Jan 27, 2021

Smart healthcare among Bloomberg's top 100 investment ideas

investments
smart healthcare
cancer treatment
Genomics
Leila Hawkins
3 min
Smart healthcare among Bloomberg's top 100 investment ideas
Bloomberg’s report on the top 100 investments ideas for 2021 includes smart healthcare initiatives and innovative new treatments...

Bloomberg Intelligence (BI) has released its first ever “100 Investment Ideas to Watch for 2021” report, with analysis on the global public companies, credits and market strategies that will significantly develop this year. 

The list is an expansion from BI’s traditional 50 companies to watch that are featured every year in the Bloomberg Businessweek The Year Ahead issue. 

The report highlights companies across an array of industries that are set to grow as the global economy recovers from the Covid-19 pandemic. Within healthcare, themes include smart healthcare, new products, and the post-pandemic recovery. 

Technology transformed healthcare around the globe in 2020, and companies will increase investment in new products and distribution channels this year. The report highlights that digitization is creating new opportunities in pharmacies, health monitoring and insurance, among other areas. Companies to watch include: 

  • Alibaba Health. The Hong Kong-based company focuses primarily on providing internet solutions for the medical and pharmaceutical industry. In 2020 stocks rose by 136% as the pandemic fuelled healthcare spending. It is positioned to dominate online drug sales in China, while the country’s push to separate drug dispensaries from hospitals and improve reimbursements will unlock major potential in a market projected to grow by 30% each year until 2024. 
  • Teladoc. US-based, multinational telemedicine and virtual healthcare company Teladoc has benefited from the widespread adoption of telehealth, and is set to capitalise on these gains. Its $18.5 billion purchase of health-monitoring company Livongo gives it a way to tackle chronic care, for instance for diabetes and hypertension.
  • ZhongAn Insurance. China’s first online-only insurance company offers low cost medical policies that are meeting the increasing demand for healthcare coverage in the country. Its deal with Alibaba to sell its policies put the firm on track for an underwriting profit for the first time since it was founded in 2013. 

Bloomberg’s analysts found the following companies set to launch innovative new products or updates in 2021: 

  • Intercept Pharmaceuticals. Although the FDA recently rejected their treatment for a type of liver inflammation called nonalcoholic steatohepatitis, if approved after resubmission in 2021 it would leave the company well-positioned to carve out a substantial lead in this area, which has high unmet medical need.
  • Illumina. Illumina develops tools for genetic analysis. Its acquisition of cancer diagnostics company Grail and a successful 2021 launch of its Galleri test could make Illumina the clear leader in a multibillion-dollar cancer-screening market, with liquid biopsies or minimally invasive blood tests. 
  • Hutchison China MediTech. This biopharmaceutical company has a growing portfolio of cancer treatments. This has recently included colorectal cancer drug Elunate, along with drugs for neuroendocrine tumors and lung cancer which are set to launch this year. 
  • Seagen. This biotech company focuses on cancer care through antibody-based treatments. There is growing acceptance of this relatively new type of drug, and in 2020 they gained approval for breast and bladder cancer products. This year they are set to receive approval for cervical cancer treatment. 

Additionally Tenet Healthcare Corp, a large US healthcare provider, is mentioned as a firm set to increase profits once the pandemic is under control, thanks to acquiring a portfolio of surgery centres in 2020. 

Commenting on the report, Bloomberg Intelligence’s Chief Equity Strategist Gina Martin Adams said: “As markets look to the fits and starts of the emerging economic recovery and additional stimulus from U.S. policymakers to drive the overall trend, the BI100 offers analysis focused on data and deep industry expertise to identify enduring opportunities for the year ahead. 

“This report serves as a guide to actionable insights in a pivotal year that will change how and where people work, how individuals and companies will be taxed, and which industries will thrive in the post-pandemic economy.”

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Jul 24, 2021

A guide to labelling compliance for medical devices

medicaldevices
Technology
healthcare
Compliance
Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.

Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.

But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it. 

On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.

Putting a plan in place

MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.

Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance.  They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.

When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.

Why labelling in the cloud offers a roadmap forward

Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.

The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.

When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.

A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.  

Future-proof technology

The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.

While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.

Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.

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