An original report based on 15+ years of observations in proton therapy

Solutions in Proton Therapy – for initiatives.

Jorn Verweij
28 Sep 18

This is an original report by Trees with Character

“Several vendors have all the expertise an initiative could wish for – still nobody is offering the one solution the initiative is in need of most”

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Executive Summary

Trees with Character, offering independent proton therapy consultancy and founded by Jorn Verweij, provides a range of solutions aimed at achieving the goal of making proton therapy more affordable and more successful by minimising — instead of merely managing — risk. Trees with Character minimises risk by the maximal utilisations of available expertise, both at the side of the vendor and of the initiative.

Over the last 15 years many vendors have either entered or expanded their market, offering a range of solutions to a growing number of interested initiatives. In this period there has, generally speaking, been a shift from large stand-alone multi-room proton therapy centers using passive scattering to smaller centers closely collaborating with existing radiotherapy departments using pencil beam scanning. During this time it has become clear that proton therapy offers clinically significant advantages over existing treatment modalities, and also that these advantages are likely to remain clinically significant for a limited but seizable subgroup of patients across a wide range of indications.

The result is that today’s initiatives have a greater choice in vendors offering starkly different and highly complex solutions, have a greater challenge in having to integrate proton therapy solutions within their existing program, and need to have a much better understanding which part of their patient population will significantly benefit from it.

Trees with Character, based on the founder’s 15+ years of experience in proton therapy as a medical physicist, team leader and program manager, not only identified a range of challenges common to all initiatives, but also the root causes of why each initiative’s organisation experiences similar struggles climbing that same learning curve. The lack of unambiguous aims, the difficulties in identifying the required experts to achieve the aim, and the (mis)communication between experts and non-experts in general (be it within the organisation, between physicians and physicists, or between initiative and vendors) are the main causes for the initiative’s organisation to pile up risk upon risk.

Trees with Character offers solutions which address these causes and which will increase the utilisation of expertise, minimise risk, reduce cost, and increase the operational and clinical performance of the initiative.

Introduction

Trees with Character provides a range of solutions. These solutions address today’s challenges in proton therapy. The challenges have been identified following 15+ years of observations in the field of proton therapy.

Many of these challenges concern the need for bridging the gap between what it is the initiative is trying to achieve (and with what priority), the expertise that is required, and how the technological expertise of the various venders aligns with the initiative’s aim — and thus what their role can be in helping achieve it.

The root cause of many challenges lies both in the absence of unambiguously defined aims, and the inability of many experts to explain in a transparent and easy-to-understand way how they will achieve these aims (which often are not clear). The latter holds also for many proton therapy vendors, most of whom show little interest in learning the initiative’s particular aims — and thus the initiative’s particular challenges.

In section 2 of the document (‘Observations in Proton Therapy’) the observed challenges are described. The solutions that Trees with Character provides to proton therapy initiatives are described in section 3 (‘Provided Solutions to PT-Initiatives’).

Observations in Proton Therapy

Trees with Character provides a range of solutions in proton therapy. These solutions are based on 15+ years of observations, networking, and hands on experiences in various roles in proton therapy. Listed here are observations assumed to be of relevance to initiatives1.

Each initiative is unique, and every lesson already learned in the field of proton therapy has to be first translated for the initiative — and the industry keeps changing…

Almost invariably an initiative is a once-in-a-lifetime project initiated in an environment not accustomed to running a project involving such capital intensive and complex technology, to be operational for several decades, and hence clouded in uncertainties. The starting point may be enthusiasm on a clinical level, or the awareness that proton therapy is of strategic importance, but for which patient groups will it be clinically significant, now and into the future? Is the proton ‘the final particle’ and here to stay, or will there be others? And why are so many centers, relatively speaking, struggling to become successful?

By now proton therapy has a history, and against the background of this history it becomes easier to understand both the relevance of the lessons learned, as well as today’s challenges.

Proton therapy, because of its reliance on the complex technology of cyclotrons/synchrotrons and the transportation of accelerated protons to the treatment room, started at research institutes with large technological infrastructures. First treatments started as early as the 1950’s, and until 1990 there were no hospital-based treatment facilities. During this period, in absence of 3D imaging, the indications treated were either immobile (brain tumors) or relatively straightforward to be reliably positioned (eye melanomas).

When in 1990 the Loma Linda University Medical Center opened its doors, proton therapy had clear advantages over conformal radiotherapy. However, with the gradual introduction of volumetric imaging and IMRT in conventional radiotherapy, these clear advantages diminished, especially as it took the proton therapy industry a good decade to catch up with the advances in imaging (and it may be argued that the industry is still not quite there).

Today proton therapy has clear clinical advantages which are here to stay (as they are based on the exploitation of the physical properties of the protons themselves). At the same time it has also become clear that these advantages are of clinical significance not for all but for a subgroup of patients across a wide range of indications.

From the beginning of the century the field of proton therapy (both the industry and the role of proton therapy as a treatment modality) has changed. Beginning exclusively with large, stand-alone, multi-room centers offering ‘passive scattering’, to, today, a variety of constellations of generally smaller, more integrated, one to three treatment room centers.

Each lesson learned was a lesson learned within a certain context. The context is likely to have changed, and it will change again. Many vendors offer various solutions, invariably build on impressive technological expertise, but no vendor offers all solutions to everybody. The first step for each initiative is to define its context (its ‘system’), and how it is likely to change. The rest will follow. 

Some proton therapy centers have failed, many struggle, few thrive — many causes, one lesson: avoid assumptions and decisions

The problems encountered by various proton therapy centers are diverse and often particular to a proton therapy center’s ‘system’. But almost invariably they have their root cause in assumptions or decisions.

Assumptions include the enduring clinical advantage of a ‘frozen’ proton therapy system over ‘evolving’ conventional radiotherapy solutions, the idea that proton therapy’s clinical significance is ‘for all to see’ and automatically results in referrals, that healthcare insurance companies will not lower reimbursement rates, that the vendor ‘understands’ what the initiative’s needs are, and that capacity will generate demand.

Decisions include ‘going it alone’, not building relationships with local, regional and or supra-regional stakeholders, selecting a vendor based on cost or relationship, not to consult or bring in expertise, and have the business case determine the required center’s capacity instead of building the business case on substantiated patient demand.

Each center is likely to have a different definition of ‘success’. It may be establishing/cementing the organisation’s reputation as an oncology center, or as a research center, or providing the best treatment solutions to all serviced patients, or providing profitable treatment solutions to a subgroup of patients.

The proton therapy initiatives most likely to be ‘successful’ are those who make fewest assumptions, few to no decisions, and known how their success is going to be defined from the very start.

It may take more than 10 years from the very first interest in proton therapy to operating at full capacity — the biggest risks are not financial or technical, they concern the initiative’s system

It may take a year, or several, from interest in proton therapy to the commitment of resources (often over other projects an organisation may be considering) to just start the initiative.

The initiative may take a year, or several, to build the project-organisation, to obtain the required human resources from within the organisation, to lay out the aim, the strategy, to map and contact the involved stakeholders, to scan the need for permits, to build a provisional business case, to build up ‘some’ expertise, visiting centers, conferences, consulting the market.

And then there is the vendor selection process. Pivotal given the vendor lock-in for the operational life-time of the center. It is the vendor’s solution which determines the size of your bunker, the layout of your building, and thus to a large extent the size of your initial investment. More importantly, the vendor also co-determines your initiative’s productivity, your access to networked-expertise, and the clinical significance of your treatment offerings 10 years from now. A selection process that, all in all, may take a year, and often longer.

Once the vendor has been decided upon the building can be designed, permits obtained, the business case completed, financing be finalised. Which may take up to a year as well.

While construction is ongoing expertise in numerous fields is to be hired, and to be build up, and peripheral equipment to be obtained. All the while the sheer number of interfaces, between the clinic/patient-building and the equipment and its control system, becomes clearer, and so do the IT-challenges. This may take a year or two, and sometimes longer.

The first patient treated is a moment to celebrate. But it does not define success. Increasing the number of patients treated week by week, month by month, reveals the level of the organisation’s preparedness. In every field from referral to workflow to IT. This may take a year, or two, or three.

From the first thought of offering the treatment modality of proton therapy to having overcome all the challenges related to the ramp up to (required) capacity can easily take 10 years. There is a long ‘gestational’ period of up to 5  years, and sometimes more, before the signatures are in place which financially commit the initiative, its organisation, the vendor and the lenders. The biggest risks to the initiative occur during this gestational period and concern the initiative’s environment or system.

Examples are dependencies on certain people (from the initiator(s) to supportive board members or members of the supervisory board), new and exciting projects within the organisation which compete with resources and for attention, changes in the financial market and or the financial position of the organisation itself, other prospective proton therapy initiatives which may affect the presumed catchment area, technological and clinical developments outside of proton therapy which challenge the initiative’s earliest assumptions, changing attitudes of healthcare insurers and or their reimbursement rates, etc. etc. All of these may stop the initiative in its tracks.

An initiative does have no control over external developments, but it can significantly decrease its dependence on these developments by defining its ‘Strategic Brief’ (aligning the project with the organisation’s vision, mission, and strategies), and by using a versatile, long-term (20 year) exploitation model to assess the impact of a range risk-scenarios. This allows the initiative to develop comprehensive risk mitigation strategies (which will most certainly help in obtaining financing as well), and significantly increase the likelihood of ‘survival’.

   

The fundament of each initiative is the exploitation model — for the answers that it provides and for the questions that it asks

Each initiative has it own unique exploitation model estimating the initiative’s revenue for a number of years. This model is essential in assessing the interdependencies between capital investment, patients treated, various types of cost and revenue. The exploitation model can be used to assess the impact of downside scenario’s as well as to identify opportunities. To determine the amount of financing required as well as the reimbursement needed to break even. To identify the number of the initiative’s ‘critical’ years as well as when surpluses can be expected.

For the initiative and the organisation the exploitation model is an essential tool from the very start. As the initiative learns the exploitation model will become more accurate and, ideally, more flexible. When it comes to financing, a detailed, accurate and flexible exploitation model (for at least 10 but preferably 20 years) is a necessity.

Several vendors are able to provide a standard exploitation model, which is helpful to estimate financial parameters, and which may be quick to show the financial advantages the vendor’s performances and services provide.

But the real strength, and necessity, for having an exploitation model is in asking the questions which are specific to the initiative. How much extra personnel do I need how quickly based on the estimated ramp up in operational hours, and which personnel will see its workload increase linearly with patient numbers? Do estimated energy costs play a big role for the initiative, and what is the impact on revenue if I add two minutes to a treatment slot because of extra imaging? Where do which part of my patients come from, and what if the number of paediatric patients coming to the center is larger than anticipated? It is worthwhile to postpone bringing another treatment room online, and if so what must be in place to avoid the center from shutting down? Which services may I be able to obtain from outside the center until demand from the proton therapy center is high enough (and to what effect), and which services are essential to have near the treatment rooms from the very beginning?

By developing an exploitation model the initiative learns to walk more rapidly.

If you know your initiative’s aim, then there is no need to learn to speak the vendors’ technical language, or to attempt to interpret their marketing claims — then you can simply ask them how they will be able to help you

The Strategic Brief, detailing the aim and its alignment with the organisation, reduces the risk the initiative will fail during the initiative’s gestational period and forms the starting point of the development of the exploitation model. It is also used to invite vendors to make it transparent to the initiative how their solutions will aid in realising the initiative’s aims.

In practice very few initiatives have clear aims, and vendors may show little interest in them to begin with. What results are initiatives not knowing which vendor-performances are relevant for what they are not really clear about they actually need. The vendors, on their part, have little choice but to provide longs lists of solutions and performances in the hope that something will stick. Unable to substantiate the relevance of all their claims against an initiative’s unknown aims, much is being said and little understood.

Not understanding what is relevant to the initiative, and given the size of the investment, the initiative sees only risks. This the initiative tries to reduce by ‘controlling’ both the vendor and the performances of is solution. By way of the legal agreement, by listing requirements, and by focusing on price. The vendor may feel compelled to provide performances which the initiative might not actually need, increasing cost, and at the same time has to bring the initial investment sum down to remain competitive. All this while the vendor-initiative lock-in remains, and the vendor needs to find its margin somewhere. The lack of clear aims on the initiative’s side, and the lack of clear substantiations of the benefit of performances on the vendor’s side, all too often result in a win-lose situation which may be difficult to overcome.

But when the initiative’s aims are clear, the vendor can be invited to substantiate the relevance of its solutions to the initiative’s specific needs and situation in a transparent and easy-to-understand manner — without the use of technical language the initiative is unlikely to understand.

The initiative and the vendor each have expertise which, when aligned, results in win-win situations and bring proton therapy forward — but in the vendor-selection process ‘expertise’ is not an awarding criterion

The initiative knows its own system. It knows its stakeholders, the strategy of the organisation, the existing referral patterns, the patients it is to treat, the indications for which it wants to be a referral center, the existing research and development that it intends to leverage. It knows what it is competing against, how hard or easy it may be to recruit personnel, and which radio-oncologists may still need convincing. It knows the rhythm of the various levels of approval to be obtained, the amount of politics that may be involved, and how risk-averse, or how eager to take on challenges, its internal boards are.

The vendor knows the usual challenges of the initiatives. How they may underestimate the duration, and the risks, of the gestational period, and the difficulty of obtaining and retaining resources from within the organisation. How the lender’s level of scrutiny may require the need for external expertise, how different and unfamiliar the challenges in radiation shielding for proton therapy are, and how intricately the bunker, the equipment, the patient building, and all the surrounding infrastructure are connected.

The initiative knows its system and may have a pretty good idea where it wants to be ten years from now. But it may not be sharing this information. The vendor may have all the expertise and experience required to provide the initiative with what it needs. But it may not be asking for this information, and focus on selling its ‘general’ solution instead.

Selecting a vendor may be the initiative’s biggest challenge and may be associated with the biggest risk. The initiative may invest heavily in trying to decipher the vendor’s communication and define a list of requirements for which it actually lacks the expertise. Or it may try to reduce risk by negotiation, trying to get ‘the best deal’, and writing a lengthy legal contract in an attempt to force the vendor to act in the best interest of the customer.

Vendors have great a amount expertise which they can also leverage to help an initiative. The expert-vendor wants to act in the best interest of the customer. The initiative wants to be able to identify the vendor whose expertise is most relevant in achieving the initiative’s aims. For this to happen the initiative is to share its aims in relation to the system, and the vendors are to transparently substantiate the claims with which they will achieve these aims, using easy-to-understand language. The initiative wants to know how the vendor will provide its solutions, and how progress is communicated, and the vendor wants to provide its solutions without being controlled in how to utilise its expertise.

Such a method of procurement, aligning the expertise of the initiative and the vendor, already exists, has already been applied in proton therapy, and has been ruled to be within the framework of the European Public Procurement Law2.

The operational solution almost every initiative is in need of most is hardest to come by — business continuity

Selecting a vendor may have the single biggest impact on the operational success of the proton therapy center. But ultimately the initiative is not in need of equipment, but in a treatment solution which is both clinically significant for the operational lifetime of the center, and which is reliably connected to its existing infrastructure. In other words: business continuity.

Today the vendor is perfectly able to define the interfaces between equipment and building, and where its responsibility ends, and that of the initiative’s organisation begins. The vendor will be able to install the equipment in time, to demonstrate it works as advertised, and also to update and or to upgrade it, including the software and the firmware, and the hardware components which are on the list to become obsolete. It is what vendors are good at.

The initiative’s organisation is left to define new workflows, and perhaps to integrate it with existing ones, to interface its patient database and perhaps 3rd party imaging and or other solutions to the control system. Systems it may have to upgrade before certain hardware components become obsolete, or software fails to communicate because certain features are no longer supported.

The organisation thus introduces new dependencies and unlikely but not impossible scenarios of failure which may prevent proton therapy treatment. These have nothing to do with the performance of the proton therapy equipment itself. The complexity of it all is not what the initiative’s organisation was set up to be in control of. It may not be what the initiative’s organisation is good at.

Several vendors have all the expertise an initiative could wish for — but which vendor is offering the one solution the initiative is in need of most?

Experts are able to solve the biggest problems, but sometimes the biggest problem is finding experts. Not just experts in proton therapy, but also experts within the initiative’s organisation — How to identify them?

Proton therapy differs from conventional radiotherapy in its application, the possibilities, the degrees of freedom, the risks. With the number of proton therapy centers on the increase, and the productivity of centers growing, proton therapy-expertise may be hard to attract.

This challenge has been identified a long time ago, and several vendors provide extensive training programs to assist and prepare their customers. But in setting up and running a proton therapy center specific expertise is required also, and as the financial stakes tend to be so much higher, the margin for error — for wrong calls, for incompetence — is so much smaller.

In practice the problem is often not the expertise itself. Proton therapy is an exciting field still in development, and today’s initiatives can still be considered ‘early adapters’. The people behind the initiative, and their organisations, see opportunities, not just risks. They observe what is happening around them, and they are ready to take on challenges. It is a de facto selection mechanism: the initiative’s organisation harbour, and attract, plenty of clever people with a range of expertise. The problem tends to be that many organisations are not ‘set up’ to utilise this expertise, and reverse to decision making instead.

Initiatives, especially once the signatures have been set and spending has begun in earnest, are keenly aware that time is money. For every month start of patient treatment is delayed, spending is at 100% and revenue at 0% — cost of personnel and interest payments can take 300’000 EUR out of the bank on a monthly basis. Treating two patients fewer per day than budgeted during one year may cost the initiative 500’000 EUR. Problems are to be resolved, challenges met, approval obtained. In response to the uneasiness that is automatically generated by high-stake under-pressure one-of-a-kind project work the initiative’s organisation may demonstrate the reflex of trying to manage, to direct, to control. And then every so many weeks it becomes decision time.

From what moment to let go of the required 100% bank guarantee? What information to share with stakeholders? Should an educational program for potential referrers be set up? Is a meeting room near the patient bunkers really required? When the budget for building consultants will be overrun, can we do without? Is it okay to upgrade a particular system if it means we temporarily have to reduce capacity?

Experts know what they have to do to achieve the aim, they can explain why they make the choices they make. They don’t have to make decisions.

When an organisation produces a lot of detailed information, and pushes all this information toward decision makers, they can’t possibly absorb all this information and be asked to substantiated how their choices will contribute to achieving an aim — an aim which may not even be defined. So they make decisions. And with decisions the risk that ‘the aim’ will not be achieved increases.

The field of proton therapy is abound with expertise. The challenges and the possibilities attract bright people. Both on the side of the vendors and on the side of the initiatives. The biggest challenge in proton therapy is the alignment of expertise. Between vendors and initiatives, and within the vendor’s and initiative’s organisations themselves. It starts with the definition of unambiguous aims which must be understood the same by the ‘owner of the aim’ and the expert who is to achieve it.

Solutions for PT-Initiatives

Trees with Character provides solutions in proton therapy both for starting initiatives, for operational centers and also for vendors (described in another report). Trees with Character provides solutions based on expertise and aimed at utilising that of others. That is how risks are minimised.

Below the services are listed and briefly described. Or go to our Services page directly.

PROTON THERAPY CONSULTANCY FOR INITIATIVES

Is Proton Therapy a realistic proposition? Why are some centers struggling? How to identify the best vendor for my project? What are the risks banks are interested in? The number of challenges is staggering. Trees with Character offer the solutions.

VENDOR SELECTION AND PROCUREMENT

In proton therapy you do not merely buy a machine, you identify a vendor whose expertise is pivotal to the success of the proton therapy center during its operational lifetime. A service to help both initiatives and vendors to make a match.

EXECUTIVE PROJECT MANAGEMENT

When running a Proton Therapy project the list of challenges seems endless. How to build expertise, and a referral network? What is a suitable strategy, how to get a realistic BC? How to identify the best vendor for my project? Where to get help?

INDEPENDENT RISK ASSESSMENT FOR INITIATIVES AND INVESTORS

Is a particular proton therapy project viable? Does the business case make sense? An independent assessment for initiatives and investors.

DEVELOPING A PROTON THERAPY BUSINESS CASE

Often the decision to yes/no continue with a proton therapy project starts with a comprehensive business case. Trees with Character specialises in making a comprehensive 20 year exploitation model which provides the input for financing models. Some example figures are shown below.

WORKSHOPS AND SPEAKER ENGAGEMENTS

We provide a workshop proton therapy which ends with a simple but client-specific business case. We also talk all things proton therapy, for everyone!

In the downloadable PDF of this report a range of output-figures is provided, three examples are shown here.

dummy-graph

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Available and required capacity

For still more information…

Have a look at our cases:

  • Procuring proton therapy equipment (link)
  • A Business Case for a proton therapy initiative (link)
  • Project Managing a proton therapy center (link)

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