Value Analysis / Value Engineering (VAVE) is a structured method for raising the value of a medical device by studying what each function costs and removing costs that do not serve a function. Value Engineering applies to designs still in development. Value Analysis applies to products already in production. Both work through function analysis, alternative generation, and controlled change.
What is Value Analysis / Value Engineering (VAVE)?
VAVE treats value as the ratio of function delivered to cost incurred. The method was formalized as function analysis: break a product into the functions it performs, price each one, then ask whether a cheaper path to the same function exists.
In medical devices, the two halves are split by lifecycle position. Value Engineering happens before design freeze, when architecture, material selection, and supplier choice are still open. Value Analysis happens after launch, inside sustaining engineering, where every idea has to clear design change control before it reaches a patient. The second case is harder, and where most device teams operate.
Why Value Analysis / Value Engineering (VAVE) matters in medical device development
Device margins get squeezed from both ends. Component obsolescence forces redesign on a schedule nobody chose, hospital procurement pushes prices down, and EU MDR 2017/745 conformity work adds fixed cost per product line. VAVE is one of the few levers that move unit cost after the design is locked.
The risk sits in the change itself. Swapping a housing resin, a connector, or a contract sterilizer touches biocompatibility, electrical safety, and packaging evidence. Under FDA 21 CFR 807.81(a)(3), a change that could significantly affect safety or effectiveness triggers a new 510(k). In the EU, MDCG 2020-3 Rev.1 governs whether a design change to a legacy device counts as significant under Article 120. A cost reduction that saves two dollars per unit and invalidates a sterilization validation is not a saving.
How the Value Analysis / Value Engineering (VAVE) process works
A disciplined VAVE cycle in a regulated environment runs roughly like this:
- Information gathering. Pull the bill of materials, cost roll-up, DHF, risk file, and field data. Complaints and returns often point to over-specified parts nobody has questioned in years.
- Function analysis. Map each component to the function it performs. Separate basic functions (what the device must do) from secondary ones. Cost that maps to no function is the first target.
- Idea generation. Cross-functional, and it has to include QA/RA from the start. Engineering-only VAVE produces ideas that die at the change board.
- Evaluation and risk screening. Run each candidate against ISO 14971 risk management. Ask what new hazards the change introduces and what existing risk controls it disturbs.
- Regulatory impact assessment. Classify the change: no submission with a memo to file, Special 510(k), or new submission. In Europe, run the MDCG 2020-3 flowcharts for legacy devices or assess the technical documentation impact under MDR.
- Verification and revalidation. Re-run only the tests the change actually invalidates. IEC 60601-1 for a power or enclosure change, ISO 10993 for a patient-contact material change, ISO 11607 for packaging.
- Implementation. Execute through design change control under ISO 13485 clause 7.3.9, with updated design outputs, DMR, and supplier agreements.
Note what governs the whole loop. FDA’s Quality Management System Regulation took effect on February 2, 2026, and incorporates ISO 13485:2016 by reference, so the design change requirements US manufacturers work to are now the ISO clauses rather than the legacy Part 820 subsections.
Common challenges and best practices
Teams usually get the arithmetic right and the sequencing wrong. Three failure patterns recur.
The first is the salami slice. Ten small changes, each individually assessed as non-significant, land inside eighteen months. Regulators evaluate the cumulative effect. Assess changes against the last cleared configuration, not against last month’s.
The second is ignoring the cost of the change itself. A resin swap saving twelve cents per unit can carry six figures of biocompatibility testing and a design transfer. Model the fully loaded cost, including QA/RA hours and validation runs, before the idea reaches a business case.
The third is treating supplier-driven change as free. When a supplier notifies a process change, that is a VAVE decision made outside your quality system. Supplier agreements should require advance notification.
Good practice looks unglamorous: a standing cross-functional review, current function-cost data, and a regulatory impact assessment written before the engineering work starts.
How SJML helps with Value Analysis / Value Engineering (VAVE)
SJML runs VAVE as part of its product lifecycle management practice, alongside sustaining engineering, obsolescence management, and total-cost-of-ownership reduction. Because design, manufacturing, and QARA sit under one roof, cost-reduction candidates get screened for regulatory and revalidation impact before they consume engineering time. Capabilities span BOM review, alternative material and supplier qualification, process validation, and structured change governance intended to keep revalidation burden proportionate to the change. Regulatory sustenance teams handle the technical file and submission-impact side.
Talk to SJML’s engineering team →
Frequently asked questions
Value Engineering is applied during design, before the configuration is frozen and before regulatory submission. Value Analysis is applied to a product already in production and on the market. The analytical method is the same. The constraints differ: post-launch changes must pass design change control, risk reassessment, and a submission-impact decision, so the achievable savings are usually smaller.
It depends on whether the change could significantly affect safety or effectiveness, per 21 CFR 807.81(a)(3). FDA’s guidance on deciding when to submit a 510(k) for a change to an existing device provides flowcharts for labeling, technology, engineering, performance, and materials changes. Many cost-reduction changes are documented in a memo to file. Material and sterilization changes are not frequent.
Every VAVE candidate is a design change, and every design change requires reassessment of the risk file. The question is whether the change introduces a new hazard, modifies an existing risk control, or shifts a residual risk estimate. Changes that touch a risk control identified in the risk management file rarely qualify as low impact, regardless of how small the cost delta looks.
At architecture, not at design freeze. Once the design is locked, most of the unit cost is already committed by material, topology, and supplier decisions. Running function analysis during concept and feasibility captures savings without triggering any revalidation, because there is nothing yet validated to disturb.
Related terms
- Design Change Control
- Sustaining Engineering
- Obsolescence Management
- Design Transfer
- Process Validation
