IVD Consulting Services
IVD Consulting Built Around How Diagnostic Programs Actually Succeed
Assay Troubleshooting
Sensitivity, specificity, cross-reactivity, hook effect, reagent stability, and matrix interference problems diagnosed by people who have solved them on real lateral flow programs.
Feasibility & Technical Due Diligence
An honest read on whether a target, reagent set, or assay concept is viable, and what it will take to prove it. Useful for internal go/no-go decisions and investor or acquisition diligence.
Platform & Material Selection
Guidance on format, membrane, label, reagent choices, and supply chain security before you commit, so early decisions do not become late-stage constraints.
Design Transfer Readiness
An assessment of whether an assay developed elsewhere is ready to manufacture, and what must be true before transfer to avoid a failed scale-up.
Manufacturing & QA Assessment
A review of manufacturability, quality system considerations, and production process requirements from a team that operates its own production and quality processes, not a theoretical checklist.
Regulatory Pathway Guidance
Direction on how your regulatory pathway shapes the development program and the documentation it requires, so the regulatory target guides decisions early rather than surprising you late. Covers common pathways such as FDA 510(k), CLIA waiver, and EU IVDR. Specialist regulatory input is coordinated through outside consultants.
We work with biotech startups and university spinouts that need experienced hands without building a full internal team. We support established IVD manufacturers and OEM companies that need specialized input or a second opinion on a stalled program, medical device companies moving into the IVD space, and public health organizations and NGO programs with strict validation and high-volume deployment requirements.
The earlier the right questions get asked, the cheaper they are to answer. Talk to us before a problem becomes a redesign.
Where Programs Stall and How We Help
Five situations we see often, and how we approach each one.
Your assay works in development, but you do not know if it will survive scale-up.
Your regulatory pathway is undefined, and timelines are slipping.
You have hit a sensitivity or specificity wall and cannot find the cause.
You are evaluating vendors or partners but lack the internal expertise to vet them.
You need a design transfer plan before your manufacturing partner starts asking questions you have not answered.
Start with an IVD Consulting Discussion
The first conversation is about understanding your program and where it actually stands. To make it useful, it helps to bring:
- Your current assay format or the platform you are considering
- Your development stage: concept, optimization, validation, or pre-transfer
- Your regulatory target, whether CLIA waiver, US FDA 510(k), EU IVDR, or still undetermined
- Your timeline and resource constraints
- Any prior CDMO or vendor experience relevant to the program
What to Expect from the First Conversation
The first conversation is about understanding your program and where it actually stands. We use it to identify the risks that matter most and agree on a sensible next step.
- A grounded assessment of where your program stands and the risks that matter most
- Alignment of your regulatory target with your development plan
- Identification of the technical issues most likely to cause delay or failure
- A prioritized set of next steps you can act on, with or without us
Frequently Asked Questions
What is IVD consulting?
IVD consulting is expert guidance on developing, validating, and commercializing in vitro diagnostic products. It covers technical problem-solving across the full arc of IVD product development, from feasibility and due diligence through regulatory pathway planning and manufacturing readiness. Specialist regulatory input is coordinated through outside consultants. At Palladium, the guidance comes from a team that develops and manufactures diagnostics directly, so it reflects practical execution rather than advice alone.
How is IVD consulting different from assay development services?
Consulting is guidance and assessment: we help you make better decisions about your program. Development is execution: we run the bench work to build and optimize the assay. Many programs start with a consulting conversation to define the path, then move into development once the direction is clear.
What regulatory pathways can Palladium help with?
We help teams align their development program with their intended regulatory pathway, such as CLIA waiver, OTC (over the counter or direct to consumer), US FDA 510(k), or EU IVDR, so documentation and validation are planned toward the right target from the start. Specialist regulatory work is coordinated through outside consultants.
At what stage should I bring in an IVD consultant?
Earlier is almost always cheaper. Engaging during feasibility or early optimization helps you avoid decisions that later become expensive constraints. That said, IVD consultants are also valuable mid-program when an assay has stalled, a transfer is approaching, or the regulatory landscape has shifted in a way that affects the development plan.
Can consulting lead into development or manufacturing?
Yes. Because Palladium Diagnostics is a CDMO, a consulting engagement can move directly into development and contract manufacturing with the same team, which removes the handoff risk that comes with using separate advisory, development, and manufacturing vendors.
We've Seen Where Diagnostic Programs Stall. We Know How to Get Them Moving.
If your assay has hit a wall, your timeline is slipping, or you just need an experienced read before your next decision, a conversation with our team is the fastest way to find out where you really stand. No obligation, just straight technical guidance from people who build diagnostics.