▲ JM Safety / CEO Kwak Jung-geun

The pandemic has brought a boom in the medical device industry. The diagnosis kits manufacturers especially took advantage of the momentum and have enjoyed a good harvest of profit. However, not everything went as smoothly as we might imagine: the cost of running complex manufacturing facilities is high not to mention strict regulations. For this reason, many medical companies tend to go for contract manufacturing. 

Established in 2020, JM Safety has focused on contract manufacturing and made a strong presence in the field of specimen transport mediums. 

Specimen transport mediums

CEO Kwak Jung-geun used to work for a vitro diagnostics company during which he traveled overseas often and observed how they outsourcing their needs and wants for cost-effectiveness. Impressed by this, he established JM Safety. 

He runs factories for specimen transport mediums in Gunpo and Uiwang while the facilities in Vietnam manufacture and supply blood pressure gauges and blood glucose meters to companies in Japan and China.

The specimen transport mediums consist of a container, sampling tools such as cotton swab, and buffer solution. The samples of patients in the mediums are delivered with utmost care to the destinations.

Competitive edge from strict quality management

As it deals with medical devices, JM Safety runs a strict quality management and system.

ISO 13485-2016, obtained by JM Safety, is quality management systems specify that an organization has to demonstrate its ability to provide medical devices and related services which consistently meet customer and applicable regulatory requirements. The standard is especially high in Europe and Canada.

In addition, the company obtained the GMP certificate of conformity from the Ministry of Food and Drug Safety. In line with these excellent achievements, CEO Kwak equipped its facilities with a ’10,000 CLASS cleanroom environment’ and ‘20~60% humidity management system’ alongside a 24 hour monitoring system through its objective validation system. 

Customization services

Kwak says, “We provide customized design and production in collaboration with a number of pharmacists, medical device businesses and hospitals. Also our excellent initial mass production in small quantities and samples meet the needs and wants of our small and medium sized clients.”

It is noteworthy that the company’s patented ‘Double Vacuum Structure Sample Container’, a sterile plastic case, endures temperature changes and external shock. It can effectively be used in South East Asia where temperature is normally high.

Kwak says, “The POCT (Point of Care Testing) market is growing yearly by 10% globally. Subsequently, the demand for specimen transport mediums is increasing steadily as the outbreak of novel viruses and diseases has become more frequent alongside the need of early diagnosis to meet the increasing number of aged people.”

He adds, “We are expanding our investment with a goal to become one of the top contract manufactures for medical devices in the nation. As part of this effort, we are set to demonstrate our excellence at the Korea International Medical & Hospital Equipment Show held in March this year.”