A conceptual shift for medical device manufacturers

A scanner’s performance ability may be high, but what it can perform has become the bigger issue

Much has changed for medical device manufacturers. Take scanner development; whereas the aim has long been to increase multi-slices, produce higher field strengths and sharper images, optimise the ergonomics and then launch the new product at a specific group of customers, in recent years this approach became insufficient.

Okan Ekinci
Okan Ekinci

‘The trend has definitely moved away from technological features to clinical topics,’ Okan Ekinci MD, Global Director of Cardiology at Siemens Healthcare, explained during a discussion with Meike Lerner (European Hospital). ‘New procedures and technologies must be integrated into overall clinical concepts. Our objective therefore no longer comprises only the development of new modalities; we must create business cases and look beyond the obvious’Speaking of current trends, Dr Ekinci explained: ‘In the past, medical technology companies were exclusively regarded as product suppliers who introduced their devices and implants to the hospitals, with doctors then researching how best to use these products. Nowadays this is no longer possible as developments have been so rapid that no hospital can promptly represent all innovations. Customers now frequently approach companies with the request to work jointly with them on how to utilise the technologies in a meaningful way on a daily basis.

 ‘One example of this is the use of new CRT implants. For at least a third of the patients we know that these implants will not result in the desired improvement – and this can be traced to a less than optimal patient- triage. To predict patients’ responses better, modern imaging modalities for cardiology should be consulted that can deliver more information about the state of the heart – where the scar tissue is, where the best vein for placing the CRT probe is and how can the implantation be navigated in better way. Our products must offer answers to such clinical questions.’

So it’s convenient for Siemens if the application of a new CRT system goes hand in hand with the acquisition of a new CT or MRI scanner…

‘The sale of large devices is certainly our business, but, along with the entire healthcare system, we have to be committed to the sustainability principle – meaning that the acquisition of large devices must reduce pressure on the healthcare system rather than create it. Therefore our strategy is to anticipate clinical developments in our product development. ‘This often gives the user the chance to explore new clinical paths without having to make additional investments. For example, since 2007 our 1.5-T MRI systems have been equipped in such a way that each scanner can carry out complete cardiac examinations. This means that all establishments that have since purchased a 1.5-T Siemens MRI could carry out cardiac examinations.

A further example is the development of solutions for interventional valve replacement in the heart catheter laboratory, which we began a few years ago. Now that this minimally invasive procedure is becoming increasingly important we are making a large solution portfolio ranging from the use of 3-D to complete hybrid operating theatres available to those who are interested. All in all you could say that we are preparing the market for future business cases. 

How do you know what implant manufacturers have in the pipeline or are likely to introduce in the near future?

‘We cooperate with different companies and joint customers. These are so-called “early adopters”, i.e. centres that lead the way with pacemakers, valves or imaging. With such customers we can work on certain clinical cases. We carry out clinical studies and then publish the solutions. This also allows us to accentuate trends ourselves.’ 

So could trends become distorted or artificially created, in the interests of the companies involved?

That’s very unlikely because we have chosen a very customercentred approach with our reference centres, for instance. In practice, this means that we searched for institutions that already have a successful, interdisciplinary way of working, which have broken down the boundaries between heart surgery, cardiology, nephrology etc. and that are trendsetters in their field. We defined the Centre Cardio-
Thoracique in Monaco as our first reference centre, the second one being the Contilia Heart and Vascular Centre at the Elisabeth Hospital in Essen, Germany. Cooperation with these centres allows us to capture and address emerging clinical trends at an early stage.

What developments are currently in the pipeline?

‘A good example of the interaction of hospitals, other industry players and us, is the development of a solution that significantly reduces radiation exposure during catheterisation. With interventions that need frequent manoeuvring of the catheter – such as electrophysiological interventions – numerous fluoroscopy scenes are being recorded. The new product will enable us to record a fluoroscopy scene just once. The link with a novel catheter positioning system will facilitate manoeuvring without radiation. And, by the way, this is a new trend. It’s not a certain modality that is at the forefront of this development but a superior objective – in this case dose reduction. Which modality should be the preferred solution in individual cases depends on the indication and is a decision made by the hospital. For instance, there’s currently some discussion around the question of whether it’s better to plan an interventional aortic valve replacement via CT or rotation angiography.

Does that mean the boundaries between modalities and their application are becoming increasingly blurred?

‘The boundaries are blurred on an equipment level as well as on the application level. With regards to the equipment, we should certainly highlight the Siemens Biograph mMR, the first and only fullyintegrated whole-body MR-PET system. We anticipate improved early detection of diseases through the integration of molecular and morphological imaging. ‘However, new integration trends with regards to applications are far more frequent: Multimodal diagnosis with Echo, CT and catheter, image fusion, FFR and OCT in the catheter laboratory and MRI-augmented EP are just a few examples of developments currently in demand in the hospital. New cardiac interventions should only be considered in a multi-modal context. Whilst this entails medical progress, it is a challenge for doctors because the traditional focus on just one individual modality no longer reflects the requirements of future diagnostics and treatment adequately. ‘For us this means our devices have to interact along clinical paths, much like players in an orchestra. Integration and interoperability are merely the basic requirements.

We need to test numerous combinations for clinical treatment standards to find out which scenarios can be marketed in which ways. It’s no longer simply enough to emphasise how many slices a device has. You have to create an entire concept, a business case that encourages all those who are part of the healthcare system – which increasingly includes medical insurers – to rethink.’ 

How would you like to become involved in this process in the future?

‘Acknowledging the last-mentioned developments, we created a business segment for healthcare consulting. As a global company, we have collaborated with best practice centres worldwide, have captured their experiences in a structured way and also developed a process maturity concept based on what we can now also advise customers in the case of changing clinical paths. ‘One example of this is the treatment procedure for ACS (acute coronary syndrome). More than 90% of patients admitted to A&E departments with chest pain have not actually had a cardiac infarction. In Germany many of these patients often remain in hospital for up to three days, occupying what should be emergency beds etc., meaning that the resulting costs, which should be avoidable, become enormous. 

In many centres in the US patients with chest pain and unremarkable laboratory and ECG results are therefore examined via CT scanner. Patients with inconspicuous coronary results can so be discharged within just a few hours. ‘With less than one millisievert, the examination dose is significantly lower than that of the annual background radiation. This model is currently also being tested in several centres in Germany. However, here comes the big “but”: Even if a cost reduction for the healthcare system can be proven, hospitals currently have no incentive to change their clinical processes. To the contrary: Whilst the full DRG flat rate can be charged for a three day in-patient stay, the hospital receives only a minimal payment for a CT examination and subsequent
discharge of a patient. Service providers therefore need to create a financial incentive to implement the new concept in practice and to engage the hospitals in these cost savings. Incidentally, in terms of figures, the CT scanner required to implement these workflow changes could actually be financed through the savings. ‘Medical technology manufacturers are therefore not merely a passive link in the value added chain within the healthcare system but involved in its reorganisation.’ 


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