Why Quality Has Become a Commercial Priority in Medtech

The total cost of quality for medical technology manufacturers could reach between $38.9 billion and $53.7 billion globally each year.

This modelled estimate applies McKinsey & Company’s established medical device quality benchmarks (6.8%-9.4% of sales) to Statista’s projected 2026 global medical devices market of $571.72 billion. It reflects avoidable costs linked to remediation, rejected products, rework, production failures, warranties and major compliance events.

The impact goes beyond the cost of correcting an individual fault. Poor quality can interrupt production, delay product launches, trigger regulatory action and weaken confidence among healthcare providers, patients and investors.

As medical technology expands beyond traditional physical devices, manufacturers are managing connected products, digital diagnostics, software as a medical device and more complex supplier networks. Regulatory expectations are also rising across major markets, particularly around quality systems, post-market surveillance, software, cybersecurity and product lifecycle controls.

This is changing what employers need from their quality teams. Technical and regulatory knowledge remain essential, but companies also need professionals who can work across manufacturing, software, suppliers and post-market data to identify risks before they become expensive business failures.

 

Key insights

• Poor quality could be costing medical device makers $38.9bn to $53.7bn a year, a commercial risk rather than just a compliance one.
• Three big 2025–26 regulatory shifts (US QMSR, EU EUDAMED, GB post-market surveillance) all push quality across the full product lifecycle.
• The fastest-growing risks now sit in software, connected devices, cybersecurity and AI, needing different skills than traditional inspection.
• Most quality hires fail on definition: wrong title focus, over-stuffed requirements, or leaving it until it's urgent.
• Stronger quality maturity is a growth lever worth a modelled $9.1bn to $17.2bn.

 

Poor quality becomes expensive quickly

The cost of a quality failure depends on when it is found.

An issue caught during design may require additional testing or a change to the product specification. The same issue discovered after production has begun can result in scrapped materials, rework, delayed shipments and investigations across several teams. Once the product reaches the market, the consequences can extend to complaints, field corrections, warranty claims and recalls.

Recent research shows how quickly these costs can grow. Lumafield commissioned an independent survey of 210 quality decision-makers across five manufacturing industries in the US and Canada. Among medical device respondents, 28% estimated that scrap represented between 5% and 10% of their total manufacturing costs.

Medical technology products often rely on premium materials, specialist components and tightly controlled production processes. A defect may therefore affect more than the individual product that fails inspection. It can expose a weakness in the design, supplier controls or manufacturing process that needs to be investigated before production can continue.

This is where experienced quality professionals add value. Their role is not simply to record a failure after it happens. They need to identify patterns, determine the underlying cause and work with engineering, manufacturing and suppliers to prevent the same issue from appearing elsewhere.

Companies often begin recruiting only once scrap, CAPA backlogs or supplier failures are already affecting production. By that point, a broadly defined Quality Engineer may not be enough. The business may need someone with specific experience in remediation, root cause investigations, process validation or the manufacturing technology involved.

 

What regulatory changes are affecting medical device quality?

As of July 2026, manufacturers operating internationally are adapting to major changes in US quality systems, EU device registration and Great Britain’s post-market surveillance requirements.

Market	Regulation or system	Effective date	What changed
United States	FDA Quality Management System Regulation	February 2, 2026	The QMSR amended 21 CFR Part 820 and incorporated ISO 13485:2016 by reference. The FDA also replaced its previous Quality System Inspection Technique with an updated inspection approach.
European Union	First four EUDAMED modules	May 28, 2026	Actor Registration, UDI and Device Registration, Notified Bodies and Certificates, and Market Surveillance became mandatory to use.
Great Britain	Medica Devices Post-market surveillance Requirements Regulations 2024	June 16, 2025	SI 2024/1368 introduced clearer requirements for proactive post-market data collection, incident reporting, trend analysis and corrective or preventive action.

The direction is consistent across all three markets, even where the detail differs: regulators now expect manufacturers to demonstrate that quality is actively managed across the full product lifecycle, not just at approval. The US shift is the largest structural change, moving the domestic framework onto the same ISO 13485 basis used internationally. The EU changes make device and certificate data centrally visible for the first time, raising the stakes on data accuracy. Great Britain's reforms sharpen post-market obligations specifically around faster incident reporting and trend analysis.

These changes are also affecting hiring budgets, particularly for manufacturers competing for regulatory affairs contractors with EU MDR, EUDAMED and post-market surveillance experience. Read more about what EU MDR means for hiring budgets in 2026.

For global MedTech businesses, this creates demand for professionals who can build consistent quality systems while recognising where local requirements differ. Experience maintaining an established system may not be enough when a company is entering new markets, integrating an acquisition or adapting several sites to a regulatory change.

The strongest candidates can show where they have implemented a change, prepared a business for inspection or brought several functions into line with a new requirement. Familiarity with the regulation matters, but employers should also test whether the candidate has translated that knowledge into working processes.

 

How are software and connected devices changing quality risk?

Traditional manufacturing quality remains essential, but many of the fastest-changing risks now sit beyond the production line.
Connected devices and software as a medical device can be affected by updates, integrations, cybersecurity threats and changes in real-world use. These issues may not be visible through conventional component inspection or pre-launch testing alone.

In February 2026, the FDA issued updated cybersecurity guidance for medical devices. It covers quality management system considerations, and the information manufacturers should include in premarket submissions, with the aim of making marketed devices more resilient to cybersecurity threats.

Post-market monitoring is also becoming more important for AI-enabled products. A 2025 study examining adverse-event reports for AI and machine learning medical devices found limitations in the existing FDA reporting system and called for a stronger approach to post-market surveillance.

This does not mean that software or AI devices are inherently less safe. It means their performance can change or fail in ways that require different monitoring and investigation skills.

For employers, the challenge is deciding where this expertise should sit.

A software quality professional may understand development controls and validation but require support from cybersecurity specialists. A post-market surveillance professional may recognise an emerging signal but need data or clinical expertise to investigate it fully.
Companies sometimes try to combine software quality, cybersecurity, AI governance, clinical safety and post-market surveillance within a single job description. That can produce a role with a very limited or non-existent candidate pool.

A stronger approach is to define who owns each risk, identify which expertise must sit within the quality team and establish where other functions will provide support. This gives recruiters a realistic brief and gives candidates a clearer picture of the role.

 

Why does supplier complexity require specialist quality expertise?

Supplier quality requirements depend on the material, technology and underlying problem, which means a general Supplier Quality Engineer brief is often too broad.

Medical technology companies rely on external partners for raw materials, components, software, testing and manufacturing. These relationships provide access to specialist capabilities and additional capacity, but they also create quality risks outside the manufacturer’s direct control.

The legal manufacturer remains responsible for the finished product, even when parts of its development or production have been outsourced.

Supplier quality professionals may be responsible for qualifying new partners, conducting audits, monitoring performance, managing non-conformances and leading supplier corrective actions. The title alone tells employers very little about the experience they need.

A quality issue involving electronic components requires different technical knowledge from a failure involving sterile packaging, moulded materials or outsourced software. A company transferring production to a new site also needs a different profile from one responding to repeated failures at an established supplier.

This is one of the most common problems we see when recruiting within quality. Employers begin with a general Supplier Quality Engineer job description when the actual requirement is much narrower.

Before going to market, companies should establish:

• Which supplier, material or process is creating the risk
• Whether the focus is qualification, performance improvement or remediation
• Which technical knowledge is essential 
• Whether the work requires ongoing ownership or short-term intervention
• What needs to improve during the person’s first six months

A clear brief will normally produce a stronger shortlist than a long list of general quality responsibilities.

 

Why do MedTech quality searches fail?

MedTech quality searches often fail because employers recruit against a familiar title rather than defining the operational outcome the new hire must deliver.

A Quality Systems Manager may be expected to maintain a mature system, build one for a growing company, harmonise processes after an acquisition or lead remediation following an inspection. Each situation requires a different background.

The most effective searches begin with the outcome the business needs rather than the title it expects to hire.

Why is hiring by title risky?

Quality job titles are inconsistent across the MedTech industry.
A Quality Engineer may focus on manufacturing investigations in one company and design assurance in another. A Director of Quality may own one production site or lead the function across an international business.

Employers should define the product, process and business problem before deciding which titles to target. This also allows recruiters to consider candidates whose current title differs but whose experience is directly relevant.

Should every requirement be essential?

Very few quality candidates will bring exact device experience, knowledge of several regulatory systems, specialist manufacturing expertise and a history of leading complex projects.

Employers should separate the experience required from the first day from the knowledge that can be developed after joining. Someone who has led a complex supplier investigation may be more valuable than someone who has worked with the same device but has never owned a comparable problem.

Overly restrictive requirements can leave a critical position open while the operational issue continues.

When should quality hiring begin?

Quality hiring should begin before an inspection, product launch, manufacturing transfer or regulatory deadline turns a capability gap into an urgent operational problem.

Urgency narrows the available options. The employer may need someone with very specific experience who can join quickly, while the strongest candidates may already be considering several opportunities.

Workforce planning should therefore be linked to product development, manufacturing transfers, regulatory deadlines and anticipated market entry. Quality leaders who identify future capability gaps have more time to recruit permanent employees, develop internal talent or secure specialist contract support.

 

Contract quality talent can fill defined gaps

When should you use contract quality professionals?
Contract quality professionals are most valuable when a company has an urgent, specialist or clearly defined project with a measurable end point.

Typical projects include:

• Regulatory gap assessments
• Inspection preparation
• CAPA backlog reduction
• Quality system remediation
• Supplier recovery
• Process or software validation
• Manufacturing transfers
• New product launches
• Interim quality leadership

Contract hiring can give companies faster access to specialist experience, particularly when the work is urgent or has a defined end point.

However, urgency alone is not a sufficient brief.

A company asking for general remediation support may receive candidates with very different experience. A business that defines the number and type of CAPAs involved, the affected product or process and the expected completion date gives recruiters a much clearer search.

Permanent hiring remains important where the company needs ongoing ownership, continuity and internal capability. In some cases, the most effective model combines permanent leadership with contract specialists brought in for a specific stage of the work.

Where the requirement is urgent, highly specialised or tied to a defined project, EPM Scientific can help you access experienced contract professionals across quality, regulatory, validation and remediation. Explore our life sciences contract recruitment solutions.

Life Sciences Contract Recruitment

 

How does stronger quality capability protect growth?

Stronger quality capability protects patient safety, manufacturing continuity, product launches and market access while reducing the resources lost to repeated failures.

McKinsey estimated that medical device companies could recover the equivalent of 1.6% to 3% of sales by progressing from baseline quality performance towards more mature practices.

Applied to the projected global medical devices market, this represents a modelled value opportunity of approximately $9.1 billion to $17.2 billion as of July 2026.

The calculation is based on an established industry framework rather than a direct measurement of the 2026 market. It still shows the commercial potential available when manufacturers identify failures earlier, reduce repeated remediation and build quality into operational decisions.

Achieving that requires more than updated procedures or new technology. Companies need professionals who understand the risk, work across technical functions and turn quality requirements into practical action.

Businesses that build this capability before a major failure have more control over how and when they improve. Those that wait until an inspection, recall or production problem exposes the gap may have fewer options and much greater pressure to hire quickly.

EPM Scientific supports medical technology organisations with permanent, contract and senior quality hiring across quality systems, supplier quality, manufacturing, software, remediation and post-market surveillance. Request a call back to discuss your quality hiring requirements.

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Sources

• Fuhr, T., Makarova, E., Silverman, S. & Telpis, V. "Capturing the value of good quality in medical devices." McKinsey & Company, 24 February 2017. https://www.mckinsey.com/industries/life-sciences/our-insights/capturing-the-value-of-good-quality-in-medical-devices
• Statista. "Medical Technology – Worldwide" (Medical Devices market forecast, 2026). https://www.statista.com/outlook/hmo/medical-technology/worldwide
• Lumafield. "The Lumafield Cost of Quality Report." https://www.lumafield.com/cost-of-quality-report
• U.S. Food and Drug Administration. "Quality Management System Regulation (QMSR)." https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr
• European Commission. "The first four EUDAMED modules will be mandatory to use as from 28 May 2026." 27 November 2025. https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en
• Medicines and Healthcare products Regulatory Agency (MHRA). "MHRA guidance on new Medical Devices Post-Market Surveillance requirements" (SI 2024/1368, in force 16 June 2025). GOV.UK. https://www.gov.uk/government/news/mhra-guidance-on-new-medical-devices-post-market-surveillance-requirements
• U.S. Food and Drug Administration. "Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions." February 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarket
• Babic, B., Cohen, I. G., Stern, A. D., Li, Y. & Ouellet, M. "A general framework for governing marketed AI/ML medical devices." npj Digital Medicine 8, 328 (2025). https://doi.org/10.1038/s41746-025-01717-9