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Menu, security, consistency: vendors point to priorities

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July 2018—Chemistry and immunoassay analyzers combined—that’s what is new about the product guide. In years past, the chemistry and immunoassay analyzer product guides were published separately. This year we integrated them and are publishing them in two issues: last month for the low-volume and point-of-care markets and this month for the mid- to high-volume laboratory market. Each company decided on its own in which issue to list its analyzer(s) and used our revised questionnaire to provide us with the detail you will find in our interactive product guide.

CAP TODAY spoke with five of the companies that have analyzers for the mid- to high-volume market. We asked them what we asked a different set of companies in the June issue—about instrument acquisition trends, the concerns they’re hearing from customers, and more. Here is what they told CAP TODAY senior editor Amy Carpenter Aquino. (Abbott Diagnostics’ analyzer is not listed in the product guide because Abbott was in the process of launching a new product line in the U.S. and could not provide details about its analyzer [http://bit.ly/Abbott_Alinity] until it was officially announced, which was after CAP TODAY’s deadline.)

What are two key trends in instrument acquisition?

Joe Amodeo, marketing manager, Atellica Solutions, Siemens Healthineers: We are seeing a longer life cycle for analyzers. Customers used to think about replacing equipment on a consistent five-year basis. That is lengthening to an average life cycle of seven years for a given analyzer, though it remains customer and instrument specific. The reliability of analyzers on the market today is always improving. As long as customers have that reliability and they’re meeting the metrics they’ve assigned themselves, they’d rather reserve those dollars.

Changes to lease classification rules issued by the Financial Accounting Standards Board in 2013 forced labs to account for instrumentation on the balance sheet. That has created an environment in which customers are required to understand any financial implications of acquiring capital if funds are not readily available. That might mean finding new and creative ways to bridge different budget cycles if their specific project isn’t funded in the preferred replacement time period.

Nadav Kaufman, senior director, product management, clinical lab menu, Ortho Clinical Diagnostics: Customers are looking for instruments that truly integrate chemistry and immunoassay diagnostic testing, with or without a track. They’re seeking instruments that allow them to grow in menu and throughput as their laboratory’s needs evolve, without requiring major capital investments like increased footprint or plumbing systems.

We’re also seeing customers enter into longer-term partnerships with vendors based on alignment with that selected vendor’s vision for the future and their capacity for continuous improvement in areas that deliver greater medical value.

Chris Cook, PharmD, senior director, antimicrobial stewardship, BioMérieux: One trend is consolidation of laboratory instruments, which means having a broader menu on the same instrument. Connectivity and analytical solutions tied to the instrument also are becoming more important.

Tamara McCarthy, senior product manager, systems, Binding Site: Approvals take longer and involve more stakeholders, which may be due to hospitals consolidating or becoming part of a larger network. Decisions made at a local level previously may now need to wait for approval from larger organizations.

Information technology departments are more involved now in the labs and health care systems. This is to ensure the safety of protected health information and compliance with HIPAA.

Vahe Ayvazian, U.S. marketing director, Abbott Diagnostics: Labs are looking beyond the instrument and assays at a total solution and how it can optimize their performance as well as add value to the entire health care organization.

We also see a concerted effort to purchase harmonized systems that are highly reliable and easy to use and address fundamental operational needs: broad menus for testing consolidation, scalability for future growth and operational capacity management, efficient footprint for return on investment, error reduction, commonality across system disciplines for ease of use, operational training, and staff optimization.

Which do you see most notably: a desire for one platform family to serve all sites, firm long-term pricing, compatibility with electronic medical record system, adaptability through middleware, ease of ordinary reporting, or menu expansion and development?

Kaufman (Ortho): Having one platform is critical to our customers as health systems become better organized. They’re looking for a one-platform family and consistency across the reagents, values, training, service, and supplies.

We consistently hear that customers are interested in more novel medical content and expanding menus. They are particularly interested in tests that can help the lab play a bigger role in driving a change in how diseases are managed. For example, the NephroCheck test for risk of acute kidney injury allows laboratories to be involved in helping physicians get in front of a complication they were previously unable to predict and manage.

Dr. Cook (BioMérieux): Our customers are most interested in menu expansion and development. We aim to expand our offering through unique, high-value medical solutions like the Vidas procalcitonin, NephroCheck, and Banyan mTBI biomarker tests.

Amodeo (Siemens Healthineers): Labs are increasingly transitioning from buying individual analyzers to purchasing total solutions from a single partner to meet their equipment needs. Total solutions encompass a variety of offerings, including equipment for sample management, a broad menu of assays, IVD analyzers, automation systems, and informatics. Taken together, such total solutions are designed to anticipate and address the existing and emerging needs of laboratories—for example, the staffing crisis and needing to generate greater throughputs at lower total cost of ownership. Laboratory and medical directors also are seeking out “end-to-end” solutions that correlate results across the lab and at the point of care for trustworthy results no matter where the testing is done. This is increasingly important as health systems continue to consolidate.

In the past 12 months, what new concerns are customers and potential customers raising?

McCarthy (Binding Site): There have been a few questions about PAMA and reimbursement. Customers are seeking more efficient testing and analyzers that can drive down costs. IT security questionnaires are becoming more prevalent. Organizations are consolidating, growing, and creating different levels of IT security. We’re seeing all of that go hand in hand.

Amodeo (Siemens Healthineers): IT security concerns and complexities are fairly new. The lab and the vendor have to support data security, risk assessment, and the ability to mitigate cybersecurity attacks. The problem is the average lab employee and vendor representative don’t have the specialized skill set to answer these questions. Trying to align laboratory, IT, and vendor resources can slow down the sales and installation processes. Everyone can do a better job of aligning to determine what security is essential so that hospitals feel comfortable giving access to vendors and connecting instruments to their network. Key stakeholders should continue to create a more robust conversation about cybersecurity.

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