Transfer of medical equipment manufacture yields higher quality and reduced costs

Embla Systems designs, markets, sells and supports sleep diagnostic equipment used worldwide by doctors, research facilities and hospitals to study sleep and to diagnose sleep disorders.

The company used to manufacture its sleep diagnostic equipment in house before making a strategic decision to focus on its commercial competencies, like product design. Manufacturing was not core to the business and could be outsourced to a trusted partner. Since 2004 Cogent Technology has handled all of the manufacturing and is effectively Embla Systems' production department.

Choosing the right partner

Transitioning the manufacturing process could have been disruptive to the business, but because Embla Systems chose a partner that operates with great attention to detail and a disciplined approach to planning, outsourcing manufacturing happened very smoothly.

Embla Systems attributes this to the support it received from Cogent Technology during the transition and Cogent Technology's ability to provide valuable and important insights into what would be required to manufacture Embla Systems' products. The dedicated production team for Embla Systems' products follows rigorous testing and calibration procedures.

David Baker, CEO of Embla Systems describes his experience. "Despite the distance between Cogent Technology and our operations team in Denver, the service we receive is better than the on-site manufacturing facility we had. Their engineers work with ours from the outset of the design process to ensure that the product is optimised for manufacture and that specified components will not quickly become obsolete."

Two companies working as one

Communication between Embla Systems and Cogent Technology needs to be excellent and openness is fundamental to the success of the partnership. That's why:

• A named account manager at Cogent Technology ensures that all of Embla Systems' manufacturing requirements are met in full.
• Scheduled status review meetings every two weeks and frequent communication between the companies ensure that any potential issues are resolved quickly.
• Embla Systems have total visibility, traceability and a detailed history for each individual product, so confidence in manufacturing is assured. Cogent Technology provides an electronic Device History Record that shows valuable data and ensures essential compliance with the BS EN ISO 13485:2003 standard for manufacture of medical equipment.
• Cogent Technology is involved at the design stage and together the two companies rapidly prototype new products and resolve any potential manufacturing issues before production begins.
• Cogent Technology provides detailed costing information and has been able to source components at lower cost than Embla Systems could.

"Cogent Technology's attention to communication and professional account management makes them feel like an extension of our operation. Few manufacturers embrace the spirit of partnership in the way Cogent Technology does. Dealing with them, you feel that they really do recognise that their fortunes depend on meeting the expectations of our customers," explains David Baker.

Commercial advantage

Outsourcing its manufacturing process had an immediate commercial effect for Embla Systems. Quality improved, manufacturing costs reduced and production was more responsive and flexible.

"Cogent Technology has developed an extremely efficient approach to compliance with the regulatory requirements for medical device manufacture. It is evident they run a tight ship, which allows them to offer an extremely cost-effective service.

"When it comes to recommending an outsource supplier, Cogent Technology are my first choice."