A new report by the FDA highlights weaknesses in medical device quality in the US over the past decade.

The FDA’s report, Understanding Barriers to Medical Device Quality, stated that while revenues in the medical technology industry have grown over the last ten years, “serious adverse events” have outpaced this growth by 8% each year.

Failures in medical device design and manufacturing process control were found to account for more than half of all product recalls.

“While medical device flaws may vary by device, some sources of error are pervasive throughout the field,” the report reads.

“Identifying and addressing systemic barriers may yield improvements in medical device quality on a large scale.”

The report was launched by the FDA’s Center for Devices and Radiological Health in order to understand and improve gaps in device quality, and outlines recommendations for both industry and federal regulators.

The analysis found that “nearly 60% of the adverse event reports” involved cardiovascular, in vitro diagnostics and general hospital/surgical equipment.

“Our efforts revealed that there are systemic gaps within the medical device industry's quality approach that result in these issues,” said the report. “Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the agency's regulatory approach.”

According to the FDA, medtech manufacturers are facing a series of challenges which are impeding device quality, such as the increasing complexity of devices, time to market competition, and cost pressures.

Identified opportunities for improvement include postproduction monitoring and feedback, creating quality incentives, and improving design and engineering.

The report also cited steps for the FDA to incorporate, such as clarifying Agency requirements and learning from regulators of similar high-tech industries.

A similar initiative is underway in Europe to improve medical device regulatory assessment processes, with support from Eucomed.

Two new devices for catheter-based treatment of peripheral arterial disease (PAD) have been launched in the EU and the US.

US-based Avinger has released the Kittycat 2 catheter (pictured) in its Wildcat line and Juicebox, a battery-powered catheter accessory.

Kittycat 2 is a smaller, refined support catheter that offers extra length (150cm) to reach diseased peripheral arteries. Its spiral fluted tip can navigate tight bends and narrow spaces, and is designed for contoured anatomy.

Juicebox is a battery-powered accessory that rotates the distal tip of Avinger’s catheters at 100 rpm, enabling the surgeon to focus on guiding the catheter. It can be added or removed during the procedure.

Avinger’s Founder and CEO, John B. Simpson, said: “We are now more equipped than ever to help as many patients as possible. By making our products even more agile and easy to use, physicians can really tackle those difficult cases that have presented a challenge in the past.”

Juicebox is sent out automatically with Wildcat catheters, including Kittycat 2.

Based in California, Avinger specialises in catheter-based technologies for the treatment of peripheral artery disease (PAD).

France is Europe’s biggest importer and exporter of medical devices. However, current reforms are driving cost reduction and efficiencies. Medtech Business in association with Espicom takes a look at the French market for medical technologies.

France is one of the top five medical device markets in the world, accounting for around 3.9% of the global market.* Within Europe, the market ranks behind Germany and is a similar size to that of the UK.

The country has a well-developed healthcare system, combining public hospitals with commercial clinics that are the main providers of elective surgical treatment. While the public sector is the largest purchaser of most diagnostic and therapeutic equipment, the private sector is the dominant purchaser of surgical equipment and supplies.

The high level of healthcare expenditure (11.8% of GDP) and the substantial health deficit are major concerns that have prompted various reform programmes aimed at curtailing costs and improving efficiency in the healthcare system. For this reason, the medical market is only likely to see moderate growth, rising from US$8.3 billion in 2011 to US$9.8 billion by 2016.

Despite several high-profile investment programmes, France continues to lag behind its European neighbours in some high-technology fields, most notably imaging and radiotherapy equipment. A second five-year cancer plan has now been launched which aims to increase the numbers of scanners.

With flagging domestic production in several sectors the French medical device market is increasingly reliant upon imports, which now account for around 80% of consumption. However, many imported products are re-exported to other countries.

 

The market in 2011

In 2011, the French medical device market (see Figure 1) is valued at US$8,280 million. Consumables is the largest product category, accounting for 20.9% of the overall market, followed by diagnostic imaging (19.8%).

Espicom estimates that the medical device market will grow at an average annual growth rate of 3.5% between 2011 and 2016 – bringing the total market value to US$9.8 billion by 2016.

Orthopaedic and prosthetic devices are expected to continue to be the most dynamic sector of the market, with growth forecast to be more than double the rate for the overall market. Conversely, diagnostic imaging is forecast to have the lowest growth during the 2011–16 period.

 

Predictions for market segments

Figure 2 shows Espicom’s predictions for the major segments of the medical device market.

1. Consumables. The market for medical consumables is estimated at US$1,729 million. The consumables market grew at an annual rate of 5.1% in US dollar terms between 2006 and 2010. Imports supply the greater part of the market. Espicom estimates the consumables market will continue to grow by an average of 3.5% over the next few years.

The wound care products market is forecast to grow at an average annual rate of 2.9% in US dollar terms during the 2011–16 period. Syringes, needles & catheters has been the fastest growing sector of the consumables market and will continue to be, with a CAGR of 4.1% to 2016.

2. Diagnostic imaging apparatus. The market for diagnostic imaging is estimated at US$1,636 million. The market grew at an annual rate of 2.8% between 2006 and 2010. France lags behind its European neighbours in the diagnostic imaging field, though the second cancer plan aims to increase provision of MRI, CT and PET scanners.

Imports supply the greater part of the market, though their market share is lower for radiation apparatus due to the strength of the domestic manufacturing industry. The USA and Germany are the major sources of supply. Espicom estimates that the imaging market will grow by an average of 2.1% between 2011 and 2016.

3. Dental products. The market for dental products is estimated at US$859 million, equal to 10.4% of the total medical device market. The dental products market grew at an annual rate of 4.2% between 2006 and 2010. It is forecast to grow at an annual rate of 3.5% over the next few years, taking the total to US$1,020 million by 2016.

4. Orthopaedic & prosthetic devices. The market for orthopaedic & prosthetic devices is estimated at US$1,336 million, equal to 16.1% of the total medical device market. The orthopaedic & prosthetic devices market grew at an annual rate of 9.2% between 2006 and 2010.

Imports have seen particularly high growth in recent years, though a corresponding increase in exports in this sector indicates that not all imported products are destined for the domestic market. The majority of orthopaedic imports are supplied by Switzerland and the USA.

The orthopaedic & prosthetic devices market is forecast to grow at an annual rate of 6.1% in US dollars over the next few years, taking the total to US$1,794 million by 2016.

5. Patient aids. The market for patient aids is estimated at US$1,131 million, equal to 13.7% of the total medical device market. The patient aids market grew at an annual rate of 4.5% between 2006 and 2010.

French imports of patient aids far exceed the value of the domestic market due to a high level of re-export activity, particularly for pacemakers. Switzerland and the USA are the leading suppliers of portable aids, whilst the USA and China are the major sources of supply for therapeutic appliances.

The patient aids market is forecast to grow at an annual rate of 3.9% over the next few years, taking the total to US$1,367 million by 2016.

 

Imports

The value of French medical device imports has recorded a steady rise over the past decade, reaching US$10.4 billion in 2008 before falling back to US$10.3 billion in 2009.

Imports of consumable items amounted to US$1,780.6 million in 2009. Imports fell by 1.0% over 2008 in US dollar terms (though they increased in euro terms). Syringes, needles, catheters & cannulae are the largest subcategory.

Diagnostic imaging imports totalled US$1,564.0 million in 2009, equal to 15.2% of the total. This was the weakest performing category in 2009, with a fall of 16.4%.

Imports of orthopaedic & prosthetic devices were worth US$1,549.1 million in 2009, equal to 15.1% of total medical device imports. This was the fastest growing category in 2009, with a rise of 26.6%. All three subcategories – artificial joints, orthopaedic appliances and other artificial body parts – recorded strong growth.

Patient aids are the largest import category, with imports worth US$2,624.1 million in 2009, equal to 25.5% of total medical device imports. Pacemakers accounted for 54.7% of imports in this category in 2009, but also accounted for more than half of patient aid exports.

The leading suppliers of French medical imports in 2009 were the USA, Switzerland and Belgium, with the UK ranking eighth as a supplier with imports worth US$288,964 (2.8% of the total).

 

Exports

In 2009, medical device exports registered a 3.0% fall in value to US$9.2 billion, having recorded steady growth in previous years with a CAGR of 6.8% for the 2005–2009 period.

In 2009, 69.5% of all French medical device exports were sent to the rest of the EU, with the Netherlands taking a 17.6% share, followed by Germany with 14.4%. The UK took 6.6% of French medical device exports.

Outside Europe, the leading destination is the USA, which accounted for 9.1% of exports. The USA is the leading destination for French exports of diagnostic imaging apparatus.

Next month, Medtech Business will look at the medical technologies market in Germany.

This article is based on information from Medical Market Outlook reports published quarterly by Espicom Business Intelligence. *All figures are in US $. For further details of the 66 markets covered, please visit www.espicom.com/outlookm1

The NHS is not using high-value diagnostic imaging and radiotherapy equipment to its full capacity and is failing to meet patient needs as a result, according to a report from the Government’s Public Accounts Committee.

The report, ‘Managing high value equipment in the NHS in England’, stated that poor co-operation between trusts is leading to a “scandalous” shortfall in provision of vital services such as post-stroke scans.

NHS Supply Chain has said it is working with the DH to address the issues raised by the report and the “significant challenge” of procuring costly but much-needed equipment.

The NHS in England spends approximately £50m per year on MRI and CT scanners and linear accelerators for radiotherapy. However, the Committee said, the use of this equipment to provide services is “fragmented and uncoordinated”.

The number of CT scans carried out per machine in a year was found to vary between 7,800 and 22,000, with availability ranging from 40–100 hours per week.

Shockingly, the report found that only 50% of stroke patients received a CT scan within 24 hours – an essential service for determining immediate treatment.

Margaret Hodge, Chair of the Committee, said the way high-value equipment is bought and used by the NHS “is not providing value for money”. She described the shortfall in post-stroke CT scans as “scandalous” and the inequalities in usage between regions as “unacceptable”.

“The Department of Health has got to look at how machines can be used more efficiently to make the best use of scarce resources,” she concluded.

The report highlights the challenge for the new NHS Commissioning Board to ensure that Foundation Trusts work together to ensure access to capital equipment.

Health Minister Simon Burns commented that more streamlined procurement of scanners had already begun: “The NHS has saved up to 15% on scanners by working with NHS Supply Chain to co-ordinate large orders over time with other trusts. This is the NHS working smarter.”

“We are currently working with the Department of Health to consider the recommendations in the report,” said Andy Brown, NHS Supply Chain’s Managing Director for Diagnostics. “Buying and maintaining equipment during times of budgetary restraint will provide a significant challenge for NHS trusts and our range of frameworks to plan, aggregate, purchase or lease and maintain high-end equipment will be invaluable to the NHS.”

J&J is creating a new biotech and health IT ‘innovation centre’ as part of its pharmaceutical facility in San Diego.

The healthcare giant expects 18 to 20 life science start-up companies to join the new centre, to be called ‘Janssen Labs at San Diego’.

Diego Miralles, who oversees J&J’s San Diego centre, said: “It’s a completely ‘no-strings attached’ business model.”

He said that start-up companies in the new centre will pay a monthly ‘licensing fee’ to J&J, but the landlord agreement does not grant J&J an equity stake in the businesses.

He estimated the innovation centre will be made up of “modular and flexible” offices available for companies developing mostly biotech and health IT-related technologies. The companies would share a common area for the storage of high-end research equipment, as well as office supplies and other tools.

J&J plans to open the new centre by April 2012.

Siemens Hearing Instruments has released a number of innovative audiology devices aimed at improving workflow and reaching a wider range of care environments.

The company’s new audiometers and digital video otoscopes extend the choice available from one specialist point of contact, promising to simplify procurement, save clinical time and reduce costs.

New audiology devices now available from Siemens include:

• Otopod and Amplitude Audiometers – tiny, portable wireless audiometers suitable for use in the fitting room, home or bedside
• Kamplex PA5 Paediatric Audiometer – a free field audiometer for testing children’s hearing with one-handed operation
• a high-resolution USB Digital Video Otoscope, which links directly to a PC.

The new devices join Siemens’ existing range of audiology workflow solutions. A wider range of audiological accessories is also now available.

“Our single approach to providing a wide range of audiology workflow solutions gives audiologists more choice and specialist advice,” said Mark Laben, Product and Marketing Manager at Siemens Hearing Instruments.

“Healthcare departments and practices are facing increased pressures to invest wisely and redesign audiology workflow processes. By having workflow that integrates together, audiologists will have more time to spend with the patient on quality matters such as talking through fittings and answering concerns.”

Based in Crawley, West Sussex, Siemens Hearing Instruments provides digital hearing instruments and software, patient management systems and audiology equipment to the NHS and retail dispensers in the UK.

US rehabilitation therapy company Bioness has received CE Mark Approval and FDA clearance for its Ness H200 Wireless system for hand paralysis patients.

The advanced wireless hand rehabilitation device uses mild Functional Electrical Stimulation (FES) to help patients to grasp and release objects while performing daily life activities.

The Ness H200 Wireless system aims to improve hand function, increase therapy time and encourage motor recovery in those suffering from hand paralysis resulting from stroke or other central nervous system disorders.

Todd Cushman, Senior Vice President of Global Business Development and Marketing for Bioness, said: “It is well known in rehabilitation that frequency of therapy and training has a direct impact on outcomes. Simply put, the more patients are able to be active and integrate therapy into their day to day lives, the better their outcomes.”

The device consists of three components: a wireless, lightweight stimulation support (orthosis); a small handheld remote that communicates wirelessly with the system; and a clinician’s programmer that allows patient activity tracking.

The company expects the equipment will become commercially available to neurorehabilitation hospitals and centres in the US and Europe, as well as to consumers for home use, later this year.

Based in California, Bioness specialises in neurostimulation devices to restore mobility and independence to people suffering from nerve damage.

The application of a bio-decontamination programme, including the use of hydrogen peroxide vapour (HPV), by Gloucestershire Hospitals has reduced the incidence of Clostridium difficile infection.

In three years, the Trust’s infection control programme – which includes the use of cohort wards and antibiotic control as well as UK company Bioquell’s HPV technology – has achieved a 65% reduction in C. difficile infection rates (from 771 cases to 267).

C. difficile (pictured) is the leading cause of hospital-acquired diarrhoeal disease in the UK, and its control is a major target for healthcare professionals.

Over the three-year period, 2,763 areas were decontaminated using HPV within the hospital. HPV can eradicate all biological contamination, providing a clean environment for patient re-admission.

C. difficile endospores are usually resistant to decontamination and can survive for months on hard surfaces, creating a reservoir of infection. The HPV process ensures complete surface sterilisation, breaking down endospores,

Deputy Nursing Director Paul Garrett commented: “HPV technology has played an important part in helping to reduce C. diff infection as part of an overall bundle of interventions. The Bioquell system has now been successfully integrated into the daily operations of our hospitals.”

Based in Hampshire, Bioquell is a leading supplier of bio-decontamination equipment and services, including its unique HPV technology.

A new imaging technology could help to identify lung cancer more accurately, enabling earlier intervention and minimising surgery.

Diffusion-weighted MRI, which measures water movement in lung tissue, can differentiate benign from malignant lung lesions.

A Belgian study has found that the new scan can help to diagnose lung cancer more accurately than the current standard method, a PET-CT scan.

The new scan is non-invasive and requires no radiation exposure.

The research analysed 50 people who were due to be operated on for lung cancer or suspected lung cancer:

• With PET-CT scans, 33 patients were diagnosed correctly, 7 incorrectly and 10 were undetermined.
• With diffusion-weighted MRI scans, 45 patients were diagnosed correctly and 5 incorrectly.
• The 10 cases undetermined with PET-CT were correctly diagnosed using diffusion-weighted MRI.

Dr Johan Coolen, from University Hospitals Leuven in Belgium, said: "Our study has shown that diffusion-weighted MRI scans could become an appropriate diagnostic instrument for preoperative lung cancer patients in the near future. PET/CT scans can wrongly diagnose cancer as they can misinterpret inflammation in the lungs as a malignant lesion. Diffusion-weighted MRI is more accurate, which could help avoid unnecessary surgical procedures for those people without malignant disease.”

According to Professor Marc Decramer, President of the European Respiratory Society, the new European Respiratory Roadmap places strong emphasis on the need for more effective screening and the potential value of personalised, targeted medicine.

“With the development and evaluation of new technologies such as the diffusion-weighted MRI scan, we can work towards achieving these goals,” he commented.

The UK medical device market is one of the biggest in the world, with growth relying predominantly on imports. But it is also a significant exporter of medical technologies. In the second of two articles looking at the domestic market, Medtech Business in association with Espicom takes a look at the UK medtech export market.

The UK is a significant global exporter of medical devices (including medical equipment and medical supplies) and remains among the world’s top 10. But the sector has faltered in recent years. Exports peaked in 2006 at US$7,238.5 million, but have fallen every year since then. In 2009, exports dropped to US$5,394.4 million – roughly the same level seen in 2005. The orthopaedic sector was hit especially hard in 2009. (For more details, see Figures 1–3.)

Consumables

Medical consumables were the largest individual export area in 2009, valued at $1,140.0 million,* or 21.1% of total exports. This was a fall of 3.8% compared with 2008, with a 2005–09 Compound Annual Growth Rate (CAGR) of –1.8%.

Consumables are defined as wound care products (medical dressings, sutures, sterile, surgical and dental goods), syringes, needles and catheters. Within this category, catheters and cannulae amounted to $279.7 million, virtually unchanged from 2008, but significantly lower than the 2005 level of $410.6 million. Exports of medical dressings amounted to $503.7 million, a fall of 8.3% compared with 2008.

Diagnostic imaging

Diagnostic imaging is not historically one of the UK’s stronger sectors. In 2009, UK exports of diagnostic imaging apparatus amounted to $1,131.3 million – 21.0% of the country’s total export market. In recent years, the electrodiagnostic sector has been its biggest source of growth. The 2009 total showed a fall of 0.1% compared with 2008, with a CAGR for 2005–09 of 5.4%.

Electrodiagnostic imaging exports amounted to $575.1 million, a rise of 23.4% over 2008 due largely to a big rise in MRI exports. Radiation apparatus exports were far lower at $83.4 million, although this too represented a strong increase of 28.2% on 2008 figures. Exports of imaging parts and accessories fell sharply in 2009, by 21.4% to $472.9 million.

Orthopaedic products

Exports of orthopaedic and prosthetic products saw a sharp fall in 2009. Exports totaled $1,231.5 million in 2008, but fell by 46.7% the following year to reach $656.2 million. Artificial joints fell by 67.1% to $71.5 million, while other orthopaedic/fracture appliances fell by 49.8% to $445.2 million.

As outlined in Medtech Business’s first UK market article (July 2011), imports in this sector also saw a sharp fall in 2009. Espicom suspects that much of the reduction is due to a change or relocation of multinational manufacturing and repackaging activities.

Patient aids

Exports of patient aids amounted to $1,054.5 million in 2009, a fall of 5.2% compared with 2008.

Portable aids fell by 8.0% to $762.1 million, while therapeutic appliances rose by 2.9% to $292.4 million.

Dental products

Exports of dental products reached US$148.2 million in 2009 – 2.7% of the total. This is an increase of 4.1% over 2008; the total fell sharply in 2007, but has since recovered a little.

Dental cements amounted to US$70.2 million in 2009, a rise of 17.7% over 2008.

Leading destinations

In 2009, the single leading destination for UK exports was the US, with $768.1 million (4.2%) of total exports. The largest shipments to the US were diagnostic imaging products, which amounted to $188.8 million, 16.7% of exports in this sector. This was followed by consumables, which amounted to $136.5 million, 12.0% of exports in this product area. The US also received 31.7% of dental product exports, valued at $47.0 million. (See Figures 4 and 5 for more details.)

More than half of UK exports went to the EU-27 countries. Shipments totaling $3,016.7 million (55.9% of total exports) left the UK for the EU-27. The principal recipient within the EU was Germany, accounting for 13.4% of exports, valued at $720.6 million. Almost a quarter (22.3%) of diagnostic imaging apparatus exports went to Germany. Belgium was the single biggest importer of UK consumables (18.6%) and UK orthopaedic and prosthetic products (17.2%) – in both cases outstripping the US. Other leading destinations within the EU were France, Ireland and the Netherlands.

Next month, Medtech Business will look at the medical technologies market in France.

This article is based on information from Medical Market Outlook reports published quarterly by Espicom Business Intelligence.
*All figures are in US $. For further details of the 63 markets covered, please visit www.espicom.com/outlookm1