By Dimitar Karaivanov, CEO and co-founder, Kanbanize.
Dimitar Karaivanov
As many know, the pharmaceutical industry is heavily regulated and specialized, with slow drug-development timelines, strict processes and quality requirements, and rigid silos. Without a direct relationship with patients, the industry also struggles to understand customer desires and expectations beyond what clinical data reveals. These constraints might sound utterly incompatible with Agile methods, frameworks and principles, however, Agile in pharma is on the rise.
In short, agility means quickly adapting to changes in the market. This includes external demands such as new regulations that impact drug development, or internal shifts such as new leadership or changes in processes. In the context of a business, an Agile organization is one that has a strong foundation of established core practices and capabilities, with a high degree of flexibility and ability to make timely course adjustments to address change.
In response to seismic shifts in the industry and digital technological advancements, many pharmaceutical companies are reassessing traditional operating models as the need to drive efficiencies, bring new innovation to market and fuel strategic growth initiatives is paramount. Pharmaceutical companies are responding to this shift and using it as an opportunity to establish cost-competitive, outcomes-focused operating models, centered around Agile principles, to drive profitable growth and competitiveness.
There are several frameworks for “going agile,” but one method in particular that has increased in popularity in the pharmaceutical industry is Kanban. As companies embark on their Agile journeys, one of the main principles that makes Kanban appealing is that it can be layered onto pre-existing processes and operations and does not require companies to reinvent what they are already doing.
Moreover, the focus is on incremental, evolutionary change to foster long-term flexibility and continuous improvements. For an industry that has been historically reluctant to change, Kanban is the perfect method for pharmaceutical companies to become agile and adopt a flexible architecture that allows it to scale across the enterprise in a natural and human-centric way.
Benefits of Agile Adoption
The biggest advantage that the Agile philosophy provides to pharmaceutical companies is the flexibility in delivering value in multiple contexts. This industry involves a lot of communication, daily R&D work, and an innovation-oriented mindset. To accelerate innovation, shorten time-to-market and increase operational efficiency, pharmaceutical companies are adopting Agile practices, leading to significant changes in the way they operate.
Reshaped R&D Departments
Disrupting the traditional waterfall-oriented operation model that is hierarchical and organized by siloed teams that are separated by specific areas of expertise, Agile organizations have smaller, integrated teams that include relevant subject experts and different levels of hierarchy.
Creating a team that is “fit for purpose” starts with strategically identifying who must be on the team and defining clear responsibilities and goals. With an Agile method like Kanban, organizations break the rigid silos and form cross-functional working groups to increase organizational agility, transparency and employee engagement.
Further on, the smaller groups are more flexible, so they can iterate faster and accelerate overall operational efficiency.
Faster Decision-Making
Doing away with unneeded hierarchy, and being informed about where projects stand using a visual workflow representation like a Kanban board, teams are empowered to make decisions within their defined scope, helping to remove bottlenecks, avoid miscommunication and improve flow of work.
To accelerate their development times, some pharmaceutical companies introduce daily progress discussions. Others transfer a big part of the decision making to the team meetings, to shorten approval chains and eliminate progress blockers.
As a proof point, by combining these approaches and extending Agile workflow to more than a dozen different departments, in one year, a pharmaceutical company was able to double its R&D capacity without adding new resources.
Increased Collaboration
Moving away from blindly relying on clinical data, companies are gathering new insights and launching continuous improvement initiatives for their products to meet the needs of all stakeholders. In the pharmaceutical industry, Agile encourages a shift toward decentralized innovation across organizational borders, involving a high level of collaboration between external parties and the in-house R&D department in an agile organization. New R&D models, like “Virtualized R&D,” are also on the rise. With virtualized R&D, pharmaceutical companies can access specific expertise while also minimizing the buildup of infrastructure through collaboration with external partners.
Achieving Agile Transformation
Implementing Agile practices in pharmaceutical companies comes with some challenges. Being a research-intensive industry, a lot of the staff tends to be highly specialized and used to sequential and rigid ways of working. Also, the overall company culture leans towards a focus on stability, pre-defined work and strong process orientation.
When introducing Agile methodologies, there are automated software tools that help companies create a stable workflow, enhance communication and visualize different workflows for initial implementation and for long-term success.
In Agile, a widespread method and tool for work visualization is Kanban. Kanban is focused on continuous, small incremental and evolutionary changes to the current process, without disrupting what is already successfully being done. The teams visualize their project workflow and work items on Kanban boards to ensure a high level of transparency and alignment.
By segmenting the boards to match their specific workflow, teams also unhide bottlenecks and easily discover weak spots in the work process. Optimizing those allows them to increase their efficiency and operational capacity.
The Health Care business of LexisNexis Risk Solutions has announced the results of a survey designed to identify provider data governance decision-makers in provider organizations and understand data governance challenges and their impact on operational efficiency.
The survey shows that while provider data integrity is vital for efficient care coordination, the lack of a designated department responsible for this information serves as a barrier to its effective use.
Information on a provider’s location, specialty, contact information and availability is essential for care coordination throughout the healthcare system. Common errors range from unlisted locations and contact details to whether a provider accepts new patients. The COVID-19 crisis has made the need for accurate provider information more apparent as increased patient volumes require intense and well-coordinated care.
The results of the LexisNexis Risk Solutions Health Care survey, conducted in collaboration with Xtelligent Healthcare Media, show the following:
1. 73 percent of survey respondents from various departments reported job roles directly tied to governing provider data. The departments include Information Technology (IT), Information Systems (IS), Electronic Health Records (EHR), Health Information Management, Population Health and Care Coordination.
IT department was the most common owner of this information, cited by 38 percent; followed by IS department, cited by 35 percent; and EHR, cited by 34 percent. Only 18 percent indicated having a dedicated data governance department in charge of provider information.
46 percent of all respondents identified the lack of a single department or role responsible for provider data governance as the major challenge currently facing their organizations.
2. 63 percent of respondents believe that provider data governance helps improve care coordination and 53 percent believe it helps improve data integrity.
3. Lack of resources to support proper data governance was the second biggest challenge organizations face, according to 44 percent of all respondents.
“Ensuring accuracy and integrity of provider data will reduce pressure on providers and promote better patient care during a time when patient intake is guaranteed to increase,” said Josh Schoeller, chief executive officer of LexisNexis Risk Solutions Health Care. “Having accurate, up-to-date provider details across the healthcare enterprise has positive implications for patient care and organizational efficiency, and the results of our survey highlight the urgency of developing a cohesive strategy for provider data governance.”
The survey results are based on over 100 qualified responses from organizations across the industry, including independent hospitals, teaching hospitals, independent physician groups, and federally qualified health centers. The complete survey results report is available for a free download. [Download survey results.]
Maestro Health, a tech-enabled third-party administrator (TPA) for employee health and benefits, released “The Poor Health of America’s Healthcare System,” a whitepaper that examines why Americans are disengaged with and distrustful of the healthcare system.
The findings are based on a survey of more than 1,000 consumers about the difficulties they’ve faced in navigating the healthcare system and making decisions about the quality and cost of their care.
The study found 70% of respondents feel that today’s healthcare system is difficult to navigate, and 39% said they don’t feel they have the support they need when it comes to understanding their healthcare. Without guidance on which services are covered and which providers are in-network, high-quality and cost-effective, people overpay and put their own health at risk.
Employers must take an active role in educating their health plan members about their benefits to instill confidence in navigating the complexities of the healthcare system.
“The healthcare industry is currently under a spotlight with a lot of players looking to disrupt the way we receive and pay for care. To build back trust in our healthcare system, the average American needs to better understand their own health plan, including what is covered and how to best use that coverage,” said Anne Brunson, CCXP, vice president of service operations at Maestro Health. “Navigating that information alone can be daunting, so employers should play an active role in increasing transparency and educating employees, which ultimately drives down employer costs.”
In addition to uncovering feelings of distrust and a lack of understanding, the survey revealed that the high cost of healthcare is causing people to put their health at risk—61% have been more concerned about the medical bill than their health while receiving care. Other key findings from the report include:
55% said they have avoided seeking out care because of cost.
65% don’t understand their medical bills.
31% don’t know how to tell if a provider is in-network.
36% said that virtual access to their providers, via apps and portals, improved their healthcare experience.
“Given the statistics we found in our most recent report, it’s not surprising that many people struggle with their healthcare today. We know there’s room for improvement, and we want to be a leader in driving change in the industry,” said Craig Maloney, CEO at Maestro Health.
“One of our core missions at Maestro Health is to reconnect people with their health and wellbeing by providing optimal support and removing barriers to access. We do this through a unique combination of data, analytics, care management and claims repricing services designed to empower our members with the resources they need to navigate the system and achieve better health outcomes.”
For more information about how Maestro Health works with employers to administer self-funded healthcare plans, please visit: www.maestrohealth.com.
Science 37, the industry leader in decentralized clinical trials, today launched an electronic health record (EHR) integration feature for more than 10,000 health facilities and 280 million U.S. patients.
With this connection, patients using Science 37’s best-in-class technology platform can easily authorize and share their health record in real time to more effortlessly participate in decentralized clinical trials.
“With decentralized or virtual trials, a critical hurdle for patient participation is securely linking their electronic health record to the study site,” says Chris Ceppi, chief product officer at Science 37.
“Traditionally, when a patient authorizes the retrieval of a medical record, it involves sharing paper documentation, multiple emails, and sometimes using physical drives to transport data. By integrating electronic health records directly into the Science 37 technology platform, we’re delivering a seamless experience, enabling patients to instantly authorize retrieval of their personal health information with study teams. The EHR data, collected automatically via secure and standardized APIs, makes it easier, more timely, and improves confidence in data integrity, privacy, and security.”
Science 37 leads the way in conducting decentralized clinical research, underpinned by its premier technology platform, which was designed to optimize the patient experience and high-quality data collection. The technology platform ensures site teams can orchestrate a decentralized study on a single global platform including patient engagement, eSource data capture, full electronic clinical outcomes assessment (eCOA) capabilities and roles-based access for telemedicine.
Built hand-in-hand with investigators, study coordinators, mobile healthcare providers, sponsors, and patients, the Science 37 technology platform ensures the highest level of usability, reliability, and configurability.
“As we see more of the industry adapt to decentralized or virtual research, we consistently invest in strengthening our technology platform and making sure we continue to lead the way,” said Ceppi. “By adding features such as integrated EHR retrieval, we help to deliver on our promise to accelerate clinical research by putting the patient first.”
By Gary Larson, executive vice president and general manager of HIE solutions, eHealth Technologies.
Gary Larson
The Strategic Health Information Collaborative (SHIEC) Annual Conference took place again, this time as a five-week virtual event from August 17 to September 15.
Having come to grips with my lost opportunity to socialize with several hundred of my closest friends and colleagues, the fact that this year’s SHIEC sessions were spaced out over such a long stretch of time provided an interesting opportunity to reflect on the state of affairs in health information exchange (HIE).
In one sense, the 2020 conference resembled previous years – a gathering of largely the same group of industry representatives who eat, sleep and breathe HIE and reinforce among ourselves what we already know to be true.
We already know that our healthcare system will improve only as health information exchange improves. We already know we will never have a truly efficient and effective healthcare system until:
we are able to acquire, validate, and normalize health records from all points of care
we are able to curate and present records in a meaningful way at the point of care
we establish workable standards for interoperability between systems and networks
we remove the barriers to sharing healthcare information
we provide public health services with comprehensive, high quality health data in a timely manner
These are inarguable truths, yet many of us are frustrated with the painstakingly slow progress we seem to make year-upon-year.
Irrespective of loving friends and family, you might feel unheard, lonely, or confused about your internal issues. Even though they will try their best, they might not be able to guide you and help you ease your troubles, and here the counseling experts come to your rescue.
The therapy experts can understand the plethora of imbalanced emotions an individual suffers from and ways to deal with it. The common questions one asks themselves before enrolling for therapy are:
Do I need counseling for my emotions?
Am I weak because I need external help for my emotional understanding?
How to find a competent therapist and psychiatrist near me who can help ease the troubles?
A person, irrespective of their troubles in their daily life, can seek a therapist to deal with a situation they are facing. To break down the confusion associated with therapy, keep reading further to know more about counseling.
How to choose your mental health professional?
Your mental health expert will affect your treatment plan immensely and thus requires alertness on your part while you select one for yourself. It is important to follow some guidelines before you make the final decision. Here is what you should keep in mind before you settle for the one.
In 2011, hc1 was born from the belief that every patient is unique and should be treated that way. When the high-value care movement began, healthcare organizations focused on increasing value through cutting costs, but hc1 knew that sustainable high-value care could only come through improving patient outcomes.
hc1 set about to determine how it could help achieve this goal: Tap into the heartbeat of healthcare—laboratory data. If labs could organize every individual’s information intelligently, they could unlock an unprecedented level of clinical decision support to personalize and improve care for all patients.
Today the hc1 High-Value Care Platform eliminates waste and personalizes care for health systems and diagnostic laboratories nationwide by turning previously static lab data into actionable healthcare insights. Its flagship products, hc1 CRM and hc1 Test Utilization, helped forge a broad set of laboratory and health system partnerships.
Building upon this foundation, in 2018 it introduced a new era of high-value care—precision prescribing—when we invented hc1 Opioid Advisor and hc1 PGx Advisor, which leverage the hc1 platform to optimize medications using targeted pharmacogenetics and medication usage analysis. hc1 PGx Advisor empowers physicians to make personalized prescribing decisions supported by clinical pharmacists with access to holistic patient information, including genetics.
Using the hc1 platform, health systems can improve clinical outcomes and reduce medical spend in these ways:
Helping labs better serve their physicians and patients
Ordering all of the tests (and only the tests) a patient needs to achieve timely, accurate diagnosis and treatment
Identifying the right drugs based on each patient’s unique genetic markers
Prescribing drugs with the lowest risk of therapy failure and adverse side effects based on a patient’s complete pharmacological history and lifestyle
A new initiative launched by Health Level Seven International (HL7) seeks to use its widely recognized data exchange standards to help health care researchers more effectively acquire, exchange and use data in translational and clinical research.
The effort, called Vulcan, intends to use a model for collaboration among diverse stakeholders in the translational and clinical research community to define a common set of standards that can be implemented internationally, built on current agreements to use the HL7 Fast Healthcare Interoperability (FHIR) standard to facilitate data exchange.
“Improving data sharing can bring significant benefits to medical research, which is often a time-intensive and costly process that unnecessarily delays progress in discovering treatments for medical conditions because researchers are unable to share critical information,” said HL7 International CEO Charles Jaffe, M.D., Ph.D. “Project Vulcan aims to develop common solutions to help partners overcome these challenges.”
The initiative is the latest to use HL7’s FHIR Accelerator Program, which seeks to expand the FHIR standard and enhance market adoption through a programmatic approach that diverse stakeholders can use. The Accelerator Program aims to motivate and support market collaborations, seeking to speed the availability of FHIR to tackle important interoperability needs. Project Vulcan represents an ambitious new use of the FHIR Accelerator Program, pulling together a diverse multi-stakeholder group that includes government and regulatory agencies, standards development organizations, academic sites, technology vendors and patients.
With the advent of FHIR there is a clear path to utilize FHIR and other existing standards to execute the interoperable exchange of data for clinical research.
“Using FHIR to assist translational and clinical research is a natural extension for the standard,” said Rob Goodwin, co-chair of Vulcan and Vice President of Pfizer’s Global Product Development Operations Center of Excellence.
“Delivering a new therapy to market now takes 10 to 15 years at an average cost of $2.6 billion,” said Goodwin, who’s also on the TransCelerate Clinical Oversight Committee of TransCelerate BioPharma, a non-profit organization that works across the biopharmaceutical research and development community to improve the delivery of new medicines.
“The most powerful way to make research faster and less expensive is to bridge clinical care and clinical research, while keeping patient safety and compliance in mind,” said Amy (Nordo) Cramer, Vulcan co-chair and Pfizer Global Product Development Strategic Partnerships. Cramer continued, “Vulcan’s contributions in using FHIR to streamline data collection and submission, protocol representation, clinical trial setup and management, and for other data-intensive purposes will be a game changer for clinical research.”
Organizers of Vulcan are encouraging other entities to participate in the effort. More information about Vulcan and the project’s goals can be found on its website, www.hl7.org/vulcan.
