By Simon Wyatt
The email and phone traffic in the few days and indeed weeks, post 23rd June this year, increased substantially at Contamac, with questions and even some concern from our customers, over the surprising decision to “Brexit”, after a 43-year membership.
Of course, nothing has actually changed overnight and the medium and longer term consequences are completely unknown. The next step, anticipated to happen toward the end of 2016, is for Parliament to invoke Article 50, which is the process to formally begin our exit from the European Union. This, of course, assumesthat a majority in Parliament votes for this, as only an Act of Parliament, not the referendum itself, can invoke Article 50.
Once the Article is invoked, there is a 2-year process to determine how and to what level, the UK’s exit happens. This involves negotiations with all remaining 27 EU members and any decision requiresa majority of at least 20 members, 65% of the EU population. A daunting prospect given the often bitter disagreements that have hampered the EU.
For our business and more importantly our customers, we anticipate no changes and will continue to provide our manufacturers globally, with the best quality products and services.
Whilst the UK and indeed Europe and the rest of the world face difficulties, and with that undoubted change, I believe we are also facing changes and challenges in our industry.
Perhaps the most significant of these are changes in the regulatory environment. At Contamac we are not a finished device manufacturer and as such, cannot have our materials “approved”. We are therefore somewhat removed from the growing challenges of having products registered or re-registered in different countries, but the sheer volume of enquiries we receive from manufacturers seeking technical information makes us acutely aware of the task facing you. We have developed a significant “library” of documents over the past 2-3 years, to support you in dealing with technical questions regarding the material and encourage you to contact us for support.
We are also hearing more and more of the impact on tightening up on CE mark approvals. The start of this has seen more policing of notified bodies, with many of the smaller companies no longer accredited. The net result is a lack of suitably qualified Auditors, far fewer notified bodies and “time to audit” being lengthened, assuming always your notified body will give you a date for your CE audit!
As an industry, we have a duty to ensure our products are safe and effective and provide the patient with the best possible outcomes. As such we should accept, if not readily embrace, regulations which seek to enforce safety and quality standards. I’m sure none of you will disagree. However there needs to be a balance and there should not be excessive regulation, resulting in ever increasing cost and less and less notified bodies to provide the mechanism to obtain the required approvals.
The industry needs innovation. Whilst for many millions of people cataract surgery restores vision, the “premium IOL” market has largely disappointed. As in many industries, innovation is often driven by small businesses and there is a danger the new regulatory environment will stifle or even stop the source of many new ideas and products. That is not a sensible outcome and a compromise must be reached.
The greatest challenge facing us all, however, is the continuing fall in the price of a finished IOL. It is hard to understand how it is possible that a medical device implanted in the body, with a life expectancy of now approaching 30 years, costs less than a fairly modest lunch. This, against a background of higher and higher regulatory costs and in addition to costs rising generally, is creating real financial concern and pressure.
In any business, there is a need to manage and control costs. If your selling prices are falling, there is some sense in seeking to pass this “pain” directly to your supplier. I would urge caution in such a simplistic approach. Back to regulatory and changes in the ISO standards. ISO 9001:15 is very much focussed on risk management and this should apply to your approach to controlling costs.
For those of you that attended EFCLIN in April this year, you may have seen my presentation “Do you really know your material supplier”. Whilst I will not repeat the whole presentation here, I believe it is relevant to reiterate some of the key points.
With all the changes and challenges I have mentioned above, I do understand manufacturers seeking lower material prices or indeed, seeking to make the material themselves. But, and I believe it is a big but,:
Manufacturing material may appear simple
At Contamac, we have nearly 30 years of experience in manufacturing contact lens and IOL materials. To maintain consistently high quality requires significant investment and skill. Those of you who have visited our facility always comment “I had no idea how much was involved in making the material”.
I can buy my material cheaper elsewhere
Of course, it is right that there is choice and competition in the market, but before making such a decision or indeed if a decision has already been made, following ISO 9001:15, have you undertaken a proper risk assessment?
- Have you ever visited your material supplier?
- Do you carry out regular supplier audits?
- Do you have a supplier agreement?
- Do you understand your supplier’s business plans? Will they be around to support you in the future?
- Does your supplier invest in R&D to provide new products and technology?
Your choice of material is perhaps the most important decision you will make. With all the regulatory changes and financial pressures, please ensure it is an informed decision.
At the time of writing, I am getting ready to set off for the AAO in Chicago, where I look forward to seeing many of you. Contamac is exhibiting so please do come and see us.