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Working with both SMEs and well-established healthcare and life sciences companies, the team at Onyx Health see the challenges experienced by both, when launching a new medical technology that has the potential to change how a disease is diagnosed or managed.
The advantages a well-established company has is resources, in terms of cash, people and experience. Research undertaken by Kent Surrey Sussex Academic Health Science Network (KSS AHSN) identified that the NHS was more likely to adopt technologies from established companies because of the lower risk involved.
So how can an SME compete in this environment to infiltrate the NHS?
Most new medical technologies come about because a researcher, a medic or a business can see a gap in the market or they are able to use their knowledge and expertise to visualise what will be needed in the future.
It is important to identify just how great this need is. According to KSS AHSN, hospitals in the North East are very open to change and innovation, while those in other parts of the country are clearly displaying their closed for business signs. When undertaking your initial market research, always stretch beyond who you know or local contacts. Talk to medics, researchers and patients from other areas of the country. Patient advocacy groups usually have a very good grasp of what is going on in the market and are a great point of contact, especially as many fund research.
If you have identified a gap in the market, who is to say others have not as well. If there is already an established product on the market, that company may be planning to bring out newer technologies to supersede it. Get hold of their annual reports, read the investor briefings on their website, look at what they are saying about their research and product development. Established companies, especially those with shareholders, love to tell investors about their futures pipeline to keep their share price up.
When bringing a product to market, timing is crucial. If a medical technology stays in research too long, perhaps due to poor clinical trial recruitment, or simply the technology not doing what it says on the tin, the market need may have been filled or a more refined technology may now be needed.
There is a careful balance to play between not bringing the technology to market too soon, when it does not quite work correctly or your data is not published, to spending too much time continually refining it or procrastinating so you miss the boat. Medical technology companies often take a leap of faith when releasing a new product on the market. Quite often products are refined once they have been used in real-world clinical setting for a couple of months. The advantage the larger companies have is that they have aftersales technical support and service engineers available to support the customers if a product does not perform as it should.
For an SME with limited technical support, it may be wise to do a soft launch in a location where you can easily offer support and learn more about how the product performs in everyday clinical settings. In pharmaceuticals, post marketing surveillance studies are undertaken to see how the products work, not just in those patients who have been carefully screened, monitored and supported in Phase lll clinical trials but in real-world settings. The same goes for medical diagnostics and devices.
Today we operate in an “evidence-based” healthcare environment. Published data is a basic market entry tool, without it healthcare professionals will not be convinced your product works. A CE mark may be important to you but to a clinician, it is simply a mark of safety. If your technology is going to change clinical practice then it needs to be compared to the “gold-standard”, or market leader. Without this type of data, you will struggle to get your product adopted within the NHS.
The NHS is legally obliged to fund and resource medicines and treatments recommended by NICE’s technology appraisals, so a positive NICE appraisal recommendation carries a lot of weight, but this is not the case for a NICE Guideline. The NHS Constitution states that patients have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if their doctor believes they are clinically appropriate. A technology appraisal can include medicines, medical devices, diagnostic techniques, surgical procedures and health promotion activities. Not all products, devices and diagnostics are reviewed by NICE.
However, a NICE recommendation is not a guarantee for success or sales. Without the backing of healthcare professionals, CCGs or patient groups then funding will unlikely become available for your product.
NICE is only representative of England. In Scotland, you need to work with the Scottish Medicines Consortium and in Wales, the All Wales Medicines Strategy Group.
If you are going to change how a disease is to be diagnosed and/or managed, you need to learn how to educate and be prepared to overcome challenges that come with changing years of ingrained clinical practice. Time and time again we see companies who believe that uptake of their product within the NHS will simply come from making doctors aware of it, usually through media relations. While making healthcare professionals aware of any new product is important, it is only a very small milestone in what needs to be achieved to change clinical practice. Healthcare professionals purchasing behaviour is like consumers in that they need to have heard about a product from at least 7 or 8 different sources before they act. Once they become aware of a new medical technology many will want to learn about it, why do they need it, what clinical problem will it solve, how they can use it, can they test it, how will they be trained to use it?
The key here is to keep it simple. A video demonstrating how the product works with an expert clinician providing a voiceover and insight into the need for the product is a great place to start. This video can be imbedded into a product presentation, shown from a tablet computer or downloaded from your website. The easier it is for a healthcare professional to grasp what your product does, the easier it will be for them to identify the clinical need.
Every product coming to market that is going to change clinical practice needs a champion. We divide these down into two categories – influential key opinion leaders and product champions. An influential key opinion leader will use their influence and opinion to shape the market for you, but they will not necessarily endorse your product. They may, for example, call for a change in how a disease is diagnosed or bring together their peers to challenge current practice.
A product champion is more likely to endorse your product, talk to other colleagues about it and look at ways of working with you to bring it into their Trust or Clinical Commission Group (CCG) and practice. Key opinion leaders are often known in the field by their peers and product champions. It is important to work with a few key opinion leaders and product champions and identify those who are likely to be early adopters.
In December 2016, NHS Improvement forecasted that NHS trusts would end 2016/17 with a potential deficit of £750-£850 million, which is a significant decline on previous year’s figures. There is however, no spare money in the NHS nor no new money. By 2020 the NHS is committed to deliver £22bn in efficacy savings.
This will be achieved by:
If you are selling a medical technology into a hospital trust then you will need to link it to their cost efficiencies programme.
While the deficit in primary care is not too bad, CCGs are always looking for opportunities to reduce costs. A medical diagnostic that can be used in primary care to prevent a patient being referred to secondary care, could be very appealing to a CCG.
Getting a healthcare professional to champion your medical technology is only the start of a very long procurement process if you are selling to a hospital trust. Today trusts are looking at which medical technologies they will purchase as part of the 2018/19 budget process, but before you even get to submit a quote, there are many hurdles to jump over and customers you need to work and engage with.
Product Champion – needs to develop a business case to purchase the medical technology, showing where the technology will fit into existing practice, what cost efficiencies it will achieve, how it will be used, cost saving made, purchase and running cost.
Multidisciplinary Team – are there other stakeholders within the trust who need to be brought on board to support the use of your medical technology? Do your due diligence, hidden stakeholders can often de-rail the purchasing process. In some cases, they may just not know enough about the product or be concerned that it is going to add to their workload. In other instances, they may act as great advocates for you.
You need to understand how the money is going to flow to purchase your technology. If a trust is purely purchasing a device, it is likely to be funded via the medical equipment capital spend budget. However, if there are consumables to consider as well, the cost of these may come from the clinical directorate budget. Some trusts allow clinical directorates to purchase products under the £5k mark, or agree a consumable rental deal paying for them at a higher rate until the cost of the technology is paid. Whatever route you go down you will be fighting against others for a share of the budget.
It is very important that you get to meet and build a relationship with the procurement team at the directorate level as they will be the people championing the purchase of your technology at a trust level. On average, we are seeing this whole process take up to 12 months to clamber through.
If your medical technology is going to cost the trust more that £125k per year, the trust must go through a tender process. In advance of this it is worth trying to get onto a framework. The NHS Supply Chain can be a first point of contact, but there are also 4 regional Commercial Procurement Collaboratives based throughout the UK, who all have frameworks for different clinical areas. If your product is on a framework there will be no need to tender. However, you need to repeat this process for Scotland, Wales and Northern Ireland.
Managed service contracts are also popular as they help the trust delay upfront payments and manage VAT
One of the big deciding factors as to whether a medical technology is purchased is the “after-sales” service you offer. Procurement teams will take your delivery and installation charges into consideration (often offered free of charge) and they will want to see your service contracts, understand how long it will take an engineer to get to them if there is a call out and agree what training and support you are providing on an annual basis, especially as clinical teams in hospitals are fluid.
From our experience, any company launching a disruptive medical technology needs to plan carefully, never underestimate the time and effort it will take to achieve adoption, keep pushing ahead and do not think that a positive NICE review is going to generate significant sales. If your product is good enough, eventually you will crack the system.
Karen Winterhalter – Director, Onyx Health
Alex Gandhi – Client Account Manager, Onyx Health