By Dr. Jörn Meissner
Imagine you are getting ready to cut the ribbon on a brand new proton therapy facility.
Simply providing this life-saving cancer treatment to patients who might not otherwise have access to it is enough to guarantee the success of this business venture — right? Not so fast. Most new proton therapy centers have to overcome daunting challenges in order to even make it out of the ,starting gate, and the difference between failure and success is in the details. To overcome these challenges, it is a good idea to define key performance indicators (KPIs) at the outset of your business plan and manage the developing project to optimize them.
Perhaps the most important KPI is evaluating the potential number of patients in your region who are likely to need your service. That doesn’t just mean examining the rates of certain treatment indications. It also means factoring in the competition. In addition to nearby proton therapy facilities, there are other oncology disciplines, ranging from surgery and chemotherapy to other radiation oncology treatments. When turf wars arise it limits referrals, so newcomers to the area should pursue alliances with local providers and insurance companies, to ensure those organizations recognize the benefit of referring their existing patient population to proton therapy.
In some cases, this means educating peers on the value of the treatment. The media often report on the high cost of proton therapy treatment and, naturally, public opinion is influenced by this. Showing them the growing body of medical evidence illustrating the cost and outcome benefits of proton therapy is an important step in making sure your fellow physicians understand the value of the service you’re bringing to the community.
The next step is choosing the number of treatment rooms you will need. Historically, multi-room facilities were the standard, but now single-room centers are an emerging trend, particularly in countries like the U.S., where overall access to proton therapy is relatively more abundant than in other countries.
While the single-room return on investment will be lower than that of a multi-room, the investment itself is also lower. In some cases, a single-room might even fit into an existing building. Multi-room facilities allow for treating more patients, having several clinical partners and setting up dedicated rooms (for pediatric patients, for example). In these facilities you can also plan for relatively efficient capacity increases by adding equipment to a still empty vault.
Now that you’ve decided on a number of treatment rooms, you need to select a proton equipment vendor who can accommodate that goal. Pencil beam (spot) scanning and adaptive treatment technologies, such as intensity-modulated and image-guided treatment, are the cutting-edge capabilities that should be offered by the vendor you choose.
The system you are building will easily operate for 20 or 30 years, and replacing existing equipment with new equipment from a different vendor is difficult. Hence, you select your vendor at the beginning and trust that they keep up with new clinical features at the leading edge of clinical research and provide you with upgrades. And rest assured, once you have defined your clinical parameters there will still be enough vendors for a competitive bid.
Although proton therapy buildings look similar from a superficial point of view, in reality they must be designed and built specific to the vendor of choice. In parallel to selecting an equipment vendor, you will need to choose the team that will design and construct your facility. At this juncture it’s important to remember that spending may become disproportionate to your facility’s development progress. At the start, you will probably spend close to 30 percent of your budget, and you will have reached more than 80 percent a long time before you even go clinical.
Construction of the vault at the
Heidelberg Ion Therapy Center in Germany
To reduce the building design time, hiring a team that has worked with your vendor is most efficient. While a brand new design team may be able to provide a drawing set in eight to 10 months, an experienced team can do this in four to six months and have fewer deviations from the equipment vendors’ requirements. Following the vendor’s construction requirements is instrumental in saving time, and although deviations may seem like they could lower costs, remember that the vendor will have to evaluate change requests and possibly come up with new building requirements, all of which takes up valuable time.
The KPI for schedule is a process. Schedule changes must constantly be compared to the baseline schedule. Schedule delays must be compensated for by acceleration of other parts. The metrics for this should, in part, be graphically represented, so that creeping schedule delays become easily visible.
It is often overlooked that an official radiation shielding review is required for a proton therapy facility. Such a review can take anywhere from two to six months, depending on the shielding consultant, the methods and the complexities. Here is a point in the building process in which the developer should rely on experienced help. This is done only once for a proton therapy site, and the training and learning curve for self-made shielding evaluations may compromise the project schedule.
Implement a shield design that is conservatively safe at the onset of the architectural design. If the shielding is later reduced, the design team will appreciate the extra space they have, whereas needing thicker shielding walls at a later stage in the design will result in costly delays.
Will construction transition smoothly into equipment occupancy?
Once the construction schedule has moved along to such a point that equipment occupancy is possible, the proton installation should happen in parallel with the finalization of overall site construction. Since the installation and commissioning of the proton therapy equipment can easily take 12 months or more, it is important to fulfill the proton vendor’s requirements as quickly as possible to allow him to start his installation.
The proton vendor will have readiness requirements for the areas it will occupy, such as finished walls, floors, access floors, lights, cable ways, piping, ventilation, steelwork and overall cleanliness. Within a few months of starting installation, the vendor will need to have the electrical power ramped up to full capacity, and cooling water and ventilation operational to the full specs.
At this stage, you should prioritize the needs of the vendor. Split mechanical and electrical systems in such a way that those services needed by the proton equipment can be ramped up independently from the needs of the rest of the facility.
No matter how experienced the contractors and design team may be, during the construction period there will be many unforeseen requests and changes. Most of them are from the contractor to the design team or to the proton vendor. Most of these requests come on short notice and have the potential to cause delays if the response is not given in a few days. A good project manager will set up processes to track the cost and schedule impact of change requests before allowing them to be evaluated in detail.
With proton equipment being installed on site, the intensity of daily activity coordination increases substantially for a few months. Construction activities in the proton area must be coordinated with the vendor’s site manager and often must be performed in specific time windows (for example, roof and block wall closing, interior build-out in proton equipment areas, and changes to MEP systems). There are three things to watch: the availability of the project manager and his/her team on-site; the turnaround time for request of information or decision time for change requests; and the cost development based on a budget, plus future cost-risk assessment, as the baseline.
Has your physics team been adequately validated and trained by the proton vendor?
A few months into the installation process, the proton vendor will start commissioning its system and producing radiation. From this moment (if not sooner) special safety rules will be in effect and access to the proton areas must typically be authorized by the proton vendor and the radiation safety officer on an access-by-access basis. Any remaining construction activities should be finished before this milestone.
About two to three months before handover of the first treatment room to the clinical customer, it is a good idea for the customer’s medical physics team to get involved with the vendor’s verification and validation efforts. Initially, participation will transfer know-how and provide on-the-job training. In the later phases the software and data transfer systems will be used and their integration tested. Formal training must accompany the on-the-job training, and clinical commissioning processes and procedures should be developed by this team.
The proton vendor will hand over a verified and validated system that conforms to its specifications. Clinical processes, quality assurance procedures for the treatment and workflows are to be developed and tested by the customer. With a well-organized clinical and medical physics team with prior experience, this clinical commissioning can then be done in a two- to three-month period for a multi-room facility. To achieve this goal it is important for the clinical teams to also gain experience on other sites, or in specific training centers, probably up to a year before the expected handover.
While clinical commissioning focuses on quality assurance aspects, the ramp-up of patient treatments can be used to optimize workflow issues. The ramp-up of the patient numbers should be planned to allow for workflow improvements, and also for the clinical partners to get used to referring patients. Through this process, your new proton facility will build momentum at a comfortable pace that ensures functionality at the most efficient and effective rate possible when you are finally humming along at peak operational capacity.
About the author: Dr. Jörn Meissner is the founder and managing director of Meissner Consulting GmbH. He has been involved in building, design and project management for more than 15 proton therapy facilities worldwide.