Table 3 Extraction of original statements

Regulation for medical devices

“[W]ho gives us the mayor quality guarantee is Cofepris…”

Mexico (O.1._201409251747_MEX)

“[B]ecause we had to make the experience that the regime of medical devices … in comparison to the regime of pharmaceuticals is frequently criticized due to its putative rather liberal market access requirements.”

Switzerland (O.1._201409020858_ZRH)

“[F]or all other products especially medical devices that are classified as high-risk products there are requirements that these have to work. How this is measured is not clearly described.”

Germany (O.1._201410291400_TUT)

“[E]ach car that is being validated hast four wheels and confirm with a specific quality norm and for medical devices it is the same”

Germany (O.1._201406260812_ZRH)

“[I]ndeed we have a discussion that we could say that since ever there have been sometime problems also with hip implants and other implants. But this is almost not possible to avoid because for technical innovations you obtain a better understanding based on practical experiences…”

Germany (O.1._201409020858_ZRH)

Eligibility for medical devices

“…[t]he standard list is based on evidence that is already 6 to 10 years old, obsolete, and it will be used for additional 6 years.”

Mexico (O.1._201410031215_MEX)

“…[b]ut what exists already which has years, our work will be to update and to classify or segment.”

Mexico (O.1._201410311530_ZRH)

“[I]t doesn’t imply any problem, no, because the standard list contains good products.”

Mexico (O.1._201409251747_MEX)

“[M]edical devices have relatively immature HTA methodologies that frequently fail to address the lower levels of evidence associated with medical devices…”

United Kingdom (O.1._201409181100_ZRH)

“[C]urrently it seems that in the ministry of health there will be more focus on new responsibilities with a focus on HTA.”

Switzerland (O.1._201408211231_ZRH)

Procurement regulations and practices

“…[i]t is very economic driven and what is cheaper is what will be purchased.”

Mexico (O.1._201409251542_MEX)

“[T]he provider of service packages has a free ticket to select the medical device that he will provide to the hospital.”

Mexico (O.1._201409180852_MEX)

“[T]here have been problems like always and we try to prevent this with a new tender.”

Mexico (O.1._201409251542_MEX)

“[I]f we are lucky in procurement there are administrators that have experience and know what they are procuring. But normally this is not the case and they base their documentation on the standard list that isn’t always updated and that is very generic and in consequence we are purchasing sub-standard quality.”

Mexico (O.1._201410311530_ZRH)

“…[i]t is not the best quality because the standard list is very obsolete and not updated and there are no specific guides to make an evaluation.”

Mexico (O.1._201409191334_MEX)

“…[t]he administrator now use providers for service packages … but the quality is not guaranteed because these providers don’t have to provide what has been included in the standard list and they can provide what they want.”

Mexico (O.1._201409191334_MEX)

“[S]o what I am trying to say is that it is not just the cost you need, you need have really good health economist data to support your products really well, and to also calculate the actual full treatment cost including the health benefits and the cost of the revision or failure or lack of performance …“

United Kingdom (O.1._201407211627_YRK)

“…[w]e are under huge fiancial pressures to trying to save money and we will save on certain, any reasonable thing we can but you cannot compromise the quality on patients safety and outcomes.”

United Kingdom (O.1._201407221144_BOL)

“[T]he expectation was that hip joint should have a survival ship of 90 % at 10 years at post market.”

United Kingdom (O.1._201408011100_LUZ)

“…[a] new product and the clinical data isn't gonna be there and how do you fight against that. And that is when you need that senior engagement where you end up … And quality is there, finance is there, they than gonna said to me "but how does it interact in the patient?”

United Kingdom (O.1._201407221144_BOL)

“[I] think what we do is continuing to mature and it gets better each year.”

United Kingdom (O.1._201408011100_LUZ)

“[S]o HTA they are useful but they are not anything like what is a clinical outcome.”

United Kingdom (O.1._201408241352_LUZ)

“[W]ell there are hospitals where the price takes over priority so that the surgeon just has to accept what he get provided.”

Germany (O.1._201408061342_DOR)

Programmes targeting quality and supporting procurement

“…[i]n Mexico we are missing something such as a department that monitors clinical practice…”

Mexico (O.1._201410070910_MEX)

“…[w]e have different social security systems and in consequence the secretary of health doesn’t have full regulatory control.”

Mexico (O.1. _201410061100_MEX)

“…[t]here is no culture of quality assurance even we have good structures … but when you go to a health centre you find disinformation, …, no continuous information, no one monitoring clinical practice…”

Mexico (O.1._201410061100_MEX)

“…[o]r we do have two systems doing the same and in some way they are competing and this causes confusion.”

Mexico (O.1._201410061100_MEX)

“…[u]nfortunately we cannot make a patient monitoring of more that 2 to 3 years because of the system.”

Mexico (O.1._201409251747_MEX)

“…[w]e have indicator that doesn’t represent quality assurance but it is somehow a constant monitoring of the quality by means of the indicator that we are using.”

Mexico (O.1._201411191930_ZRH)

“[I]n my opinion a registry is a good basis for decision-making…”

Switzerland (O.1._201408121000_BAA)

” [P]rimarily we are interested in the outcome quality.”

Switzerland (O.1._201407291401_ZRH)

“…[t]o make sure, that surgeon use evidence based, to decide on their prosthesis.”

United Kingdom (O.1._201407231054_LON)

“…[t]he implant registry for us in joint replacements, is our key source of information with the devices. The spontaneous reporting with incidence … gives you incomplete numerators and you don’t now the nominators. If I am producing registry data … real time survival ship data, performances, mix of devices and than some decisions in terms of sizes, materials used, etc. So it is a very powerful tool for getting indicators on post market performance.”

United Kingdom (O.1._201408011100_LUZ)

“…[t]hey will be able to tell how long the implant has been available and what level of evidence there is to support its use …”

United Kingdom (O.1._201408072230_ZRH)

“…[c]lass II and III devices have a safety-profile, but this does not include evidence of clinical efficacy.”

United Kingdom (O.1._201409181100_ZRH)

“[S]o the ODEP system would set up on the basis of guidance given by NICE … The expectation was that hip joint should have a survival ship of 90 percent at 10 years at post market … than they gave indications of how well the performance was of those devices well against set NICE criteria at a 10 year mark.”

United Kingdom (O.1._201408011100_LUZ)

“[W]ell, the surgeon can’t use the Beyond Compliance implants unless they have been specifically trained and is agreed by the manufacturer and the champions surgeons. Beyond Compliance are being used by a limited number of people.”

United Kingdom (O.1._201408072230_ZRH)

“…[wi]mplant registries, which company devices, and that from all perspectives is a key item for gaining continuous information about the involving, safety profile…”

United Kingdom (O.1._201408011100_LUZ)

“[J]ust think in the patient. When you are facing the problem of an artificial cardiac valve and you get informed by the health professional that they don’t have information about the clinical value but that they can assure you that it doesn’t cause any electric shock and doesn’t oxidize…”

Germany (O.1._201408201611_KOL)

Cost-related factors

“[W]e are drawing attention to the economic aspects but not to what the surgeon needs…”

Mexico (O.1._201410031215_MEX)

“…[t]he aspect is fundamental economically; that what is cheaper is that what will be purchased.”

Mexico (O.1._201409251542_MEX)

“[U]nfortunately in our country what we do is that we don’t focus on the best quality but on the best price. In consequence this impairs the delivery of quality of care, but this is only one aspect …”

Mexico (O.1._201409171712_MEX)

“[N]ow, the person who is just buying hips is not thinking about the added value to the hospital. That is why the procurement people got to think on value and they need to understand all the elements that could make up that value. Otherwise they make own purchasing decisions.”

United Kingdom (O.1._201407210956_LEE)

“[W]ell, there are hospitals where price dominates everything…”

Germany (O.1._201408061342_DOR)

“…[I] did experience in one healthcare facility that they switched from one cicatrice material to another because of a lower price … we observed more wound problems than before.”

Germany (O.1._201408061342_DOR)

Knowledge-related factors

“[T]he surgeons’ opinion is important to determine the services he is going to have and to calculate required quantities.”

Mexico (O.1._201410081050_MEX)

“[b]ecause the procurement staff is deciding we don’t always receive what we need or what the patient requires.”

Mexico (O.1._201409191220_MEX)

“…[w]e as surgeon do not always agree with a provided product. Based on our experience and knowledge we believe in other products of higher quality and superior performance…”

Mexico (O.1._201409251747_MEX)

“[T]he surgeon is asked to work with what he has.”

Mexico (O.1._201409251747_MEX)

“The decision if we use a new implant system is always done by the user and the user is the surgeon”

Germany (O.1._201408051326_FRA)

“[I] had the impression that the surgeons weren’t very satisfied when they were not involved in decision-making.”

Germany (O.1._201406260812_ZRH)

“…[t]he expertise of the surgeon is very crucial. He is responsible for what the patient gets implanted and therefore he needs to be convinced of what he is using during surgery.”

Switzerland (O.1._201408121000_BAA)

“[I]n Switzerland much is in the responsibility of the surgeons and the hospitals”

Switzerland (O.1._201409081044_BER)

“… [i]n the end it is up to 90 % the surgeon.”

Switzerland (O.1._201407101428_LUZ)

Clinical evidence related factors

(please consult quotations for programmes targeting quality and supporting procurement)

Procurement framework related factors

“[I]n some situations what we have seen is that they use an inadequate implant size … but there haven’t provided another implant…”

Mexico (O.1._201410091420_MEX)

“…[t]hey start the surgery and when they are gonna to use the implant system they realize that it is incomplete …”

Mexico (O.1._201409171712_MEX)

“[E]ach surgeon no matter how experienced he is needs to be trained on a new implant … each patient that is suffering damages due to wrong is not acceptable.”

Switzerland (O.1._201408121000_BAA)