Mergers and Acquisitions in MedTech: Positioning Your Company for Success
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Mergers and Acquisitions in MedTech: Positioning Your Company for Success
The MedTech Mergers and Acquisitions (M&A) scene is more active than ever. As global healthcare needs grow and regulatory landscapes shift, strategic acquisitions are becoming a key route to innovation, growth, and market expansion. For emerging MedTech companies, understanding this environment and positioning themselves smartly within it can shape their future.
Recent activity shows that opportunity is abundant for companies that are prepared. Strategic buyers are on the lookout for innovative technologies, strong product pipelines, and solid regulatory foundations. But having a breakthrough product is not enough. Success in M&A hinges on preparation, documentation, and systems that can stand up to intense due diligence.
The Current M&A Landscape: A Shifting Landscape
The MedTech M&A scene has evolved dramatically over the past year, marked by fewer deals but significantly larger transactions. While deal volume dropped by over 40%, the average deal size surged to $636 million, driven by strategic acquisitions like Stryker’s $4.9B purchase of Inari Medical and Thermo Fisher’s $4.1B buyout of Solventum’s filtration business.
Strategic Focus: Bigger Bets, Sharper Targets
Major players like Johnson & Johnson and Medtronic continue to lead the charge, but their strategies are shifting. J&J, for example, has spent over $30B on acquisitions since 2022, including Shockwave Medical ($13.1B) and Abiomed ($16.6B). These deals weren’t just about scale as they targeted technologies that redefine standards of care, particularly in cardiovascular intervention.
Medtronic, meanwhile, is leaning into tuck-in acquisitions to transform slower-growth units into innovation hubs. With 11+ deals in the past five years, the company is focused on strategic adjacencies and long-term portfolio optimization.
Trends Driving the Market
- Portfolio Shifts: Companies are divesting non-core assets and doubling down on high-growth areas like robotics, diabetes, and structural heart technologies.
- Private Equity’s Role: PE firms are increasingly active, both as buyers and partners in divestitures, helping streamline portfolios and unlock value.
- Cultural Fit Matters: Executives emphasize that successful deals go beyond financials. Shared values and aligned visions for patient impact are now critical to integration success.
What Strategic Buyers Seek: The Acquisition Criteria That Matter
To attract the right buyer, emerging MedTech companies need to align with what strategic acquirers value most. Here is what consistently matters:
Technology Differentiation & Market Position
Buyers want technologies that offer real clinical advantages such as better outcomes, simpler procedures, or cost savings. Proprietary tech backed by strong patents is especially attractive.
The best targets complement the buyer’s existing portfolio and address unmet clinical needs. Think AI diagnostics that plug into existing imaging platforms or minimally invasive tools that expand surgical options.
Regulatory Clarity
A clear regulatory strategy is a major plus. Companies that have engaged with the FDA, gathered solid clinical data, and understand approval pathways stand out.
Detailed documentation like pre-submission notes, trial protocols, and quality systems reduces risk and speeds up integration. It also boosts valuation.
Commercial Potential
Buyers assess market size, competition, and go-to-market strategy. Companies with clinical relationships, distribution channels, or early traction are more appealing.
Technologies that target large markets with clear reimbursement paths, and show signs of physician adoption, are especially valuable.
Financial Performance and Scalability
Even early-stage companies need to show a viable business model. Efficient use of capital, clear milestones, and scalable operations build credibility.
Detailed financials like cost breakdowns, revenue forecasts, and funding needs help buyers model ROI and integration scenarios.
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Getting Acquisition-Ready: Preparing for Due Diligence
Due diligence represents the most critical phase of any acquisition process. Companies that invest in comprehensive documentation and systematic organization significantly improve their chances of successful transactions and favorable valuations.
Product Documentation
Keep everything up to date: design requirements, risk files, and testing protocols. Use document control systems to manage versions and changes.
Requirements management is key. Acquirers want to see how products were developed, validated, and maintained. Full traceability from concept to release builds trust.
Risk & Quality Systems
Risk documentation such as hazard analyses, mitigation controls, and post-market surveillance plans is essential. Quality systems should be fully implemented and certified (ISO 13485 is a big plus).
Design controls should be complete and easy to navigate: planning, inputs/outputs, reviews, V&V protocols, and change logs. A well-organized design and development file makes due diligence smoother and less risky.
Testing and Validation Evidence
Strong testing documentation is essential to prove your product’s safety and performance. This includes everything from software testing protocols and biocompatibility studies to electrical safety tests and clinical evaluations.
To stand out, companies should maintain:
- Detailed test plans
- Clear procedures
- Organized results
This shows a systematic approach to validating product performance. When testing documentation is thorough and easy to navigate, acquirers can quickly assess technical risks and regulatory readiness.
Validation should not stop at product launch. Ongoing monitoring, post-market studies, and performance tracking signal a commitment to continuous improvement — something buyers value highly.
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Intellectual Property and Regulatory Assets
Your IP and regulatory documentation are more than just paperwork — they are strategic assets. Patent portfolios, FDA submissions, and clinical data all play a key role in valuation and deal structure.
To prepare:
- Keep patent files current
- Document freedom-to-operate analyses
- Develop a clear IP strategy
On the regulatory side, maintain organized records of:
- FDA correspondence
- Clinical trial data
- Post-market surveillance reports
Well-managed documentation shows a strong compliance history and gives acquirers confidence in your ability to navigate future regulatory hurdles.
How Jama Connect® Supports M&A Readiness
Requirements management and traceability are critical for M&A success and that’s where Jama Connect shines.
The platform helps companies maintain acquisition-ready documentation throughout the product lifecycle by:
- Connecting requirements to design decisions, tests, and regulatory submissions — giving acquirers full visibility into development processes.
- Organizing documents with version control — making it easy for due diligence teams to trace product history and compliance.
- Generating detailed reports — showcasing the maturity of your quality management system and development discipline.
- Supporting collaboration across teams and locations — ensuring documentation integrity even in distributed environments.
With Jama Connect, medical device and life sciences companies can confidently present their development story and proof of compliance, a major advantage during acquisition discussions.
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Building Long-Term Value Through Strategic Preparation
The MedTech M&A landscape is evolving fast. As healthcare needs grow and technologies advance, new opportunities are emerging for companies that are ready.
Success isn’t just about having a great product. It’s about:
- Operational excellence
- Regulatory sophistication
- Systematic development processes
Investing early in documentation, requirements management, and quality systems pays off. These capabilities lead to faster development, lower regulatory risk, and better product quality.
If you’re looking to strengthen your M&A readiness, start by evaluating your documentation systems. Book a demo with Jama Software to see how structured requirements management can streamline your development and boost acquisition appeal.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Tom Rish and Decoteau Wilkerson.
Senior Product Marketing Manager at Jama Software
Tom Rish is a biomedical engineer with over 15 years of experience developing medical devices. His work has spanned the entire MedTech product lifecycle, from initial concept through market launch. He is passionate about helping others navigate the complex journey of bringing a device to market so that patients around the world can benefit from life-changing technologies. Tom is currently a member of the Product Marketing team at Jama Software.
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