Development and manufacturing of neurosurgical implants such as hydrocephalus valves, shunt systems and telemetric sensors

Christoph Miethke GmbH & Co. KG

Potsdam (headquarters Ulanenweg 2) · Potsdam (production site Fritz-von-der-Lancken-Straße 10) · Berlin (warehouse)New on Amplifa

1992Founded

3 locationsPotsdam (2), Berlin (1)

50+ countriesDistribution on five continents

About MIETHKE

Christoph Miethke GmbH & Co. KG is a company based in Potsdam specializing in medical technology that has been developing and producing neurosurgical implants since 1992. The focus is on the treatment of hydrocephalus (water on the brain): the portfolio includes adjustable and pre-set valves, complete shunt systems (VP and LP shunts), ventricular and lumbar catheters, reservoirs, instruments and active implants for telemetric intracranial pressure measurement (M.scio, ICPicture). The hydrocephalus implants are made predominantly of titanium – a special titanium alloy with stricter requirements than in aerospace – supplemented by silicone catheters and PEEK reservoirs. Production is carried out as single-series production in historic 19th-century barracks buildings using state-of-the-art manufacturing technology, including on sliding-headstock lathes, as well as sterilization, warehousing and distribution. The products are sold in over 50 countries on five continents; the distribution partner is Aesculap AG (B. Braun), with which a joint venture (B. Braun Miethke GmbH & Co. KG) exists.

Site: Potsdam
Processes: Turning (sliding-headstock lathe) for implants, Single-series manufacturing of neurosurgical implants (valves, shunt systems), Sterilization of medical devices, Development and design of neurosurgical implants and sensor technology, Technical service of electrical devices (accessories), Development and production of neurosurgical implants (shunt systems, valves, sensor technology), Telemetric intracranial pressure measurement (M.scio, ICPicture), Sterilization, warehousing and distribution
Materials: Titanium (biocompatible), Special titanium alloy (stricter requirements than aerospace), Silicone (catheters, membranes, reservoirs), PEEK (Burrhole reservoir), Titanium (biocompatible alloy), Special titanium alloy, Silicone, PEEK
Certificates: DIN EN ISO 13485:2021 / ISO 13485:2016, EU Quality Management Certificate MDR (EU) 2017/745, ISO 13485, MDR (EU) 2017/745 QM certificate
Founded: 1992
Industries: Medical technology, Neurosurgery

01
Development and design
02
Machining (sliding-headstock turning, titanium)
03
Assembly of the implants
04
Sterilization
05
Warehousing
06
Distribution (incl. B. Braun Aesculap)
07
Technical service

Materials and Technologies

Titanium (biocompatible alloy)

Core material of the hydrocephalus implants: well tolerated, lightweight, stable, non-magnetic (MRI-compatible)

Ti-Leg.

Special titanium alloy

Meets stricter requirements than in aerospace to ensure reliable valve function

Silicone

Catheters, membranes and reservoirs

PEEK

Burrhole reservoir

Locations

Potsdam (headquarters)

Headquarters, development, production, distribution

Lot size: Single-series
Materials: Titanium, silicone, PEEK

Potsdam (production site)

Production site

Lot size: Single-series
Materials: Titanium, silicone, PEEK

Sliding-headstock lathe

Berlin (warehouse)

Warehouse

Products and Components

**M.blue hydrocephalus valve**Titanium · Neurosurgery

**M.blue plus valve with XABO catheter**Titanium/silicone (antibiotic-impregnated) · Neurosurgery

**MIETHKE valve portfolio (shunt systems)**Titanium/silicone · Neurosurgery

Inside the production

Industries

Medical technologyNeurosurgery

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Turning (sliding-headstock lathe) for implantsMachining	–	–	–	–	Titanium, Titanium alloy
Single-series manufacturing of neurosurgical implants (valves, shunt systems)Assembly	–	–	–	–	Titanium, Silicone, PEEK
Sterilization of medical devicesSurface	–	–	–	–	Titanium, Silicone
Development and design of neurosurgical implants and sensor technologyEngineering	–	–	–	–	–
Technical service of electrical devices (accessories)Testing	–	–	–	–	–

1 Anlagen & Maschinen

Machine	Manufacturer / model	Quantity	Working area	Year built	Site
Sliding-headstock lathe	–	1	–	2001	Potsdam

Additional services

Development and production of neurosurgical implants (shunt systems, valves, sensor technology)Telemetric intracranial pressure measurement (M.scio, ICPicture)Sterilization, warehousing and distributionInstruments and accessories (THOMALE GUIDE, Tunneller, XABO)Digital applications (MIETHKE App, HC&ME App, product finder)Technical service for electrical devices

Reference customers

B. Braun / Aesculap AG (sales cooperation and joint venture B. Braun Miethke GmbH & Co. KG)

Quality and Certification

The QMS under DIN EN ISO 13485:2021 / ISO 13485:2016 as well as an EU QM certificate under MDR (EU) 2017/745 (notified body DQS Medizinprodukte GmbH, NB 0297) cover the development, production, sterilization, warehousing and distribution of the implants, instruments and accessory parts as well as the technical service of electrical devices. The products are marketed with CE marking under NB number 0297.

Evidence	Potsdam (headquarters)	Potsdam (production site)	Berlin (warehouse)
ISO 13485
MDR (EU) 2017/745 QM certificate