Creating the perfect STORM

Creating the perfect STORM
OPN-article-STORM

Peter Ogrodnik

Peter Ogrodnik, author of Medical Devices Design:  Innovation from Concept to Market and professor of medical devices design at Keele University, talks to OPN about his career in medical engineering

 

You wrote Medical Devices Design a couple of years ago, what led you to do this?

I have been working in medical engineering for over 20 years. It all started with a chance telephone call that has led to a long-term working partnership with Professor Peter Thomas. Between us we have conducted some exciting research related to fracture management and developed some new medical devices along the way. During that time I realised that there was no core text I could refer to that would help me through the process of converting a good idea for a medical device to a commercial reality. That was the ‘light bulb’ moment: I thought I’d better write one.

 

 

You said you developed some real medical devices. What are they?

A number of years ago, Peter Thomas, my colleague Ian Moorcroft and myself created a company to commercialise some of our research. Through this spin-out company we took a piece of research equipment from lab to market. This was STORM – a reusable theatre device to help surgeons reduce fractures of the lower limb. At first it was only for diaphyseal fractures of the tibia but now that it’s in the marketplace, surgeons have used it for calcaneum fractures, pilon fractures, plateau fractures and fractures of the distal femur. Since its launch, STORM has been used in the UK, Germany, the USA and beyond. It has recently been modified to accommodate nailing, and has been used in the USA for suprapatella nailing. One thing we are proud of is that in Germany an independent research group looked at the impact of using STORM, and one of the surprising outcomes was that it reduces X-ray exposure to the surgeon by 50 per cent.

storm

STORM was developed as a part of a research project examining how fracture movement effects fracture healing. As a part of this project we were among the first to show how smoking affects fracture healing. But, more interestingly, we were also vanguards in the use of remote monitoring for the assessment of how a fracture is healing away from the hospital. This we started in the 1990s, long before smart-phones were even a glint in someone’s eye.

IOS image

We also learned how to help bones heal in the way that nature intended. STORM was able to take out all of the complexity of the external fixation systems that were in the marketplace. Also, it brought a degree of repeatability to the reduction process, which meant that we could design a fixator from first principles. This design resulted in IOS, our external fixator for tibial fractures.

The apparent simplicity of IOS hides a high level of complexity. Once again we were surprised with our results. Not only are patients up and mobile the day after their operation, but some have apparent ‘normal’ gait within a few weeks. What has truly amazed us is that the shortest healing time for a tibial fracture has been just over eight weeks.

 

 

How does being a professor at Keele University fit in?

I am very lucky; the Institute of Science and Technology in Medicine is one of the highest rated research centres in the country. It is based on the Royal Stoke University Hospital grounds, and this means I have all the R&D support I need at my fingertips. Everything is available, from basic research through cellular engineering and pharmaceutical development, to linking with NHS research funding streams.

I want to be able to pass things on to the next generation, and my book was aimed at doing this for industry; however, I have also noticed that the industry itself is finding it difficult to attract good design staff with a strong medical engineering ethos and a high degree of knowledge about the regulatory requirements.

 

What are you trying to do about this?

Recently I proposed a new MSc in Medical Engineering Design. The aim of this course is to give a solid grounding in engineering design principles but within a medical devices regulatory context. Hence anyone graduating from this MSc could start work at a medical company’s design office with relative ease. Hopefully the course will be able to produce 10 really high-quality medical device designers in the first year who will quickly be snapped up by the industry.

 

How is this course different to the other medical engineering courses around?

This course’s USP is that it has been developed with the industry in mind and is to be delivered by people, such as me, who have done this in the real world. Also, it is not focused on any particular discipline – we could be talking trauma, hips, giving sets, IVD, rehabilitation, computer software, or apps – it all depends on company interaction.

 

What do you mean by company interaction?

There are three answers to this. First, we have an industrial liaison panel to which medical engineering companies are, heartily, invited. There will be a physical panel that will meet on a regular basis but also a virtual panel so that all interested parties can interact with the course and its students, irrespective of location. Secondly, all of the students will be encouraged to do an internship with a company, preferably over the summer between the end of the taught session and their project, but it’s flexible. For the company this is like a long interview and for the student it is perfect for their career development. Finally, every student has to undertake a project, which must be design led.

This is a fantastic opportunity for industry or clinical staff to get someone to test out an idea without spending a lot of money. The best thing with a project like this is that it builds a relationship that could lead anywhere – just as it did with me, Peter and STORM.

 

Can anyone from industry take this MSc?

There is no reason why not. I am considering a part-time stream for industry and clinicians, but demand will dictate this. I am also organising a series of short courses that are more industry-friendly, covering a range of topics in medical devices design.

The first four courses are aimed for mid-2017 and will focus on: Introduction to the medical devices directive; Risk management and assessment for medical devices; Quality in design for medical device designers; and Validation, verification and clinical evaluation of medical devices.

 

Contact Peter Ogrodnik with any questions by email:  p.ogrodnik@keele.ac.uk

For further information about internships at Keele University, visit www.keele.ac.uk/internships

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