For years, pharmaceutical and medical device development have occurred in silos. Now, with increasing costs associated with development and a heightened focus from regulatory bodies on patient outcomes, both industries must evolve past conventional approaches to trial conduct1. Convergent development enables each industry to attain new manufacturing, clinical and regulatory knowledge by forming partnerships with those who have already acquired this expertise.

As a major component of convergent development, combination treatment approaches―which unite two or more different types of regulated drugs or medical devices to enhance patient outcomes―and their supporting trials, provide a chance for each industry to leverage a mutually beneficial partnership to help ensure their respective products stay on or are approved for market. Additionally, the mHealth revolution presents an opportunity to cultivate innovation and can lead to stronger real world evidence of the effectiveness of medical treatments.

Streamlining medical device development by applying lessons learned from Pharma

Medical device manufacturers consider quality, credibility and seamless product substitution as important principles when determining the economic value of a clinical benefit.  For many years, the pharmaceutical industry has adhered to a development model based on these same requirements. Recently, this rigorous approach to trial conduct has become even more important due to increasing medical costs and changing global regulations for medical device manufacturers.2

Health spending is projected to grow at an average rate of 5.8 percent from 2012 to 2022, which is one percent faster than the expected average annual GDP growth (19.9 percent of GDP by 2022), according to a Center for Medicare and Medicaid Services report.3 Similarly, with the average cost of bringing a low-to-moderate 510(k) product from concept to market set at around $31 million,4 medical device costs are increasing as overall industry spending increases.

For manufacturers looking to reduce development costs, there can be multiple challenges related to time and budget. However, an effective solution exists: In many cases, manufacturers can pair a medical device with an existing drug to create a new combination treatment. It is, in fact, possible to pull critical research from existing pharmaceutical clinical trials and conduct a smaller, less costly, combination clinical trial.

The benefit is that a large amount of the research has been conducted. The pharmaceutical product has been approved by various regulatory bodies, reducing costs and elevating the new combination’s chances of succeeding.

Now, pharmaceutical companies are embracing the opportunity to partner with device manufacturers to help bring new combination products to market.

As a partner, pharmaceutical companies also can help supply solutions that help strengthen real-world evidence and provide more comprehensive proof-of-product claims, while maintaining the right balance between quality and cost.

Moreover, due to the benefits of combination products for companies and patients, CROs have recognised the value of connecting these two industries. A successful partnership can help increase efficacy throughout the entire pipeline and provide more cost-effective trials.

How CROs can help transform device development

CROs have the expertise to connect medical device development to a wide-range of pharmaceutical experts, help foster relationships with product owners of existing drugs, and align combination trials with cost-saving strategies.

To start, a CRO can facilitate ways to foster innovation, while streamlining routes to market. For instance, CROs can enable different stakeholders to understand which data points are most important early in the development process, helping them to tailor the trial’s data collection targets in more reliable, cost-effective ways.

Next, a CRO can apply a value-based healthcare model to cultivate trust between patients, providers, industry and payers. For example, CROs can enable transparent conversations in forums designed to produce effective solutions that help define and measure trial outcomes in ways that benefit all stakeholders.

Partnering with a CRO can also improve cost and operating efficiencies, and streamline existing business models—without compromising quality.3 Since many devices are paid under value-based contracts that reward cost and clinical quality performance over periods of 90 days to one year, it is easy to overlook cost and clinical returns that may play out over decades. A CRO could help develop more forward-thinking contracts for combination trials that more reliably guarantee value-based reimbursement.

And, lastly, forming a strategic partnership can allow for systematic savings by leveraging supply chain and distribution efficiencies, and separating sales activities from service delivery.3 A CRO can set up purchasing processes that position medical device manufacturers to invest in bundled product purchases, for example, at a lower cost than purchasing individual items from multiple suppliers.

Using medical devices, wearables and apps to enhance pharmaceutical development

One of the most significant partnerships is occurring in precision oncology medicine, where pharmaceutical companies, device manufacturers and regulatory agencies are improving patient outcomes together. As pharmaceutical companies create targeted therapeutics, device manufacturers design companion diagnostics to be paired with a specific drug, and the regulatory agencies work with drug and device manufacturers to evaluate and approve tests and drugs.

To strengthen the real-world data and evidence of these oncology trials, medical device manufacturers also offer custom device solutions that have built-in software and programmed algorithms to minimise patient effort and decrease the complexities around patient compliance.

Data from wearable sensors, such as the ZIO Patch from iRythm Technologies and the AliveCor Mobile ECG, allow continuous monitoring of status for more customised care, helping to reduce hospital visits, by detecting and responding to adverse events in real time. The data collected adds R&D value and can detect early efficacy.

Digital technologies, such as wearables and diagnostic tools, are important because they enable pharmaceutical companies to create more patient-centric trials. Such technologies can revolutionise drug development in areas like novel clinical endpoints, advances in patient benefit, demonstration of value and in patient reported outcomes.

In fact, many highly competitive technology companies see healthcare organisations as their next big opportunity. Apple, Google and IBM now have several business ventures in the healthcare industry. Recently, ICON and Intel formed one such partnership to enhance digital healthcare capabilities and insights.

Pharmaceutical companies have the opportunity to leverage these technologies to reduce the total time that patients must invest in reporting their outcomes and status, while also improving the quality of real-time patient data. As a result, this approach delivers better long-term patient engagement solutions.

Further, there remains an opportunity to enhance patient trust in pharmaceutical health apps. Currently, 32 percent of patients trust pharmaceutical apps, while 30 percent are willing to share information with a pharmaceutical company.1  With 76 percent of patients placing their trust in personal health management apps1, pharmaceutical companies can borrow from these apps’ design and interaction practices to develop apps that patients will place more confidence in.

Since CROs are positioned to apply broader healthcare trends and practices to help implement patient-centric trials, they can serve as a bridge between the trial, pharmaceutical company, medical device manufacturer and the patient.

How CROs can help enhance patient trust and engagement

A CRO can provide health information technology that is accessible and easy to use. They can deliver support in the development and management of digital technology for more patient-centric portals and experiences.1 And they can help to streamline trials by providing big data analytics, mhealth and optimised digital workflows.1

This all supports targeted, personalised therapies with tools that deliver real-world evidence. Ultimately, a partnership with a CRO also can assist in developing and targeting patient behaviours that optimise health outcomes and ensure sustained engagement outside the clinical setting.

Through partnerships, CROs, pharmaceutical companies and medical device manufacturers can exchange thought leadership and innovative approaches in addition to:

  • Sharing development strategies from each industry,
  • Working to proactively avoid potential pitfalls,
  • And, gathering effective real world evidence to determine the value of products in development.

As healthcare companies converge within an evolving ecosystem, harnessing learnings and achievements from strategic partners can help each player achieve success. To learn more about medical device strategy and market access, contact our Medical Device and Diagnostic Research group leaders.

References:

  1. https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-pharma-and-connected-patient.pdf
  2. http://economics.oxfordre.com/view/10.1093/acrefore/9780190625979.001.0001/acrefore-9780190625979-e-105
  3. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/downloads/proj2012.pdf
  4. https://mdepinet.org/wp-content/uploads/S5_1_Martinsen.pdf