Question 1

What should I look for when evaluating a contract manufacturing partner for complex capital equipment?

Accepted Answer

Your CM should function as a technical extension of your team — not just a build shop. For complex opto-mechanical, photonic, and electro-mechanical systems, the most important attributes are domain expertise, communication discipline, and a track record with programs of similar complexity. A generalist CM who assembles consumer electronics or high-volume commodity parts is not equipped to handle the tolerances, documentation rigor, or engineering judgment your program requires. Look for a partner who already understands your system — not one who will learn on your dime.

Question 2

How do you assess a CM's communication style before committing to a program?

Accepted Answer

Ask directly how they handle deviations, schedule changes, and scope questions mid-program. At Fixyte, every program has a single point of accountability from kickoff through delivery. You should have direct access to the people making decisions — not a rotating cast of project coordinators. Proactive, honest communication is non-negotiable for us. If something changes, you hear about it from us before it becomes a problem.

Question 3

When is the right time to engage Fixyte?

Accepted Answer

The earlier the better. Ideally, you engage us once you have a defined design package or are approaching production-readiness — but we can also add value earlier in the NPI process through DFM review, tolerance analysis, and manufacturing planning. What we need to scope a program: a representative design package, target volumes, timeline, and acceptance criteria. We don't require a finished, stamped drawing set to start a conversation.

Question 4

Can Fixyte scale with our program as volumes grow?

Accepted Answer

Fixyte is purpose-built for 10–150 units/year. If your program grows within that range, we scale with you — same team, same processes, better efficiency as we learn the build. For programs that grow beyond that range into true high-volume production, we'll have an honest conversation about whether we're still the right partner, or whether a transition plan makes more sense. We won't hold a program that has outgrown us.

Question 5

Is a facility visit possible?

Accepted Answer

Yes, and we encourage it. Walking your build environment and meeting the team is one of the most efficient ways to assess fit. Contact us to schedule a visit alongside an initial program discussion.

Question 6

What types of assembly work does Fixyte perform?

Accepted Answer

Fixyte specializes in the assembly and integration of complex optical, photonic, and electro-mechanical capital equipment. Core capabilities include: Precision opto-mechanical assembly and alignment, Photonic system integration (laser sub-systems, fiber coupling, beam delivery), Multi-component optical system builds, Electro-mechanical assembly and system integration, Sensor and detector integration, Custom alignment fixture design and use, Defense and aerospace sub-system assembly, Prototype, first article, and low-to-mid volume production builds (10–150 units/year). We do not perform PCB/PCBA fabrication, injection molding, or high-volume commodity assembly.

Question 7

How is logistics and delivery handled?

Accepted Answer

Logistics are scoped at the program level and documented in the SOW. Every delivery includes a complete documentation package: build records, inspection data, traceability records, and quality documentation. Packaging and shipping requirements are agreed at kickoff. For repeat production programs, we can maintain inventory of long-lead components and coordinate phased deliveries on your schedule.

Question 8

How do you handle raw material procurement and incoming parts?

Accepted Answer

We manage procurement of program-specific materials and components, including long-lead optical and mechanical components. Supplier selection, lead time risk, and any sole-source dependencies are identified during the Development Phase and documented in the procurement plan before work begins. Customer-supplied materials are accepted, inspected, and tracked within our build documentation.

Question 9

What does Fixyte's quality management approach look like?

Accepted Answer

Every program at Fixyte is executed with a documented quality plan: defined inspection checkpoints, acceptance criteria, and build traceability from component to finished system. We use first-article builds to validate the process before committing to a full production run, and every deviation from spec is documented and resolved — not worked around. We are building toward formal ISO 9001 certification and operate with ISO-aligned practices today.

Question 10

What types of quality control and testing do you perform?

Accepted Answer

Testing and acceptance criteria are defined at the program level and documented in the SOW. Depending on program requirements, this can include: dimensional inspection, functional sub-system testing, system-level integration testing, optical alignment verification, and final acceptance testing against customer-specified performance criteria. Full test records are delivered with every program.

Question 11

How is intellectual property protected?

Accepted Answer

All programs begin with a signed mutual NDA before any technical information is exchanged. Customer designs, drawings, specifications, and process data remain the customer's property. We do not retain or reuse customer IP for any purpose beyond the program it was provided for.

Question 12

What certifications does Fixyte hold or pursue?

Accepted Answer

Fixyte is actively pursuing ISO 9001 certification and operates with ISO-aligned quality practices today. For defense programs, we are ITAR-compliant — all personnel on ITAR-controlled programs are US persons, and we maintain the documentation and access controls required. We are not currently ISO 13485 or AS9100 certified, but operate with practices aligned to both frameworks. For programs where specific certification is required, we're happy to discuss program-specific quality agreements.

Question 13

What is Fixyte's production volume range?

Accepted Answer

10–150 units per year. This is the volume range where generalist contract manufacturers can't provide adequate engineering oversight, and where large design-build firms aren't economically viable. It's also the range most common for complex capital equipment OEMs — instruments, sensors, diagnostic platforms, photonics systems, and defense sub-systems.

Question 14

What does "build-to-print" vs. "engineering partnership" mean at Fixyte?

Accepted Answer

Build-to-print means we execute your program from your design package — drawings, BOMs, specifications — with no design changes unless you request them. Engineering partnership means we engage earlier: reviewing designs for manufacturability, flagging tolerance stack-up risks, and helping plan the NPI process before the first part is ordered. We offer both. Most customers start with a hybrid — bring us a design, and we'll tell you what we see before we commit to building it.

Question 15

What is your typical contract structure and pricing model?

Accepted Answer

Fixed-price milestone-based contracts for well-defined programs. Time-and-materials for programs with incomplete documentation or evolving scope. We do not absorb risk we cannot price. Every contract includes a signed SOW with defined milestones, payment tied to milestone completion, and explicit scope boundaries with a change order process for anything outside them.

Question 16

What is a First Article Build and why does it matter?

Accepted Answer

The First Article Build is Phase 3 of our engagement model. Before committing to a full production run, we build and validate a single unit against your specifications — functional testing, dimensional verification, and documentation review. This protects both parties: it confirms the build process is production-ready before volume commitments are made. Any issues found at first article are far cheaper to resolve than issues found mid-run.

Question 17

What is a Contract Manufacturer (CM)?

Accepted Answer

A contract manufacturer is a third-party company that builds products from a customer's design — the customer owns the design and IP, the CM executes the build. At Fixyte, we specialize in low-to-mid volume contract manufacturing of complex capital equipment: the precision optical, photonic, and electro-mechanical systems that most generalist CMs aren't equipped to handle.

Question 18

What is an OEM?

Accepted Answer

OEM stands for Original Equipment Manufacturer — the company that designs, brands, and sells the end product. Fixyte's customers are OEMs who need a manufacturing partner to build their systems at 10–150 units/year without maintaining a full in-house production operation.

Question 19

What is opto-mechanical assembly?

Accepted Answer

Opto-mechanical assembly is the integration of optical components — lenses, mirrors, prisms, beam splitters, detectors — into precision mechanical structures and housings. Maintaining exact positional tolerances (often sub-micron) is essential to preserving optical performance. It requires specialized tooling, cleanroom protocols, and domain knowledge that generalist CMs typically don't have. It's one of Fixyte's core competencies.

Question 20

What is a Statement of Work (SOW)?

Accepted Answer

The SOW is the governing document for every Fixyte program. It defines scope, deliverables, acceptance criteria, milestone schedule, payment terms, and change order procedures. Nothing starts without a signed SOW — and nothing outside the SOW happens without a change order. This protects both parties and ensures there are no surprises at delivery.

Question 21

What is a Bill of Materials (BOM)?

Accepted Answer

A BOM is the complete list of components, sub-assemblies, and materials required to build a unit — including part numbers, quantities, sourcing information, and approved substitutions. For Fixyte programs, the customer-provided BOM is one of the core inputs to program scoping. We review it for procurement risk, lead time issues, and any sole-source dependencies before committing to a build schedule.

Question 22

What is ITAR?

Accepted Answer

ITAR (International Traffic in Arms Regulations) governs the manufacture, export, and handling of defense-related hardware and technical data. Any CM working on defense programs must be ITAR-compliant. At Fixyte, all personnel on ITAR-controlled programs are US persons, and we maintain the access controls and documentation practices required by DDTC regulations.

Question 23

What is a First Article Inspection (FAI)?

Accepted Answer

A First Article Inspection is a formal verification that the first production unit meets all drawing and specification requirements before the production run proceeds. It includes dimensional inspection, material verification, and functional testing as applicable. At Fixyte, the First Article Build phase produces FAI documentation as a standard deliverable, giving customers a complete record of process validation before volume production begins.

Question 24

What does DFM mean?

Accepted Answer

DFM stands for Design for Manufacturability — the process of reviewing a design to identify features or tolerances that will be difficult or costly to manufacture, and recommending changes before production begins. Fixyte offers DFM review as part of early-stage program engagement. Catching manufacturability issues before parts are ordered is almost always cheaper than discovering them mid-build.

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