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Medtech

A new era in
medical technology

The medtech sector faces a challenge. The pressure on health costs is rising and the regulatory requirements are increasing globally. In the digital age, connected products and alternative business models are called for. This may sound simple, but it is actually also complex as the cost pressure is restricting the ability to innovate.
Innovations for new markets

For medical technology companies, four fields of action are key to mastering the competitive market dynamics:

  • Product innovation: The increase of chronic cardiovascular diseases such as diabetes or hypertension offers potential for growth.
  • Mobile health: The rise of post-acute care services such as rehab, nursing home or outpatient services creates new opportunities for user-friendly, smart mobile health products.
  • Regulatory approval: In order to exploit new sales opportunities in the APAC and BRIC markets, companies have to cope with additional regulatory approval procedures.
  • Digitalization: The lifecycle of medical technology products has decreased significantly due to the digital transformation. This requires manufacturers to provide more efficient product and production engineering as well as additional expertise in the area of usability.

Spotlights

Innovative infusion pump system

An infusion pump was to be furnished with new functionality for blood glucose control in intensive c An infusion pump was to be furnished with new functionality for blood glucose control in intensive c An infusion pump was to be furnished with new functionality for blood glucose control in intensive c

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Development compliance according to ISO 62304

In response to strict regulatory requirements, as part of the process of developing a new infusion p In response to strict regulatory requirements, as part of the process of developing a new infusion p In response to strict regulatory requirements, as part of the process of developing a new infusion p

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Value creation begins with innovation

Medtech companies have a proud tradition of innovation.

As a long-standing partner, Zuhlke has accompanied many companies on their path to marketable products.

In our experience, successful companies excel by tackling these strategically important issues.

Quality, trust, transparency

As a responsibly-minded partner for integrated solutions, Zuhlke has been supporting medtech companies from the initial idea to successful market launch for many decades in the following areas:

  • Product engineering according to ISO 13485, FDA21 (Part820) and 93/42/EWG MDD
  • Production engineering: conceptual design and development of production facilities as well as equipment and audit systems according to GMP
  • Technological consulting: technological due diligence, conformity consulting, regulatory pathway and value engineering
  • Business consulting: evaluation of new business models and innovation management based on proven methods
  • Piloting and production: GMP-compliant prototypes and production of very small series in our own workshop

As an experienced partner for solutions, Zuhlke ensures that you comply efficiently with the regulatory demands and capture new markets thanks to a short time to market.

In every project, you profit from our valuable experience in the sector and our experts’ proven track record.
Your contacts

Let's shape the future together

Photo: Mr Stefan Sarbach

Stefan Sarbach

Partner & Director
Agile Consulting

+65 8869 3104
Photo: Mr Jonas Trindler

Jonas Trindler

Managing Director
Agile Consulting

+65 6921 7804