The FDA has approved Cordis Corporation’s Empira and Empira NC RX PTCA dilatation catheters for the treatment of coronary artery disease.

Both balloon catheters are designed to allow cardiologists to open patients’ narrowed coronary arteries during angioplasty procedures.

Dr Campbell Rogers, Chief Scientific Officer and Global Head of R&D at Cordis, said that the company “worked closely with physician-customers and incorporated their feedback into the design of these next generation devices. We believe the unique design of the Empira Balloon Catheters will meet physicians' needs and has the potential to improve patient outcomes”.

The two medical devices bring several design and technology alterations to Cordis’ portfolio of Empira balloon catheters. They feature the company’s next generation Duralyn Flex balloon material, which is 50% more flexible than the material used in the current Fire Star and Dura Star RX PTCA dilatation catheters, to improve crossability and recrossability, the ability to pass through a lesion.

Cordis Corporation is a Johnson & Johnson company, and develops and manufactures interventional vascular technology. The company works with interventional cardiologists, radiologists and vascular surgeons to treat patients with vascular disease.

The products are expected to be launched for sale in early 2012.

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.

A new childcare product designed to improve posture and assist spinal development has been launched by a UK company.

The PosturePadJunior wedge cushion (pictured) from Derby-based Jolly Back Enterprises was developed with support from the Healthcare and Bioscience iNet, which is part-financed by the European Regional Development Fund (ERDF).

Designed by physiotherapist Lorna Taylor, the product was launched during National Back Care Awareness Week.

Taylor received an iNet Innovation, Advice and Guidance grant, which enabled her to design and test the wedge cushion prior to commercialisation. She is working on a DVD to train teachers and nursery managers in manual handling and back care.

The same company launched the Jolly Back chair earlier this year, using the same wedge-shaped cushion technology to prevent or reduce back pain. The product has 23 UK distributors and has sold worldwide.

“As a children’s physio, I am concerned at how child development is being adversely affected by current lifestyles,” said Taylor, who noted that correct positioning of babies can “allow core strengthening of the back and neck”.

Taylor described the PosturePadJunior wedge cushion as “a simple means of naturally supporting the spine for comfort and physical development”.

iNet advisor Dr Ros Graves commented: “Lorna has shown incredible resourcefulness by coming up with simple but effective products and bringing them to market so efficiently. The potential impact of all her ideas is enormous so we are delighted to have been able to help.”

The Healthcare and Bioscience iNet is an initiative delivered by Medilink East Midlands that assists companies and inventors in the healthcare sector to develop new technologies, products and services. It brings together firms, academics and public service representatives.

GSK and the McLaren Group have entered into a long term strategic partnership until at least 2016.

The McLaren Group will share its knowledge in engineering, technology, analytics, and strategic modelling to help improve performance across GSK’s global divisions.

Ron Dennis, Executive Chairman, McLaren Group and McLaren Automotive, says the partnership “engages two great British companies” in a “multi-faceted and ground-breaking way”.

A new state-of-the-art learning facility will also be built as part of the agreement at McLaren’s Headquarters in Woking by 2013.

The partnership will initially focus on GSK’s manufacturing, research and development and consumer healthcare divisions.

Glaxo will evaluate whether it can use McLaren’s engineering and technical expertise to its own manufacturing processes. It’s believed that McLaren’s approach, technology and processes it applies to its Formula 1 team could lead to improvement in GSK’s production line performance and improve cost and customer service.

The pharma company’s R&D organisation is also examining whether McLaren’s expertise and technology could improve their own clinical research processes by increasing the speed of trial design, and allowing for real time patient monitoring and treatment adjustment.

Also its Consumer Healthcare business will work alongside McLaren’s Formula 1 unit which analyses team performance during a Grand Prix to enable GSK to respond quicker to competitor activity and customer needs, and inform decision making on various issues. Analytical and performance management tools developed and used by the Group will also be utilised to improve GSK’s ability to come to faster decisions around longer term investments.

Andrew Witty, GSK, CEO, says the partnership highlights the company’s innovative thinking which continues to look for “inspiration and fresh perspective” from outside the sector on how to achieve its strategic goals.

“I am delighted to announce this partnership with McLaren which brings together two British companies whose continued success hinges on the ability to innovate and rapidly respond to change and competitor activity,” said Mr Witty. “McLaren has an unparalleled reputation for innovation built on rigorous analytics and fast decision making.”

McLaren boss Ron Dennis says the agreement is the first between the Group and a major pharmaceutical corporation. “Specifically, our intention is that GSK will harness McLaren’s world-beating Formula 1-bred technology, processes and operational dynamism, in order to enhance its performance across a wide variety of its divisions in a way that none of its competitors can match,” he added.

Talking business isn’t restricted to exclusively speaking English. Xavier Louyot (pictured), Dolce Hotels and Resorts, explains how multilingual content can create global opportunities for your business.

Generating content for global markets and communicating to a multilingual audience is a challenge that comes part and parcel of a global position or organisation, especially given the pressure to standardise and comply with internal and international standards.

A common risk is to see the meaning in your messages either lost or altered because of these language differences. Culture, translation, writing, and design always interweave in curious ways when presenting to a multilingual audience; so keeping it simple is often the key to avoid misinterpretation and to keep communication lines clear and concise.

By putting some simple techniques into practice you can ensure that you get your message across effectively and accurately to your associates and clients, not just in their language, but in ways that show that you value and respect their culture.

Keeping it simple

Start by keeping sentences short and, where possible, use bullet points. This is good practice in any presentation; but is even more important if you are communicating to audiences in a language that is not their mother tongue. Bullet points allow a speaker to identify clear key points and keep audiences focused on the most important or relevant elements of the presentation.

In the same way that sentences should be short, the vocabulary and grammar chosen should be as easy and simple as possible for audiences to understand. Sticking to plain words and sentence structures will ensure the audience is focussed on the presentation and not pre-occupied by a word they cannot translate or understand.

Of course, there will always be times when it’s hard to avoid certain words or expressions that do not translate. Perhaps you need to use a colloquial term or a reference to the local dialect, either way, in this instance it is useful and completely appropriate to give audiences an explanation or definition of the word or expression. This enables you to put it within the intended context and avoids any confusion or the message being diluted.

A common interest

It’s often hard with multilingual audiences to find a shared interest but it’s this common ground that helps communities come together and can really make or break a conference. Including references or giving examples that resonate across cultures is an effective way to develop a rapport with your audience and, at the same time, bring delegates together. Building this sense of camaraderie amongst audiences can often lead to more productive breakout sessions and networking around a conference or event.

Finally, it’s useful to remember that it’s best to use formal language when addressing a multilingual audience. Informal vocabulary is very specific to each culture and is not always learnt when a language is being taught at school or university. Sticking to formal language ensures you don’t alienate your audience or worse still, offend them.

The above are just a small amount of tips and hints to put into practice when communicating to a multilingual audience; but most of all, the best tool you have is your smile. A person who smiles exudes friendliness, openness and approachability.

Even if audiences don’t understand everything you have said, say it with a smile and they will feel comfortable enough to approach you with a question. For something that is universally understood and costs nothing to give, the value of a smile cannot be underestimated when it comes to breaking down language barriers and engaging international audiences.

Xavier Louyot is Global Director, Marketing and PR for Dolce Hotels and Resorts.