Robert Barzelay
Managing Director at GlobalStrategists
@Stephen. You're absolutely right. I have consulted companies that did not have a regulatory and/or reimbursement strategies at all. Designing clinical trials without first investigating what exactly a FDA or Medicare/aid were looking for. Then after expensive. self-designed trials and a handful of publications they went to the FDA only to find out that their requirements were completely different. Same with the insurers. That killed quite some companies I know. And they even had enough money, at the (wrong) start.

But again, for start-ups these long, tedious, expensive processes are often impossible to finance, leading to premature, sudden death.

Stephen Glassic
Available: Biomedical Equipment Technician, Field Service Engineer, Electronic/Electromechanical Technician
Another problem is that even after something has FDA, CE, etc. approval, it still has to be accepted by insurance companies (including Medicare and Medicaid). I wonder how much money changes hands in that process. Until there is insurance company approval, it is only available to those can afford to pay out of their own pocket.

Robert Barzelay
Managing Director at GlobalStrategists
Bureaucracy is killing (not aiding) innovation, new ideas, new developments, new concepts and start-up companies. And those that “make it” won’t last long because of one or a combination of 3 reasons:
(1) Running out of funds
(2) A (too) quick take-over by a large corporation
(3) Their collapse because of cheap copycats.

Over the past 25 years, virtually all countries instituted their own pre-marketing authorization process. Instead of streamlining such processes worldwide, e.g., once okayed in the USA, Germany, France, or whatever other major country with the least corruption and the most advanced healthcare system, then such device’s use should be considered safe and efficacious globally. Who can convincingly defend the presumption that a medical device approved, sold, used and recommended in Sweden, would not have the same outcome in Australia? Are Swedish bodies different than Australians’?

The whole regulatory process is a moneymaking machine, and every country wants to make its own millions. Not only the respective governmental institutions, but also those companies and individuals that claim to be experts in the regulatory processes and act as advisors, consultants or lobbyists. Then there are the “connections” between regulatory and insurance, which are in certain countries very apparent. Not to mention tender boards. And I am not only talking about obscure places where corruption is a way of life, even in purported “clean” countries you get nowhere, if you don’t come up with some pleasant sweetener.

But it is not only the regulatory paths that push up healthcare costs. What about the legal matters, and I am not only talking about the exorbitantly high insurance premiums the medical world has to cough up to protect themselves against an ever more litigious society. I mean the cost of IP protection, which is also a national source of income (for the few). Legal expenses for patent research, (global) patent applications, patent protection and monitoring, and litigations have gone up exponentially. For the multinational I used to work for legal costs went up from 0.5% to well over 5% of revenues in 8 years time. For quite a number of companies these legal costs became their death knell.

The result is that healthcare costs are skyrocketing, and only the fittest (not always the best) survive. As for innovations, being from the “Start-Up Nation”, I know first-hand how many great ideas and products are being developed. More than two-thirds (if not more) never sees the daylight. Simply because they can’t manage to get enough funds to achieve their goals. Investors prefer the quick ROI’s in HiTech deals. They don’t want to spend huge amounts in Life Sciences, and don’t have the patience to see returns in 8-10 years.

The solution is actually so simple. Change the system GLOBALLY.
Virtually every disease or illness has its medical association or society as well as patient communities or circles. Let them set up lean organizations for specific specialties, consisting of medical, scientific, technical, financial and legal specialists, and have them institute and supervise product tests and clinical trials to validate and approve a product. First of all evaluations will be done by independent experts, they will be focused on a specific field, e.g. main: endocrinology, sub: reproductive medicine, and there will be less bureaucracy. They will be valid for global use, and be faster, focused and definitely better because it is the disease or illness that lies at the basis, not a lengthy, supposedly universal approval system.

This will cut costs tremendously, speed up the use or introduction of new or better treatment modalities, and attract investors to fund the Life Sciences industries.
GlobalStrategists.com

Stephen Glassic
Available: Biomedical Equipment Technician, Field Service Engineer, Electronic/Electromechanical Technician
There will always be a certain amount of risk no matter how diligent we all are. There is risk in almost everything in life. Delaying development and acceptance of a promising treatment or medical device can also create risk to patients who could benefit from it sooner. In those cases, everything should be done to help speed the acceptance process for the greater good while taking care at the same time to make sure nothing important is overlooked. If there was a process in place to help speed up promising advancements (especially where there is no current treatment and/or serious illness or death is common or inevitable) patients will benefit, costs may come down and capital investors will be more willing to put up the cash. Finding a way to create more collaboration between companies, universities and health organizations may also help.

John Abbott
Consultant, Medical Devices & Regulatory Affairs
I don't think the issue here is one of FDA being "overcautious" but rather a lack of understanding of "risk" by the general public. In the end, the FDA reflects the "will of the people" regardless of how uninformed "the people" are. We constantly hear after some disaster (man-made or natural) that we must make sure this "never happens again". And so the legislature passes laws that impose absurd requirements of "zero risk" which we all know is impossible (although I can guarantee a way to ELIMINATE the risk of injury from medical devices - remove them ALL from the market). We are constantly bombarded by so-called "experts" who claim to know that it is possible to guarantee a hazard will never happen. And then, of course, it happens anyway and we run around trying to assign blame instead of helping the injured and managing the residual risk in a reasonable and logical manner.

Yes, I know, our elected officials are expected to know better and yet we continue to elect the same people over and over. Sigh...

John Abbott
Consultant, Medical Devices & Regulatory Affairs
Welcome to the wonderful world of EU politics. For example, the fellow in DG SANCO causing so much trouble with regards to the EN Annexes ZZ is a lawyer with no formal training in medical devices. His interpretation is strictly from a legal perspective with little or no comprehension of the impact his actions have (or will have) on products and patients. Like many in the legal profession, he operates on the presumption that the guys who wrote the laws were "right" and infallible. Although a philosophy perhaps not unique to the EU...

BTW: I also disagree with the implication that the CE marking process is somehow less robust of less safe. The data simply do not support this claim. And you cannot just point to anecdotal cases (like PIP or MoM hips) as systematic evidence. In fact, it is unlikely that a more stringent regulatory process or additional clinical testing would have prevented either of these cases. PIP was an after-the-fact criminal act pure-and-simple and the MoM hip problem was mostly improper installation by the surgeon - maybe poor training, maybe simple incompetence.

Gordon Millar
Owner.
One point which I omitted was that in terms of Brussels bureaucracy, about three years ago, my younger brother in law, a career UK civil servant who has moved from various posts with wildly different portfolios announced that he was considering taking a Brussels based role to write policy on medical devices. With no knowledge, never having been inside a factory in his life, he thought he would get up to speed within six months. This was at a family gathering. Can you imagine my eruption? Fortunately, he did not pursue the idea. It does however raise the question of how decisions are reached and by whom and in reality, there is little functional difference on either side of the "Pond" apart from the USA being more concentrated on its own market requirements and perhaps slightly protectionist in some respects. I would echo Richard's comments about CE marking being no easy touch. In fact, due to the differing national interpretations of our wonderfully harmonious EU policy making, it may be even more difficult to navigate through the process.

Richard Little
Chief Executive Officer at Exsurgo Rehab Ltd, NZ & UK
I was a little disappointed in some of the comments that imply that CE is somehow a less robust process, our company follows exactly this strategy of releasing in the EU before the USA but our experience is not that the PMA is more robust or drives a better product that part of the design, manufacture and delivery is exactly the same, the US just takes longer consumes more funds and at the end ot the day, in our case, just hurts the patients by delaying them being able to recieve the equipment they need which directly and negatively effects their health and that at the end of the day is what it should all be about.

Gordon Millar
Owner.
As Birgit indicated earlier, the EU is supposedly a union but in reality it is fragmented in the approach each member state takes to regulatory issues. In discussion with a Brussels bureaurocrat a little while ago, he described the system as being a broad church with several denominations. Harmonisation within Europe is therefore inevitably difficult to achieve. It is also correct to say that there is increasing resistance to dictats being issued by Brussels, especially when they are seldom authored by people with the requisite expertise.

Erik Vollebregt
Partner at Axon Lawyers
Hi Ian, I wasn't suggesting that mere use would create a proven clinical track record. I am referring to a typical feature of devices, being that they evolve in relatively short generational cycles and the additional features are often incremental yet necessitate another good clinical look at the new generation of the device. In a situation like that (in which also other regulatory systems - like the US - allow for a lighter clinical substantiation) it is not necessary to run the same type of trial that you would run something completely novel.
I think your description of what doctors do does point to a flaw in the EU proposal so far, and that is the lack of an obligation to report to authorities (suspected) device incidents on the part of doctors. In my practice I see many doctor issues being blamed on the devices.
You address another important question and that is the one of whether market access is the place to look at cost-effectiveness. I think not. It is a question that does not belong in a market access process, but rather in reimbursement - which are different things and are treated as separate things in most countries. If a device is not cost effective that may be a reason not to reimburse it, but it should not be a reason to refuse market access.

ian Yellowlees
Director at Quantics Biostatistics
I'm in the interesting position of being both a doctor with 30 years clinical experience and now the (medical) director of a Statistical consultancy.
As a Dr, I'm appalled to discover the lack of rigorous safety, efficacy and process control regulation in the devices world. To think that I trusted these devices for all those years...
As Director at Quantics I entirely agree with Dennis King's comments about trials.
Two further comments
1) Just because a device has been in use for years does not mean it has a proven track record in any analytical sense of the verb. (Erik Vollebregt). What we (Drs) do often uses a device, or is informed by the results from a device. A common saying amongst Drs is that 1/3 of what we do is useful, 1/3 probably harmful, and 1/3 not known either way. We just don't often know what falls into which category. Health care systems are staring to get a grip on this, which of course is a GOOD thing.

2) There is talk of the doom scenario that would follow if many devices were removed from the market, but this of course assumes that the devices removed are a) Useful, b) safe, c) cost effective. If they are, then companies should be able to provide the (robust) evidence and keep them on the market. If there is no evidence, there is no known loss (to the patients).

Clearly an updated approach is required and there are many legitimate concerns and issues about how it is done, and by whom, and how to avoid "throwing out the baby with the bath water". But I fully support the need for change.

David Sheets
Global Distribution Sales Manager
seriously - what's wrong with some of these countries???

with FDA, SFDA and CE, there should really be no other requirements. Still, CE could tighten things up a bit - just look at all the fat / contouring devices over there, there must be 30 of them (of which the majority can not even be sold as such in the US)

Evan Friedman
President and CEO at Intronix Technologies Corporation
yes, we recently did the Singapore thing. There were no specific requirements except for CE and perhaps US FDA clearance, and then there was a regulatory system that cost $$$ with a recurring fee, and look: neighboring countries are doing the same. Well, at some point companies are just going to look at the hard numbers and go ahead and not clear products in these markets. Wonder what will happen then?

David Sheets
Global Distribution Sales Manager
yes, it will have a huge impact - and maybe for the good. however, why the need for so many countries to implement their own regulatory strategy is, well, let's face it, a scam to some degree.

I mean really, does Singapore need their own requirements beyond SFDA or KFDA? more and more countries are implementing their own requirements because of the money it brings it to register. then there's the sometimes hassle if you want to change distribution partners....

Dennis King
President and CEO, STATKING Clinical Services
I have always been concerned about the clinical requirements for CE Mark. Many Sponsors tell me that instead of a statistically powered pivotal trial in the US they will run 30 patients in a (sometimes one-armed) clinical study in order to get CE Mark. What could a clinical trial with 30 patients prove towards either safety or efficacy? I guess this is the difference between a market driven approach to product approval versus the government regulated approach here in the US.

Erik Vollebregt
1st Partner at Axon Lawyers
Allow me to join the discussion too since my name is mentioned as 'person on top of things'.

Some observations on the discussion so far:

- it is incorrect to say that the EU doesn't require clinical substantiation for devices. The system is however flexible in how a manufacturer substantiates safety and performance of the device in the mandatory process of clinical evaluation, which allows a more tailored approach for the device concerned (as Ingmar de Gooijer explains above). Notified bodies oversee that the manufacturers make the right choices and member states accrediting notified bodies check if the notified bodies require sufficient substantiation from the manufacturers.
- SMEs will indeed likely have a hard time under the new rules, I just posted an article about that on my medicaldeviceslegal.com blog.
- the new rules will impose strict supply chain chain controls, with autonomous legal obligations for distributors and importers (this we can say for sure because other EU legislation requires this type of supply chain regulation for CE marked products)
- the rules are by no means final yet and the ENVI committee of the EU parliament that does the preparatory work for the Parliament's plenary has not yet established an internal final proposal to the plenary (scheduled for 10 July) and is currently processing an enormous pile of amendments proposed by other parliamentarians. A lot of what ENVI's rapporteur does is highly political and some of the more far out proposals are clearly intended to create a position to compromise from (as Ingmar de Gooijer explains above in this discussion). Then there are the member states, which are the black box in this process. They have to agree to whatever the Parliament comes up with for the proposal to become law, and I see a lot of maneuvering behind the scenes with the Parliament trying to pitch its proposal in a way that the Council (the member states) can agree with it easily. The member states have other things to do in the mean time (solve a major economic crisis) and are divided on the hottest political points (PMA-like system, which would require them to hand over significant sovereignty to the EU and pay for a costly system, and that is difficult to defend at home).

So we are dealing with a situation of political fog of war for the moment that makes it hard to predict where exactly things will land. But we can say that things will change significantly, because the Commission's proposal already proposed significant changes.

John Abbott
Consultant, Medical Devices & Regulatory Affairs
Yes, there is a certain amount of "Not Invented Here" syndrome in play here as well as an opportunity to increase tax revenues while providing local employment.

But to speak for the countries a little... would you want product safety and effectiveness in the US to be determined by some other country's rules over which you have no input or control? I think THAT is more the issue here.

Of course, there is also the money...

David Sheets
Global Distribution Sales Manager
I hear ya about the ASEAN community....they see the $$$ involved and wants theirs too

only a matter of time before companies weigh the sale benefits of smaller countries and walk away from dealing with the inept regulatory bodies, like the HSA. the money they put on smaller distribution companies preclude some of them to continue selling some products - and don't look for the principals to pick up the tab (unless you're direct, like an Allergan, J&J or something)

Erik Vollebregt
1st Partner at Axon Lawyers
@ Dennis King In my view that would really depend on what you're testing. If it's an incremental update to a device with a proven clinical track record for a number of previous generations for example it may be entirely appropriate to have a small and focused trial. I don't have an opinion about the "difference between a market driven approach to product approval versus the government regulated approach here in the US" as long as the approval mechanism for devices and for the underlying clinical trials protect the trial subjects sufficiently and lead to good medical devices being admitted to the market.

It has been proven that the 'government regulated approach' (whatever that means because the EU does not have a regulatory or ethical vacuum here as you seem to want to suggest) that you refer to neither leads to demonstrably safer devices nor to proven faster market access. In the end what one should want I think is an efficient regulatory system that admits safe and products that perform according to their specs. In that respect I think the EU system has done quite well so far, and now it's being improved.

David Sheets
Global Distribution Sales Manager
FDA (USA), KFDA (Korea), SFDA (China) over HSA (Sing)? absolutely

CE? not necessarily