FUSE Case Study Ref.No.: 23208 First Users Action FUSE htp://www.fuse-network.com

Title IMPLANTABLE ELECTRONIC PACEMAKER Advanced functions and reduced manufacturing costs

Technologies used Analogue ASIC

Industrial sector (PRODCOM code) 331 Medical & Surgical equipment

Abstract LEM BIOMEDICA is an Italian monoproduct company, 11 people staffed (mostly dedicated to R&D), which is active since 1970 in manufacturing and selling cardiac pacing equipment: implantable and external pacemakers, leads and accessories (NACE PRODCOM code 3310). 1996 Company's turnover was of 678 KEURO for a sales volume of 265 pcs, mostly on Italian and Greek market, in front of a total world-wide market size of 300,000 pcs/year. In spite of the fact that LEM BIOMEDICA was in the past one of the most active in innovation (first pacemaker using lithium battery, first physiological pacemaker and first VDD - ventricular stimulation in accordance with atrial sensing - pacemaker were introduced on the market by this Company), its sales were now suffering a dramatic decrease due to product obsolescence and high manufacturing costs. The current LEM product is the result of assembling in a hermetic can battery, coil, sensor and feedthroughs and an hybrid bought from an US supplier. When asked for improving performance of core hybrid circuit, the supplier declared not be interested. The chances for LEM to react to its drastic losses in market position were or closing the Company or investing by itself in upgrading existing product by adopting analogue ASIC technology. In 1996, thanks to the new technology and to the FUSE support LEM decided to become technologically independent. While some knowledge about digital ASIC management was already present within the Company, present Application Experiment resulted in new significant knowledge gained by the Company about analogue ASICs, as well as in a completely renewed range of pacemaker models: highly reliable, extremely safe in operation (that is mandatory for life aid devices), very small in size and weight, low power consumption due to the use of CMOS technology, improved in functionality like rate responsive function, unipolar and bipolar choice, diagnostics Analogue ASIC design and realisation started on 01/02/97 and ended on 30/10/98 for an overall project duration of 21 months. The chip size is 31,5844 mm2: 40% analogue, 1,6% digital and 17,3% high voltage. Total costs of the investments (including the hybrid, software for programming the pacemaker and mechanical part) amounted to 1,246,000 EURO, with 121,000 EURO for the AE only. ROI is 275% on the total investment and 2810% on the FUSE investment only. The payback is 1,4 years on the total investment and 0,2 year on the FUSE investment only.

Company LEM Biomedica S.r.l Loc. Spedaletto, 50030 Cavallina di Mugello (Fi) Italy

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You can also benefit from microelectronics Analogue ASIC technology provided LEM Biomedica S.r.l with the means of improving its products and enhancing its market position. You can also achieve significant benefits by acquiring the right microelectronics technology and utilising it in your product or manufacturing process. You can get help from FUSE to realise this. FUSE is a technology transfer programme, funded by the European Commission to stimulate the wider use of microelectronics technologies by European enterprises to increase their competitiveness and enhance their economic growth. The demonstrator described here is one of many examples in the public FUSE portfolio covering the whole spectrum of microelectronics technologies and spanning a wide range of applications and industry sectors. FUSE provides you with: Best practice in acquiring specific microelectronics technologies and conducting full development projects through the FUSE portfolio of real life demonstrator documents. Local training and expert support to plan your innovation realistically and help you conduct your project successfully. Further information and support relating to this and other demonstrators can be obtained from the addresses below.

Further information   Guiding Technology Transfer Node For further information and support regarding this case study, please contact a Technology Transfer Node (TTN) in your region. Homepage: http://www.fuse-network.com CESVIT Via del Ferrone, 5 I-50124 Firenze Italy