Driven by the current financial crises and the rising health care cost, analyses on the estimated costs of treatments in relation to their expected health benefits have become increasingly important in decision making the last few years. Decisions whether or not to reimburse healthcare products or to incorporate treatments into guidelines are based on its cost-effectiveness rather than just safety and efficacy. Health Technology Assessment (HTA) agencies such as NICE evaluate technologies on their use of resources in addition to patient benefits, and medical device companies include health economic outcomes in their clinical trials much more than in the past. So when aiming for full market adoption of your medical device, there are 5 critical elements you need to consider bringing your device to market in Europe.

1. Clinical proof for market entry
When bringing a medical device to market in Europe clinical proof is needed on safety and performance only. As a result clinical efficacy and effectiveness data are typically scarce or lacking upon market entry, because the collection of such data is a time-consuming and expensive effort: Let the R&D cost of bringing a new drug to market speak in that respect.

2. Clinical proof for reimbursement and clinical guidelines
Consequently, postmarket clinical projects after CE-mark are often needed when aiming to have your device reimbursed; and taking it a step further, become part of guidances such as recently was the case for the WatchBP Device by NICE. So what are those cost-effectiveness parameters and how to collect them in the most cost-beneficial way?

3. Health economic parameters
The main direct cost of a medical device are the cost of the physical goods, the procedure, and the days spent in hospital. The main elements of indirect cost are lost productivity resulting from mortality or morbidity, and – the least quantifiable one in monetary terms – pain and suffering.

4. Clinical Study Outcomes
Translating these cost factors into parameters to collect in a clinical study, these are:
1. Data on the procedure or intervention – who is involved and for how long
2. Serious adverse events
3. Survival
4. Effectiveness
5. Quality of Life (QoL)
The above seems straightforward, however one needs to look at the details. For example, it makes a huge difference when dealing with an implantable device needing surgical intervention under general anaesthesia, or a tubing for an infusion pump. Also the type of patient and disease involved will make a difference: survival is more relevant parameter in a patient with cancer than a patient with incontinence.

5. Clinical trial options
Clinical study tools to collect the required information include: health economic modelling using existing data from data-bases and/ or literature, prospective comparative studies (ideally a randomised controlled trial – RCT), and prospective observational studies (registries).
The modelling option is the least costly, but data are often incomplete and outdated. A RCT is the gold standard as it allows proving benefit of one treatment over the other – which is especially important when alternative treatments are available for a patient. Disadvantages of such study design are that it is by far the most expensive option, and that data are collected in a controlled setting. The latter is of note as health economics is also about the efficacy of an intervention in daily practise - i.e. effectiveness – because factors like access to care, compliance, patients, and providers may impact treatment effect and may well differ from country to country. In my opinion, you should therefore also consider the less costly option of a well set up prospective observational study as this can be designed to collect effectiveness data. Including other postmarket clinical activities, such as surveillance (also refer to my previous blog), would make such clinical project even more cost beneficial.

As you may conclude from the above there is no such thing as one size fits all when designing a clinical project to capture the health economic elements addressed above. With the increasing focus on cost-effectiveness, however, for most medical devices such clinical data is needed justifying the choice for your product. Especially when aiming for wide spread adoption of your device, the key to a successful market entry in Europe is to give the afore mentioned 5 critical elements some timely thought.

I will post another blog on possible strategies also; so stay tuned or contact me when you want to exchange thoughts in a more direct manner.

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About Annet Muetstege

My name is Annet Muetstege and I am a clinical research expert, based in The Netherlands, with over 20 years of experience in all aspects of clinical evidence planning and execution especially in medical devices. I am the co-founder of Applied Clinical Services, November 2012.
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  1. Lisa Olson says:

    Annet, thanks for a great article that outlines topics that need to be addressed before a clinical study starts and for success of the product in the long term.

    I believe another question to ask is; what is the best way to obtain all of these important items, the safety and efficacy data, proof for reimbursement and health economic data? In the past, a clinical study was broken up in parts – to alleviate the costs that are involved in the study and the ability to easily close the study down when it wasn’t feasible any longer.

    I feel the biggest challenge, isn’t the collection of the information, it is creating a longer term product strategy and keeping to this strategy in the most cost effective way.
    CoreVantageSolutions.com, ClinBridge.com

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