
MedTech, Tools, and Devices
Supporting the Life Cycle of MedTech Companies & Products
We help medical technology companies strategically develop markets, meet financing sources and raise funds, deal with health regulatory agencies, and adhere to life in the capital markets.
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Our Approach
Through the coordinated efforts of Mintz and ML Strategies professionals, you have one team to address all of the routine steps and unanticipated challenges of shepherding products through entire life cycle — from concept and design to development and testing, and through the final product launch and commercialization. You also have strategic business advisors who have experience working with large medical technology companies and who provide a comprehensive range of guidance, including in complex transactions, regulatory matters, and patent strategy.
Public company compliance — maintaining compliance with SEC-mandated reporting
Mergers and acquisitions — asset or whole company acquisitions and divestitures; mergers of equals
Strategic alliances — joint venture and collaborative research agreements; development and licensing arrangements
Financings — public securities offerings, private equity transactions, venture capital investments
We will help you at any stage of portfolio development to ensure you are on the right path to successfully protecting your competitive position in the marketplace. Our attorneys produce technically excellent patents tailored to international jurisdictional requirements and provide strategic advice on comprehensive portfolio development. We author complex patentability, freedom-to-operate, and inventorship opinions. And we conduct portfolio audits.
Products Liability — Develop comprehensive product liability prevention strategies, and provide education and training to management, sales force, and development teams
Intellectual Property — Technically knowledgeable professionals with experience successfully defending companies against claims of infringement, and in enforcing patent rights against infringing competitors
Health Care Enforcement Defense — Vigorous defense against state or federal government investigations or litigation, representation in negotiations of Corporate Integrity Agreements with HHS OIG, and guidance through the self-disclosure process
Regulatory — Counseling on regulatory and reimbursement status of products and procedures, and on strategic pathways for bringing new products to market
Compliance — Advice to maintain compliance with fraud and abuse laws, and to remain in compliance with FDA and related requirements, including those for product approval, arrangements for outsourced services, advertising, and responses to FDA 483s and warning letters
FDA — Preparation and prosecution of marketing applications, devising effective government relations strategies, and responding to FDA enforcement actions
What Our Clients Are Saying
Meet Mintz
Our team of Mintz and ML Strategies professionals will help you address the challenges involved in shepherding your product through its entire life cycle.
Related Practices
- IPRs & Other Post-Grant Proceedings
- Licensing & Technology Transactions
- Securities & Capital Markets
- Debt Financing
- Venture Capital & Emerging Companies
- Mergers & Acquisitions
- Patent Prosecution & Strategic Counseling
- FDA Regulatory
- Health Care Compliance, Fraud & Abuse, and Regulatory Counseling
- Clinical Trials & Research
- Employment Litigation & Arbitration
- Data & Privacy Litigation and Investigations
- Medicare, Medicaid & Commercial Coverage & Reimbursement
- Product Liability & Complex Tort