Surmodics

To improve the detection and treatment of disease by being the partner of choice for developing life-changing medical technologies.

Surmodics SWOT Analysis

Updated: October 6, 2025 • 2025-Q4 Analysis

How to Use This Analysis

This analysis for Surmodics was created using Alignment.io™ methodology - a proven strategic planning system trusted in over 75,000 strategic planning projects. We've designed it as a helpful companion for your team's strategic process, leveraging leading AI models to analyze publicly available data.

While this represents what AI sees from public data, you know your company's true reality. That's why we recommend using Alignment.io and The System of Alignment™ to conduct your strategic planning—using these AI-generated insights as inspiration and reference points to blend with your team's invaluable knowledge.

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The Surmodics SWOT analysis reveals a company at a critical inflection point. Its greatest strength, the FDA approval of the SurVeil™ DCB, is directly aligned with its largest opportunity: a successful commercial launch that could transform its financial trajectory. However, this is counterbalanced by significant weaknesses, including a damaging product recall on another key device and persistent unprofitability. The primary threat is formidable competition from established giants who dominate the market Surmodics is entering. The strategic imperative is clear: execute a flawless SurVeil™ launch, rebuild trust by resolving quality issues with its Pounce™ device, and strategically streamline the business to focus all resources on winning in the high-growth vascular device market. Success hinges entirely on near-perfect commercial and operational execution over the next 18 months.

Medtronic Boston Scientific Abbott Laboratories Becton, Dickinson and Company Teleflex

No past cycles

Mission & Vision SWOT Analysis OKR Plan Retrospective AI Strategy Data Acquisition

To improve the detection and treatment of disease by being the partner of choice for developing life-changing medical technologies.

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Strengths

APPROVAL: Landmark FDA PMA approval for SurVeil DCB is a game-changer.
PARTNERSHIP: Abbott distribution deal provides immediate market access.
REVENUE: Medical device revenue grew 23% in Q2'24, showing momentum.
TECHNOLOGY: Core coating science remains a key differentiator and asset.
PIPELINE: Growing portfolio of thrombectomy and radial access devices.

Weaknesses

RECALL: Pounce Thrombectomy recall erodes trust and impacts Q3 revenue.
PROFITABILITY: Continued net losses driven by high R&D and SG&A spend.
IVD: Stagnant In Vitro Diagnostics segment is a drag on overall growth.
CONCENTRATION: Heavy reliance on SurVeil's successful commercial launch.
SCALE: Lacks the commercial infrastructure of multi-billion dollar peers.

Opportunities

LAUNCH: Flawless execution of SurVeil commercial launch via Abbott.
EXPANSION: Leverage SurVeil momentum to cross-sell other device products.
DATA: Use TRANSCEND clinical data to drive adoption and reimbursement.
INTERNATIONAL: Secure key international approvals for the device portfolio.
DIVESTITURE: Strategic review of IVD unit to focus on core device biz.

Threats

EXECUTION: Any missteps in the SurVeil launch could be catastrophic.
COMPETITION: Medtronic & BD hold >80% of the DCB market, a major hurdle.
SUPPLY-CHAIN: Manufacturing ramp-up must meet Abbott's demand flawlessly.
LITIGATION: Potential for lawsuits related to the Pounce product recall.
MACRO: Hospital capital budget constraints could slow new tech adoption.

Key Priorities

LAUNCH: Nail the SurVeil DCB commercial launch with Abbott flawlessly.
QUALITY: Resolve Pounce recall issues to restore confidence and revenue.
PIPELINE: Accelerate adoption of the broader vascular device portfolio.
FOCUS: Evaluate strategic options for the IVD business to sharpen focus.

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Surmodics OKR

Updated: October 6, 2025 • 2025-Q4 Analysis

The Surmodics OKR plan demonstrates exceptional strategic alignment, directly translating the four critical priorities from the SWOT analysis into clear, actionable objectives. This plan rightly places overwhelming emphasis on 'NAIL THE LAUNCH,' acknowledging that the company's near-term fate hinges on the SurVeil™ commercialization. The objectives to 'RESTORE TRUST' and 'GROW THE PORTFOLIO' provide crucial balance, ensuring that recent quality failures are rectified and that the company avoids becoming a single-product story. Finally, 'SHARPEN FOCUS' addresses the long-standing drag from the IVD business. This is a focused, disciplined, and realistic plan designed to navigate a pivotal moment, turning strategic insight into measurable execution.

Medtronic Boston Scientific Abbott Laboratories Becton, Dickinson and Company Teleflex

No past cycles

Mission & Vision SWOT Analysis OKR Plan Retrospective AI Strategy Data Acquisition

To improve the detection and treatment of disease by being the partner of choice for developing life-changing medical technologies.

NAIL THE LAUNCH

Execute a flawless SurVeil™ commercial launch with Abbott.

MANUFACTURING: Achieve 99.5% on-time, in-full delivery of SurVeil™ to meet all of Abbott's Q4 forecasts.
SUPPORT: Equip 100% of Abbott's sales reps with advanced training & materials, achieving a 9/10 readiness score.
ADOPTION: Secure formulary approval and initial orders from 75 target high-volume hospital systems by end of Q4.
DATA: Publish one new analysis from the TRANSCEND trial data in a major peer-reviewed medical journal.

RESTORE TRUST

Resolve Pounce™ quality issues and regain market confidence.

REMEDIATION: Complete 100% of required actions for the Pounce™ recall and submit final report to the FDA.
RELAUNCH: Re-introduce the updated Pounce™ system to the top 25 key opinion leader (KOL) physicians.
MONITORING: Reduce post-market complaint rates for the Pounce™ family by 50% compared to pre-recall rates.
INVENTORY: Rebuild Pounce™ safety stock to 60 days of supply to ensure product availability upon re-launch.

GROW THE PORTFOLIO

Drive adoption of our broader vascular intervention tools.

CROSS-SELL: Achieve a 20% increase in sales of Sublime™ and Telemark™ products to new SurVeil™ accounts.
TRAINING: Conduct 50 physician training labs on the full radial access and thrombectomy product portfolio.
EVALUATIONS: Initiate 100 new product evaluations for non-DCB devices in hospitals across the United States.
BUNDLING: Create and launch three new product bundle offerings that combine our access, support, and therapy devices.

SHARPEN FOCUS

Finalize the strategic path for the IVD business unit.

ANALYSIS: Complete financial and operational assessment of all potential IVD strategic alternatives by Nov 15.
RECOMMENDATION: Present a final, data-backed recommendation to the Board of Directors at the December meeting.
COMMUNICATION: Develop a clear internal and external communication plan for the chosen strategic direction.
STABILITY: Maintain IVD segment revenue and operating margin within 5% of forecast during the evaluation period.

METRICS

Medical Device Revenue Growth Rate: 40%
SurVeil™ US Market Share: 15%
Adjusted EBITDA: Positive

VALUES

Integrity
Innovation
Teamwork
Excellence
Accountability

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Surmodics Retrospective

AI-Powered Insights

Claude

Gemini

GPT

Surmodics Q2 2024 Earnings Call Transcript & Press Release
Surmodics Investor Relations Website & Presentations (May 2024)
Surmodics Form 10-Q filed with SEC (May 2024)
Public financial data sources for market cap and stock info
Surmodics company website for mission, products, and leadership

Medtronic Boston Scientific Abbott Laboratories Becton, Dickinson and Company Teleflex

No past cycles

Mission & Vision SWOT Analysis OKR Plan Retrospective AI Strategy Data Acquisition

To improve the detection and treatment of disease by being the partner of choice for developing life-changing medical technologies.

Toggle Theme

What Went Well

APPROVAL: SurVeil™ PMA approval from the FDA was a massive Q2 '24 win.
REVENUE: Medical Device segment revenue up 23% year-over-year in Q2.
PARTNER: Milestone payment received from Abbott, strengthening cash position.
GUIDANCE: Raised FY2024 revenue guidance based on SurVeil™ launch timing.
MARGINS: Product gross margin improved to 65.1% in the second quarter.

Not So Well

RECALL: Voluntary recall of Pounce™ Thrombectomy System hit Q2 results.
IVD: In Vitro Diagnostics revenue was flat, showing continued sluggishness.
LOSS: Net loss increased to $8.7 million for the quarter, burning cash.
EXPENSES: R&D and SG&A expenses remain high, pressuring profitability.
SENTIMENT: Pounce™ recall created negative sentiment despite SurVeil™ win.

Learnings

QUALITY: Post-market surveillance and quality systems are paramount for trust.
FOCUS: The Medical Device segment is the undisputed engine of future growth.
PARTNERS: Strong partners like Abbott are essential for market access.
COMPLEXITY: Commercial launches are complex and require immense focus.
DIVERSIFICATION: Relying on one product's launch carries significant risk.

Action Items

LAUNCH: Support Abbott to ensure a flawless, aggressive SurVeil™ launch.
POUNCE: Complete remediation of Pounce™ devices and restore market access.
SPEND: Prudently manage operating expenses without stifling growth drivers.
IVD: Complete the strategic review of the IVD business by year-end.
PIPELINE: Continue to advance and promote the Sublime™ and Telemark™ lines.

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Organization	SWOT Analysis	OKR Plan	Top 6	Retrospective

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Surmodics Market

AI-Powered Insights

Claude

Gemini

GPT

Surmodics Q2 2024 Earnings Call Transcript & Press Release
Surmodics Investor Relations Website & Presentations (May 2024)
Surmodics Form 10-Q filed with SEC (May 2024)
Public financial data sources for market cap and stock info
Surmodics company website for mission, products, and leadership

Founded: 1979
Market Share: Emerging player in devices; strong niche share in hydrophilic coatings.
Customer Base: Hospitals, clinics, and large medical device OEMs.
Category:
Medical Devices
SIC Code: 3841 Surgical and Medical Instruments and Apparatus
NAICS Code: 339112 Surgical and Medical Instrument Manufacturing
Location: Eden Prairie, Minnesota
Zip Code: 55344
Congressional District: MN-3 MINNEAPOLIS
Employees: 500

Competitors

Medtronic View Analysis

Boston Scientific View Analysis

Abbott Laboratories View Analysis

Becton, Dickinson and Company Request Analysis

Teleflex View Analysis

Products & Services

No products or services data available

Distribution Channels

Surmodics Business Model Analysis

AI-Powered Insights

Claude

Gemini

GPT

Surmodics Q2 2024 Earnings Call Transcript & Press Release
Surmodics Investor Relations Website & Presentations (May 2024)
Surmodics Form 10-Q filed with SEC (May 2024)
Public financial data sources for market cap and stock info
Surmodics company website for mission, products, and leadership

Problem

Peripheral Artery Disease (PAD) treatment
Thrombosis (blood clot) formation
Poor biocompatibility of medical devices
Need for reliable diagnostic components

Solution

Drug-coated balloons (SurVeil™)
Mechanical thrombectomy systems (Pounce™)
Hydrophilic and lubricious coatings
IVD substrates and stabilization reagents

Key Metrics

Device revenue growth
SurVeil™ market penetration
Product gross margin %
New coating customer agreements

Unique

Proprietary drug-delivery coating tech
Vertically integrated device development
Decades of surface modification expertise
Non-inferior clinical data vs. leader

Advantage

Extensive patent portfolio (IP moat)
Long-term OEM customer relationships
FDA PMA approval on a key device
Strategic distribution with Abbott

Channels

Abbott's vascular sales force
Surmodics' direct sales team
OEM partnerships
Medical device distributors

Customer Segments

Hospitals and cath labs
Interventional cardiologists/radiologists
Large medical device manufacturers (OEMs)
In vitro diagnostic test manufacturers

Costs

Research and development (clinical trials)
Sales, general & administrative (SG&A)
Cost of goods sold (manufacturing)
Regulatory compliance and quality assurance

Surmodics Product Market Fit Analysis

Updated: October 6, 2025

Surmodics enhances medical procedures by developing market-leading vascular intervention devices and surface technologies. Its platforms, like the SurVeil™ drug-coated balloon, offer physicians superior tools to treat peripheral artery disease, leading to better patient outcomes, fewer complications, and lower healthcare costs. It transforms complex vascular challenges into successful, minimally invasive solutions.

Improved patient outcomes via innovative drug-coated balloons.

Enhanced procedural success with advanced catheter technologies.

Reduced complications through superior surface modification.

Before State

Risky, invasive peripheral artery surgery
Sub-optimal device performance/biocompatibility
Poor drug delivery in vascular procedures

After State

Minimally invasive endovascular treatments
Superior device deliverability and safety
Targeted, localized drug delivery to site

Negative Impacts

Long patient recovery times and high costs
Device thrombosis and inflammatory response
Systemic drug toxicity, repeat procedures

Positive Outcomes

Faster patient recovery, lower healthcare burden
Improved clinical outcomes, fewer complications
Increased procedural success, higher efficacy

Key Metrics

Customer Retention Rates - High (>90% for top coating customers)

Net Promoter Score (NPS) - Not publicly available, estimated 40-50

User Growth Rate - Device segment growing >20% pre-SurVeil launch

Customer Feedback/Reviews - Limited public reviews; focus on clinical data

Repeat Purchase Rates) - High for consumables (catheters, coatings)

Requirements

Pristine clinical data for FDA approval
Robust physician training and education
Secure supply chain for commercial launch

Why Surmodics

Leverage TRANSCEND trial data for SurVeil
Partner with Abbott for market access
Scale US-based manufacturing operations

Surmodics Competitive Advantage

Proprietary paclitaxel drug-delivery tech
Decades of coating science expertise
Vertically integrated device development

Proof Points

SurVeil FDA Premarket Approval (PMA) 2023
TRANSCEND trial non-inferiority results
Long-term partnerships with top device OEMs

Surmodics Market Positioning

AI-Powered Insights

Claude

Gemini

GPT

Surmodics Q2 2024 Earnings Call Transcript & Press Release
Surmodics Investor Relations Website & Presentations (May 2024)
Surmodics Form 10-Q filed with SEC (May 2024)
Public financial data sources for market cap and stock info
Surmodics company website for mission, products, and leadership

Strategic pillars derived from our vision-focused SWOT analysis

Lead in drug-coated balloon technology.

Expand proprietary thrombectomy/radial access portfolio.

Be the indispensable surface technology partner.

Maximize value from In Vitro Diagnostics segment.

What You Do

Develops and commercializes vascular intervention devices and coatings.

Target Market

Interventional physicians and medical device manufacturers.

Differentiation

Proprietary drug-delivery coating tech
Vertically integrated R&D to manufacturing

Revenue Streams

Medical device product sales
Coating license fees & royalties

Surmodics Operations and Technology

AI-Powered Insights

Claude

Gemini

GPT

Surmodics Q2 2024 Earnings Call Transcript & Press Release
Surmodics Investor Relations Website & Presentations (May 2024)
Surmodics Form 10-Q filed with SEC (May 2024)
Public financial data sources for market cap and stock info
Surmodics company website for mission, products, and leadership

Company Operations

Organizational Structure: Two-division: Medical Devices and In Vitro Diagnostics (IVD).
Supply Chain: Vertically integrated design, R&D, and manufacturing in the U.S.
Tech Patents: Over 200 issued and pending patents, primarily in surface modification.
Website: https://www.surmodics.com/

Top Clients

Board Members

Surmodics Competitive Forces

Threat of New Entry

LOW: Extremely high barriers due to extensive R&D costs, lengthy and rigorous FDA approval processes, and deep IP moats.

Supplier Power

LOW: Surmodics is vertically integrated for many key components and materials, reducing dependence on single external suppliers.

Buyer Power

HIGH: Large hospital networks (GPOs) consolidate purchasing power, demanding clinical evidence and competitive pricing.

Threat of Substitution

MEDIUM: While DCBs are a standard of care, new technologies like drug-eluting stents or atherectomy devices are viable alternatives.

Competitive Rivalry

VERY HIGH: Dominated by giants like Medtronic, Boston Scientific, and BD with massive scale, R&D budgets, and sales channels.

Analysis of AI Strategy

Updated: October 6, 2025 • 2025-Q4 Analysis

The Surmodics AI SWOT analysis highlights a significant opportunity to leverage unique, high-value data assets. Its strengths are not in current AI capabilities but in its proprietary clinical and materials science data, which could fuel powerful predictive models for R&D and manufacturing. The primary weakness is a lack of internal AI talent and infrastructure, creating a major execution gap. The path forward is not to compete on broad AI but to apply it surgically. Surmodics should prioritize using AI to accelerate its core innovation engine—designing better coatings and devices faster—and to optimize the manufacturing and commercialization of these high-value products. The biggest threat is not an external AI disruption, but rather internal inertia causing competitors to gain an insurmountable efficiency and innovation advantage by adopting AI more aggressively.

Medtronic Boston Scientific Abbott Laboratories Becton, Dickinson and Company Teleflex

No past cycles

Mission & Vision SWOT Analysis OKR Plan Retrospective AI Strategy Data Acquisition

To improve the detection and treatment of disease by being the partner of choice for developing life-changing medical technologies.

Strengths

DATA: Rich, proprietary datasets from clinical trials like TRANSCEND.
R&D: Decades of materials science data on polymer and drug interactions.
PROCESS: Controlled manufacturing environment generates valuable QC data.
IP: Potential to patent AI-driven discoveries in coating formulations.
NICHE: Focused domain in vascular devices allows for targeted AI models.

Weaknesses

TALENT: Lack of a dedicated, scaled AI/ML engineering team in-house.
INFRASTRUCTURE: Legacy data systems may be siloed and not AI-ready.
BUDGET: Limited capital to invest in large-scale AI compute resources.
CULTURE: Engineering culture may be more traditional, less AI-centric.
SCALE: Insufficient data volume compared to giants like Medtronic.

Opportunities

DESIGN: AI-powered simulation to accelerate new coating/device design.
TRIALS: Predictive analytics to optimize clinical trial patient selection.
MANUFACTURING: AI for predictive maintenance and yield optimization.
COMMERCIAL: Machine learning to identify ideal physician targets for sales.
DIAGNOSTICS: Enhancing IVD products with AI-driven result interpretation.

Threats

COMPETITION: Competitors using AI to achieve faster R&D breakthroughs.
REGULATION: Evolving FDA guidance on AI/ML in medical devices (SaMD).
PRIVACY: Risk of data breaches with sensitive clinical and patient data.
COST: The high cost of AI talent and infrastructure could divert funds.
OBSOLESCENCE: Falling behind the AI curve could render R&D less efficient.

Key Priorities

DESIGN: Pilot AI/ML models to accelerate next-gen coating formulation.
EFFICIENCY: Use AI to optimize manufacturing yield for key products.
TRIALS: Leverage AI to analyze clinical data for new insights/papers.
SALES: Implement AI tools to identify high-potential physician adopters.

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Surmodics Financial Performance

AI-Powered Insights

Claude

Gemini

GPT

Surmodics Q2 2024 Earnings Call Transcript & Press Release
Surmodics Investor Relations Website & Presentations (May 2024)
Surmodics Form 10-Q filed with SEC (May 2024)
Public financial data sources for market cap and stock info
Surmodics company website for mission, products, and leadership

Profit: Net Loss (TTM): ~($25M)

Market Cap: ~$450 Million

Stock Performance

Annual Report: Available via SEC EDGAR database.

Debt: ~$29 Million in long-term debt.

ROI Impact: Near-term ROI suppressed by R&D spend and commercial launch costs.

SWOT Index

Composite strategic assessment with 10-year outlook

/ 100

Challenger

ICM Index

STRATEGIC ADVISOR ASSESSMENT

Surmodics has a high-ambition vision (societal impact) but faces significant execution risk, capping its Achievability. The SWOT is balanced, with a game-changing opportunity (SurVeil) offset by severe competitive threats and internal weaknesses (recall). The OKRs are strong and category-shaping. The low Growth Multiplier reflects the immense difficulty of capturing market share from deeply entrenched competitors, making survival and modest growth the most probable 10-year outcome despite the breakthrough technology.

SWOT Factors

Upside: 69.0 Risk: 73.0

OKR Impact

AI Leverage

Top 3 Strategic Levers

Flawless execution of the SurVeil™ commercial launch.

Resolve Pounce™ quality issues to restore clinical trust.

Expand the device portfolio beyond the SurVeil™ DCB.

AI Disclosure

This report was created using the Alignment Method—our proprietary process for guiding AI to reveal how it interprets your business and industry. These insights are for informational purposes only and do not constitute financial, legal, tax, or investment advice.

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