Taking your medical technology idea from concept to marketplace takes a team. And through the coordinated efforts of Mintz Levin and ML Strategies professionals, you have one team to address all the routine steps and unanticipated challenges of shepherding your product through its entire life cycle. We will help you protect your new idea, navigate the regulatory landscape, access funding, and develop collaborative relationships for product development and distribution.
What’s more, we take a full-service approach to regulatory, compliance, and enforcement matters, and we will effectively advise you on national, state, and local issues. That includes conducting compliance audits, assisting you in the implementation of compliance policies, and providing educational updates on new developments. We will also advise you how federal and state fraud and abuse and anti-kickback statutes affect your relationships with your customers, suppliers, and health care providers.
Supporting the Life Cycle of Products
- Concept & Design
Our patent professionals provide patentability, validity, freedom-to-operate, and infringement opinions to ensure the uniqueness and manufacturing availability of your new product or concept. Your Mintz Levin IP team is international and will work across continents to assist you in filing patents and trademarks through the US Patent & Trademark Office (USPTO), the European Patent Office (EPO), the UK Patent Office, and the World Intellectual Property Organization (WIPO) as well as national patent and trademark offices in countries that do not belong to WIPO.
Our Corporate & Securities attorneys will help you access the capital required to carry your product through the development phase. We will facilitate introductions to potential funding sources if necessary. As part of this step, our patent professionals will conduct thorough infringement, freedom-to-operate, and validity analyses of competing products and assist you in filing, licensing, or acquiring additional offensive and defensive patents. If needed, we will also vigorously prosecute infringers.
- Testing & Approval
We will represent you before government agencies at the US federal and state levels and internationally to help move your product through every approval needed. This includes determining the appropriate regulatory options for your product and assisting you in submitting 510(k) notifications or pre-market approval applications.
If clinical trials are necessary, we will assist you in identifying and negotiating agreements with clinical researchers, CRO service providers, data analysts, and providers of other services required for the design and conduct of sound clinical trials. As well, we will represent you in negotiating outsourcing agreements for services such as manufacturing and packaging.
- Product Launch & Commercialization
Our attorneys will guide you through everything that needs to happen to bring your medical technology to the marketplace and keep it there. If additional funding or business relationships are needed, we can structure public or private financing transactions, and negotiate joint ventures, licensing agreements, and other collaborative arrangements. We will also assist you in obtaining coverage and adequate payment from third-party payors and new codes. Our attorneys also develop and implement corporate compliance programs. In the event your product is removed from a marketplace, we can guide you through the steps needed to bring it back to that market.
Compliance & Regulatory Counseling
Our attorneys will counsel you on how best to comply with the applicable laws and regulations related to your medical technology and business operations. We regularly advise medical technology manufacturers on the regulatory and reimbursement status of products and procedures and on strategic pathways for bringing new products to market.
Our advice includes helping you stay in compliance with state and federal fraud and abuse laws when interacting with health care professionals and structuring your business arrangements. We also provide counsel on compliance with the federal Physician Payments Sunshine Act and similar state laws.
To that end, we draft compliance program policies and codes of conduct and provide advice on implementation. We also provide compliance training for board members and employees, including specialized compliance training for sales force employees.
We will advise you in all aspects of FDA regulations and issues related to your medical technology. We regularly counsel medical technology manufacturers on compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and related requirements, including requirements for product approval, arrangements for outsourced services, advertising and other promotional issues, and responses to FDA 483s and Warning letters. In addition to helping you with FD&C Act matters, we also prepare and prosecute marketing applications, devise effective government relations strategies, and respond to FDA enforcement actions.
Whatever stage of development your medical technology business is in, we will assist you in accessing additional funding to support its expansion. Our start-up and emerging clients often rely upon us to assist them with their early-stage venture financings. Over the years, we have developed extensive relationships with many venture funding entities, and we will provide introductions to you if needed. We represent some of these venture funds in identifying and investing in young companies.
Private equity transactions have been on an upswing, and our attorneys have grown with the trend, representing both the investor entities and companies in which they invest. And as public offerings have begun to come back post-recession, the number of IPOs and follow-on offering deals is increasing. We help our public clients (and private clients seeking to go public) achieve their goals efficiently, advising them in developing and conducting roadshows all the way through deal closing.
Government Relations & Regulatory Affairs
When necessary, we will work with our colleagues in the firm’s government relations affiliate, ML Strategies, LLC, to represent you in legislative and regulatory issues that may impact your medical technology or business, such as patent legislation, clinical trials, reimbursement issues, federal funding for programs, and orphan drug legislation.
Health Care Enforcement Defense
If a business practice related to your medical technology becomes the subject of a state or federal government investigation or litigation, our attorneys will vigorously defend you and advocate for a resolution that best suits your business objectives. We have successfully defended medical technology manufacturers against allegations of:
- Offering or receiving kickbacks or other financial inducements
- Filing false claims with state and federal health care programs, or causing such claims to be filed
- Marketing devices in violation of the Food, Drug, and Cosmetic Act
- Maintaining financial relationships that create unlawful conflicts of interest
In addition to being your defense counsel, we can represent you in negotiations of Corporate Integrity Agreements with the Office of Inspector General for the Department of Health and Human Services (HHS OIG) and guide you through the HHS OIG’s self-disclosure process.
When an intellectual property dispute related to your medical technology arises, you will have patent litigators with technical knowledge and extensive industry experience on your side. Our bench includes legal professionals with experience and technical knowledge of medical technologies, microprocessors, electronics, digital imaging, telecommunications technology, and optics. Our experience includes successfully defending companies against claims of infringement, and in the enforcement of patent rights against infringing competitors.
Joint Ventures & Other Strategic Alliances
It’s crucial to have legal counsel who know your business and the medical technology industry to structure solid agreements that address your business needs and goals. Our attorneys have the reputation of being the most knowledgeable attorneys in the medical technology, biotech, and pharmaceutical industries for negotiating strategic agreements, including:
- Joint venture and collaborative research agreements
- Development, services, and university licensing arrangements
- Agreements to develop new products and technology
We leverage our attorneys’ knowledge of business, communications, technology, and intellectual property law to provide you with exceptional business-focused legal advice in these complicated transactions. And we leverage being recognized as one of the leading life sciences law firms in the United States in every negotiation. Each time we represent you in a negotiation, we will assign attorneys knowledgeable about your business, the medical technology industry, and the ins-and-outs of complex transactions.
Patent Prosecution & Counseling
Our attorneys 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 team crafts global strategies for clients in the medical technology and other cutting-edge industries. We produce technically excellent patents tailored to international jurisdictional requirements; provide strategic advice on comprehensive portfolio development; author complex patentability, freedom-to-operate, and inventorship opinions; and conduct portfolio audits.
We keep our eyes on the global nature of business and work closely to provide efficiency in US and European filings. Our attorneys throughout the US collaborate regularly with foreign associate firms around the world to ensure the quality of international filings and to mitigate the need for you to manage that process.
Our attorneys represent some of the most successful technology companies in the world, including highly recognizable names in medical technologies. We also represent entrepreneurs, start-ups, and the financing organizations which support them.
The medical technology industry is rife with lawsuits against manufacturers with the best intentions. Mintz Levin’s approach is to limit your product liability exposure on all fronts. We work with you to develop a comprehensive product liability prevention strategy, advising you on warnings and product labeling, and providing education and training to your management, sales force, and development teams. We also advise you on the implications of regulatory action as well as review your insurance and, if needed, negotiate upgrades to your coverages.
If your medical technology becomes the target of product liability or complex tort claims, we prepare a vigorous defense strategy that takes into account the implications of the case on your business as a whole — from reputational harm to potential regulatory action. Your defense strategy is based on what you decide will work best for your business objectives, whether that is taking the case to trial or settling it. We defend medical technology manufacturers in complex personal injury matters as well as commercial warranty and contract litigation involving products, including class actions.