Industries MEPSCo Serves

MEPSCo works with one category of manufacturer: companies that build a medical device as a final product and sell it into an FDA-regulated market.

That distinction matters. Device-as-a-product companies carry direct FDA exposure on the finished product. Their manufacturing equipment has to be validated to a documented standard. Their GAMP documentation has to hold up to audit. The stakes on every procurement project are compliance stakes — not just operational ones.

MEPSCo doesn’t work with device-as-a-component manufacturers. Different procurement needs, different regulatory exposure, different buying psychology. The expertise here is built specifically around the manufacturers who own the finished product and the FDA relationship that comes with it.

Medical Device Manufacturers

Who they are

Medical device manufacturers building a finished product — a diagnostic instrument, a fill-and-finish assembly, a labeled and validated device — that goes to market under FDA oversight. Past R&D. In or entering production.

The threshold where MEPSCo typically gets called in: manual production is breaking down at the volume where it stops working for that specific product, whether that’s a jump from 1x to 10x output or 50x, or aging automated equipment is creating recurring downtime or compliance exposure, or a product is transferring from R&D into manufacturing and the team doesn’t have the automation procurement experience to run the project.

Named clients in this vertical

Hologic
Philips Medisize
Argonaut Manufacturing Services
SMC Ltd.
MesaLabs
West Pharma
Invivoscribe

What they’re dealing with

Management has issued the automation directive. The internal team looks around and realizes nobody on staff has run a GAMP-compliant equipment procurement project from start to finish. The senior automation engineer who did this work retired or moved on. The junior engineer assigned to the project has never written a URS.

Or: a vendor quote came in at twice the budget. Or: the vendor they hired to build the equipment is issuing change orders. Or: Quality is asking about the validation documentation and there are no good answers.

These aren’t edge cases. They’re the standard conditions under which medical device manufacturers come to MEPSCo.

What MEPSCo delivers

The full equipment procurement lifecycle — CRD through IQ/OQ/PQ and knowledge transfer — run by a fractional automation engineer with 96+ completed projects in medical device manufacturing. The junior engineer takes over sustaining activities when the project ends. The company gets senior-level execution without a senior-level salary on the books between projects.

Diagnostics and IVD Manufacturers

Who they are

In vitro diagnostics companies manufacturing assay systems, reagent kits, diagnostic instruments, and related products for clinical and point-of-care use. Often R&D-origin companies that have cleared regulatory hurdles and are moving into commercial-scale production for the first time.

Case studies in this vertical

What they’re dealing with

IVD manufacturers hit a specific version of the automation wall. The product started in a lab. It scaled through R&D. Now it needs to scale into regulated manufacturing — and manual assembly at research volumes doesn’t translate to a validated production line without an experienced automation engineer managing the transition.

The materials are often non-standard. Foamy reagents. Magnetic particle suspensions. Lyophilized beads. Odd-shaped containers. Standard automation vendors don’t always have experience with these materials and may not disclose that during the quoting process.

The regulatory exposure is real. IVD products regulated under 21 CFR Part 820 require the same GAMP documentation standard as other medical devices. The fact that the product started in R&D doesn’t reduce the validation requirement — it often increases it, because the manufacturing process is being defined at the same time the equipment is being procured.

What MEPSCo delivers

R&D-to-production transfer experience. Non-standard material handling. POP/POC before equipment procurement begins. GAMP documentation built for products that are still being defined as the project runs. 96+ projects includes filling lines, lyophilized bead manufacturing, mag-particle suspension fill, and assembly machines — the equipment types that IVD manufacturers actually run.

CDMOs — Contract Development and Manufacturing Organizations

Who they are

CDMOs that manufacture medical devices and diagnostics under contract for device-as-a-product companies. They may own the manufacturing process without owning the product, or they may be building capability to win contracts they don’t yet have.

Case studies in this vertical

What they’re dealing with

CDMOs face a version of the automation problem that has an additional layer of urgency: the client relationship. A CDMO wins a contract by promising capability. If the automation procurement takes too long or the GAMP documentation doesn’t hold up to the client’s audit — not just FDA’s — the contract is at risk.

Documentation gaps that would be a compliance problem for an internal manufacturer are a contract liability for a CDMO. The client sees the validation records. The client’s quality team audits the CDMO’s processes. The CDMO’s ability to retain and grow the relationship depends on documentation that meets both FDA standards and the client’s standards.

What MEPSCo delivers

Speed and documentation quality. Two custom fill units designed, built, and delivered to a Carlsbad CMO in under two months. GAMP documentation built to FDA standards that also holds up to client audit. Equipment qualified correctly the first time so the CDMO doesn’t spend the first production run cleaning up validation gaps.

A Note on Fit

MEPSCo is built for device-as-a-product companies. If your company manufactures a component that goes into someone else’s device, the procurement needs and regulatory exposure are different. MEPSCo may not be the right fit.

If your project is still in R&D and the product isn’t finalized, the right first step is Proof of Principle or Proof of Concept work — not equipment procurement. MEPSCo can support POP/POC, but committing to a full procurement engagement before the product is defined creates expensive rework.

The Manufacturing Automation Assessment is the right starting point to determine fit before either side commits to anything.

Common Questions

Does MEPSCo work with pharmaceutical manufacturers?

No. MEPSCo’s expertise is built specifically around medical device manufacturing automation. The equipment types, regulatory framework, procurement dynamics, and documentation requirements in medical device manufacturing are distinct from pharmaceutical manufacturing. MEPSCo works with medical device manufacturers, diagnostics and IVD companies, and CDMOs — specifically device-as-a-product companies in FDA-regulated environments.

What is a device-as-a-product company and why does the distinction matter?

A device-as-a-product company manufactures the finished medical device that goes to market — a diagnostic instrument, a fill-and-finish assembly, a labeled and validated device. They carry direct FDA exposure on the finished product. A device-as-a-component manufacturer builds a part that goes into someone else’s product. Different regulatory exposure, different procurement requirements, different documentation standards. MEPSCo is built for device-as-a-product companies.

Does MEPSCo work with early-stage companies that are still in R&D?

Not for full equipment procurement engagements. If the product isn’t finalized, committing to automation procurement creates expensive rework when the product definition changes. MEPSCo can support Proof of Principle and Proof of Concept work for companies at the R&D-to-production transition. A Manufacturing Automation Assessment is the right starting point to determine where a company is in that transition and what support makes sense.

Can MEPSCo support a CDMO that needs to build automation capability to win a new contract?

Yes. CDMOs building capability ahead of a contract need the same GAMP-compliant procurement process as internal manufacturers — and they need it fast enough that the timeline doesn’t cost them the client relationship. MEPSCo has delivered custom automation builds to CDMOs in under two months. Speed and documentation quality aren’t trade-offs in this model.

Does MEPSCo work with IVD manufacturers whose products involve non-standard materials?

Yes. Non-standard materials — foamy reagents, magnetic particle suspensions, lyophilized beads, odd-shaped containers — are a specific area of MEPSCo’s project history. Standard automation vendors sometimes decline these projects or don’t disclose their limitations during the quoting process. MEPSCo has case studies covering foamy reagent fill, mag-particle suspension, and lyophilized bead manufacturing.

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