implantable drug pumps, intraocular lenses, glaucoma and retinal implants, silicone breast implants, dermal fillers, and tissue implants.” More information on The Fredonia Group’s “Implantable Medical Devices Market Report” may be found at freedoniagroup.com.


High-Growth Market
“Drug Device Combination – a High Growth Market” is a report released by Research and Markets focusing on drug-device combinations, which are chemically or physically united or co-packaged as separate, cross-labeled products.

“In the next five years, the market is expected to grow at an annual rate of 11.8%, reaching $10.6 billion,” according to the report. “Cardiovascular applications make up about 64% of the drug-device combination market, and it is further broken down into stent grafts, coronary stents, and peripheral vascular stents. However, it is the smaller market of antimicrobial catheters that offer the highest growth potential for the overall market in the next five years.”

The report continues that the fastest growing macro-markets of antimicrobial catheters are the segments into micro-markets, such as urological catheters, cardiovascular catheters, peripherally inserted central catheters, oximetry catheters, thermodilution catheters, and wound-drainage catheters.

Beyond the catheter growth, the report suggests that closed-loop glucose monitor and insulin pumps will record a high growth rate through 2014.

The report suggests that two major segments, steroid eluting electrodes and photodynamic therapy, will see the slowest growth rate due to a slow development of new products in these markets. “The challenges crippling the growth of the market in the future are expected to be issues involved in cross-industry partnerships, jurisdiction issues, patient safety, and interoperability issues.

Visit researchandmarkets.com for more information on this report or to purchase a copy.

Disposables Growth
In addition to the implant report, Fredonia Group Inc. released the “World Disposable Medical Supplies Industry Forecast for 2014.” The forecast suggests that disposables should rise, globally, by an annual rate of 5.5% through 2014, to $169 billion. Based on the advanced nature of medical delivery systems and widespread insurance coverage of residents for primary healthcare procedures, the developed countries will absorb more than 70% of this total. Demand in the developing countries, as a whole, will expand faster as the availability and accessibility of basic healthcare services improve, the report goes on to explain.

Wound management supplies will remain the top-selling group of medical disposables, with demand forecast to increase 4.6% annually to $30 billion in 2014 – with wound dressings based on alginate, foam, collage, and growth factor substances posting the best growth based on expanding applications in the treatment of moderate-to-severe lacerations.

The report also looks at the world demand for nonwoven medical disposable, stating it should increase 4.4% to $25 billion in 2014, with growth driven by strengthening of the infection prevention standards within healthcare.

Diagnostic and laboratory disposables should register global demand of nearly $23 billion in 2014, up 7% annually from 2009. Blood glucose test strips and other diabetic-related testing supplies will see the fastest gains as recommendations of medical organizations throughout the world encourage diabetic patients to broaden self-testing activities.


Manufacturing Trending UP
As the forecasts continue to predict strong growth through the life science sector, the United States Manufacturing Technology Consumption (USMTC) report, jointly compiled by AMT – The Association For Manufacturing Technology and AMTDA, the American Machine Tool Distributors’ Association, reflects a similar trend in manufacturing as a whole, of which medical device manufacturing is a sector.

November U.S. manufacturing technology consumption totaled $318.18 million. This total, as reported by companies participating in the USMTC program, was down 17.7% from October but up 81.1% when compared with the total of $175.68 million reported for November 2009. With a year-to-date total of $2,792.58 million, 2010 is up 82.7% compared with 2009.

This report, jointly compiled by trade associations that represent the production and distribution of manufacturing technology, provides regional and national U.S. consumption data of domestic and imported machine tools and related equipment. Analysis of manufacturing technology consumption provides a reliable leading economic indicator as manufacturing industries invest in capital metalworking equipment to increase capacity and improve productivity.

Keeping it Going
Ultimately, growth within the life sciences will continue at a quick pace during the next few years, with development of R&D pipelines, alliances, and partnerships being a key factor for success.

The audience is ripe – as more than 100 million people in the U.S. alone are living with chronic diseases, more than 133 million American adults are either overweight or obese, and life expectancy is climbing to all-time highs – and the medical device companies are addressing these needs.

As the economy continues to chug back to full force, the only obstacle appears to be the differing of opinions between the medical device manufacturers and the FDA. Perhaps if they come to a meeting of the minds, these growth projections will not just be projections but will be the reality of a growing field that is quickly, and effectively, delivering what the U.S. healthcare system requires.