The Importance of Balloon Catheters Set to Inflate

In the field of interventional cardiology, drug-eluting balloons and flexible electronics mounted to balloons are among the hottest new technologies. While coronary stents--both the bare metal and drug eluting varieties--have revolutionized the field of cardiology, they are not without their drawbacks. Device companies are looking to either improve stents or working on alternate technologies that can address the same problems. For instance, the drug-eluting balloon could prove to be a useful tool in treating stenosed arterial vessels as well as in-stent restenosis instead of the stent. 

The balloon on the far left was developed by Interface Catheter to facilitate coating with drugs as well as mounting of electronics onto its surface. Image provided by the company. 

To support this evolution, Interface Catheter Solutions (Laguna Niguel, CA) developed a textured balloon technology to facilitate coating with a drug. Normally, the surface of such balloons is very smooth, making it difficult to coat. The traditional method of overcoming this challenge is to first coat the balloon with a polymer, which serves as primer before it is "painted" with a drug layer, explains Mark Geiger, vice president of sales and marketing at Interface Catheter. The company has developed a balloon with a textured surface that avoids the need to be initially coated with a polymer.

As it turns out, the coating supports not just adhesion of drugs but it also facilitates the attachment of flexible electronics. It remains to be seen which of those two areas--drug-eluting balloons or balloons equipped with electronics--will ultimately have a bigger impact on the practice of cardiology. The field of flexible electronics, however, is certainly gaining steam. "With the advent of companies like MC10, the use of the balloon, which is such a familiar platform, could really be extended by using them in conjunction with electronics," Geiger says. "The two applications that have risen to the top in those discussions are renal denervation (RDN) and atrial fibrillation." For treating atrial fibrillation, balloons with electronics mounted onto them can be used to both sense and ablate tissue. 

Vessix Vascular's technology provides an example of the advantages of balloon-based renal denervation systems. Above everything, the company's technology is fast. The device can accomplish renal denervation in 30 seconds per artery. In general, renal denervation appears to be highly effective in hypertension that has been nonresponsive to drug therapy.

Within the field of renal denervation devices, balloons aren't used universally, but a growing number of firms active in this field have become interested in balloon based technologies with electronics mounted onto them. "These types of technologies are different from each other but they use a balloon with some sort of electronics mounted to it," Geiger says. "It is really the convergence of the clinical unmet need, the familiar platform in balloon technology, and the advent of flexible electronics that have really allowed this to be realized." 

Ultimately, the potential applications of electronics-enabled balloons could be enormous. Although, balloons in general will likely continue to find a growing number of applications. "We are just getting started. Balloons are a bit like baking soda," Geiger says. "We are always discovering new uses for them."

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

MID Hopes to Take TAVR to the Next Level

MID Hopes to Take TAVR to the Next Level

Although the company was founded in 2010, the genesis of Micro Interventional Devices (MID; Bethlehem, PA) is roughly thirty years in the making, says the firm’s founder and CEO Michael Whitman. The firm has developed a self-sealing cardiac access and closure device that can facilitate procedures such as transcatheter aortic valve replacement (TAVR). “Tissue healing and wound healing is where I spent most of my career,” Whitman says. In the past three decades, he has also learned much about percutaneous coronary procedures; while working at Johnson & Johnson in the 1990s, Whitman was involved in the launch of the coronary stent. He later went on to found Power Medical Interventions, a pioneer of computer-assisted surgical devices that went public in 2007 and was acquired by Covidien in 2009. 

Highlights

  • October 2012: Initiates “first-in-man” trial of Sutureless Transapical Access and Closure 
  • August 2012: Secures $100,000 Funding from Ben Franklin Technology Partners. 
  • May 2012: Secures bridge financing to advance clinical development of Permaseal. 
  • December 2011: Positive data announced from Permaseal animal study. 
  • April 2011: Acquired Endovalve Inc.

 Focus Going Forward

  • Complete STASIS study. 
  • Receive CE Mark clearance and commence commercialization in Europe. 

Challenges of Current TAVR Technologies

  • Lack of control and accuracy in delivery for the surgeon.
  • Steep learning curve for the surgeon to perfect the technique.
  • Difficult to achieve consistent outcomes. 
  • Technique and tissue quality vary from patient to patient.
  • Moderate to severe paravalvular leaks.
  • Time consuming.

Leadership

  • Michael P. Whitman, president and CEO
  • Willard Hennemann, PhD, chief science officer
  • Michael Hansberry, director of operations
  • Pete Datcuk, director of product development

Contact

“When you look at TAVR, it is almost prima facie obvious that a catheter-based technology is going to superior to an invasive surgical procedure where your chest is cracked.” As TAVR technology becomes more widely adopted and the procedure evolves, the need for ancillary tools to support the core technology becomes a necessity. It is possible to anticipate what that toolbox will be before demand for it exists, Whitman says. “It takes years and years of experience or time in the OR to be able to anticipate those things,” he acknowledges.

The idea for the company was hatched following a conversation Whitman had with an executive at a large device company, which highlighted the need for a supplemental TAVR technology to simplify closing the apex during the transapical approach of the procedure.

“For TAVR, the transapical approach when done with a reproducible access and closure device may be superior to transfemoral approach. This is based on data that has been compiled in the European experience,” Whitmans says.

In October 2012, MID announced that a human patient had been treated using the firm’s Permaseal self-sealing, cardiac access and closure technology. The patient was the first to enroll in a European clinical trial known as STASIS, which stands for “Sutureless Transapical Access and Closure Study.” The study will investigate the use of the technology in 40 patients receiving Edwards Lifesciences’ Sapien XT via transapical delivery. The company anticipates that top-line data from the study will be available in 2013.

MID also has plans to commercialize the first fully percutaneous mitral valve replacement device. Known as the Endovalve, the technology is covered by four U.S. patents. The Endovalve also will make use of the company’s Permaseal platform, which will enable it to be delivered via the transapical approach.

In the long term, the company plans to expand its focus, and will introduce a portfolio of products to treat structural heart disease. Like the introduction of TAVR itself, it is likely that the company’s first products will be commercialized in Europe before hitting the domestic market.

 

“Creating a commercially viable product that can be manufactured in a cost effective way that maintains regulatory compliance is a byproduct of experience and collaboration.”

—Michael Whitman, president and CEO 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

An Engineer Takes on Global Regulatory Processes: Asia, Latin America, and More

In Part I and Part II of this series, we discussed the regulatory approval processes for medical devices in the US and in Europe. The markets in these countries are significant and are often given priority consideration when medical device companies form their overall regulatory strategies. However, developed and developing countries in Asia and Latin America are gaining increasing importance as emerging markets in the medical device arena. Anglophone countries such as Canada, Australia, and New Zealandalso represent important medical device markets. In Part III of this series, we will look at some of the unique features within the regulatory processes in some of these markets.

European or American regulatory approval of a medical device can facilitate device approval in other countries. Demonstrating compliance to internationally-recognized medical device standards such as IEC 60601-1, often already achieved for a CE marked device, can bolster the acceptance of a device in many other international markets. Registration dossiers for many countries contain similar elements to those one would find in a CE Technical File or a 510(k). Having a quality system implemented per ISO 13485 and/or FDA GMPs can also support regulatory submission files in other countries.

Nevertheless, a CE marked or FDA approved device does not remove all roadblocks in the quest for world market presence of your product. Despite efforts to harmonize regulation of medical devices via international collaborative groups such as the Global Harmonization Task Force (GHTF), some factors hamper progress. Many countries are in the process of implementing regulatory requirements for medical devices for the first time.Language barriers and cultural differencescan stymie technical understanding and garble collaboration, even between countries sharing a common border. Local authorities may not operate with the same information as regional or country regulatory authorities. Import and export regulations vary from country to country, as do distribution and product reimbursement practices. All of these elements can affect the time to approve and commercializeyour medical device in the international market.

Canada, Australia, and New Zealand

Canada

The MedicalDevices Bureau of the TherapeuticProducts Directorate (TPD) is Canada’s regulating body for medical devices. Medical devices are categorized into four risk classes (Class I, Class II, Class III, and Class IV); all Class II, III and IV devices must procure a Medical Device License (MDL) prior to commercialization. The amount of information required as part of the regulatory submission depends on the device class; Class III and IV devices must also provide a Premarket Review Document which includes a summary of safety and effectiveness studies, including clinical studies if applicable. Canadian regulationsrequire class II, III, and IV device manufacturers to furnish a CAN/CSA ISO 13485 quality system certificate issued by special third party auditors which are recognized by Canadian Medical Devices Conformity Assessment System(CMDCAS). Review time for approval depends on device class; target times range from 15 days for Class II devices to 90 days for Class IV devices. Device manufacturers must provide a list of known open software issues when a product is released onto the market.

Australia

The Therapeutic Goods Administration (TGA) is responsible for medical device regulation in Australia. Approval of medical devices in Australia is similar to the process in Europe. Medical devices are divided into four risk classes (Class I, Class IIa, Class IIb, and Class III), and implementation of a quality system compliant with ISO 13485 (or equivalent) is necessary. Product conformance to the Essential Principles specified in the Australian regulation must be demonstrated; for most devices, a conformity assessment is performed by the TGA or by an EU Notified Body for a fee. A CE Technical File (or Design Dossier) is commonly used to show compliance. A local sponsor must be appointed to manage the manufacturer’s submission to the TGA.

New Zealand

New Zealand’s medical device regulator is called MedSafe, and is a business unit of the Ministry of Health. Devices must be registered on MedSafe’s database, Web Assisted Notification of Devices (WAND). There is no pre-market approval process in New Zealand. A local sponsor that has the legal responsibility for the medical device must be identified by the manufacturer. The sponsor ensures that a medical device is notified to the WAND database within 30 days of the product being placed on the market. A manufacturer must ensure that appropriate documentation (e.g., certification from FDA, EU or Australia’s TGA) demonstrating device safety can be furnished to MedSafe upon request.

Latin America

There are some common elements that comprise the approval process and required submission documentation for medical device approval in many Latin American countries. These include:

  • A Technical File or Report similar to a CE Technical File (technical description, device safety test results, biocompatibility data, labeling, etc). The required amount and type of information varies depending on the country.
  • A Certificate of Free Sale (CFS) issued by the public health authority in the country of origin, whichdemonstrates that the device is cleared for sale in the US, Europe, or another country which has an established trade agreement with the country where registration is desired.
  • Product registration in most countries is valid for 5 years
  • Most countries divide devices into four risk classes (I, II, III, and IV or similar), ranging from low risk to high risk.
  • Many countries require certain regulatory documents to be translated by a qualified individual into Spanish or Portuguese, as applicable, and notarized.

In recent years, efforts have been made to harmonizelegislation in Latin American countries in a manner similar to the European Union. However, no legislative agreements have yet been definitively established, and local laws continue to vary. As a result, some countries may require minimal information for device registration, while others require substantial supplemental technical information for the same device. It is helpful to have local representatives as part of one’s regulatory team who are knowledgeable about the local cultures and laws to facilitate preparation of documents for submission, and to aid in navigating importation and distribution requirements.

Brazil

Brazil represents the largest medical device market in Latin America. Brazil is one of the most recent Latin American countries to adopt medical device regulation. Nevertheless, Brazil’s device approval process is notoriously lengthy and submission costs are the most expensive in Latin America. Brazil’s regulatory agency, ANVISA, generally employs ahigher level of scrutiny during the review process compared to other Latin American countries. Device approval requires certification to Brazil’s Good Manufacturing Practices (B-GMP, similar to FDA GMP), which can take up to 2 years to obtain due to the enormous backlog in facility auditing. After device approval, follow up B-GMP inspections are conducted every 2 years. Recent regulation has established an abbreviated registration process called “Cadastro” for lower risk devices, which permits circumvention of GMP inspection.

Documents required for submission in Brazil include a Trade Permit issued by the State, samples of labels and instructions for use translated into Portuguese, and a description of all manufacturing and quality control process steps. A Technical Report is required which includes a list of safety relevant components translated into Portuguese.

Mexico

Like Brazil, Mexico’s traditional approval process for medical devices is notably long (12-18 months). In 2010 a simplified equivalency process was implemented in Mexico for devices that are cleared for sale in the U.S. or in Canada, which can shorten the review process to as few as 30 days. The fast track process requires technical documents to be translated into Spanish, and includes the following elements (among others):

U.S.fast-track required documentation (all must be translated into Spanish and notarized):

  • Certificate to Foreign Government (CFG), a FDA issued document for export of products that can be legally marketed in the U.S.
  • Establishment Inspection Report (EIR) –an FDA site audit report;
  • A copy of the 510(k) or PMA documentation
  • Canadian fast-track required documentation:
  • A copy of the Medical Device License (MDL) (notarized Spanish translation);
  • CAN/CSA ISO 13485 quality system certificate;
  • ISO 17021 Certificate (Proof of CMDCAS accreditation of third party quality system auditor)

Argentina

Argentina’s device registration time currently averages 4-6 months. Required documentation for registration includes, among other elements, a Certificate of Free Sale (CFS), a notarized declaration of Good Manufacturing Practices translated into Spanish by a qualified translator, and instructions for use translated into Spanish.

Venezuela

Venezuelan law specifies 20 working days for the device approval review process. Because the Venezuelan Ministry of Health is currently working with reduced hours of operation, actual turnaround time for product registration is 1 to 3 months. Registration requirements include provision of 3 letters of recommendation from physicians that have used the device in another country where the device is approved. Sterilized devices must also be tested by a local accredited institution as part of the approval process.

Peru

Device registration in Peru requires a Certificate to Foreign Government (CFG) (FDA issued document for export of products that can be legally marketed in the U.S) and a Letter of Authorization.

Chile

Currently a medical device may be sold in Chile without governmental authorization, as there are no registration requirements.

Asia

Japan

Japan is one of the largest markets in Asia for medical devices. Medical devices must be registered with Japan’s medical device regulatory agency, Pharmaceuticals and Medical Devices Agency (PMDA). Japan classifies devices into four risk categories (Classes I, II, III, and IV). In addition to implementing an ISO 13485 compliant quality system, manufacturers of high risk medical devices (Class III and IV devices and some Class II devices) mustundergo a rigorous quality system audit by the PMDA. Higher risk devices also require submission of a Summary Technical Document (STED) to demonstrate safety and performance.

Historically, the Japanese review process has tended to take anywhere fromabout 8 months to 21 months for approval, depending on whether a device is determined to be substantially equivalent, improved, or a brand new medical device per the Japanese regulation. Recently,PMDA has implemented an action program with the intention of accelerating the review process. Activities include hiring more device reviewers, allowing for more subcontracting of clinical studies, and an overall reorganization of the review department within PMDA. Review time for device approval in 2011 was reduced to between 5 and 10 months, depending on device type.

 China

Development and reform in China are causing medical device regulations to evolve at a rapid pace. China’s medical device regulatory authority, the State Food and Drug Administration (SFDA), classifies devices into 3 risk categories.Device approval includes submission of a dossier to the SFDA as well as type testing. For Class II and III products, SFDA does not accept Notified Body or CB Scheme product safety test results; type testing must be conducted by a SFDA recognized test laboratory on Chinese soil to the Chinese safety standard (which is similar to the IEC 60601-1 standard). There is generally a large back log for type testing. Manufacturers wishing to import medical devices must also submit a notarized quality system certificate demonstrating compliance with ISO 13485 or FDA GMPs. Class III products manufactured outside of China are subject to an onsite product audit prior to registration approval. Class III devices are also likely to require clinical studies conducted in China prior to approval, in particular for devices which contact the central nervous system. For devices which do not require clinical studies, the total product registration time can take approximately 12-18 months.All regulatory submission documents must be in both Chinese and English; translation costs can be significant.

Korea

As in Japan, Korea’s regulatory authority, the Korea Food and Drug Administration (KFDA), classifies devices into four risk categories (Classes I, II, III, and IV). For Class II, III, IV devices, registration is obtained by submitting a Technical File and conducting type testing by a third party. For some higher risk devices, the technical file may also require clinical study data as part of the submission. Companies must also obtain certification to Korean Good Manufacturing Practices (KGMP) via a third party organization which works together with KFDA to conduct a compliance evaluation.

India

In India, medical devices are classified as drugs. Only some devices are regulated; the government supplies a list of about 40 categories of products which require product registration. It is expected that more products will require registration in the future. Registering a device in India requires, among other things, an ISO 13485 certificate for the manufacturer’s quality system and an authorization letter from the Indian government. A meeting with the government for a fee prior to applying for this authorization can help pave the way for approval.

Singapore

Regulations in Singapore have recently changed to require product registration for most medical devices. Devices are classified into four risk categories (A, B, C, D). Products which have already been approved in another market such as the U.S., Canada, or Europe may follow an abbreviated registration process.

Hong Kong

Hong Kong does not currently require medical devices to be registered in order to be commercialized. While registration is voluntary, it is likely that registration will be required in the future.

Conclusion

While U.S. or European approval of a medical device can substantially ease the burden of registration and approval in other countries around the world, harmonization of medical device regulation is still far from being realized. In developing countries in particular, the regulatory approval process is evolving and dynamic. In Latin American and in Asia, language and translation efforts impart a cost and schedule impact to the registration process, and should be considered in regulatory strategy planning. In such markets, installing a local presence to work closely with regulators and to facilitate importation and distribution of product is an important asset for successful approval and commercialization of medical devices.

More from this series:

An Engineer Takes on CE Marks and European Commercialization 

An Engineer Takes on FDA Clearance and Approval 

+++++++++++++++++++

Karen Brentnall is senior quality engineer at Stratos Product Development. She has 16 years of experience in product development and quality engineering, during which she developed expertise in class II and III medical device product development. Prior to joining the quality and regulatory world, she worked for eight years as a mechanical design engineer. She has played an active role in the design, development and manufacture of numerous medical devices including the SuperSonic Imagine Aixplorer diagnostic ultrasound system, the Boston Scientific Rotablator rotational artherectomy system, several therapeutic catheter devices and LVADs, and a hemodialysis machine. Her expertise includes development and maintenance of documentation to support medical device regulatory submissions, including risk management, quality planning and verification. Her capabilities also include implementation and maintenance of quality management systems per the FDA medical QSRs and ISO 13485.
 

Diamonex Biocompatible Coatings From Morgan Technical Ceramics

Suited for such medical implantable applications as left-ventricular-assist-device (LVAD) heart pumps and artificial joints, the new range of diamond-like-carbon (DLC) biocompatible coatings exhibit good adhesion and wear resistance. The precision coatings of the Diamonex range provide a superhard, low-friction surface with properties approaching those of natural diamond. The low coefficient of friction, ranging between 0.03 and 0.25, increases device mechanical efficiency at startup and during operation as well. In addition, the DLC coatings feature a high hardness of 15 to 30 GPa, which prevents fretting and galling while enhancing durability. They can be applied to both flat surfaces and 3-D parts via direct-ion-beam or radio-frequency plasma-enhanced chemical vapor deposition techniques. Smooth and highly conformal, the coatings typically are applied in a thickness ranging from 2-5 µm.

Fairfield, NJ

Radio-Frequency Connectors by Intelliconnect USA

A manufacturer of standard coaxial and triaxial radio-frequency (RF) connectors offers a custom design service for adapting these products into nonstandard medical connectors for use in specialized medical equipment. The company fabricates a series of triaxial connectors, for example, that are designed to minimize system noise while providing an isolated ground. Their clamping construction and weatherproof sealing optimize termination to various twin-axis and triaxial cables. The company additionally provides a series of rugged, waterproof microminiature connectors, along with multipin power- and signal-transmission systems. Capable of operating at temperatures ranging from –65° to 165°C, the customizable RF connectors are suitable for use in such medical applications as cochlear ear implants, RF cancer treatment, RF ablation, biomedical test equipment, and bionics.

Crossville, TN

MD+DI's Most Popular Content of 2012

MD+DI's Most Popular Content of 2012

1.) The U.S. Medical Device Industry in 2012: Challenges at Home and Abroad

Healthcare reform, regulation, and R&D hurdles must be overcome to gain access to the big opportunities for the medtech industry.
 

2.) Medical Device Tax 101

The 2.3% excise tax on medical device sales is on its way. Here’s a primer to help companies prepare.
 

3.) Manufacturer of the Year: The 10 Finalist Companies

The 10 finalists for MD+DI's Manufacturer of the Year grow leaps and bounds in technology innovation.
 

4.) Medical Device Manufacturers of the Year 2012

This year's Medical Device Manufacturers of the Year are helping to bring healthcare into the digital age.

5.) Senate Overwhelmingly Passes Unprecedented Medical Device User Fee Act

The FDA Safety and Innovation Act nearly doubles the user fees paid by medical device manufacturers from a total of $295 million in the last five years to $595 million over the next five years.
 

6.) Medtech Issues in the 2012 Election Year

Our coverage of the 2012 U.S. presidential and congressional races.
 

7.) 40 Medtech Innovators Under 40

Meet the new class of medtech industry innovators.
 

8.) SCOTUS Upholds Affordable Care Act; Device Tax Continues to be a Worry

The Supreme Court upheld most of President Obama’s Patient Protection and Affordable Care Act, a decision that means the medical device tax slated to go into effect next year will stay in place.

9.) Medtech Salary Survey 2012 Sneak Peek

An advance look at the topline results of our annual survey on compensation in the medical device and diagnostic industry.
 

10.) Experts Pick What's Hot in Medical Device Technology

MD+DI asked members of its editorial advisory board to share their thoughts on which current medical device technology breakthroughs are most important.
 

The Top 10 Medtech Predictions for 2013

The Top 10 Medtech Predictions for 2013

Although the title of a recent InMedica report is “10 Predictions for 2013 in the Medical Electronics Industry,” the scope of the projections apply to the medical device industry writ large. If last year is any indication, the predictions are likely to be accurate; in 2012, the UK-based research firm had a dozen predictions, nine of which were correct and two were just short of their forecasts.

Without further ado, we bring you the top 10 predictions for the coming year.

  1. Obamacare to Have Mixed Effects. First the bad: the much-discussed device tax provision of the Affordable Care Act will decrease hospitals spend on medical technology. Meanwhile, per-capita spending on healthcare overall is set to continue its upward trajectory. Use of advanced imaging modalities like CT and MRI will rise as reimbursement penalties linked to them increase. On the bright side: the field of healthcare IT and telehealth are expected to grow, driving demand for technologies that are compatible with EMR systems.
     
  2. European Medtech Market to Slump. InMedica predicts that 2013 could be the “the most challenging period for medical device suppliers in 2013, in the last 15 years.” Thanks to austerity measures and reimbursement cuts, European demand for new medical technology is expected to be low.
     
  3. Southeast Asia Pacific Set to Expand. A new directive provides a single standard for medical device certification for seven Southeast Asian countries in the region, which will help fuel demand for technologies such as ultrasound, digital x-ray, and PACS. The growth opportunities are significant, considering that more than 600 million people lack sufficient access to healthcare services in the region.
     
  4. Telehealth Market to Surge. InMedica predicts the telehealth market will expand by 55.0% globally in 2013. “We see healthcare reform as important in pushing the growth of telehealth,” says Theo Ahadome, a senior Analyst at InMedica. While there is no direct reimbursement planned for home monitoring technology in the United States, hospitals will be penalized for readmissions, sparking demand for home monitoring technology.
     
  5. Adoption of PACS and VNA Managed Services to Grow. The global market for Picture Archiving and Communications Systems (PACS) is picking up steam. Early in 2012, MarketResearch.com predicted the market would grow at a CAGR of 10% to reach $5.4 billion by 2017. In the United States, the vast majority of radiology departments now have PACS. The data, however, is often siloed and not shared across different hospital departments, Theo Ahadome explains. In addition, the costs to store the data are rising, as providers generally must store records for seven years after the most recent treatment. As a result, vendor-neutral archive (VNA) services, which enable storing and sharing of data across manufacturer systems, are expected to expand.
     
  6. Market Share of EMR Vendors to Grow. Especially in the United States, demand is growing for hospital-wide technologies to track medical records. In large part, this is because of the Meaningful Use incentive program for electronic health records (EHRs) in the United States. The second stage of Meaningful Use rules have been announced, which call for interoperability of health information.
     
  7. X-ray Technology Goes Wireless. The international market for general radiography x-ray equipment began shifting to wireless technology since 2009. InMedica predicts that, in 2013, 37% of unit shipments of general radiography flat-panel detectors will be wireless.
     
  8. Demand for Non-Invasive Treatment Expands. Owing to cuts in healthcare budgets and reimbursement for hospital-acquired infections, demand for technologies that cut the risk of infection during treatment is growing. Also contributing to this trend is the European Society of Intensive Care Medicine, which recently recommended broader adoption of non-invasive ventilation to cut infection rates associated with endotracheal intubation.

  9. Neonatal Care Product Market to Take Off. The BRIC nations, China in particular, are driving the expansion of this space, which has traditionally seen slow growth.
     
  10. Wearable Fitness Market to Continue Growth. In 2012, 17 million wearable devices were shipped worldwide. Of that total, 16 million for fitness and wellness applications. Heart rate monitors accounted for the biggest slice of the total in 2012. In 2013, InMedica forecasts the share of activity monitors in the wearable fitness devices market will expand to 44.0% from 32.0% in the prior year.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Related

Image by Sam Churchill.

Medtech Snapshot 2012

Medtech Snapshot 2012

MD+DI's editors gathered data and sought out expert analysis to get a sense of the medical device and diagnostic industry’s performance in 2012. We identified trends in the areas of manufacturing, corporate finance, regulatory, and international. Read on to find the information you need to put the past year in perspective and prepare for 2013.

 

FDA Continues Push Toward Efficiency and Transparency 


Medtech Industry Still Feeling Fallout from Recession


New User Fee Law Requires More Manufacturers to Register for FDA’s Establishment Database


Ireland is a Popular Location for Medtech Manufacturers

Ireland is a Popular Location for Medtech Manufacturers

Beyond its beauty and charm, Ireland offers significant benefits for medical device manufacturers. Medtech heavy hitters like Becton Dickinson and Boston Scientific have had a presence in the country for more than 20 years. Fifteen of the top 20 medical device companies have set up shop in Ireland, according to IDA Ireland. The government-funded organization's goal is to attract foreign investment, says Ivan Houlihan, vice president of IDA Ireland.

How Ireland Ranks Globally

#1

? In the world for corporate taxes.

? For business legislation for foreign investors.

? For the availability of skilled labor.

? In the world for inward investment by quality and value.

? In the Eurozone for ease of doing business.


#2

? Globally for the number of inward investment jobs per capita.

? Most attractive country globally for foreign direct investment.

? Most globalized economy in the world.


#3

? For direct inward investment flows.

? For availability of finance skills.


#4

? In the world for labor productivity.

? Best country to do business.

Sources: The IMD World Competitiveness Yearbook 2011, The 2011 IBM Global Location Trends, NIB/FDI Intelligence Inward Investment Performance Monitor 2011, and Ernst & Young Globalization Index in cooperation with Economist Intelligence Unit, Jan 2011, Forbes.

With more than 250 medtech suppliers and OEMs, Ireland holds a strong manufacturing position in Europe and is the continent's second-largest exporter of medtech products. Last year Ireland’s medtech exports reached c.$9.7 billion.

Most devices are exported to the United States, Germany, Japan, and other parts of the UK. Ireland's main competitors in Europe are Switzerland and Germany. However, Ireland is the only European country with U.S. preborder clearance. Galway is the central manufacturing hub, but there are facilities located throughout the country. Some strong advantages to doing business in Ireland include:

  • A stable environment.
     
  • A quality workforce and the youngest population in Europe (more than 38% are under 25 years old).
  • A proven track record.
     
  • A supportive infrastructure.
     
  • A 12.5% corporation tax rate.

Although the region has been challenged by the financial crisis, gross domestic product growth returned last year, and the government is focused on structural reform that looks to maintain Ireland's strong position.

Ireland's GDP GettingBack on Track

? Last year GDP grew for the first time since 2007. 

? Modest (0.7%) growth expected in 2012,
driven by external sector. 

? 2013 outlook: 1.9% growth or more. 

? Export growth getting stronger and a key to recovery.

Fifteen of the top 20 medical device manufacturers have operations in Ireland. In all, the country is home to 250 medtech suppliers and OEMs. Source: IDA Ireland.