Sustaining engineering for medical devices

Sustaining engineering for medical devices

While the growth and success of a medical device company may hang on innovation that transforms the marketplace, it is your company's mature products that form the bedrock of your financial future. These products may have lifespans that may stretch over five to 20 years, and so to ensure they stay updated, compliant and cost effective, you need robust sustaining engineering.

Sustaining engineering is the technical support of mature products. It encompasses activities such as obsolescence management, addressing customer complaints, bug fixing and feature enhancements. The process also ensures the continuing regulatory compliance that is imperative to provide for continued use of your company's medical devices.

How sustaining engineering improves your bottom line

Sustaining engineering is becoming increasingly crucial to maintaining profitability in the medical device industry. Historically, companies in this sector have shown an average annual growth of 5 percent and maintained healthy margins between 23 and 25 percent. However, margins are projected to decline to 16 percent by 2020. What is driving this decline?

Buying power has shifted from physician preferences hinging on personal experience in independent clinical settings to larger organizations making choices based on statistical analysis of both the safety and efficacy of procedures. These larger organizations focus on cost-savings, down to fractions of pennies.

Changes in the acceptance of orthopedic devices also illustrate this change. Previously, surgeons dictated purchases. As fewer of these specialists operate independently, their preferences are becoming secondary to those of accountable care organizations that coordinate lower-cost care from hospitals, doctors and associated providers.

Hospital consolidation has also created networks with centralized decision making. Executives and purchasing organizations, rather than individual physicians, influence procurement.

The shift to cost-centric buying decisions offers an advantage to existing devices over newly developed ones. A mature product can more readily accommodate the corporate pressure for the price reductions than a newer introduction, the cost of which must include the recovery of increasing research and development expenses.

The bureaucracy involved in payment systems also plays a role in the selection of your devices. While established devices have existing reimbursement codes, obtaining payment for a novel product is more complicated. Payers will demand data, including clinical evidence and evaluations of care economics, to prove the superiority of your company's new device over one in current use.

Sustaining engineering maximizes the life of an existing device and can also serve to maximize your organization's profits.

Advantages of outsourcing

You want to keep your top innovators focused on the next product which will drive the growth of your company. But they continue to be pulled into sustaining engineering tasks for mature products. One solution to cutting these distractions is the discontinuation of a product, which unfortunately would also result in the loss of future profits the device would generate.

A better answer is to partner with a team that offers the engineering expertise you need. Outsourcing to a qualified provider will aid you not only in keeping your top talent focused on new innovations, but it will also maintain the levels of quality that are critical to preserving the acceptance of your product in restructured markets.

Syncroness delivers

When components go end-of-life, or new functionality for existing products is required, we can aid your company in staying current. When we take on these tasks, your staff will be free to dedicate their time to innovation and development of future products. For more information on Syncroness' sustaining engineering capabilities, visit

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