Tag: healthcare and life sciences

Is the Medical Device Industry Prepared for the New EU Medical Device and In Vitro Diagnostic Regulations? | Blog

The EU had planned to implement a new set of regulations – the European Union Medical Device Regulations (EU MDR) in May 2021 and In Vitro Diagnostic Regulations (IVDR) in May 2022 – to establish stringent device controls, improve transparency and product traceability, and strengthen clinical evaluation and post-market surveillance. But a series of overwhelming events has forced EU regulators to shift the MDR implementation from May 2020 to May 2021.

The global COVID-19 pandemic is the primary cause of this deferment. However, constant pushbacks from trade associations have also played a role, as has strong evidence of the industry’s under-preparedness to comply. For example:

  • Under the existing Medical Device Directive (MDD) there are 58 Notified Bodies (NBs) –organizations that have been designated by a member state to assess the conformity of certain products before being placed on the EU market – that cater to the industry. With the new regulations, there will be only 11 NBs with an EU MDR designation and three with an IVDR designation to handle a workload of 500,000 medical device technologies available in the European market
  • Reclassification and up-classification of both existing and new products under the new regulations put considerable financial and administrative strain on small and mid-sized firms
  • Increased complexity in documenting the additional requirements of clinical evaluation and post-marketing surveillance, as the industry moves toward a lifecycle approach, to necessitate proactive monitoring of device performance.

To overcome these challenges, stakeholders across the medical device industry, including medical device manufacturers, contract research organizations (CROs), and service providers, should focus on specific areas.

  • Medical device manufacturers should outline a compliance strategy to adapt to the regulatory reforms. As the regulations also increase the cost and time required to enter the European market, they should also build alternative business plans, with a focus on budgeting resources and redefining product portfolio and market entry strategies to remain competitive. To achieve compliance and build a collaborative and transparent framework, they should also update their legacy systems and embrace cloud-based solutions
  • CROs and service providers can provide strategic support to medical device manufacturers in building a regulatory roadmap and enhancing technological capabilities. Also, the new regulations’ stringent data requirements will increase the focus on data collection and management tools, and data governance and security. Service providers should align their clinical and post-market offerings with EU MDR and IVDR offerings to gain traction. For instance, HCL’s regulatory Center of Excellence (CoE) now provides end-to-end MDR and IVDR compliance services to manufacturers.

The medical device industry is exploring multiple ways to continue to stay relevant in the European market. While some organizations are leveraging the EU MDR and IVDR transitional provisions (MDD and IVDR certificates issued before May 2017, which will remain valid until they expire or May 2024, whichever comes earlier) to extend their market presence, others are building their regulatory capabilities and deploying both internal and external workforces to do so. Cook Medical, for instance, is hiring 20 full-time EU MDR-specific roles and working with over 70 contract-based individuals. Likewise, service providers such as Capgemini and TCS are seeking to hire regulatory specialists.

The launch date’s extension by a year might just provide the much-needed relief and time all stakeholders need to build their capabilities to comply with the new regulations.

For more insights on the impact of EU MDR and IVDR on the medical device industry, please see our recently published viewpoint Regulatory Overhaul of the EU Medical Device Market or contact [email protected], [email protected], or [email protected].

 

The 2020s Will be the Decade of Virtual Clinical Trials | Blog

Virtual clinical trials – wherein trial data is collected through sensors or remote monitoring devices carried by the patient – can deliver many benefits to pharmaceutical companies, including cost savings, better patient recruitment and retention, and improved data quality.

In 2011, Pfizer conducted the first-ever randomized clinical study that managed participants using mobile phones and the internet. Over the next few years, the virtual approach waned because of limited success stories and the considerable upfront capital investment required for sensors and platforms.

However, with recent technological advances, the proliferation of wearables (smartwatch shipments have doubled in the past several years), and the FDA’s urging clinical trial sponsors to keep their research ongoing via telemedicine in the wake of the COVID-19 situation, the clinical trial landscape is ripe for disruption by virtual trials.

Indeed, as a bellwether of growing viability, the first virtual trial conference was conducted in December 2019. During the two-day event, the key discussion points were understanding the decentralized model, regulatory challenges for virtual trials, and ensuring compliance for such trials.

Enter technology companies and Big Tech

To build momentum and drive synergies, pharma companies have started to partner with technology companies to test the virtual trials model. For example, in 2018, Novartis, Sanofi, and UCB individually partnered with Science37, a tech company focused on patient-centric models for clinical research, on patient-friendly clinical trials at home. Boehringer Ingelheim followed suit in 2019.

Numerous startups that address some aspect of virtual trial requirements have emerged. For example, VirTrial, a telehealth platform that allows pharmaceutical companies and Contract Research Organizations (CROs) to create patient-centric trials by replacing some in-person visits with virtual visits, was founded in 2018. Since then, it has ramped up its capabilities and expanded internationally across 31 countries. Also in 2018, IQVIA, a leading CRO, enhanced its portfolio by launching virtual research solutions aimed at patient-centric trial design and execution. And today, numerous companies, including Clinpal, Covance, Medidata, ObvioHealth, PRA Life Sciences, and Transparency Life Sciences, boast their own virtual trial platforms.

Not wanting to be left out of this highly lucrative market, the Big Tech players are also exploring additional opportunities. For example, Apple, Best Buy, and J&J recently collaborated to launch a virtual study to gauge whether the Apple Watch could help reduce a person’s risk of stroke. Apple has also been involved in this space through its ResearchKit, an opensource software tool for medical researchers, doctors, and scientists to collect data on people suffering from diseases. Similarly, Verily, a Google sister company, has teamed up with pharma majors to modernize clinical trials and improve patient engagement and recruitment, and aggregate data from wearable devices.

Technological advances

Of course, much of virtual clinical trials’ success lies in the strength, viability, and rigor of the technologies that support them. The picture below shows the technologic interventions that enable the virtualization of a clinical trial.

Technologies that enable the virtualization of clinical trials

And fortunately, the above technological interventions speed up patient recruitment, improve patient adherence and monitoring, and eliminate data siloes by having a single source of truth in the cloud – ultimately enabling a smooth and virtual experience during a trial.

The road ahead

Delivery model and technological advances and co-innovation among stakeholder organizations have set the stage for trials to transition from traditional to virtual. Technology players are more capable, risk-tolerant, and knowledgeable than before, leading to increased trust and synergies with pharma companies. While pharma companies are resorting to the motto of “fail fast, win cheap,” virtual trials hold great promise to revolutionize the trial landscape. And what better time than now, when the field is ready, and the fruit is ripe?

COVID-19 Highlights Life Sciences’ Need for an Adaptable Supply Chain | Blog

With cases topping one million globally, governments and health care agencies across the world are working to contain the spread of COVID-19 through several safety measures including the complete lockdown of high-risk countries. While this might prove effective in controlling the pandemic, enterprises across multiple industries are struggling to mitigate its growing impact on the supply chain.

Forced quarantine in manufacturing countries like China has significantly affected major industries including automotive, electronics, pharmaceuticals, and medical devices and supplies, highlighting the limitations in their existing supply chain models. The impact on the overarching life sciences industry is particularly acute, because it cuts across the entire ecosystem, and could potentially enable the spread of COVID-19 due to the diminishing supply of active pharmaceutical ingredients and medical supplies such as masks and hand sanitizers from the key supplier, China.

Despite acknowledging the risks of a single sourcing strategy, many organizations in the life sciences industry continue to work with a single supplier in low-cost regions like China and India to capitalize on their lower costs for labor and materials. This is risky in and of itself. And it also results in sub-contracting situations that lack transparency into the tier-2 and tier-3 suppliers, which further complicates risk management.

Here are our suggestions for how organizations in the life sciences industry can combat the global supply chain crisis:

  • Move beyond traditional and short-term remedial measures and devise a long-term proactive strategy with risk mitigation measures in place, at least for tier-1 and tier-2 suppliers. For tier-3 suppliers and beyond, at the minimum understand the potential risks involved
  • Establish a robust supplier monitoring system that maps sub-tier dependencies to ensure effective and efficient execution of risk mitigation strategies
  • Invest in infrastructure and technology that ensures transparency across the global supply chain, and next-generation supply chain management software that leverages technologies such as machine learning, artificial intelligence, and data analytics to gain real-time visibility into the supply chain
  • Develop predictive models that account for uncertainties and risk factors to realistically assess supply and demand and modify sourcing strategy as needed. These models can also help in running simulations to better define the associated impact, which in turn can serve as input for building comprehensive risk management programs

Despite the extra costs associated with building a proactive supply chain and qualifying multiple suppliers, doing so allows organizations to rapidly respond in pandemic-like situations, thereby reducing reliance on inventory management. Building an adaptable supply chain model that remains operational under any critical situation is the key to managing sourcing risk and avoiding global supply chain disruptions.

Please share your views on the impact of COVID-19 on the global supply chain with us at [email protected], [email protected], and [email protected].

 

Dassault Systèmes Acquires Medidata to Ride the Platform Wave in Life Sciences | Blog

When news first hit in late April 2019 of speculation around Medidata Solutions being acquired by Dassault Systèmes – a France-based software company that develops 3D design, 3D digital mock-up, and product lifecycle management software – Medidata’s stock value went soaring. The deal immediately made sense. The fact that Dassault Systèmes was looking to ramp up its offerings for life sciences companies made Medidata, which we recently recognized as a Leader and Star Performer in our PEAK Matrix™ for Clinical Trials Products 2019, an attractive acquisition prospect.

 

Everest Group Life Sciences Clinical Trials Products PEAK Matrix Assessment 2019

 

Fast forward to June 2019 and the deal is done. The all-cash transaction is valued at US$5.8 billion and represents Dassault Systèmes’ largest acquisition to date. It will finance the deal with a €1 billion loan, a €3 billion bridge-to-loan facility, and available cash. It’s the first time the French company has resorted to external funding, which only accentuates how much it prizes Medidata as an asset.

The strategic intent behind the deal

Dassault Systèmes began focusing on the life sciences market a few years ago with the vision to improve the penetration of digital technologies in the industry. Its last life sciences-focused acquisition was that of Accelrys in 2014, which helped Dassault Systèmes establish BIOVIA, its brand for biological, chemical, and materials modeling and simulation, research, and open collaborative discovery.

With the acquisition of Medidata Solutions, Dassault Systèmes makes a statement that it is serious about achieving this vision. The acquisition will make life sciences Dassault Systèmes’ second largest industry focus, after transportation and mobility. Medidata grew at a CAGR of 17 percent during 2015-2018, driven by its dominance in electronic data capture through its flagship product, Rave.

Dassault Systèmes prides itself on its 3DEXPERIENCE platform, which is meant to enhance digital collaboration in complex sectors like aerospace, infrastructure, and mobility. Dassault Systèmes now looks to extend these benefits to life sciences. By adding Medidata’s clinical and commercial offerings to its own 3D experience expertise, Dassault Systèmes aims to create a platform that offers complete digital continuity to the life sciences industry, addressing complex challenges such as personalized medicine and patient-centric experiences.

Unpacking the companies’ synergies

Synergy area

Dassault Systèmes

Medidata Solutions

Value proposition

 

Design, modeling, and visualization software, with leading capabilities for the aerospace, defense, and consumer goods industries. Dassault Systèmes now aims to bolster its life sciences division

 

Life sciences clinical and commercial software pure-play, with deep domain expertise and strong consulting pedigree

Coverage of the life sciences value chain

 

Drug discovery, manufacturing, and supply chain Clinical and commercial operations

Key technology offerings

Design, modeling, simulation, and virtualization software Data capture, real world evidence, advanced analytics, AI-driven insights, and operations management

Customers

Customers are mostly in the aerospace, defense, and consumer goods industries

Sizable number of European life sciences clients, including medical devices firms such as Medtronic, FEops, Novo Nordisk, and Kavo Dental

1,300 life sciences companies, three quarters of which are in America. This includes most of the Big Pharma and CRO firms

Product coverage across the value chain

Product coverage across the value chain

Key opportunities

Dassault Systèmes is sitting on a lot of cash. This will give Medidata the financial muscle it needs to make the right investments in talent and technology to compete with the big players like Oracle Health Sciences and Accenture.

The integration of capabilities could lead to the creation of a unique end-to-end platform for life sciences across the entire value chain. Medidata has clinical and commercial capabilities, and Dassault Systèmes has offerings for drug discovery, manufacturing, and supply chain.

Potential risks

It’s not clear how the integration of Medidata’s products with the broader 3DEXPERIENCE platform will take place. It could be a challenge linking Medidata’s clinical trials and commercial operations solutions with Dassault Systèmes’ design and visualization offerings.

Dassault Systèmes’ has diversified offerings across several industries. In the long run, this may dilute Medidata’s brand image as a leader and focused player for clinical trials technology.

Closing thoughts

The life sciences industry needs aggressive digitalization to realize efficiency gains and reduce the lengthy timelines between drug conceptualization and drugs reaching the market. We’ve seen technology vendors coming up with integrated solutions for clinical trials to help enhance trial efficiency. While the need for a platform is evident, technical debt and change management issues hinder this platform-centric vision. This is a high growth market, which is likely to attract more interest in the coming 18-24 months. More SaaS companies will need to pivot to the platform conversation to scale and remain relevant. We will be tracking this space closely.

The Rise of BigTech in Healthcare | Blog

A couple of weeks ago, my colleague and partner-in-crime, Abhishek Singh recapped his experience at HIMSS 2019, healthcare IT’s annual jamboree.

Now, I want to expand on one of them – how BigTech firms are homing in on healthcare (got to love almost-alliteration). Here are my key observations on how different BigTech firms are approaching the business of healthcare, based on what I saw and heard at HIMSS.

Google

The focus for the Mountain View-based company has been to develop a secure and compliant cloud platform, which has tools unique to the healthcare industry. It claims that the Google Cloud Healthcare API has significant momentum in the industry to really bring silos of data together. It has enabled FHIR integration as well. The general release of the platform is still sometime away though. On a lighter note, while Google is using AI to solve complex and messy problems in a range of industries, its HIMSS booth had a demo to help address the much dreaded fax plague in healthcare, allowing users to fax medical information to Google Drive, the company’s cloud storage service (as someone on Twitter pointed out), following Eric Schmidt’s observation that healthcare is still in the “stone age.”

Microsoft

The company, reinvigorated under Nadella’s leadership, is taking a smart approach to healthcare across two levers:

  • Utilizing broader technology bets with healthcare-specific use cases. It launched a service to help healthcare firms move large sets of patient data to its cloud (Azure) and connect with other systems. This is one of several attempts to connect patient health records in the cloud. It announced the availability of its healthcare chatbot in the Azure marketplace, as well as the launch of an API for FHIR in Azure
  • Leveraging a partner ecosystem. Microsoft is taking an ecosystem-based approach to accelerate healthcare adoption, using partners such as CitiusTech, DXC Technology, and Philips, to develop more cases on its technology offerings.

Oracle Health Sciences

Oracle is taking a dual approach – doubling down on a focused play in healthcare data and analytics, as well connecting with its life sciences focus – as the ecosystem converges. It announced integration between Quorum’s institutional review board (IRB) and goBalto, its recent acquisition focused on clinical trial site selection and activation. And it introduced Connected Care, a telehealth and remote patient monitoring tool initially aimed at improving stroke outcomes. Its other big focus was on Oracle ERP Cloud as the single stop solution to help unify a health system’s enterprise systems (HR, financial, supply chain) on an integrated platform.

Salesforce

Salesforce has bet big on verticalizing its CRM strengths to help deliver personalized patient experiences (CRM as the gateway to digital transformation.) It already has a bunch of use cases across the care lifecycle. Its focus is now on leveraging a partner network and adding more healthcare-centric functionality to its core set of products. For instance, it launched a feature to add social determinants of health information to patient profiles to improve outcomes. It also announced Fairview Health Services as a client deploying Health Cloud, Marketing Cloud, Heroku, and MuleSoft to centralize and manage patient touchpoints. Building from its progress at HIMSS18, where it collaborated with Cerner, Salesforce also announced new healthcare solutions using Health Cloud, built by consulting partners such as Accenture, Deloitte Consulting LLP’s Deloitte Digital, Huron, IQVIA, Silverline, Simplus and Torrent Consulting.

Uber and Lyft

Both ride sharing companies had a presence on the exhibition floor, and Lyft made a major splash and co-sponsored the opening reception as well. The common use cases they’re both addressing are around social determinants of health. An example is Lyft’s partnership with Allscripts (Lyft Concierge) to help patients get to appointments and lead healthier lives.

Ever since Amazon formally announced its move to shake things up in healthcare, the industry has been abuzz with an equal mix of anticipation and trepidation. While many are fixated on the idea that Amazon will take a Customer Experience (CX) route to healthcare, similar to its ecommerce disruption, I think this belief is misplaced. Why?

As we noted in our earlier analysis, Amazon is best placed to solve more messy problems in healthcare. Not many people realize how Amazon is already playing a role in reshaping healthcare’s supply issues. For instance, more than half of the products available on the Amazon Business platform are medical commodities such as syringes, IV bags, forceps, etc. It is targeting healthcare organization’s tail spend (typically 20 percent), which is focused on purchasing, pricing, suppliers, etc. This plays into its deep strengths in warehousing, distribution, and logistics.

At the end of the day, Amazon is just one of the growing number of technology companies looking to tap into the $3.4 trillion U.S. healthcare market. If HIMSS19 was any indication, BigTech is only going to accelerate its focus on solving key issues, with an ecosystem-driven approach. My bet for HIMSS20 is for someone showcasing curated Netflix content for improving mental health. One can always dream!

Three Digital Healthcare Takeaways from HIMSS 2019 | Blog

I experienced three pleasant surprises at last week’s Healthcare Information and Management System Society (HIMSS) conference. They were all about a perfect storm that is building to correct all that has been wrong in the digital healthcare space all these years.

Healthcare Companies are Exploring Cures for Their #DigitalHeadache

Payers and providers alike are growing increasingly disillusioned with the outcomes of their digital programs. In fact, 78 percent of the healthcare leaders we surveyed in late 2018 indicated some sort of failure with their digital initiatives, whether big or small. The good news here is that most forward-thinking leaders are going back to the drawing board to redefine their digital strategy. Anthem, Intermountain Healthcare, and New York Presbyterian are great examples of organizations that have taken up the cudgels to fix digital healthcare where it fails – organization and culture.

There’s Increased Focus on “Enabling” the Patient Experience

To make the “patient experience” successful, enterprise leaders are taking a step back and focusing their attention on creating experiences for their workforce, clinicians, and partners (e.g., physician group, CMS, government agencies.) Don’t get me wrong, patients still need to be at the center of our universe. However, the personas that enable and deliver experience for patients need a fix first.

Innovation is Coming from Unexpected Sources

It was heartening to see the likes of Amazon, Google, Microsoft, and Salesforce steal the march from the big boys in the healthcare tech space – i.e., Cerner and EPIC – in asserting themselves as the technology visionaries in healthcare. Their focus on healthcare microservices is a relief for healthcare executives trying to navigate the “all or nothing” approach of the EMRs.

There is one player that seems keen on reinventing itself: Optum. Through a nimble product and services strategy, Optum is touching upon on all the hot buttons – MLR, analytics, PBM, and claims. Optum is the specialist vendor to watch out for when it comes to healthcare.

Last, but not least, what really took the cake were the innovative and exciting POCs related to clinical AI and visualization that Israel and Ireland – yes, the countries – showcased in their booths. These were some of the most fully baked solutions that I have seen in my 10 years attending HIMSS.

Hence, it’s with good reason that I left fairly impressed with the developing ecosystem knocking on the doors of healthcare organizations that are hungry for outcomes.

I will sign off by sharing an illustration from our recent study that analyzed the investments 27 of the leading healthcare payers and providers have made in artificial intelligence (AI), a key marker in the world of digital healthcare. This study objectively analyzed these investments from the perspective of ROI achieved.

Assessing 27 healthcare players (payers and providers) on their Artificial Intelligence investments

As you can see, there is a wide variance even within such a small sample set of healthcare organizations. FOMO (Fear Of Missing Out) pushed a lot of organizations to invest in the flashy new toy called AI. However, not all of them embarked on their investment journey by first enabling the core components of capability.

The difference between the best and the rest in healthcare is simply this: the ones to get the best ROI – those on the top right – are taking their journey through step functions that enable not only technology but also an organizational culture of innovation.

Please contact me at [email protected] if you’d like to hear more about my take-aways from the HIMMS conference or our study, named “Dr. Robot Will See You Now: Unpacking the State of Artificial Intelligence in Healthcare – 2019.”

 

Telematics in Insurance – A Big Opportunity yet to be Fully Explored | Sherpas in Blue Shirts

Price competition used to define the competitive dynamics of the P&C insurance industry. However, as margins started squeezing with low interest rates and rising claims costs, it became imperative for insurers to focus on product differentiation in order to attract new customers and drive premium growth.

This is when usage-based insurance (UBI), an insurance product model where the premium varies according to the risk of claims that the insured’s policy-related behavior poses, started gaining traction. UBI is noteworthy as it offers a remarkable opportunity for insurers to deliver hyper-personalization and evolve from a product-centric to a customer-centric business mindset.

To date, the auto insurance segment has been the most aggressive adopter of the UBI model, which is enabled by the underlying telematics infrastructure. Telematics technology enables insurers to capture each customer’s driving data, which is then used to continually update the customer’s risk profile and compute the payable premium. Data collection devices have evolved from black-box to OBD-II dongles to in-built telematics units in automobiles and smartphones.

UBI’s Business Case is Strong; however, Sourcing Gets Complicated for Insurers

We expect the market for UBI to grow substantially at a CAGR of ~40 percent during 2018-2020, with an estimated 35-40 million UBI policies in force by the end of 2020. This is certainly impressive growth.

However, to launch UBI products, insurers must make substantial investments in connected devices and data infrastructure. Moreover, not all insurers have the scale, risk-appetite, investable capital, or technology expertise to make significant inroads into UBI. Thus, insurers are leveraging third-party vendors to support their telematics journey.

Yet, the vendor ecosystem is fragmented, making it challenging for insurers to determine what organization to partner with.

Here’s the breakdown of the three major categories of telematics vendors:

Telematics Service Providers (TSPs)

These have the capability to manage the entire value-chain, from telematics device sourcing to device deployment and maintenance to end-customer engagement to telematics data management. However, as a single TSP might not be able to provide access to all the underlying connected devices, insurers must pre-strategize their requirements for data depth and breadth. There have been cases where insurers have entered into partnerships with multiple vendors with varying competency to leverage connected devices and technology maturity.

Data exchanges

The core value proposition of this class of vendors lies in their access to huge volume of data and their data handling capabilities, which reduces the burden of data management at the insurer’s end. Players that have entered this market also have developed a modest understanding of the insurance sector, which enables them to provide risk assessment support to insurers. However, while data exchanges typically can augment insurers’ telematics journey, they cannot provide end-to-end support.

OEMs

OEMs have emerged as significant competitors to the other classes of vendors due to their direct control of the point-of-sale. As the telematics unit is prebuilt into the automobile, insurers do not have to worry about the entire infrastructure management of telematics devices. However, partnering with an OEM could also mean loss of revenue from value-added services.

Telematics in Insurance – A Big Opportunity yet to be Fully Explored - potential impact

Service Providers as the Orchestrator – Big Opportunity Waiting to be Capitalized

With each of the categories of vendors specializing in specific parts of the telematics value-chain, insurers face a big challenge in connecting with different parties for different values, and in managing the multi-vendor ecosystem.

This is where IT/BP service providers can enter the picture. To date, they have failed to establish a competitive differentiation for themselves in this market. However, considering they have a sound understanding of insurers’ businesses, operations, and IT systems, they could provide significant value as the orchestrator of this branched ecosystem.

They could look to source the best value from different classes of vendors by tying partnerships with select technology vendors across the ecosystem. Then, they could serve as a specialist to help insurer wrap their operations around telematics technology to drive product differentiation.

In this model, service providers could – potentially – offer an integrated value proposition that would involve: owning the implementation risk; providing value-added services such as risk assessment and customer management support; managing the complexity involved in coordinating with multiple classes of vendors; and assuming responsibility for the risks (e.g., business risk, technology lock-in, etc.) associated with engaging with niche firms.

This could be a win-win-win scenario, for insurers, end-customers, and providers.

How service providers ultimately decide to capitalize on the telematics opportunity remains to be seen. However, they should be cognizant of not frivolously trying to compete where their expertise does not lie, and instead leverage their strengths to make themselves most relev

The Future of Life Sciences Clinical Trials: Take-Aways from Medidata NEXT | Sherpas in Blue Shirts

Now in its 12th year, Medidata NEXT brings together several thousand life sciences professionals across seven global events to discuss the future of clinical trials. Here are my take-aways from the New York City edition, which occurred over two days in late October.

  1. Clinical + commercial data is the future: As the life sciences industry moves toward outcome-led business models, companies can unlock significant value by collapsing the silos between clinical and R&D and sales and marketing. Bringing together commercial and clinical / R&D data allows them to generate more meaningful insights into patient behavior and preferences, and spark the discovery process for newer therapies and approaches. A number of life sciences firms have already begun tapping into this powerful data combination. For example, Medidata earlier this year acquired SHYFT Analytics, the maker of a cloud data analytics platform specifically designed for the pharma and biotech industries. And IQVIA started down this path with the OCE platform after the merger of Quintiles and IMS and subsequent company renaming.
  2. Platforms are becoming mainstream: Everybody’s jumping on the platform bandwagon. Examples include the Accenture-AWS-Merck research platform, ZS’s REVO Analytics, and Medidata’s Intelligent Platform for Life Sciences. The hallmarks of these and other platforms in this space are the combination of products and services in a utility-based construct, where customers can plug in and plug out based on need. Customers at Medidata’s NEXT event voiced a pressing need for technology partners to underwrite the risk of innovation by orchestrating the ecosystem (aka guaranteed outcomes).
  3. Moving from real world data to real world evidence: Life sciences enterprises are starting with low hanging fruit such as EHR-to-EDC integration through various sites to unlock value from data. To truly move the needle from data to evidence, and thereby help life sciences firms navigate outcome-based contracts, ecosystem participants – including enterprises, technology vendors, service providers, data providers, intermediaries/brokers, and patient advocacy groups – need to put more skin in the game and focus on end outcomes, such as patient experience, satisfaction, and clinical/health impact.
  4. CROs Are A-Changing: The CRO market is at an interesting inflection point as the traditional model has a limited runway for growth. The IQVIA model of combining clinical and commercial expertise is a sign of things to come, and CROs are doubling down on technology adoption to navigate this change. Another example is Medidata’s announcement of a five-year agreement with Pharm-Olam to unify operational systems to support study executions on the Medidata Cloud, providing a single, unified view of clinical trials to all stakeholders.
  5. Crowdsourcing clinical trials – are we there yet?: The industry is abuzz about the possibilities resulting from developments that aim to advance patient engagement, such as ePRO and advancements through Apple Watch and ResearchKit. While a crowdsourced clinical trial is some time away, several important steps have already been taken to help bring patients to the center of the clinical trial design and process, and assume greater ownership of their health outcomes. One particularly interesting use case is that, following GSK’s and its partners’ Patient Rheumatoid Arthritis Data (PARADE) study, Apple has obtained FDA clearance (not approval) to investigate the feasibility of using a mobile app to recruit and enroll patients in a study and gain insights about rheumatoid arthritis in a real-world setting.
  6. Accelerating cloud adoption: While life sciences firms have been putting an increasing number of enterprise applications and data on the cloud, they have been hesitant to do so with R&D and clinical data. However, the recently announced Accenture-Merck-AWS research platform signaled a changing wave of initiatives. For example, AWS and Google’s and Microsoft’s cloud platforms were prominently present at Medidata NEXT. We expect these lead steers in the market to accelerate the cloud movement in the life sciences industry.
  7. Partnerships are key to unlocking value in the digital ecosystem: Life sciences firms need to forge closer bonds with payers, providers, patient advocacy groups, etc., to truly bring the vision of a converged ecosystem to life. Several prime examples of this shift have emerged in the past year or so. One is the outcome-based contract struck between Amgen and healthcare services company Harvard Pilgrim for the cholesterol drug Repatha. Another is Medidata’s work with the Biden Cancer Initiative (BCI) community to coordinate a consortium of clients to share IoT data in order to analyze determinants such as quality of life and disease progression.
  8. The pivot to patient-centricity hinges on trust orchestration: While life sciences firms have been trying to become more patient-centric, there’s a sizable trust deficit with their core constituents. In fact, as the following exhibit illustrates, the pharmaceutical industry ranks at the bottom of the perception scale among adults in the U.S., second only to the federal government. As life sciences companies collaborate more closely with payers and providers, the ecosystem needs to reaffirm trust with patients and other stakeholders. Trust assurance is going to be key for the future of a converging healthcare ecosystem. In this context, how life sciences firms coordinate care with payers and providers will be crucial in reinstituting trust with patients and enabling care coordination.

The Future of Life Sciences Clinical Trials Take Aways from Medidata NEXT business sector blog image

The life sciences industry stands at the cusp of change. To truly move towards a patient-centric and outcome-based ecosystem, stakeholders need to collapse the traditional stack, break through silos, and embrace collaboration.

Market stakeholders, including Medidata, have made an interesting set of investments, on a platform of growth, in these areas.

Check back here often to see our analysis of how various life sciences stakeholders are collaborating to coordinate care and assure patient outcomes, ultimately to advance the future of life sciences.

The Digital Health Unicorns Are Proving Their Value | Sherpas in Blue Shirts

In August 2016, Everest Group published an analysis of hot digital health startups that were disrupting the status quo of the industry landscape. It ended becoming a unicorn-spotting analysis…cut to February 2018, and by healthcare and life sciences organizations have acquired three — Flatiron Health, NantHealth, Practice Fusion — and among the top 25 players. While we speak, there are multiple conversations around the others as investor interest peaks.

HC startups Blog

What are the key business reasons behind these three acquisitions?

  • Flatiron Health by Roche: Flatiron Health has an end-to-end cloud-based EHR platform (OncoEMR) exclusive for oncology that curates the evidence-based drug development process. As oncology is one of Roche’s major focus areas, this is extremely valuable for the company while devising cancer drugs. No wonder Roche agreed to a US$1.9 billion acquisition price, in addition to its existing stake in the company. Flatiron Health also has a OncoAnalytics module that leverages big data analytics for better diagnosis and treatment.
  • NantHealth by Allscripts: NantHealth is a cloud-based healthcare firm that aims to improve patient outcomes and personalized treatment. Its proprietary learning system, CLINICS, utilizes machine learning and cognitive computing to provide information for better care delivery, tools and insights for efficient care financing, and wellness management programs for enhanced patient engagement. NantHealth fits well within Allscripts’ ambitious plan to build a healthcare company that drives innovation in patient care and improves evidence-based research in R&D processes.
  • Practice Fusion by Allscripts: Practice Fusion is a web-based cloud EHR platform that also provides patient engagement and practice management assistance. Unlike traditional EHR platforms, Practice Fusion provides a simple and intuitive user interface. Beyond these capabilities, this acquisition also adds ~30,000 ambulatory sites to Allscripts’ client base in the hard-to-crack independent physician practices segment.

What’s working with these healthcare startup acquisitions

Here’s what is common among these recent acquisitions:

  1. Data is the new oil: The real asset is access to critical healthcare data. Companies that convert the data into actionable insights, resulting in better patient care, emerge as clear winners.
  2. Uberization of everything: Healthcare enterprises have struggled with huge fixed investments in EHR platforms, on-premise infrastructure, etc. This has created a deep dent in their profitability numbers. Because Flatiron Health, NantHealth, and PracticeFusion and are cloud-based companies, there are no more fixed costs, everything is demand-based. Clearly, the as-a-service model has become the choice for healthcare firms.
  3. Care – of, by, and for the people: Accelerated R&D cycles, augmented physician capabilities, and improved precision in diagnosis and treatment all ultimately result in improved patient care, enhanced clinical outcomes, and boosted patient engagement. All three of these acquired companies focus on improving at least one of those factors. And they all allow the acquiring companies’ patients to take center stage.

Digital moves from pilot to program

At a broader industry level, these acquisitions mirror the change in sentiment around digital initiatives. Our research shows signs that enterprises are moving beyond proof of concept to proof of value. While digital, as a market, lends itself to smaller deals with focuses on design thinking, first principles problem solving, and business model redesign, we see these initiatives now scaling up.

Digital HC blog
As the digital marketplace matures, investment activity is only going to intensify. While early adopters are reaping rich rewards, valuations and competition for viable targets are likely to skyrocket. It’s clear that healthcare enterprises see significant business value, and are willing to put their money where their mouth is. Stay tuned to this space for more analysis of what’s happening in the healthcare and digital spaces.

IT Services Opportunities with the NHS: Patient Care and Advanced Technologies | Sherpas in Blue Shirts

It should come as no surprise that global services activity in the U.K. has dropped significantly in all sectors in the aftermath of the Brexit referendum. Indeed, according to our Transaction Intelligence database of sourcing deals, in the healthcare space, the U.K.’s National Health Service (NHS) awarded 13 outsourcing deals in 2015, 11 in 2016, but only four in the first half of 2017.

However, our research indicates that the policy of patient-centric care introduced by the National Institute for Health and Care Excellence in 2012 is likely to drive ample long-term opportunities for innovative IT service providers that offer technology enablers.

EG KTFor example, under the NHS’s RightCare initiative, the NHS may look to accelerate the adoption of value-based care. Funding is focused on allocative value (how well assets are distributed to different areas of healthcare), technical value (how well resources are used to achieve valid outcomes), and personalized value (determined by how well an outcome matches patient expectation). Additionally, with increasing demand for telemedicine, NHS trusts will be on the lookout for providers that develop mobile applications aimed at remote healthcare management to support the growing importance of care at home for chronic conditions.

A robust cybersecurity network is equally imperative in the wake of recent instances of data breaches such as the March 2017 WannaCry attack, in which the medical records of 26 million NHS patients were hacked. Service providers can help the NHS protect its IT infrastructure from malicious cyber attacks by offering threat intelligence solutions, threat detection and mitigation applications, Blockchain-powered Electronic Health Records (EHRs), and persona-based security platforms.

While third-party providers can profit from these long-term opportunities, they need to be cognizant of the changing competitor landscape, particularly from tech start-ups that are testing the waters to realize potential demand in the U.K. healthcare sector. For instance, DeepMind, a London-based artificial intelligence start-up, worked with the NHS in 2016 on technology to improve care coordination.

To take advantage of growing consumerism in the U.K. healthcare space – e.g., e-Referral and e-Consult services – we recommend that IT service providers increase their investments in growing technological areas such as security, mobility, analytics, and IoT. But first and foremost, they must offer services that focus on patient care. Doing so would help the NHS avoid a repeat of its failed National Programme for IT, which was aimed at cost savings and efficiency, but was abandoned after nine years at a cost of £10 billion in 2011.

We will continue to watch this space and actively share our thoughts and perspectives. In the meantime, you can stay up-to-date on our latest insights in the healthcare domain through our dedicated research on the Healthcare & Life Sciences sector.

How can we engage?

Please let us know how we can help you on your journey.

Contact Us

"*" indicates required fields

Please review our Privacy Notice and check the box below to consent to the use of Personal Data that you provide.