Outcome is the New Income

The number of people suffering from lifestyle-related health conditions is approaching critical mass and the problem looks set to worsen. As the years go on, the number of afflicted people is rising, placing an increasing financial burden on national authorities.

This proliferation of lifestyle diseases has driven the healthcare reforms we’ve seen, particularly over the last two or three years. They already cost governments huge amounts of money, and will only become more expensive.

Dealing with the problem requires a fundamental shift in the way healthcare is approached. Rather than receiving money for providing an isolated drug, medication, or therapy, pharmaceutical companies—and other stakeholders within the sector—should be paid by medical outcomes (delivering actual results from the medication and managing the disease as required).

Updating Models for Success

It’s self-evident that the existing payment and prescription-focused structure must change. The questions are, how do we want to go about it, and how quickly can a solution be implemented? We must measure success with funding models that are governed by outcomes and the factors that drive those outcomes, which reach beyond delivering the drug. There must be a balance between demanding more of the patient, the healthcare professional, and the pharmaceutical company.

Taking a more holistic approach to healthcare is central to this required shift. Currently, the healthcare system and pharmaceutical companies tend to see medication as the key treatment ingredient, while medical devices, connected patient services, and other associated holistic solution elements are regarded as little more than necessary evils or marketing gimmicks to handle the medication—or sell the drug. With a stronger focus on outcomes, however, these peripheral aspects will need to take on a far greater significance in the eyes of all stakeholders—including pharmaceutical companies.

It’s not good enough that drug firms only think about the solution components, such as devices and connected services, shortly before market launch. Instead, they need to think about these strategic solution components at least three years prior to the treatment being made available (before Phase III), so it becomes an integrated part of the solution and how outcome should be improved. It’s all part of providing end-to-end solutions that are focused on outcome, as delivering outcome will equal income in the future for the pharma industry.

Providing the Full Treatment

Some patients get very ill and their conditions develop into multiple disorders, including psychological problems. In situations like this, the role of the caregivers and/or the family becomes extremely important. In order to improve patient outcomes and provide effective, solution-based therapies, we have to build these additional elements into treatment plans. It’s not just about the patient—it’s the people and stakeholders around them, as well. That change will have to happen on a grand scale and include all key industry stakeholders. Harmonizing these different groups—many of which have competing interests—will be a major challenge, but integration is possible.

However, one of the biggest hurdles in bringing about this change is establishing a commonality between the industry regulators, pharmaceutical companies, and patients. If changes made by pharmaceutical companies aren’t acknowledged (and paid for), or if patients, healthcare professionals, doctors, and the local communities don’t hold up their end of the bargain, the change will not be sustained. To ensure success, we need to have a number of different ways of measuring outcomes and to agree on methodologies. Everybody involved needs to understand their role and commit to playing it. If anybody is not delivering their share, there needs to be consequences.

Assuming Responsibility

Creating a system based on greater interaction between healthcare stakeholders will no doubt result in improved efficiencies and better patient outcomes, but it also brings significant responsibilities. Patients often fail to act as they are asked to, so we will need to change patient behaviors as well as the behavior of all players.

A recent project completed with Bayer that focused on the German pharmaceuticals company’s fully integrated BetaConnect product helps to administer and monitor betaferon injections for the treatment of Multiple Sclerosis. The approach aims to reduce relapses for patients, which means improving outcomes. BetaConnect not only eases injections for patients, but also enables patients, nurses, and caregivers to manage and monitor diseases better.

This injection data—including speed/depth, date/time, and volume—is uploaded in real time, via cable or Bluetooth, to a computer or mobile device, and is then passed through a central database and shared between the relevant people around the patient. Many approaches only include devices that simply deliver the drug, but Bayer’s product provides a 360° view of both patient and disease. This is one of the first end-to-end approaches out there, although Phillips-Medisize and Medicom are developing similar solutions for other clients in other disease areas.

Survival of The Fastest

The increased collaboration between industry stakeholders that is so central to improving overall healthcare will begin soon. Some areas of the sector, however, will adapt to the new model more quickly than others.

Big pharmaceutical companies, for example, are hardly known for being nimble. Their decision-making procedures are often slow, which could make life more difficult for them—but regulators and healthcare institutions are similarly challenged by their lack of speed. On the other hand, increased interaction can really benefit smaller and mid-sized pharmaceutical and biotech firms, which have the potential to be much faster at implementing changes and even have a chance of being the first-movers—thus setting the standard.

No doubt there will be a couple of years of intense competition to define, implement, and harvest the benefits of this new, outcome-based paradigm. The winners will be those that adapt most quickly, internally, as well as in the way they deal with their stakeholders. This is very much a first-movers’ game—the system is extremely immature and on the lookout at the moment. It will be vital for companies to prove that they can operate and market new solutions in this new environment over the next two to three years.

Case Study: Working Together For Success

Pharma companies save time and money by partnering with innovative drug delivery device specialists. The Phillips-Medisize and Medicom combination, is a leading player in this space and provides full end-to-end solutions from devicestrategy and concept through commercialization, by handling all the industry critical factors in the shortest possible time. The joint company works with its customers on the long-term strategy for the drug and its delivery system with special knowledge in personal connected health drug delivery solutions, carrying out a 360-degree overview of the specific therapy to determine the optimum device strategy. One client request illustrates how efficiently and successfully these partnerships can work to solve drug delivery device problems.

The Problem

We were approached to design a next generation, re-usable auto injector for their customer’s drug, to replace the existing auto injector(s) in global markets. Part of the strategic review included the consideration of electronics integration to offer significant enhancements to the user-friendliness of the whole drug administration process.

The Solution

We developed the first range of conceptual designs based on both commercial and technical key drivers and constraints, which expressed some of the client’s key ideas and mandatory requirements to improve dose compliance, and, in turn, patient outcomes. We were responsible for the conceptual program and subsequent full development program with few interaction points with the customer. Together, they discussed the sort of information that would be transmitted as well as the features of the connectivity system used to transmit dose-monitoring data. From the start, there was a clear strategy that we would manufacture the product and supply it to the customer, with the complete packaged product ready for distribution to global markets.

All user studies were jointly executed. However, we typically drove protocols and development of all stimuli materials and models for user studies, while the customer executed the user studies.

The Outcome

The device program was initiated in 2011 and launched in the EU in 2014 and in the US in 2015. Very fast turn-around from first ideas to launch of a new ground-breaking device.

  • Bill Welch

    Bill Welch is Chief Technical Officer at Phillips-Medisize Corporation. Bill Welch has more than 25 years of contract design, development, and manufacturing experience, primarily in the drug delivery, medtech, and diagnostics markets. Bill has been with Phillips-Medisize since 2002.

    • Morten Nielsen

      Morten Nielsen is President at Medicom Innovation Partner, a Phillips-Medisize company. Morten has been with Medicom since 2011. He previously worked with PA Consulting Group, Lawson/Intentia, Olicom, DGM/DS and S&W Medico Teknik.

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