During verification test to check the specification, input and output from DSD, what is the probability of having to change the budget for additional experiments? Also, how well are the budget change proposals accepted?
I would say having to request a budget change for additional experiments is quite probable. When making design verification tests in response to outputs from a DSD, it is highly unlikely that everything will pass the first time around and results will come up that will force you to consider aspects of the project that were not considered before, just like in the project simulation we had just completed. Using that simulation as an example, the root cause of the failure could have been narrowed down to the adhesive that was used on the label, which may have been an industry standard adhesive. Because it may have been an industry standard, the team may not have considered how it would have after being soaked in a heated water bath. Now, they need to increase the budget in order to buy and test more adhesives to find one that does not peel off at a heated temperature. If the contents and scope of the budget change is reasonable, then it is likely to be accepted with little to no difficulties, however if the budget change is requesting tens of thousands more dollars than the original allocation, then it may require a little more effort to convince the team that is reviewing the budget change request to accept it, if they do not outright deny it.
As @pv223 mentioned I would say that it is extremely probable for a budget change to occur to accommodate for additional testing. In my own personal capstone project we had an initial design which we wanted to use and following testing we had realized that the project would not meet the customer requirements. In order for our client to be satisfied with the product we were required to revamp and change the entire design of the project. When this occurred, additional features were introduced into the project that required additional testing protocols which were not accounted for in the first proposal. Unfortunately, in our situation we were only allotted a specific amount of money for the budget and we were required to reach into our own pockets in order to pay for the additional testing protocol materials. I would imagine that in the industry there would need to be a type of request for additional funds and a presentation would probably be given to the higher level managers for the request. In this case the request could either be accepted or denied. If the request were accepted that would be the best case scenario for the team and all changes could be implemented. If not, then the team would have to adapt and be able to stay within the allotted budget while accomplishing the given task at hand.
During verification testing, it is quite common to encounter unanticipated issues (like adhesive failure in water) that drive budget increases for additional experiments. One way to mitigate this is to incorporate contingency funds into the initial project budget. For example, proactively allocating 10-15% of the total budget for unexpected testing adjustments can reduce friction when additional funds are needed later. Furthermore, leveraging iterative testing cycles allows early detection of design flaws, thereby minimizing cumulative costs. Documenting these test outcomes and budget impacts builds a solid business case for any budget modifications. Additionally, using project management software to track and forecast expenditures strengthens proposals for extra funding. Implementing regular status meetings to update stakeholders on testing progress can also ensure transparency and foster trust, making it easier to secure additional funds if necessary.
The probability of having to change the budget for additional experiments during a verification test depends on several factors,
1) Strict protocols: If the design has to meet strict parameters, variation in input and output can cause repeating the process.
2) Experimental Variability: Certain factors, parameters which were not considered during the blueprint of the planning, can lead to unexpected increase in budget.
3) Contingency planning can address many factors that influence supply chain resilience, including inventory and capacity. There should be some leeway space for additional experiments required. Hence it is preferred to keep a slightly higher margin of funds.
4) Risk Assessment: If past verification tests have failures or required additional validation tests, it's advisable to have additional funds.
Budget change proposals are accepted based on,
1) Proper justification: A properly documented proposal stating the cause of increase in budget makes it easier for acceptance.
2) When it comes to change orders, the project budget can take on three concurrent states:
- Baseline. The original baselined project budget.
- Current. The baseline plus any approved change orders. – the Control Budget
- Pending. The baseline plus any approved change orders plus any proposed change orders that are pending approval.
3) Flexibility: If funding sources allow for adjustments, approval rates are higher.
4) Communication: There should be transparent communication between stakeholders to help manage budget change proposals.
5) Early Engagement with Regulatory Bodies: Initiating conversations with regulatory agencies early in the development process can provide valuable insights and reduce the likelihood of costly redesigns or delays.
A medical device cost breakdown reveals that major cost drivers include design validation, regulatory compliance, and iterative prototyping. By optimizing these stages—particularly through smart prototyping and the use of digital twin technologies—companies can achieve significant savings, potentially reducing expenses by 20-30%.
Individual medical device development phases are closely connected with risks that the individual steps bring about. For example, developing a new medical device is quite costly and risky; its success significantly relies on the application of accurate processes. Product designers and developers attempt to reduce these risks; however, tough competition encourages them to investigate the sources of risks during the medical device development process, which can threaten the medical device development process in terms of price, timing, and quality.
Ref : 1) https://topflightapps.com/ideas/medical-device-development-costs/#5
f we’re running verification tests to check the specs, inputs, and outputs from the DSD, the probability of needing a budget change depends largely on how well the initial planning and risk assessment were conducted. Thorough upfront validation can reduce unexpected costs, but unforeseen issues during testing may still require additional funding.
As for how well budget change proposals are accepted, it often depends on the justification. If the additional tests are essential for meeting compliance or ensuring reliability, they are more likely to be approved. However, if the request appears to stem from insufficient planning, stakeholders may push back. Clear documentation and a strong rationale are key to securing approval for budget adjustments.
References:
- Office of the Under Secretary of Defense for Research and Engineering. Systems Engineering Guidebook.
- University of California, Davis. Preparing a Proposal Budget Handbook.
While I understand the viewpoint that budget changes should be expected in a project plan, if the DSD is well specified, large shifts should not be highly expected. Shifts in budget usually occur for products that unexpectedly fail testing and require additional rounds of testing, or different methods of testing. Additional testing, which will require more financial support, will also occur if additional testing is requested from an authoritative body, whether that be from within the company or externally. With these points in mind, in plain speaking terms, companies do not like to spend money. While financial support and budget shifting may not always be pleasant to the business, it is a necessary expense.
