Newsletter > Newsletter No. 01

SME’s: participation results in market share gain

The Dutch family business, Wassenburg Medical Devices, succeeded in accessing new markets and increasing  turnover by 40% by participating in standardization at the national and European levels. An additional profit outweighed costs to a large extent.

Wassenburg Medical Devices at the  time employed 55 people. The company specializes in producing high-quality machines for cleaning and disinfecting endoscopic instruments used in hospitals. The company decided to participate in standardization to increase the quality requirements in a standard relevant to their product. If they were successful, they would have a competitive advantage because their products already met this quality level…

SME gains market share through standardization participation

  The market for these products is targeted to hospitals. In The Netherlands, Wassenburg has achieved a market share of 60%, but exporting appeared to be difficult because in most countries the domain of the hospital-segment is rather closed.

The opportunity – influencing the quality aspects of a new standard
In most European countries the products have to meet the requirements of the European Directive on Medical Devices. This directive provides extra status to European standards developed by the European Committee for Standardization (CEN).  In this case a standard on washer disinfectors was developed in cooperation with the ISO. Mr. Wassenburg decided to get involved in the development of this standard at the national as well as at the European level. His purpose  was to  achieve a high level of quality in this standard because for the competitors it would be a problem to meet this level whereas Wassenburg had already done so.  Partly thanks to his involvement, this has happened, despite the fact that manufacturers of lower-quality products were also represented.

New regulatory requirements – competitive advantage
ISO published its standard, ISO 15883 in 2006 but a draft was available earlier. Because of problems with BSE disease, the British government decided in 1999, to issue a Health Technical Memorandum, HTM 2030, on the validation and verification of washer-disinfector processes at individual hospital sites. The requirements of the draft text of ISO 15883 have been included in HTM 2030. This memorandum has the status of an advisory , but it has opened the British market for Wassenburg.

The results
In the first year, 2000-2001, Wassenburg sold 40 machines and this number has now risen  to 80. Wassenburg’s turnover has increased by  40%. The yearly fees for participation in standardization plus costs for travel and accommodation amounted to EU 6 000, not counting the time spent by Mr. Wassenburg. However, the additional profit margin outweighed these costs to a large extent.


Study by Dr. ir. Henk J. de Vries
Rotterdam School of Management, Erasmus University, The Netherlands

Standards for business – How companies benefit from participating in international standards setting