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Wismed, Where Medicine and Physics Meet

What the company does

Wismed is a small medical device manufacturer with offices in Poland and South Africa. Wismed was started by Polish- born Anaesthesiologist and CEO, Pawel Wisniewski with one flagship medical device. Following the success of this one innovative, high- quality product, the company was able to since expand its product offering and receive funding from the EU for further development.

The Wismed team is part of every step of the lifecycle of the device from concept to realisation, ensuring great quality at every touch point.

The Current Landscape

Medical technology is dominated by large companies and there are numerous barriers to entry for start-up companies in this field. Regulatory compliance and product certification is a huge, incurred cost, and there are challenges with the switch from Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) due to lack of regulatory authorities to meet the demand of the industry. Other challenges for start-ups are licensing, machinery, and protection of IP / patents.

One of the strategies that Wismed has applied is to outsource manufacturing, which means that they can channel resources towards design and development. It is through product innovation and being first-to-market that Wismed was recognized in Europe with the award of funding in the category of Intelligent Development to foster innovation and research in minimally invasive urology.

Building lasting partnerships and surrounding themselves with reliable and knowledgeable vendors has been instrumental in their success thus far. Collaborative work with thought -leaders and reliable partners is key to the supply chain but also for development.

Product innovation is the best way to compete with larger companies and to achieve progress. For a start-up company it is important to find (through innovation and research) a niche field and become extremely good in this field. One should ask the question if one’s company can be the best in the world at this and pursue it with all energy.

Company Birth Story

As a medical specialist with over 30 years of experience as an Anesthesiologist, using the operating theatre as an observation platform, Dr Wisniewski is passionate about designing simple solutions that rely on sound physics principles and are based on a deep understanding of medicine.

It all started with an observation in theatre of a single surgeon having difficulties with, at the time a new minimally invasive procedure. As an Anaesthesiologists, Dr Wisniewski was in the perfect position to watch the surgeon work and the problem was quickly apparent. The next step for Dr Wisniewski was to talk to as many surgeons as possible to establish if they all encountered a similar problem.

Then a prototyping phase followed which was very creative; testing the prototype with surgeons in a simulated environment helped to conclude core development.

Finally, Dr Wisniewski invested his life savings into the production of dedicated tooling and manufacturing of the device. The regulatory requirements for medical devices were less stringent at the time and the way to market easier.

The Solution

Wismed is currently in the advanced stages of developing a novel medical device that is expected to improve the outcome of kidney stone treatment and to reduce recurrence of the disease. They are developing a new approach to the treatment that allows the complete removal of small stone fragments, including sand and dust residues and by doing this, to prevent recurrence of the disease which is very common with the current treatment methods. Wismed is also developing a device that is expected to reduce pressure inside the kidney during laser fragmentation and therefore reduce complications.

The Team Culture

As a small company, it was important for Wismed to create a culture of mentorship within the team. Driving a performance culture on its own without driving personal growth can be destroying. Founder Dr Wisniewski identified a power leader with knowledge of each job function within the company, this not only allowed each team member to be more effective under the guidance of a mentor, but also ensured their personal growth.

A founder quote

"We develop medical devices with such care and attention to detail as if we, ourselves, would be the first patients on whom these devices are used." – CEO, Pawel Wisniewski

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