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All things Pharma

The words that count

ZephyrTM A new brand of healing pacemakers speed up treatment

ST. JUDE MEDICAL has gained European CE Mark approval of its Zephyr pacemaker family, and the first implants of these devices in Europe have taken place. The Zephyr pacemaker saves clinic time by automatically performing all standard follow-up testing before the appointment. It can also tell physicians which device timing settings are optimal for the patient’s needs.

When a Zephyr device is interrogated during a follow-up visit, the stored diagnostics, trends and measurements from the automatic tests are displayed for evaluation. Physicians can program the device’s AV timing in about 90 seconds to deliver optimal therapy.

“Zephyr pacemakers offer built-in disease management options that result in better patient care in less time,” said Professor Tiziano Moccetti, M.D., chief of the Cardiocentro Ticino in Lugano, Switzerland, who performed the first implant of the Zephyr DR pacemaker in Europe. “Zephyr pacemakers allow me to quickly optimise therapy for all of my patients individually.”

“Clinic time is a valuable commodity,” said Michael J. Coyle, President of St. Jude Medical’s Cardiac Rhythm Management Division. “Zephyr pacemakers eliminate some of the waiting and ‘down time’ during followups, without compromising care.” For more information, visit www.sjm.com.

A new brand of healing

  A UK COMPANY HAS produced the first artificial skin graft replacement to achieve full, consistent wound integration and persistence. This represents a major landmark in regenerative medicine.

Cambridge-based Intercytex Group plc, a tissue repair specialist, has completed a clinical trial in which the laboratory-made skin product ICX-SKN was fully and consistently integrated into the human body. All other living skin graft replacements currently available biodegrade within weeks.

In the trial, a sample was excised from the upper arm of six volunteers and replaced with ICX-SKN. After 28 days, all the grafts were vascularised and overgrown with the hosts’ own cells, healing the wound site.

Living skin grafts are the optimal treatment to obtain wound closure for certain types of wounds and burns. However, skin grafting is a traumatic process that creates an additional wound. ICX-SKN represents a potential alternative. Dr Stephen L. Minger of King’s College, London, an acknowledged world expert in regenerative medicine, commented: “I think these results are a real breakthrough in the field of wound healing and regenerative medicine. To have an off-the-shelf skin replacement product will revolutionise the treatment of burned and skin-damaged patients.”

For more information, visit www.intercytex.com.

Eizo to supply BUPA with monitors

  DIAGNOSTIC IMAGING SPECIALIST Eizo Nanao Corporation has been chosen by leading private healthcare provider BUPA to provide monitors for all diagnostic and clinical review requirements across its UK network of hospitals. The decision was announced at UKRC (see page 7).

“We are delighted to be given this opportunity to work with BUPA,” said Rob Musson, Business Director for Eizo in the UK. “We believe we are the only company able to provide such a broad-ranging solution that suits the needs of users across all major departments.”

Fiona Maclachlan, BUPA Hospitals Head of Diagnostic Imaging, said: “We are very pleased to be working with Eizo, who is going to supply all of our diagnostic and clinical review monitors for the hospital network. We were impressed with the comprehensive range of monitors that Eizo offers, enabling us to provide a flexible solution for image review across all areas within our hospitals.” BUPA will connect its Eizo monitors to the Eizo RadiNET Pro quality control system, which enables unified management of multiple monitors used in the PACS environment. The new system will enable BUPA Hospitals to develop PACS across its national structure, in line with the NHS Connecting For Health programme.

For further information, visit www.radiforce.co.uk.

What claims can you validly make for a product? Neil R. Armstrong of MeddiQuest looks at what the regulatory environment means for medical device marketing, and how changing your message can impact on the status of your product.

Forgive me if I start with a short tale from a bygone era…

Developing a medical device

For some years now, I have concentrated almost exclusively on new medical devices and new technologies. Frequently I visit a new potential customer who shows me their prototype product and asks me: “How will this be regulated?”

I always have to give the same answer: “Show me the whole product, including the labelling. Show me the indications for use. Show me the claims you intend to make. Then I’ll be able to tell you.” How a medical device will be regulated is not based simply on the physical device, but also on the words we put around it:

• What procedure(s) is it meant to be used in?
• What patient population (e.g. adults, children) should it be used on?
• How invasively should it be used?
• How long should it be used for?

The blacksmith in the story let his enthusiasm run away with him when he was in ‘sales mode’, and needed the apprentice to point out to him that his words had fundamentally changed the nature of the product. Listen to a modern hospital sales representative, let alone the owner of a business describing his new product, and you will discover that the same mistake persists to this day.

When we are designing and developing a medical product, we need to take a holistic stance and develop the ‘whole product’ together, including the promotional materials, the website, the instructions for use and the packs, boxes and labels. Only then can we be sure that we understand ‘what the product is’.

Following the label

Once we have determined the product and sought regulatory sanction to market it, we have essentially fixed the allowable use and claims. Many salespeople forget this, start promoting off-label uses in their enthusiasm to get a sale, and cause major problems for their organisations as a result.

Imagine an inexperienced sales representative confronted with a famous senior surgeon praising the product and keen to demonstrate exactly how he uses it. On his next call, the representative is keen to drop the surgeon’s name and endorsement into the conversation… and by accident the company has started endorsing an off-label use.

Another common problem is a lack of internal communication. Frequently the manufacturer goes for a limited (use or claims) approval in order to get the product onto the market quickly, expecting to follow up later with a more complex regulatory submission – but this is not communicated effectively to the sales force. Then there’s the over-zealous creator.

Frequently I deal with a product’s inventor who believes passionately in it. He is convinced that the product has another use or that he can make another claim for it, and he is determined to include this in the regulatory submission. However, the marketing team know this claim will be of no interest to a clinician, particularly if it is technological in nature and not outcomebased – and the regulatory team know it will be a nightmare to prove.

Approval and value

It is increasingly important to demonstrate the health economics advantage of a new device or new technology. However, this is separate from the performance and safety issues that need to be demonstrated to gain regulatory sanction for a product.

If clinical trials are required to gain regulatory approval, it is common sense to structure these in such a way that they also provide health economic evidence. However, if this means additional patient trials, it will be better to seek regulatory sanction without any health economic justification and then to demonstrate the latter with legally market product, at a fraction of the cost and complexity of a clinical trial.

The global market

Today, due in large part to the Internet, even the smallest single-product companies tend to think of themselves as players on a global stage. But there are many pitfalls for the unwary in international trade. Commercial laws, particularly those concerning the advertising of healthcare products, vary markedly from one country to the next; and increasingly, governments are assuming extra-territorial positions when it comes to Internet marketing.

The lure of export sales can seduce a business into international trade, but for the medical technology company it is essential always to check the basics:

• Are the translations really accurate?
• Does the clinical practice differ?
• Will a local partner take as much care of your legal and regulatory duties as they do of their own?

There is a great temptation to rely on a local partner to translate literature, develop contracts or terms and conditions of sale, train and manage their own sales force, and even manage regulatory submissions – but many organisations have paid a high price for such abdication of responsibility.

Top tips for marketing in the regulatory environment

1. Decide what you want to say about your product as you design it.
2. Make sure that any revisions to your marketing message are well communicated within your organisation.
3. Train your employees on the use of the product, the claims that can be made for it and the need to limit themselves to these.
4. Do not make unnecessary claims that will give no commercial or clinical advantage.
5. Do not rely on local partners to be as ‘law-abiding’ as you are!

Keep it real

The spoken and written words that a company puts around its medical device are frequently a larger part of the whole product than the physical device itself. We need to control the evolution of the words just as much as that of the physical product.

Neil R. Armstrong is Principal Consultant and CEO of MeddiQuest Limited, a UK-based Regulatory Affairs Management Company. Neil has over 25 years’ experience in Engineering, Manufacturing, Quality and Regulatory Affairs roles with leading medical technology companies such as Smiths Medical, Teleflex Inc.
and The Automation Partnership. He is currently a Director of The Organisation of Professionals in Regulatory Affairs (TOPRA) and Chair of the Institute of Quality Assurance’s Medical Device Quality Group.
MeddiQuest works in partnership with ‘hi-tech’ and ‘start-up’ organisations to help them introduce products rapidly to new markets while maintaining regulatory compliance. For more information, visit www.meddiquest.com.



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