Decades of Medical Expertise

Modern single-use endoscopes, glass, metal and plastic eye speculums, housings for blood glucose monitors and hearing aids or surgical sutures: KH has been supplying the healthcare industry since the 1980s and is constantly expanding its expertise. Benefit from our experience in medtech and high-volume production. We are ISO 13485 certified.

Range of Services

We deliver what your project requires—including process steps that we redesign together with you.

  1. Development
  2. Tool shop
  3. Injection molding
  4. Surface technology
  5. Assembly & Packaging
  6. Clean room production

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Niia pilot project

For the Swiss company Pharmasens, KH developed a manufacturing concept for the housing of the reusable insulin patch pump, niaa. When applied to the body, it enables people with diabetes for the first time to administer insulin directly through the device without a smartphone. To achieve this, all functionalities had to be integrated into a housing measuring just 45 mm in diameter and 18 mm in height. KH leveraged its expertise in tooling, injection molding and surface finishing and handled the complex assembly process.

In-Mold Labelling (IML)

01 - Seamless surfaces for the medical sector—achieved through In-mold Labelling. Durable and available in the look of your choice. KH would be happy to advise you.

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Complex assembly with 13 components

02 - Electric motor with worm gear, drive unit, level sensor, circuit board and more, electrical connections. Assembly takes place in a low-particle-count cleanroom with ESD protection.

 

Precise Light Guidance

03 - The light ring in the center of the housing requires extreme positioning accuracy for the IML preform. Precise balancing of translucency and opacity on the housing body.

 

2K Injection molding with hard-soft connection

04 - Three soft button areas made of TPE on the housing (PC) connected by a thin web. Produced using two gate locations and an indexed mold.

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Precision Printing Technology

05 - A subdued black-panel/vanishing effect, silver logo and scratch-resistant coating. A total of six print layers are applied to the flat film, which is then 3D-formed.

 

Poka-Yoke and 100% EOL inspection

06 - Health requires absolute product safety. KH relies on the Poka-Yoke principle in the manufacture of niia and conducts a multi-stage, 100-percent end-of-line inspection after assembly.

Innovative strength combined with experience

It really is possible: overmoulding glass – and even combining it with metal. When it comes to innovative projects, KH’s development department puts its expertise to good use and finds clever solutions on an industrial scale. We have also been impressing customers in the medical sector for many years with our standard expertise.

This cassette collects irrigation fluid and the removed lens during cataract surgery. Manufactured for a Swiss customer in a cleanroom (Class 7) from ABS and consisting of three individual components.

Winner of the TecPart Award: an eyecup that combines three different materials—sapphire glass, stainless steel, and POM. These materials are joined together via a form-fit connection through injection molding, without the use of any adhesive.

For accurate blood glucose readings: over ten individual components, including numerous 2K mouldings made from PC/PC and PC/TPE. These are complemented by intricate seals, a camera element, hot-molding, colour-change laser components and more.

MDR - Even more safety for medical products

Since May 2021, the MDR (Medical Device Regulation, EU 2017/745) has regulated the requirements for medical products in the European Union and improved their quality and safety. In combination with the EN ISO 13485:2016, the MDR implicates an «end-to-end» monitoring of the entire value-added chain, including the subcontractor. As a partner of high-profile customers, KH Medical has established the necessary conditions required to fulfil all aspects of the MDR. It is our pleasure to support you with you products.

European manufacturing in accordance with EN ISO 13485

  1. Clean room ISO 14644-1 Class 8 with bio-monitoring, more on request
  2. DIN ISO 9001 and EN ISO 13485 certified
  3. Risk assessment and process FMEAs
  4. Requalification of devices/facilities
  5. IT system validation
  6. Risk-based supply management according to 2013/473/EU
  7. End-to-end monitoring of critical (sub) contractors

References