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High Costs, Low Margins, and Regulatory Hurdles Hinder Pharma’s Adoption of Advanced Manufacturing Technologies

Pharmaceutical manufacturers face financial and regulatory barriers that outweigh the benefits of modernizing their production processes

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By Mike Tracy · · Advanced Manufacturing TechnologiesDrug ProductionDrug ShortageMike Tracy
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Pharmaceutical manufacturers face financial and regulatory barriers that outweigh the benefits of modernizing their production processes

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The ongoing drug shortage crisis in the U.S. underscores a critical need for innovation in pharmaceutical manufacturing. As manufacturing issues, outdated technologies, and geopolitical risks contribute to shortages that impact patient care and elevate healthcare costs, the introduction of Advanced Manufacturing Technologies (AMTs) offers a beacon of hope. AMT technologies promise to enhance quality control and reduce production downtime, yet their adoption in generic drug production remains low despite obvious benefits.

Why is the pharmaceutical industry slow to adopt technologies that could revolutionize drug availability and cost?

Mike Tracy, a C-Level Healthcare Operations Strategist, dives into the complexities of integrating Advanced Manufacturing Technologies in drug production. Mike points out that while AMTs can drastically reduce bottlenecks in drug production, the significant initial investment and stringent regulatory landscape pose substantial hurdles.

“Every AMT has a high startup cost and generic drugs have very razor-thin margins to begin with. We’re not talking about a new drug that’s not already out in the market where you’re going to have a high margin and it makes sense to invest millions,” Tracy explains.

Every AMT has a high startup cost and generic drugs have very razor-thin margins to begin with.
— Mike Tracy, C-Level Healthcare Operations Strategist

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About the author

Mike Tracy
Mike TracyChief Operating Officer at enGen

With a fulfilling history within the healthcare industry, Mike establish thoughtful, metric-based direction for new and improved initiatives, processes, and programs to refresh employee engagement, satisfy customers, and revamp operational efficiencies. By employing effective cost analysis, he identify avenues for appropriate cost reductions without jeopardizing staffing and operation needs. For example, Mike accomplished a 20% reduction in SG&A cost for technology by engineering a standard operating model, automation development, and revising processes in my current position. Alongside expert cost analysis, he ensure all implementations align with company goals and missions while assessing community needs.

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More Healthcare Insights

Denials get a queue, underpayments just look like paid claims

Denials get a queue, underpayments just look like paid claims

Underpayments in healthcare revenue cycle operations lack the visibility of denied claims because they don't trigger alerts or queue workflows. Without dedicated ownership and line-level verification against contract terms, paid claims that fall short of their contractual amount pass through undetected.

  • 01Denial workflows activate on rejection events, but underpayments produce no event, leaving paid claims unverified by default.
  • 02The speaker says many provider groups lack line-level contract intelligence to check each paid line against the applicable terms.
  • 03Payment received and payment checked are separate tasks: one verifies acceptance, the other verifies correctness—and the second often has no assigned owner.

Nov 6, 2026

A zero-paid claim line is not automatically an underpayment

A zero-paid claim line is not automatically an underpayment

A zero payment on a claim line isn't automatically an underpayment; contract terms, particularly packaging rules, determine whether zero is correct. Chasing unsupported findings damages credibility with payers and weakens the position of legitimate disputes, so revenue cycle teams must verify the full contract terms and effective dates before treating any payment difference as a finding.

  • 01When a contract packages add-ons into the primary procedure, the add-on line may legitimately show zero payment because it is folded into the primary procedure reimbursement.
  • 02Pursuing payment differences that lack contract support burns credibility with payers and can weaken the team’s position on later disputes, including valid ones.
  • 03Always verify the complete contract terms, fee schedules, carve-outs, amendments, and the specific version in effect on the date of service before treating a payment variance as a recoverable underpayment.

Nov 6, 2026

A clean, paid, closed claim can still be short of the contract

A clean, paid, closed claim can still be short of the contract

Practices can receive payment on closed, clean claims that still fall short of negotiated contract amounts because billing ends at coding, submission and posting, while no role owns checking whether payer payments match fee schedules. The speaker argues that contract-level payment review is a separate, complementary function that compares closed claims to contract terms and, run continuously, helps surface shortfalls in time to act within timely filing windows.

  • 01Correctly coded and billed healthcare claims can still result in underpayment.
  • 02Practices should review closed-claim payments against contract terms to spot underpayments.
  • 03Discrepancies in claim payments can persist despite adherence to billing protocols.

Nov 6, 2026

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About the Expert

Mike Tracy
Mike Tracy

Chief Operating Officer at enGen

With a fulfilling history within the healthcare industry, Mike establish thoughtful, metric-based direction for new and improved initiatives, processes, and programs to refresh employee engagement, satisfy customers, and revamp operational efficiencies. By employing effective cost analysis, he identify avenues for appropriate cost reductions without jeopardizing staffing and operation needs. For example, Mike accomplished a 20% reduction in SG&A cost for technology by engineering a standard operating model, automation development, and revising processes in my current position. Alongside expert cost analysis, he ensure all implementations align with company goals and missions while assessing community needs.

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