by Steve Moscoe

Despite a murky future for the ACA and raging pandemic, Point B sees opportunities for life sciences in 2021 

The life sciences industry has been both a potential hero and a casualty of the global pandemic. Though attention on science has yielded some short-term benefits, challenges remain as organizations attempt smart and safe business under difficult conditions.   

The year ahead will reveal trends unique to the U.S. healthcare industry, all of which will impact providers, payers, and life sciences organizations. Key trends will include: 

Changes in the Affordable Care Act (ACA) 

The ACA’s impact can be felt throughout the entire healthcare ecosystem. If the ACA is abolished or carved up, millions may be denied care, and providers may be faced with unreimbursed costs for services rendered and pharmaceutical products.  Life sciences companies, whose biopharma related products are becoming increasingly more expensive to develop, will be faced with difficult choices: reduce volumes of treatments available to patients or take significant write-offs by providing those products at a significant reduction in price or at no cost to patients. The impact on the profitability of even the most stable life sciences companies will be significant. 

Care delivery 

The impacts of COVID have accelerated trends that were already nascent in the healthcare patient-focused value chains including: 

  • Clinical trials. The early months of the pandemic interrupted many Phase I-II and especially Phase III clinical trials. While the industry has broadly accelerated development of processes and organizations that support Decentralized Clinical Trials (DCT) and started adoption of Decentralized Clinical Trial Management Systems (dCTMS), trials are still highly dependent on patient enrollment and patient access to care. Therefore, an extended decentralized clinical trial model that relies on an almost local provider network may be appropriate for some trials. While this can improve patient access and engagement, there is still a need for more active clinical trial management by the sponsor and site managers. 
  • Research funding and political priorities. The government’s ability to quickly fund high priority research and development activities has been proven through “Warp Speed” initiatives for COVID vaccine development and production. While a new administration could push for investment in scientific research for life sciences, it may be competing with other initiatives. Life science research that does receive funding will likely be more application-focused on high-probability of success treatments for disease states with larger populations.  The result will be disease advocate organizations competing for reduced government programs.  Venture capital, private equity firms, and foreign investors will likely step in where government has ceased funding – likely driving the cost of certain healthcare even higher, putting more pressure on politicians to control the costs of innovative treatments. 

Priorities for Life Sciences  

Given these concerns, Point B believes life sciences needs to be focused on the following key areas. 

Patient & Provider Experience 

Life sciences can simultaneously address the needs of their customers while reducing cost and burden for patients, providers, and payers. To do that, we recommend focusing on: 

  • Patient & Provider Experience Design. Life sciences can apply lessons from technology and other industries in which the Customer Experience (CX) guides product offerings and delivery. The best treatment options need to be delivered in a way that motivates doctors and patients to seek it out amongst other treatments fighting for attention.   
  • Technology. Telemedicine, including telehealth and remote patient monitoring (RPM), offer ways to monitor and deliver clinical trial and routine health experiences. Though still nascent in its ability to monitor and diagnose multiple aspects of a patient’s vital signs, RPM is rapidly developing.  dCTMS applications for distributed trials are also in different stages of maturity, but are invaluable in improving enrollment, experience, patient compliance, elevating the effectiveness of clinical trial managers, and ensuring better data collection for the sponsors. 

Smart Growth 

Commercialization is a challenge for all life sciences companies. Overcoming regulatory hurdles, predicting market demand, determining launch dates, and navigating global markets for access all require tight coordination across development, production, marketing, sales, and internal regulatory affairs groups, not to mention external entities like CDMOs and government regulatory bodies.  We see the priorities for growth include: 

  • Lean Commercial Launch. Each launch has its own profile set by market demand, supply and manufacturing constraints, capital availability, and many other variables. Knowing what to do and when based on inflection points in the product life cycle takes great skill and agility. Applying lean concepts to existing or new processes can ease launch challenges. 
  • Operational Excellence. Many life sciences companies apply Operational Excellence (OE) concepts to manufacturing or quality related processes but miss opportunities that lie in the supply chain, external networks or technology transfer processes. Applying agile Operations & Process Improvement (OPI) techniques to processes that get products to market quicker and more efficiently can keep them moving during high demand, while conserving resources during periods of low demand. 

Workforce Experience 

We expect that changes in care delivery and provider engagement will continue to evolve after the immediate disruption of COVID-19 has past.  Likewise, buoyed by ever expanding technology capabilities and the efficiency loss inherent in physically moving people and goods over congested infrastructure, we expect shifts in how and where we work and collaborate to accelerate.  At first glance, this workforce experience trend may appear to be a variation of customer experience (CX) focused on employees instead of customers.  While that can be part of the change, this trend includes areas such as the “Lab of the Future.” There are many potential improvements around research and development laboratories, but most are connected to “Human Centered Design.”  Building flexible lab spaces helps scientists reconfigure their research environment to reflect their changing needs.  And designing processes that allow the researchers to focus on their science rather than the lab supply chain or infrastructure or administrative services is key.   

Adaptive Supply for Changing Demand 

A key learning from the pandemic is that supply and demand can spike or crash depending on external events.  A dynamic response to ever-changing events requires: 

  • Predictive Analytics and Adaptive Modeling. Once the organizational culture is in place, analytics tools, including machine learning (ML) and artificial intelligence (AI), can be introduced to permit analysis in traditional areas of supply chains, and more dynamic areas like network modeling 
  • Contract Development and Manufacturing Organizations (CDMO). There are many operational hand-offs and regulatory challenges unique to each organization and product.  Managing this complex network takes life sciences skills and complex program management. 

The Bottom Line 

While these aren’t the only trends facing the industry, these capabilities can serve as investments for when more normal times return. Point B can help get you there.  Please contact us to discuss the opportunities and challenges presented to your organization by these trends.