The popularity of consumer health and fitness wearable technologies (“wearables”) such as the Fitbit and Apple Watch is growing. As individuals are becoming better informed and thus, more empowered to play an active role in managing their health, it is unsurprising that the wearable market is expected to flourish. Health wearables, by definition, are autonomous, non-invasive technologies worn by individuals that are capable of measuring, tracking and storing data on physiological responses.1
While there is still uncertainty as to whether wearables directly contribute to positive behaviour change with regards to lifestyle habits and treatment adherence, they still have the potential to impact healthcare (Figure 2).2 2 By providing a platform that facilitates telemedicine and allows remote and ambulatory monitoring, wearables can significantly improve the provision of healthcare.1,2 1,2
As healthcare systems are becoming more focused on preventative actions, wearables will play an increasing role in patient care. Healthcare professionals (HCPs) and patients are able to access real-time longitudinal health data instantly, therefore, allowing wearables to assist in the management of chronic conditions such as diabetes.1-3 1-3
Wearables can be broadly classified as consumer general wellness device (e.g., health and fitness trackers like the Fitbit and Apple Watch) or regulated medical grade devices.4 4
The U.S. FDA has released a guideline to provide medical and wellness device manufacturers with clarity on the differences between general wellness and regulated medical devices.
In this guideline, general wellness products are categorised as products that are low risk and have an intended use that either:4 4
Wearables that fall into the above categories will not be required to comply with pre-market review and post-market regulatory requirements. Health wearables that are medical grade and pose a higher risk would be regulated by the U.S. FDA.
In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA) as per the Australian regulatory guidelines for medical devices (ARGMD) — which are currently under review — or the In Vitro Diagnostics (IVD) guidance.5,6 5,6 Health wearables, whether as a stand-alone product and for the software contained within, would fall under the definition of a medical device and would be classified according to the risk they pose (Table 1).
Given the technological advancements and innovation, an independent review of medicines and medical device regulation in Australia was conducted and published in March 2015.7 7 With regards to medical device regulation, the panel recommended that:7 7
At CRC, we understand what it takes to bring innovative new technologies to market. Health wearables will undoubtedly play a key role in healthcare, allowing patient and HCPs to work together to improve the diagnosis and management of conditions and diseases. Our expert team are ready to work with you to bring your innovations to those who need them the most.
1. Glaros, C. & Fotiadis, D.I. Wearable devices in healthcare. Intelligent paradigms for healthcare enterprises. Systems thinking. (eds B.G. Silverman, A. Jain, A. Ichalkaranje, & Jain, L.C.) 237-264 (Springer, New York, 2005).
2. Piwek, L., Ellis, D.A., Andrews, S. Joinson, A. The rise of consumer health wearables: Promises and barriers. PLOS Medicine 13, e1001953, doi:10.1371/journal.pmed.1001953 (2016).
3. Georga, E.I., Protopappas, V.C., Bellos, C.V. & Fotiadis, D.I. Wearable systems and mobile applications for diabetes disease management. Health and Technology 4, 101-112 (2014).
4. United States Food and Drug Administration. General wellness: Policy for low-risk devices. Guidance for industry and food and drug administration staff. (Silver Spring, 2016).
5. Therapeutic Goods Administration. Overview of the new regulatory framework for in vitro diagnostic medical devices (IVDs). (Canberra, 2011).
6. Therapeutic Goods Administration. Australian regulatory guidelines for medical devices. (Canberra, 2011).
Better access to healthcare information has raised patients’ expectations leading to them independently garnering an understanding of their condition and managing their own healthcare (Figure 1).1 Healthcare professionals (HCPs), therefore, are now no longer the sole decision-maker when it comes to healthcare choices.1,2 In response to the changing customer base, the biopharmaceutical industry is moving away from product-centric approaches to ones that are patient-centric.
A number of industry trends and patient factors are contributing to this shift from product-centricity to patient-centricity (Figure 1).
Decreased productivity and over-investment in R&D, saturation of large disease states and an increased focus on niche indications where it is difficult to get return on investment are all limiting the impact of product-centric approaches.3
Furthermore, patients are becoming more value-minded due to the rise in out-of-pocket expenses from new but costly health innovations and a growing range of lower-cost generic medicines following a rising number of patent expirations.3,4
Patients are increasingly key to approval and reimbursement decisions as regulatory bodies not only require real-world patient data but are also considering patient preferences and actively seeking patients’ input.1
Figure 1. Drivers shifting the decision-making from HCPs to patients.1,4
The biopharmaceutical industry, therefore, is under increasing pressure to create value to the patient while demonstrating commercial productivity and growth.
It is important to understand what it means to be patient-centric. Patient-centricity can be defined as acknowledgement that the needs of a patient or a distinct patient population — including their physiological, psychological and social needs — are at the core of decision-making.1,5
Increasingly, the industry is integrating patient-centric approaches across all stages of drug development from clinical trials to marketing (Figure 2). In doing so, companies will be able to create more value for patients through solutions that give patients the best possible health outcomes.4
Figure 2. Patient-centricity across all business functions.
Keeping patients at the core of key business functions can give biopharmaceutical companies a competitive edge for strong commercial growth as they develop and deliver meaningful health technologies (Figure 3).
Patient-centricity can inform clinical trial design and assist with patient recruitment and retention thereby driving the development and delivery of new, high-value health innovations.6,7 Furthermore, companies will be able to gain clarity on where their core activities and competencies are and how they align with patients’ needs thus, informing their strategy, decision-making and resource allocation.6
Figure 3. Patient-centric business functions can help drive commercial growth.6,8
Engaging and collaborating with patients and other stakeholders is a key step to acquiring important data on patients’ needs, behaviours, utilisation patterns and health outcomes.4 The amalgamation of this data can provide valuable insight and inform strategies for improving medicine use, increasing uptake and driving commercial growth (Figure 4).
Figure 4. Steps to becoming patient-centric.
When it comes to increasing revenue, productivity and growth there are three broad categories of patients to keep at the core of commercial strategies, those: 8
A white paper published by Kinapse Consulting suggested that significant culture shift would be required for companies to be successful in patient-centricity. This involves shifting their focus from disease to patient segments and providing integrated healthcare spanning the full spectrum of a patient’s needs, however this could prove challenging.4
A more achievable option encompasses multi-faceted strategies (Figure 5) to increase productivity, growth and demonstrate value should be targeted and optimised to HCPs and patients and aim to: 4,8
Figure 5. Patient-centric strategies for increasing product uptake.
At CRC we strive for quality and excellence as our expert team collaborate with our clients to develop innovative, patient-centric medical affairs solutions that will boost commercial productivity and growth. Our competitive advantage coupled with our extensive expertise in medical affairs and strong ties to the biopharmaceutical industry will allow us to reinvigorate your product portfolio, expand access and increase product uptake. We will achieve this through effective and innovative stakeholder engagement and management, medical communication and health education, brand planning and pre-launch and launch strategies.
Interactions between biopharmaceutical companies and healthcare professionals (HCPs) are under increasing scrutiny. New regulations and calls for transparency are making it more difficult for sales representatives to access HCPs.1 1
As the biopharmaceutical industry becomes increasingly patient-centric in their activities, the role of medical affairs is expanding. This has led to a rise in the number of projects initiated and led by medical affairs thus creating a need for field-based medical affairs people who are therapeutic area experts such as medical science liaisons (MSLs). It has been reported that, on average, biopharmaceutical sales representatives spend approximately 2 minutes with HCPs whereas the length of engagement between MSLs and HCPs is around 1 hour.2 2
HCPs benefit from interactions with MSLs
Biopharmaceutical products are becoming more complex due to the development of new technologies such as genomic sequencing. As a result there is an increasing amount of complicated scientific and medical information available.2 2 HCPs, therefore, are demanding more detailed information and educational materials that will help them navigate their way through these new technologies and products.2 2 This is where MSLs are able to provide the most value to HCPs.
As therapy experts, MSLs are able to translate this complex and specialised scientific and medical information into practical insights to improve decision-making, thus delivering value to HCPs and patients. 2 2 Furthermore, MSLs can engage HCPs in high-level discussions that do not simply involve the translation of science but also include the exploration of health outcomes and real-world data.2 2
The dissemination of information and insights through the provision of high-quality educational materials is another way MSLs are able to be of value to KOLs, HCPs, and other stakeholders. 3 3
The value of MSL teams
The role of MSLs extends beyond that of key opinion leader (KOL) relationship management and facilitating the exchange of unbiased scientific information (Figure 1).1,3 1,3 MSLs play a key role in executing medical affairs plans that are in line with the company’s brand plan.
MSLs are able to obtain and share valuable medical insights into patients’ needs and intelligence on competitor products from KOL interactions, scientific conferences and meetings.2,3 2,3 These KOL insights can inform and drive commercial activities and product lifecycle plans. Furthermore, they can be used to help plan and design clinical trials and real world studies, which are increasingly required for demonstrating product value for approvals, reimbursements and access.1,3 1,3
CRC offers a flexible MSL headcount
Our strong expertise in medical affairs across the entire drug development lifecycle allows us to support your product launch by offering flexible and cost-effective MSL resourcing on a per project basis. This allows you to redeploy your resources to where they are needed most. We can leverage off our existing and extensive KOL and stakeholder networks, engage and nurture these relationships, create advocacy and garner valuable insights to help shape and maximise your commercial opportunities. In addition, we can provide innovative medical liaison strategies and assist you with your stakeholder management planning.
Evers, M. et al. Pharma medical affairs 2020 and beyond. (2012)
Groebel, R. Exploring the changing role of modern medical science liaisons. (2015). https://www.veeva.com/wp-content/uploads/2015/09/AR-Changing-Role-of-Medical-FINAL-8.10.15.pdf
Gupta, S. & Nayak, R. An insight into the emerging role of regional medical advisor in the pharmaceutical industry. Perspectives in Clinical Research 4, 186-190 (2013).
Real-world data (RWD) is defined as data derived from a number of sources that are associated with outcomes in a heterogeneous patient population in real-world settings.1,2 Analysis of this data generates real-world evidence that, in turn, can generate meaningful insights into unmet needs, interventional pathways and the clinical and economic impact on patients and healthcare systems (Figure 1).1,3
Figure 1. Real-world data driving meaningful insights for decision-makers.
By providing greater clarity on safety and effectiveness, RWD are able to precisely identify the risk to benefit ratio, efficiently demonstrate product value for economic evaluation and maximise return on investment.1 Hence, it is increasingly sought after by decision-makers across all levels of healthcare, from government to the clinic.
Payers are transitioning from transaction-based, fee-for-service to a risk-shared, value-based pay system.1,4 As a result, payers are increasingly demanding RWD to better manage uncertainty around interventions’ safety and effectiveness for approval and reimbursement decision-making.1
Unfortunately, due to inherent limitations with the study design, data from randomised controlled trials (RCTs) are inadequate for demonstrating an intervention’s long-term safety and effectiveness or its generalisability.
Furthermore, there is an increasing need for additional insights on epidemiology, compliance, adherence and costs in a realistic environment, which cannot be obtained through RCTs but by using a number of RWD sources (Figure 2).
Figure 2. Sources of real-world data.2
Despite the increasing reliance on RWD, challenges and limitations exist that complicate the generation, collection and use of this data (Figure 3).
The amalgamation of RWD from multiple sources presents several issues including gaps and inconsistencies in the data arising from differences in the study design and the methodologies for collection and formatting.1 These inconsistencies can also be attributed to disparities in the regulation of RWD collection, use and communication by the biopharmaceutical and medical devices industry compared to other stakeholders.1
Studies generating RWD are considered less statistically rigorous than RCTs with inadvertent biases.1,2,5 Furthermore, there is a significant amount of diversity between geographies with regards to clinical practice and the quality and detail of the data.2 As a result the RWD sets are complicated and difficult to interpret.1
Traditionally, medical consensus on health technologies and clinical practice is developed based on peer-reviewed publication of RCTs, however this process can be slow.1 As the ability of stakeholders to conduct real-world studies increases so too does the pace at which this RWD is generated and this may exceed the rate at which medical consensus is achieved.1
The cost of generating and maintaining RWD is an important limitation, more so for other stakeholders such as patient and professional groups whose funding is less stable and most likely reliant on government bodies.1 Funding of real-world studies may also be affected by issues and concerns with the security and anonymity of the data generated.1 This has not been helped by recent breaches in privacy that have affected patients’ and healthcare professionals’ confidence thus increased their reluctance to be involved in real-world studies.1,6
Figure 3. Challenges with generating robust and usable RWD.1,2
At CRC we understand RWD and its importance in demonstrating product value for approvals and reimbursements. Using our extensive knowledge of and expertise in the drug development lifecycle and the biopharmaceutical industry we can work with you to strategise, design and manage your clinical trials and real-world studies. We can also assist in patient and HCP recruitment by leveraging our existing key opinion leader networks. We understand that effective communication of RWD is essential and our expert team are ready to help you achieve this goal through innovative and strategic publication planning and management.
With the expansion of medical affairs functions across the entire drug development life cycle, what was a fledgling function has since transformed into a core business operation. However, this transformation has led to significant challenges and pressures faced by medical affairs to demonstrate product value and deliver on performance (Figure 1).
Medical affairs face significant challenges
The regulatory environment is becoming more rigorous with increased collaboration between global regulatory bodies.1,2 As a result, drug approval and reimbursements require companies’ medical affairs to generate increasing amounts of complex, real-world patient outcomes data to demonstrate product value.2,3
The expiration of patents for primary care blockbuster drugs has shifted focus towards specialty drugs.4 This has in turn, led to a reliance on medical affairs to provide an increased depth of knowledge in specialty therapy areas. However, this is stifled somewhat by the decreasing percentage of specialists that are able to be accessed by pharmaceutical company representatives.4
The advent of readily accessible medical information has resulted in the evolution of the stakeholder landscape where new and diverse players such as patients and advocacy groups are now becoming key decision-makers.3 Furthermore, demands for transparency and intensifying public scrutiny adds significantly to the compliance pressures already felt by medical affairs to increase credibility and improve stakeholder engagement.3
Medical affairs play a pivotal role in overcoming barriers to accessing healthcare professionals (HCPs). Moreover, compliance requirements mean medical affairs is responsible for providing HCPs with real-time, unbiased and transparent medical information.4
Ultimately, in such an increasingly challenging environment, the onus is on medical affairs to not only generate high level data but to translate this data into quality insights and programs that address the needs of all stakeholders, from patients and HCPs to payers and government bodies.
Figure 1. Challenges in the pharmaceutical industry and the pressures felt by medical affairs.
The value added in outsourcing
Recent trends show an increase in outsourcing of critical functional activities particularly in medical affairs, such as field-based medical teams, medical information and medical publications.1 Outsourcing medical affairs offers companies a flexible and economic solution to meet the growing demands and challenges facing the business.5 Discipline-specific teams with therapy area expertise can be formed on an ad hoc basis. This allows companies the opportunity to shift their headcounts to key initiatives, driven by the changing dynamics within the company and within the market.5 Companies can therefore increase their economies of scale, increase their strategic capabilities and broaden the value proposition (Figure 2), thereby maximising and sustaining strategic management and profitable growth.
Figure 2. Advantages of outsourcing medical affairs.
The CRC advantage and value proposition
At CRC our team of experts with extensive global and local networks allows us to strategise, plan and execute tailored medical affairs projects to unlock the product value at all stages of the drug development lifecycle. This enables our clients to re-deploy their resources to maximise commercial opportunities, thus expediting market access, increasing efficiencies and economies of scale. Our strong strategic presence in the biopharmaceutical industry, high standards of corporate governance and Medicines Australia membership ensure we achieve our client’s goals to the highest quality and compliance.
1 Otto, R., Santagostino, A. & Schrader, U. Rapid growth in biopharma: Challenges and opportunities. (Stuttgart, 2014).
2 Coopers, P. W. From vision to decision Pharma 2020. (UK, 2012).
3 Evers, M. et al. Pharma medical affairs 2020 and beyond. (2012).
4 Systems, V. Reimagining medical affairs: Creating value as stakeholders, commercial models and therapies evolve. (Pleasanton, 2015).
5 Price, B. Medical affairs outsourcing. (Titusville, 2013).
CRC provides Medical Affairs solutions to the Pharmaceutical industry throughout the Drug Development Life Cycle. Our objective is to maximise the value of therapeutic compounds from pre-launch through to commercialisation and beyond.
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