IDC News

Impending IEC 60601 leaves medical companies struggling with rules on sustainable design

The issue of ‘sustainability’ is becoming increasingly important for the medical industry since the implementation of the ‘International standard for environmentally conscious design of electronic medical equipment’ (IEC 60601-1-9) introduced in 2007. This directive is considered to be the global benchmark for companies designing sustainable medical equipment and requires manufacturers to consider the environmental impacts of their devices throughout the product life cycle.

On 1st June 2012, the 3RD edition of IEC 60601- Medical Electronic Equipment will come into force in the EU and Canada with the US following on the 1st of July 2013. This makes compliance with part 9 ‘Requirements for environmentally conscious design’ obligatory rather than optional as it has been in the past.

The difficulty for many medical device companies is that despite long standing awareness of the standard they have little or no experience dealing with issues relating to the environmental impact of their designs, with the tools and information required to comply with the standard not readily available.

The requirements IEC 60601-1-9 centre around are the need for manufacturers to identify the environmental impacts of new products and identify actions to manage and reduce the major impacts over time. This process must be documented. The key stages of any products life cycle are:

1. Manufacture – the extraction of the raw materials and manufacture of the components

2. Transport – moving the parts and assemblies within the supply chain and to the end user

3. Use – covering energy and consumables used during the product’s useful life

4. Disposal – disposal to waste streams or recycling Obtaining useable data about the impacts of these stages and the processes within them has proven to be a major problem for companies large and small. This is confirmed by a recent conference paper by Brouet et al.[1] representing global pharma companies,(including, GSK, AstraZeneca, Novartis, Pfizer and Merck), in which they concluded that the medical industry was behind other industries with its adoption of sustainability.

At Industrial Design Consultancy (IDC) we have been working overcome these difficulties in order to help companies understand and manage their environmental and sustainability issues. As well as actively supporting companies (including some of the above mentioned pharma companies) with studies and consultancy work around sustainability and life cycle assessment, IDC has also developed a series of tools which manufacturers can use themselves to ensure they comply with legislation for product life cycle and design for the environment, including IEC 60601-1-9.

One such product is the LCA Calculator (www.lcacalculator.com), a simple, low cost software tool which requires no special training and can be accessed through a standard web browser. Using data from EcoInvent, the world’s leading source of life cycle inventory (LCI) data, the online tool, guides the user through the stages of a products life, including a comprehensive inventory of materials and manufacturing processes, to deliver simple, clear and easy to interpret results. Analyses can be saved, copied and compared against comparable products or potential new designs and results can be exported as Excel data or a pdf report.

The use of the tool allows companies to meet the standard set in IEC 60601-1-9 regarding medical eco design. With the impending legislation it is important for companies to think about the most appropriate tool they can implement quickly at a minimal cost (£300 per user per year). Table 1 details how the LCA Calculator can be used to ensure new products comply with key requirements of IEC 60601-1-9

Table 1

Understanding and managing the environmental impact of products is a complicated process and one which even the largest companies have struggled with. Two of the biggest obstacles to companies addressing these issues have been a lack of available life cycle information or data in such complex formats as to be unusable. This has made it very difficult to build environmental design processes into rapid development projects. With the arrival of mandatory legislation, organisations can no longer ignore this problem but through the use of a simple tool such as the LCA Calculator, compliance with the standard and improved environmental performance can be achieved rapidly and cost effectively.

References [1] Brouel, et al, “Sustainability for Inhaled Products: A Catalyst for Change”, Drug Delivery to the Lungs 22, 2011 p327 -330.

16 May 2012

IDC Shanghai lends helping hand to China’s Industrial Dreams

Industrial Design Consultancy Shanghai Ltd, a subsidiary of IDC UK, has made the front page of the ‘China Daily’ newspaper this week for an article entitled: ‘Small international design firms lend helping hand to China’s industrial dreams.’

The article talks about the ‘significant shift’ of small design companies, like IDC, moving their business to China to create designs specifically for the Chinese market. The fact that IDC and other small companies have made this strategic decision is changing the way in which the world views China, from a manufacturer to an ‘innovator and creator.’

It is nearing the first anniversary of IDC Shanghai and already the company have worked with medical giants such as FOOSIN, China’s largest suture company and XFT whose CPR assistant won IDC the prestigious ‘Red Star Design Award.’

To read the full article please visit:

http://europe.chinadaily.com.cn/epaper/2012-04/20/content_15098078.htm

27 April 2012

IDC Designs Foot Drop System to Keep XFT One Step Ahead

Award winning product design company, Industrial Design Consultancy (IDC), has just developed an advanced medical device to help people with certain neurological conditions walk again.

The XFT Foot Drop System delivers electrical pulses to counteract the effect of foot drop (the dropping of the foot due to peroneal nerve damage or leg muscle paralysis) in patients with neurological problems. The system includes a small Functional Electrical Stimulation (FES) device which is strapped onto the patient’s leg below the knee and sends electrical signals to the peroneal nerve (the nerve that controls the movement of the ankle and foot), stimulating the muscles to raise the foot at the appropriate time so the patient can walk. This works in combination with a foot sensor, which detects the walking rhythm and helps regulate a normal walk.

IDC handled product development from concept right through to production support. Initially, the team focused on research with both patients and doctors to understand how the product would be used. For doctors, a key element was setting up the device for patients, so the product needed to be easy to assemble and disassemble, with the electrical stimulator, electropad and cable integrated into the strap.

Patient research also identified several areas of focus. The device would be used by patients with different neurological conditions; including stroke patients who may have lost control down one side of the body. This meant that in designing the product, IDC needed to ensure the device could be strapped on using only one hand. Patient comfort was also a key issue and led to careful consideration of materials for maximum breathability, durability and design comfort. IDC took inspiration from sports products such as knee supports which used the latest high-tech materials; this research also demonstrated how the product would behave during use.

IDC designed the strap with an embedded plastic ‘C’ shape strip to help it hang on the leg while the buckle was being clipped. This meant it could be fastened using just one hand. A velcro adjustor could also be used to adjust the strap length. The stimulator was integrated into the strap, along with the wires which connected to electropads. Part of the design challenge was in integrating all the system elements within the strap. This was achieved by including a holder for the stimulator to clip into, and a concealed zip pocket to hide all the cables and allow easy assembly/disassembly.

Another challenge was to ensure that the electropads would be in the right position to stimulate the peroneal nerve each time the strap was fitted. The design meant that the electropads could be customised to the best position for each user. This was done by moving the velcro-backed electropads along the strap, so that when the strap was worn, the electropads would be in the optimum position for the peroneal nerve.

IDC produced several prototypes of the system, using different materials, before the look and structure were finalised. There were four components of the system, with the stimulator, strap and electropads, foot sensor and remote control. These were all designed to have the same family style.

Marc Tanner, IDC’s Head of Design, comments, “We are delighted to have produced the Foot Drop System for XFT. This is the second medical product we have developed over 2011 for XFT and we have overcome many design challenges to produce a device that is highly innovative but also budget-conscious.”

After extensive clinical and user trials, the XFT Foot Drop System is now being manufactured with the ongoing support of IDC. XFT’s Product Development Manager, Jackey Woo, explains, “Combined with IDC’s excellent design, we have turned this FES device into a high-tech advanced machine. We already have SFDA certification in China, where the product has been used in more than 10 cities. We are now ready to apply for CE and FDA certification, for sales across the world.”

28 March 2012

IDC’s LCA Calculator Drives Low Carbon Vehicle Project

Revolutionary lifecycle assessment software for sustainable product design, called the LCA Calculator, has been selected as the main tool in the multi-million pound Low Carbon Vehicle Technology Project (LCVTP). Following a comprehensive review of the commercially available LCA tools, the LCA Calculator, developed by Industrial Design Consultancy (IDC), was chosen by a consortium of leading automotive companies and research partners to provide sustainability data about the way vehicles are powered and manufactured.

The LCA Calculator had been used successfully by Jaguar Land Rover for their internal projects. Therefore as a member of the project consortium, Jaguar Land Rover recommended the software as the main analysis tool for the LCVTP to assess the design of vehicles for carbon output. Previously the LCA Calculator was designed for general use across different industries, but IDC has worked closely with consortium coordinator, Warwick University, to refine the LCA Calculator and also to develop a version of the tool addressing the particular needs of automotive manufacturers.

As part of the LCA Calculator’s latest upgrade, the system now uses data from licensed from EcoInvent, which is widely acknowledged as one of the world’s most comprehensive and independently verified data sources. In addition to the EcoInvent data, the LCA Calculator also gives manufacturers the option to add or edit materials and CO2 impacts to integrate data specific to their own supply chain. IDC worked with the consortium to build on the flexibility of the LCA Calculator and it now enables users to make notes and assumptions throughout the lifecycle assessment process. These additional features mean the LCA Calculator is now also able to support compliance with lifecycle standards such as ISO 14040 and PAS 2050 standards for life cycle assessment and for carbon foot-printing.

The automotive version of the LCA Calculator has been fully tested by the consortium and is now being used by Jaguar Land Rover and Warwick Manufacturing Group. The automotive version has just been released and is available for purchase from IDC, together with a general version applicable to a wide range of products and industries. Full information about the LCA Calculator’s capabilities is available at: www.lcacalculator.com or contact sales@lcacalculator.com for a free trial.

28 March 2012

IDC Produces Palm Recognition System for Luxury Yachts

Leading product design company, Industrial Design Consultancy (IDC), has just designed and manufactured a state of the art palm recognition system for luxury yacht technology specialist, Marine Entertainment Systems (MESL).

MESL specialises in the integration of entertainment, communication, security and IT systems for the luxury yacht market. The palm recognition entry system is a ground-breaking biometric security access control system for the yachting industry based on one-touch palm vein recognition, which the system utilises to allow access to authorised individuals.

MESL came to IDC with a mature concept of the palm recognition unit and IDC further developed this concept ready for production. IDC also provided full mechanical and industrial design support to integrate the electronic assemblies designed by MESL. Working closely with the client, IDC was able to identify a construction solution and create the detailed design in only three weeks. IDC then created a series of SLA prototypes that were assembled together with the electronics to prove the functionality of the product.

Once the product had been tested and was ready for production, IDC went on to manufacture the product. The luxury nature of the palm recognition reader meant that it would be manufactured in low numbers as a hand built device. IDC’s integrated skills and facilities meant that it was able to provide a unique service to MESL; developing a turn-key product incorporating high-tech security functionality with stylish aesthetic design.

Marc Tanner, Head of Design at IDC explains, “From designing the form of the product, right through to materials and method of manufacture, we have worked closely with MESL to design a product with the special qualities expected for such a luxury market. We are delighted to have both the expertise and facilities to manufacture the palm recognition units on-site and will be producing units to order.”

19 January 2012

IDC Develops Unique Pelvic Muscle Trainer With Voice Prompt System

A unique pelvic muscle trainer has just been launched thanks to the design innovation of Industrial Design Consultancy (IDC). Working for medical device manufacturer, XFT, IDC designed a device that uses a combination of an air pressure probe and voice prompts to control pelvic muscle training programmes. The new product is called the XFT-0010.

Continue reading 1 December 2011

IDC Thought Leader Initiative

International product design company, Industrial Design Consultancy (IDC) will be keeping you connected with expert industry insight.

Launching in late 2011, the IDC Thought Leader Initiative will help busy design engineers and industrial designers, as well as students, stay in the know with the benefit of insight provided by our industry specialists.

Continue reading 10 October 2011

IDC Produces Bright Smile for Dental Business

Industrial Design Consultancy, an international product design company, has recently completed an innovative medical device development project for OSspray Ltd. (OSspray), which has accelerated the growth of the company’s key product, Sylc™.

OSspray is a successful supplier of dental biomaterials, including powders for polishing and regenerating tooth structure. One of their latest products, Sylc™, is used to polish teeth while providing a protective enamel-like layer over the surface of the teeth. Sylc™ is a highly effective dental treatment powder, which forms a mineral deposition as it is delivered through dental air-polisher equipment during treatment. Traditional air–polishing equipment can result in powder overspray which the dentist has to clean up after each procedure; additionally the air polishing tip is a disposable item and has to be replaced frequently.

Continue reading 10 October 2011

IDC Invests in Sustainable Education

International product design company, Industrial Design Consultancy (IDC), has just released an Academic version of the LCA (Life Cycle Assessment) Calculator. The LCA Calculator was launched in early 2011 and has had two major corporations sign up for the tool as well as numerous smaller businesses and individuals.

Continue reading 13 September 2011

Datchet Product Designer Receives Red Dot Award for ‘Best of the Best’ Design

Datchet-based product design company, Industrial Design Consultancy (IDC), is celebrating a red dot award for its outstanding product design. The company designs products for many different industry sectors, but it was a medical product that caught the judge’s eye. IDC was presented with a ‘red dot: best of the best’ award for highest product design quality when developing an advanced video laryngoscope for the Venner Group.

Continue reading 22 July 2011

 

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