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Free · 30 minutes · No obligation

Manufacturing Automation Assessment

Bring your production challenge. Walk away with a clear read on scope, fit, and budget.

    Before any equipment is specified. Before any vendor is contacted. Before any budget is approved. That’s when this call happens.

    The Manufacturing Automation Assessment is a free 30-minute call with Reza Bashar. You bring your production challenge. He evaluates your current setup, your volume targets, and your internal engineering resources. You walk away with a clear read on three things most manufacturers spend months trying to figure out on their own.

    What you walk away with

    Are you ready to automate?

    Not every production challenge requires automation. Some need process improvement first. Some need semi-automation at current volume before committing to a full automated line. Reza evaluates where your project actually stands, not where it’s easiest to sell a project.

    Semi or full automation?

    One of the most common mistakes in medical device manufacturing. Companies jump to full automation when semi-automation would serve them better at their current production volume and stage. Full automation on a process that isn’t ready costs more, takes longer to validate, and produces equipment that runs below capacity. See the Semi vs. Full Automation Decision Guide.

    What should you budget?

    Management needs a number before they approve anything. A 30-minute assessment won’t produce a project quote, that comes from a Budgetary URS engagement, but it will give you a defensible ballpark range to take to leadership and a clear picture of what would need to happen before a vendor is contacted.

    What Happens After the Assessment

    Three paths come out of the call. Reza will tell you which one your project is on.

    01

    Budgetary URS Engagement

    $10–25k

    If your project is ready to scope, the next step is a Budgetary URS, a requirements document complete enough to get realistic, comparable vendor quotes. Management gets a real number to approve before procurement begins. If you move forward with a full engagement, the Budgetary URS work carries over.

    02

    Full Equipment Procurement

    $50–250k+

    If your project is already scoped and you’re ready to move into vendor selection and procurement management, the full engagement starts here. MEPSCo manages the complete lifecycle from final URS through IQ/OQ/PQ and knowledge transfer.

    03

    Not the right fit right now

    NO CHARGE

    If your project is still in R&D, if you have a full internal engineering bench, or if the timeline and scope don’t align with MEPSCo’s current capacity, Reza will tell you. No obligation. No pressure.

    The assessment is the right starting point if…

    Any of these describe your situation.

    Management has issued an automation directive and your team isn’t sure where to start
    You’ve received vendor quotes that are wildly different and can’t figure out why
    You’re trying to decide between hiring a full-time automation engineer and bringing in outside help
    Your project is transferring from R&D to manufacturing and needs GAMP documentation support
    You’ve been posting for a senior automation engineer for 60+ days with no qualified applicants
    You’re a CDMO building automation capability to win or retain a client contract
    You have a fixed FDA submission or CDMO contract deadline and need to know if the timeline is realistic

    What the Assessment Is Not

    This is not a sales call. Reza evaluates your situation the same way he’d start any engagement, by asking the right questions first. If MEPSCo isn’t the right fit, he’ll tell you. If you need something other than what MEPSCo provides, he’ll tell you that too.

    The assessment is Step 1 of the 8-step GAMP process, the Customer Requirements interview, delivered as a standalone diagnostic. You get the value of that first step regardless of whether you move forward with a full engagement.

    Reza’s Background

    96+ completed equipment procurement and validation projects. 25 years in medical device manufacturing. A GAMP documentation process built from scratch at Gen-Probe in 2001, refined across every project since.

    Walt Disney Imagineering. Gen-Probe. Hologic. $150M in equipment validated during COVID for a DOD pandemic contract, on time, with no change orders. Named references at Hologic, Philips Medisize, and Kinematic Automation available on request.

    This is the engineer who built the process. Not a consultant who learned it from a course.

    “During the COVID-19 pandemic, Reza’s contributions were nothing short of extraordinary. He played a pivotal role in designing and validating $150 million worth of equipment within a remarkably tight one-year timeframe. His ability to deliver such a monumental task on time and within budget is a testament to his expertise, dedication, and exceptional work ethic.”

    MATT RICHARD · DIRECTOR OF MANUFACTURING, HOLOGIC

    “Reza continually dedicates himself to the task at hand ensuring all projects he undertakes are executed in a timely manner, within budget, meeting expected outcomes and without sacrificing quality on any level.”

    NEIL TENNANT · SALES ACCOUNT EXECUTIVE

    About the Assessment

    Is the Manufacturing Automation Assessment really free?

    Yes. It’s a 30-minute call with no charge and no obligation. Reza evaluates your situation the same way he’d start any engagement, by understanding the production challenge before recommending anything. If MEPSCo isn’t the right fit, he’ll tell you on the call.

    What should I bring to the assessment call?

    The more context you can provide, the more useful the assessment will be. Useful information includes your current production setup and volume, what you’re trying to automate and why, your internal engineering resources and any gaps, any vendor quotes or proposals you’ve already received, and any fixed timeline constraints such as FDA submission dates or CDMO contract deadlines.

    What happens after the assessment?

    Three paths: a Budgetary URS engagement if the project is ready to scope ($10–25k), a full procurement engagement if you’re already past scoping ($50–250k+ depending on scope), or a clear explanation of why MEPSCo isn’t the right fit right now. No pressure in any direction.

    How quickly can MEPSCo start after the assessment?

    Reza runs 3–4 concurrent projects. Start timing depends on current capacity and project scope. The assessment is the right place to discuss timeline fit before either side commits to anything.

    Is the assessment just for manufacturers, or can automation vendors use it too?

    Both. Automation vendors use the assessment to discuss documentation support for projects where their manufacturer customers need GAMP documentation the vendor can’t provide. The starting conversation is the same: what does the project need, and is MEPSCo the right fit?

    Is MEPSCo an automation consulting firm?

    Not in the way that phrase usually gets used. MEPSCo is one engineer, not a firm that assigns staff. People sometimes use “medical device manufacturing consultant” to describe the work, and that’s fair. See Fractional Automation Engineer vs. Automation Consultant for the full distinction.

    96+
    completed projects
    25
    years in medical device
    $150M
    validated for the DOD
    7
    granted patents,
    five jurisdictions

    Email info@mepsco-gamp.com · Phone +1 (619) 843-9373

    Located in San Diego, California. Available nationwide and internationally.