Prepared for lenders, CDCs, and federal agencies to SBA SOP 50 10 8, USDA 7 CFR Part 5001, and conventional underwriting standards. Fiduciary duty runs to the lender and the agency, never the borrower. 4,000+ engagements since 1998 covering $41.2 billion in evaluated project value. So far in 2026: 41 engagements and $1.54 billion evaluated — 17 SBA, 11 USDA.
Manufacturing feasibility joins market demand to production economics. The study establishes demand for the plant's output — contracted, identified, or market-derived — then tests the production model: capacity and utilization ramp, input cost structure, labor availability at the required skill level, and the capital budget against industry benchmarks. Pharmaceutical, nutraceutical, and medical-device plants add FDA registration and quality-system capital, clean-room construction economics, and the validation timeline that delays revenue against the construction loan. Because USDA and SBA reviewers read manufacturing studies against job-creation and rural-impact criteria as well as repayment, the study documents employment, wage levels, and local economic effect to the standard the program requires.
Methodology combines industry production and pricing data, FDA facility and device-class data, RSMeans location-adjusted facility budgets, BLS occupational wage data for the staffing model, and RMA and IBISWorld operating benchmarks. The financial model carries the utilization ramp, input-cost sensitivity, and program coverage tests across the firm's standard stress discipline, with every assumption sourced.
Every Wert-Berater financial model is fully linked with no hardcoded values, so any reviewer can stress any input. Deliverables comprise a complete narrative report and the linked Excel model, with ten-year pro forma, sensitivity analysis at ±5, 10, and 15 percent, interest-rate stress from +0.5 to +3.0 percent, and ratio analysis benchmarked against RMA and IBISWorld data.
SBA engagements are prepared to SOP 50 10 8, including its debt-service-coverage minimums of 1.15x operating and 1.00x global. USDA engagements follow RD Staff Instruction 5001 across the Business & Industry, Community Facilities, REAP, and Value-Added Producer Grant programs. Conventional engagements are built to the lender's stated coverage standard, typically 1.20x. Manufacturing reaches us predominantly through USDA B&I — where rural plant economics and job creation align with program purpose — alongside SBA 504 for owner-occupied facilities and conventional lending; Value-Added Producer Grant studies are prepared to 7 CFR Part 5001 where agricultural producers integrate forward into processing.
The firm's manufacturing and processing record spans USDA B&I and SBA engagements nationwide, including cold-chain, food-system, and industrial projects; manufacturing studies are prepared with the same fully linked financial models and stress discipline as every Wert-Berater engagement. Independence is non-negotiable: determinations follow the evidence and are not revised under pressure, and studies are built to pass lender, agency, and third-party review without exception items.
Screening the industrial market before committing to a full engagement? Manufacturing Market Risk Intelligence is a report prepared by our analysts to a published structure: supply, demand and the operating conditions in one market, with coverage shown before the order is taken. It is a market risk view, not a feasibility determination on your project, and it does not replace the study described on this page.
A feasibility study for this asset class must resolve questions that do not arise in general manufacturing: FDA facility registration class, device classification under 21 CFR, applicable Good Manufacturing Practice regime (21 CFR Part 211 for drug products, Part 820 for medical devices), clean-room ISO classification and the construction premium it carries, and the validation timeline that separates certificate of occupancy from first commercial shipment. Each of those elements affects the capital budget, the draw schedule, the revenue ramp, and ultimately the debt-service coverage the lender is asked to approve. The study integrates all of them into a single, internally consistent financial model rather than treating regulatory compliance as a narrative footnote.
Demand analysis for this asset class begins with the supply side of the market, because the regulatory barrier to entry is high enough that existing licensed capacity is a meaningful constraint on competition. The study inventories FDA establishment registrations and device listings in the relevant product category, cross-referenced against publicly available 510(k) clearance and PMA approval records, to establish how many facilities are currently authorized to produce competing product. Import and export data published by the Census Bureau and the International Trade Administration establish the share of domestic demand currently served by foreign manufacture — a figure that bears directly on the plant's addressable market and on the vulnerability of its revenue to trade-policy shifts.
On the demand side, the study distinguishes among three demand types: contracted volume supported by executed purchase agreements or letters of intent, identified demand from named distribution or group-purchasing-organization relationships that have not yet been contracted, and market-derived demand estimated from industry shipment data, hospital and ambulatory-surgery-center utilization rates, and relevant epidemiological trend data published by the CDC and CMS. Each demand tier carries a different confidence weight in the financial model. Trade-association shipment surveys, GPO formulary data, and CMS reimbursement rate schedules inform the pricing assumption. The competitive-supply analysis documents barriers — registration lead time, clean-room capital, and validation cost — that limit the speed at which new capacity can respond to a demand signal.
Four inputs account for most of the variance in debt-service coverage for this project type. The study isolates each one, sources it explicitly, and stress-tests it across the firm's standard sensitivity discipline so a reviewer can see exactly how much tolerance the project carries before coverage falls below the program minimum.
SBA reviewers applying SOP 50 10 8 to a pharmaceutical or medical device plant are looking first at whether the 1.15x operating and 1.00x global coverage minimums are met at stabilized operations, and second at whether the path to stabilization is credible. The validation timeline is the most common credibility problem: a study that starts revenue at certificate of occupancy rather than at FDA clearance will not survive SBA review. The study must also document that the owner-operator has, or has contracted for, the regulatory and quality-system expertise required to achieve and maintain registration — because a facility that loses its registration loses its revenue.
USDA Business & Industry reviewers apply 7 CFR Part 5001 and weight job creation and wage levels alongside repayment. For rural pharmaceutical and device plants, the study documents permanent full-time equivalent positions, average wages benchmarked against BLS county-level data, and the multiplier effect on local supply-chain employment. REAP eligibility, where applicable to energy systems within the facility, is addressed separately.
Conventional lenders typically require 1.20x coverage and place additional weight on contract certainty: a plant with executed offtake or supply agreements from creditworthy counterparties will receive a materially different underwriting treatment than one relying on market-derived demand projections. The study distinguishes these demand tiers explicitly so the lender can apply its own credit judgment to each layer.
The engagement begins with a fixed fee quoted within one business day of the initial inquiry. The fee does not vary with the study's finding, and no portion of it is contingent on loan approval or project proceeding. That structure is not a policy preference — it is the condition that makes an independent determination meaningful to a lender or agency reviewer who knows that a contingent-fee study has an embedded conflict.
Standard delivery is ten to fifteen business days from the date a complete data room is received. For pharmaceutical and device projects, a complete data room includes the FDA establishment registration or pre-submission correspondence, the facility program (clean-room classification, square footage by use, HVAC and utility specifications), the capital budget with contractor or design-build quotes, the validation protocol or timeline, any executed offtake or supply agreements, and the sponsor's staffing plan with proposed wage rates. Incomplete data rooms extend the timeline; the engagement letter identifies the required documents specifically.
Upon delivery, the bound narrative report and the fully linked Excel model are published to a secure client portal. The financial model recalculates when any input is changed, so a lender's credit officer can run alternative scenarios — a slower utilization ramp, a higher construction contingency, a rate increase — without requesting a revised study. Rush delivery is available where the transaction timeline requires it. The engagement closes with an explicit statement of conditions identifying the regulatory, contractual, and market assumptions on which the feasibility determination depends.
The fee is fixed and quoted within one business day of the initial inquiry. It does not vary with the study's conclusion, and no portion is contingent on loan approval or project outcome. Because scope varies — a single-product device plant differs materially from a multi-suite pharmaceutical facility — the quote is project-specific. Contact the firm with a brief project description to receive a same-day fee indication.
Standard delivery is ten to fifteen business days from receipt of a complete data room. For this asset class, a complete data room includes FDA registration or pre-submission documentation, the facility program with clean-room specifications, a capital budget supported by contractor quotes, the validation timeline, and any executed offtake agreements. Rush delivery is available. An incomplete data room is the most common cause of delay.
The core difficulty is the gap between construction completion and revenue commencement. FDA clearance, equipment qualification, and process validation — IQ, OQ, and PQ — must occur after the facility is built but before commercial shipments begin. That gap extends the interest-carry period and compresses early cash flow. A study that ignores it will not survive agency or lender review. The utilization ramp must be anchored to regulatory milestones, not to the construction schedule.
A single study can be structured to address both SBA SOP 50 10 8 and USDA 7 CFR Part 5001 requirements, because the underlying financial model and market analysis are the same. The coverage tests, job-creation documentation, and wage analysis required by each program are layered into the same deliverable. The engagement letter specifies which program standards apply so the study is built to the correct compliance framework from the outset.
The study distinguishes among three demand tiers: contracted volume supported by executed agreements, identified demand from documented but unsigned relationships, and market-derived demand estimated from industry shipment data, CMS utilization rates, and epidemiological sources. Each tier carries a different confidence weight in the financial model. A plant without contracts is not automatically infeasible, but the study will reflect the higher uncertainty, and coverage must hold under stress at the market-derived tier.
Both. The regulatory analysis — establishment registration class, device classification, applicable GMP regime, and validation timeline — is integrated into the financial model rather than treated as a separate narrative section. Clean-room construction cost, quality-system capital, and the validation period interest carry are all reflected in the capital budget and the revenue ramp. A financial model that does not account for these elements will produce coverage ratios that do not survive lender or agency review.
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Wert-Berater, Inc. is an independent provider of feasibility studies and other related services. The firm does not provide financing or equity investment advice, and does not arrange, broker, or place debt or equity capital of any kind.
All appraisal assignments are performed by Bruce E. Jones, MAI, ASA-GC, BCA, CMEA, a member of the Appraisal Institute since 2006, a staff member of Wert-Berater, Inc. and owner of Special Purpose Realty Valuation.