Dear Adam

I would add a note of caution.

We all appreciate the drivers behind this and are keen to have cheaper procurement, but we need to take a step back and consider some of the disasters that have occurred with medical devices that look similar, or indeed almost identical, to ones that have been successful previously.

 The introduction of new implants should be done in a scientific way, and in the UK at present, that should ideally include a passage through Beyond Compliance (or a robust study), and not through any back door.

Generics in medical devices and orthopaedics are likely to come to the fore, but the reality is that there is no available verifiable data to show that any of the implants produced by these companies are identical and produced exactly to the same standard as the products we know and trust. There are claims to that end, but these have not been substantiated. Orthopaedic history is littered with cheap copies that have failed. After all, that is one of the reasons the NJR started.

Also bear in mind that this likely has a pre entry A* rating, which is what is given to a product launched under beyond compliance, and not a 1A*(I have never seen 1A*) as that would imply clinical results.

 I am not convinced that this sort of implant is compatible with the GIRFT agenda either. It has no clinical results, which GIRFT is partly about.

 The other issue to consider, is that if such a product is used and the results are poor (at the present we do not know what they will be like), then the failures will be alongside the surgeon's name, and the surgeon will therefore be taking a risk. It may be difficult to sell to patients that we are selecting a prosthesis based on it being the cheapest we could find when it had no track record or provenance. Patients like to believe that we are acting independently in their very best interests.

 The other concern that should be considered is that generics may well not provide the support in terms of education, reps......., etc., that you currently get with standard implants.

I appreciate that I am presenting a view that some will find unwelcome, but a new implant with no track record, should be treated as such and evaluated critically without making assumptions because of its similarity to existing products.

With best wishes

Prof. Fares S Haddad, BSc MD (Res) MCh (Orth) FRCS(Orth)_______________________________________________________________________________________________________




I have been really interested in this email thread and the understandable caution expressed about the Orthimo programme. Having represented the BOA at the QIPP procurement group for the past couple of years and so having seen the work that has been going on behind the scenes to reduce cost in procurement, I felt that I should comment with another perspective.

I should point out that I remain by nature very cautious about implant choices, using a cemented Exeter stem for almost all primary hips (we do not even have an uncemented stem on the shelf), and so completely agree with the bemusement expressed by Roger and other non-hip surgeons about decisions to use non tried and tested implants. I don't use the Orthimo stems at present and have no conflicts of interest, with no links to any implant company (aside from teaching on Exeter cementing courses) and I do not write to suggest widespread uptake of Orthimo.

The problem that we have is that we pay too much for our implants. The evidence of the QIPP procurement group, supported by data from the NJR, shows that Trusts pay very different prices for the same implants and that the prices are not correlated to volumes used. 30% of NHS tariff costs are spent on the implants alone and, of the implant costs, only 20% of what we pay represents the manufacturing costs, with 39% spent on sales, general and administration, aka cost-to-serve (compared to typical figures in other industries of about 17%) and 35% profit. This skew in the breakdown of prices can happen because of the lack of competition in the market place.

That begs the question of whether the market can or should be shaken up to get us better value to reinvest those savings elsewhere or to treat more patients. I don't know if the Orthimo project will turn out to be the right way to do it, but it is an interesting proposal.

Yes, their implants need to be introduced carefully through Beyond Compliance (which they are) and they need to be properly evaluated, patients aware and so forth, and yes we need to be very cautious before we believe that their implants really are the same as the branded products, but at the same time it is worth considering if it is possible truly to produce a perfect copy of a tried and tested implant that could be provided as a generic off-patent implant, in the same way that generic drugs are used.

Copying prostheses is of course more contentious than copying drugs and we all know of the copies that have been disastrous. However, with our current level of knowledge, no-one could take even a cursory glance at a matt-Exeter, a 3M, a Charnley Elite or an ASR and say that they were identical to the implants from which they were copied (and the ETS doesn't pretend to have the same finish as the Exeter stem). Furthermore, one could argue that every shiny polished tapered stem on the market is a less faithful copy of an Exeter than the Orthimo stem is!

I fully accept that there might be some subtle difference between the Orthimo stems and the Exeter (or the other devices that they have copied) that we do not yet know to be of significance but which turns out to be a problem, but it is hard at the moment to see what that difference would be, given the lengths to which they have gone to replicate the design and manufacturing.

At the same time, the existing manufacturers do make changes to what we believe to be unchanged implants; I have two Exeter stems on my desk that are different, even if only relating to the laser markings - trivial, I am sure, but different. The v40 is different to the Universal Stem on which the long-term evidence is based. Implant companies also change their manufacturing plants, even from one continent to another, from time to time and so for these reasons, we cannot be sure that the branded implant that we receive now is identical to that which we received a few years ago.

Quite reasonably, education, training and support are other reasons why most of us are more comfortable with the traditional suppliers, but given the financial constraints that we now have, it is reasonable to ask how much we really need to pay for that support? I discovered recently that we have a rep whose sole job it is to look after our hospital alone; all very nice, but do we really need to pay a rep's entire annual salary (plus bonuses) to be on hand all the time to support us in using implant systems that each of us have used many hundreds, if not thousands, of times?

There will be Trusts where more support is needed, particularly on the nursing side in regions of high staff turnover, such as London, but, whatever prostheses you use, would it be better to have a system that allows Trusts explicitly to choose the level of support that they need and pay for it appropriately, which is the model likely to follow from use of an Orthimo or similar system, where prices would be based on whether you choose a gold, silver or bronze support package?

My personal view is that the Orthimo prostheses need to be introduced carefully, in limited numbers in low risk patients though Beyond Compliance and they need to be properly evaluated as any new device would be. I don't see this as a quick fix, but more the start of something that might pay big dividends in 10 -15 years time, even if it has no other effect than forcing the big companies to be more competitive.

In summary, I wouldn't expect the consensus at this stage to be anything other than sceptical, but I suggest that we should keep an open mind on this and other projects, to look critically at our current relations with industry and the way that we procure, to question why we pay so much for our implants, and to look for ways that we can reduce costs in future.

Best wishes

Adam Brooks



 Hi Mike

Adam makes some excellent points and should be congratulated, alongside othercs, for the success of this forum. This is the kind of platform that can lead and effect change nationally by influencing local procurement and negotiations, and by rationalising quite how each unit sources their implants and what is used in each situation. There are many advantages to working collaboratively to reduce costs whilst retaining the flexibility and support that current industry partners offer. There will have to be compromises on all sides but we need to mindful that we do not live in a world that is limited to straightforward complication free primaries. There will be unexpected events, complications, complex cases and revisions to deal with as well. Each unit has to carefully assess its needs, the support that its staff require and the potential impact of making changes both on individuals and organisations if things don’t go according to plan.
Regardless, there is the greater issue of how we introduce new implants / devices that needs clear governance – not just the one under discussion. The widespread introduction of untested devices should not be condoned. We should insist on clear outcome endpoints both in studies and in registries (ie in this case beyond compliance) before accepting equivalence.  This is an opportunity to define what is required for any new implants (orthimo being one of many that will appear) and make sure that we understand what we are trying to fix, and how to measure the effect of any change, before changing practice. In the past, many have benignly accepted that someone somewhere was going to do a short term follow up study and just started using new devices before they were full evaluated.
The key issue at the heart of this debate is what you define as a new implant and what can pass as a minor change that you can (perhaps inappropriately as we have sadly discovered many times) ignore. My impression is that many agree that Orthimo needs to be evaluated as a new implant. The concern is that some will accept it as equivalent to existing products prior to appropriate objective scientifically sound scrutiny. 
Apologies for filling inboxes on a Sunday.
Best wishes