Blog | 4/22/2024

The Increasing Importance of Diagnostics Development and Commercialization Partnerships in the Post-COVID Era

Donna Hochberg, PhD, Partner and Managing Director, Head of Dx, PM, and LST & Services shared insights on “The Increasing Importance of Diagnostics Development and Commercialization Partnerships in the Post-COVID Era” as part of 360Dx’s webinar series.** The discussion highlighted how multiple trends in the diagnostics ecosystem are elevating the role of partnerships in ensuring product success.


The COVID-19 pandemic brought diagnostics to the forefront of public awareness, driving broader overall knowledge and bringing investment in the industry to new heights. As the industry emerges from pandemic highs, in the midst of a challenging macro environment, partnerships have emerged as an increasingly critical tool. While partnerships have always played a significant role in in vitro diagnostic development and commercialization, current dynamics make partnerships of all shapes and sizes potentially more accessible and palatable, thereby overcoming hurdles encountered in considering M&A or fully internal programs to drive growth.



Challenging Macro Environment

  • Increasing Technical Complexity: Several technology categories including digital pathology, rapid AST, molecular/NGS diagnostics, and point of care testing are current hotspots for investment and innovation. In addition, clinical areas such as central nervous system (CND) disease and autoimmune conditions are drawing attention. What all of these topics have in common is complexity. Each category is driving demand for a mix of higher performance/high quality/high sensitivity detection, multiplexing capabilities, user friendly/automated solutions, and algorithm based answers (both AI driven and not) as well as employing novel detection technologies, biomarkers, and sample types.  Together, the requirements for technical success have become complex resulting in longer developmental timelines and higher costs.
  • Right-Sizing Post-COVID: As we emerge from the pandemic, organizations are in the process of right-sizing. During the pandemic, driven by heightened demand and resources, organizations expanded employee ranks and infrastructure. Now, to manage resources and ensure continued success, restructuring and streamlining has been needed and represents an ongoing distraction to organization working to innovate.
  • Increasing Regulatory Scrutiny:  As we navigate through the implementation phase of IVDR regulation in Europe and the imminent finalization of LDT regulations in the US, the diagnostic world is facing an era of heightened scrutiny. This scrutiny not only escalates data expectations and approval costs but also introduces significant timeline risks and uncertainties. The core concern lies in regulatory agencies’ ability to manage the surge in submissions both in the US and Europe. This regulatory shift impacts every stage of the product lifecycle, from the development process to commercialization, adding complexity and reshaping the landscape for product developers.
  • Market Access Challenges: Despite the clear recognition of the value of diagnostics during the pandemic, payers remain and in fact are increasingly skeptical of new tests. Navigating the multifaceted nature of market access, encompassing evidence generation, stakeholder engagement, and coding and rate setting, adds complexity and necessitates early consideration of market access in the R&D process.
  • Shifts in Customer Nature: The pandemic, along with ongoing trends in healthcare consumerization and decentralization, has significantly shifted the notion of a typical customer. The industry has moved beyond traditional customers such as labs and individual clinicians to include health systems and patients. This evolution of the customer base, coupled with increased awareness and education about diagnostics, has led to a higher demand for comprehensive, economically beneficial solutions. Customers are no longer simply seeking a test; rather, they desire an end-to-end solution that includes digital components, convenient care access, automation, and more. This shift not only adds complexity to the product development process but also commercialization requirements.
  • Investor Wariness: Investors are wary due to market volatility experienced during the pandemic and ongoing uncertainty, leading to greater hurdles for investment decisions.


The Evolving Nature of Partnerships

  • The six trends discussed above together are driving longer timelines, costs, and complexity across the development and commercialization cycle.  Success in navigating this complexity requires a broad array of skill sets, careful planning, and optimized execution. Partnerships can help to ensure success.
  • Executed effectively, partnerships can provide access to critical expertise, drive process and economic efficiency, reduce risk, and foster innovation.


  • As always, partnerships can take on many forms and support work across the development and commercialization cycle.


  • Not only is the evolving macro environment driving increased focus on partnerships but many of the technology areas receiving focus and investment inherently demand collaboration. For example, for the many new entrants in the POC space to achieve success, a menu of tests is needed.  Internally managing multiple development programs can be challenging.  Seeking partners to expand content is increasingly common. Similarly, the need for interoperability and access to the full workflow, makes partnerships a cornerstone success in digital pathology.
  • We are also seeing shifts in the nature of partnerships to meet the demands of the current environment. New market entrants such as biopharma and big tech are playing a bigger role. Examples of this shift include the partnership between Invitae (specialty lab) and BioMarin (therapeutics company) to provide access to genetic testing for epilepsy patients in support of therapy initiation. The partnership was so successful that other therapeutics companies joined to form an alliance. with a shared objective of democratizing access to diagnostic tools. The three way partnership between Memorial Sloan Kettering (high value test content), Sophia Genetics (algorithm and software based interpretation and support), and Astrazeneca (commercial channel) is another excellent example of the evolving partnership landscape.


Keys to a Successful Partnerships

Embarking on a partnership is a complex and multifaceted journey that can be challenging to execute. Partnerships often require highly variable, multi-step, and in some cases, multi-year processes that can significantly vary depending on the specific situation.


We have identified five keys to success:

  • Ensure shared vision and top leadership commitment so that all parties involved are aligned and can move forward toward common goals
  • Force open communication (e.g., steering committee and updates) to ensure that the partnership is proceeding as planned and all participants are contributing appropriately
  • Establish measurable milestones against which progress can be measured and to communication can be structured
  • Create relationships as well as plans to manage uncertainty so that any potential challenges and changes along the way are efficiently addressed
  • Assign top performers to project leadership roles to ensure all of the above is optimized


The pandemic left us with an opportunity to capitalize on the heightened awareness and value attributed to diagnostics. In the face of challenges and complexities brought about by the evolving diagnostics market landscape, partnerships have emerged as a critical tool to realize this opportunity. With the proper partnership strategy, diagnostics companies can navigate the complexities of the current environment, overcome market challenges, and continue to foster innovation, thereby transforming challenges into opportunities and driving future success. We encourage you to “think big” about partnerships, considering them at stages of development and commercialization where they historically may not have been considered and considering a wider pool of potential partners.


How Health Advances Can Help

Health Advances has helped leading Diagnostics, Precision Medicine, and Life Sciences Tools and Services companies to optimize their success by leveraging partnerships. To explore how Health Advances can support your organization in its partnership strategies, contact Donna Hochberg, Managing Director at

To learn more about the role of partnerships in the post-COVID era, see the link below to view the full 360Dx presentation.

**The 360Dx webinar was sponsored by MilliporeSigma


The Increasing Importance of Diagnostics Development and Commercialization Partnerships in the Post-COVID Era


Thank you to Peter Origenes, Henry Chan, Julia Strauss, and Nick Cadirov for their assistance.

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