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  • Main Subject - Leaning Health - Transforming the Health Service

    Opening Comments

    Due to client confidentiality issues, the names and identities of the client hospitals who have benefited from this process have been obscured as no self-respecting management team would like the press to know about their problems with finance and efficiency.

    Are We Healthy?

    Many people within the UK’s National Health Service (NHS) would recognise that there have been a number of significant impro
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    vements to the service over the last few years, but these same people would also recognise that there are many further improvements that could (and need to) be made, especially with so many hospitals facing deficits.

    This short article has arisen from a number of projects carried out within the NHS to rapidly improve patient pathways in both elective care and emergency admissions, as well as in administrative functions. The aims
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    of this work have been three fold:

    • Significantly improve financial performance

    • Maintain or improve standards of care

    • Increase the overall patient experience

    Healthy & Sustainable

    Before we start, it is worth stating that many organisations have been able to ‘ram-raid’ hospitals, making short term, low gain and unsustainable improvements that have irritated administrative staff and lost the support of the clinical
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    teams.

    Therefore, there is a balance to be walked, on the one hand, the need to focus on significant improvements, and on the other hand the need to bring the teams with you as they pass through the process.

    Over a period of time, we have been trialling a sustainable model for improvement in Health, Local Authorities/Council, Emergency Services and other public sector organisations, based around the PRISM model which is describe
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    d below:

    • P - Prepare the Organisation

    • R - Roadmap

    • I - Implement

    • S - Sustain the Improvement

    • M - Maintain the Momentum

    • A – Accelerate Improvements

    The PRISM model uses concepts from Lean, coupled with key tools from Risk Management, Management Development and Cultural Change to provide a framework for sustainable change in complex process environments.

    P - Preparing the Organisation

    The first, and most i
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    portant, activity in delivering the PRISM model is to scope the improvement so that the organisation is clearly focused on the right targets. We achieved this with the NHS through a management team level ‘Scoping Meeting’ to discuss such things as: Objectives, Focus of Improvements, ‘Fixed Points’ – or things that could not be changed, ‘Impact Points’ – or things that could influence the success or otherwise of the improvement wor
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    , and also identified who would lead the improvements. This was followed by training for the identified ‘Process Leaders’ who were to lead each stream of improvement.

    R - Roadmap

    Having got the organisational ‘aligned’ (in itself not an easy task), the next stage is to gain alignment from those involved in improving the process, which we have achieved through Value Stream Analysis Events (VSE) which are undertaken over a
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    2.5 day period of concentrated effort and use a variety of tools from Lean, Programme Management & Creative Thinking.

    The concept of the VSE is to help the participants to see the ‘waste’ or inefficiency in the current process, using this information to help develop a vision of how good the organisation could be in a ‘Blue Sky’ state and then coming back to reality by creating a realistic ‘Future State’ which tries to get them as
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    close to their ‘Blue Sky’ as possible, taking into account the realism of budgets, resources etc.

    Because we then have reference points, as in where the team are starting from (Current State) and where they want to go (Future State), it is then possible to create an implementation plan to execute.

    I - Implementing the Improvement

    Taking the next element of the PRISM model, we then assisted the team to Implement Improveme
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    ts through a series of Rapid Improvement Events (RIE) – each lasting 3-4 days and covering up to 4 improvement events. For example, in a recent RIE the teams led three improvement programmes:

    1. Using Breast Reconstruction and Total Knee Replacement as examples of common outpatient activity, the first team focused on improving flow through outpatients to enable them to cope with the 18 weeks rule coming in from 2007 onwards for f
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    lly booked appointments. The work achieved a saving of over ?300k and reduced the lead-time from some 7.5 months to 2 weeks to get a fully booked appointment.

    2. Using primarily elective care examples, complicated by issues arising from trauma, or emergency admissions, the second team focused on increasing the ability of theatre to start on time, which resulted in lists starting ‘on-time’ increasing from 37% to greater than 70%.
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    A secondary benefit of this is that the hospital will be able to operate on 10% more patients without increasing staff workload.

    3. The third team focused on Emergency Admission procedures, particularly looking at ‘Fractured Neck of Femur’ - a problem suffered mostly by older women who have fallen over - and ‘Max Fax’ (Maxillofacial) – often suffered by young, drunk men in fights, where the focus was on reducing the time from DTA
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    (Decision to Admit) to the patient being operated on, as well as increasing efficiency. The result was that processing times have dropped from an average of 9 hours to around 3 and there is a potential to save more lives every week through a significantly improved patient pathway.

    One of the greatest side effects of the work undertaken has been some of the comments we have received on our journey, including such things as:

    “The
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    rocess is stressful, but delivers more than any other change programme we have done previously.” Assistant Director (Elective Care)

    “It is certainly a radically different and exciting way to improve patient pathways quickly, efficiently and safely.” Operations Director

    “The work really complements the improvement work we already have to do, but brings a refreshing, high impact approach to our traditional methods.
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    Service Improvement Manager

    S - Sustaining the Gain

    Making improvements in Health is one thing, sustaining them is another and the fourth element of the PRISM model is concerned with Sustaining Improvements through a ‘Change Agent Development’ (CAD) programme which focuses on developing the technical and leadership skills of the ‘Process Leaders’ who lead the areas being improved, by combining profiling with lea
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    ership and ‘Lean’, enabling them to sustain and improve the process which have been transformed.

    M - Maintaining the Momentum

    It is important to recognise that sustainable transformational change takes time, and we have found that it can require up to 1 year to become embedded and for organisations to realise all the benefits that are possible, including the teams becoming familiar with the process. This doesn’t mean that
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    hospitals have to spend a year before there are any improvements as these accrue every month, actually it means that to realise the full benefits, which are measured in millions and sometimes tens of millions, whilst also improving the patient experience and staff morale, requires continual focus over an extended period.

    The last element of the PRISM model is to 'Maintain Momentum' which is concerned with ensuring the organisatio
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    n continues to achieve benefits over the extended journey it needs to go through. This includes re-scoping the improvement, planning further activities and getting the Change Agents 'up to speed' and capable of running events in their own right.

    Without this on-going focus, there will be a tendency to ‘drift’ and for people to revert to previous ways of working and more importantly, previous ways of making improvements, which wit
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    out the focus on Rapid Improvement will often prove to have less impact and take much longer to achieve.

    Closing Comments

    The NHS have made significant improvements over the last few years and the professionals who work within it are performing brilliantly, often with broken processes which cause financial as well as ‘people’ problems, for example some 65% of complaints received by one hospital worked with were related to
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    delays in the way they handled bookings in outpatients.

    Combining the professional expertise, with existing improvement tools within the NHS, combined with external expertise and Rapid Improvement tools, is a winning combination for the 21st Century Health Service.

    In the words of one Chief Executive, "I would never have believed that so much could be achieved in such a short time and in such a professional and exciting fashion.


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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