At McDonald Hopkins, we bring together the experience and expertise of our startup-VC team, national Healthcare Practice Group, and Intellectual Property Department to offer digital health, telemedicine, biotech, medical device, therapeutics/diagnostics and other companies in the Medtech industry the legal and business guidance they need.
- Our startup-VC team has experience working with entrepreneurs and their respective startups at all stages of a company’s life cycle in an outside general counsel role, including venture capital financings, formations, private debt and equity offerings, mergers and acquisitions, corporate governance, securities law compliance and commercial technology transactions. We offer strong experience to help you generate incredible value out of technologies.
- We provide strategic counsel that helps to minimize risk and maximize value on all key issues (investor issues, negotiating important terms in JDA’s and other agreements, setting up the portfolio for maximum returns, avoiding wasteful spending, etc.).
- McDonald Hopkins’ national Healthcare Practice Group offers Medtech companies the expertise to tackle almost any industry or legal challenge. For over 50 years, our firm has provided legal service to individuals and entities in the healthcare industry. Our national practice enables us to provide a unique perspective on the issues facing healthcare entities in the rapidly changing healthcare environment. We utilize our knowledge of the business, financial, and operational components of the healthcare industry to deliver value beyond traditional legal services. Our diverse services include counseling on business arrangements, transactions, regulatory compliance, fraud and abuse considerations, HIPAA and business associate privacy matters, data protection, litigation, restructuring, and more.
- The singular focus of our Intellectual Property department is to help our clients stay a step ahead. We provide powerful, cutting-edge legal and business expertise across all facets of intellectual property law. Our team of experienced intellectual property attorneys delivers a comprehensive range of innovative solutions and insightful industry expertise across a diverse group of technical disciplines.
The attorneys in our Intellectual Property Department help Medtech companies create, secure, maintain, and exploit every possible competitive advantage in the marketplace to grow their business. Our team can assist Medtech companies with a wide range of issues, such as filings, registration, maintenance, prosecution, and licensing agreements. Our full range of intellectual property services include:
Branding strategies and trademark
Entrepreneurial company services
Litigation and dispute resolution
Every client’s needs and goals are different – but with our hands-on, in-depth approach you get a team of attorneys who understand your business and provide customized service designed to meet your needs.
Medical devices, digital health & therapeutics
Our firm’s attorneys are dedicated to representing medical device, digital health, therapeutics/diagnostics companies, funds and financing sources that invest in or finance these Medtech businesses, research centers, and universities that develop and commercialize Medtech devices and services. The list of services on the right identifies all of the areas where we have provided legal services to Medtech companies and related businesses in the industry. That depth and expertise allows us to provide trusted advising services aligning our client’s business goals with sound legal strategy.
Our experience sitting on both sides of the table –from assisting entrepreneurs looking to raise capital to advising funds and capital providers looking to invest –gives you a unique advantage in the capital marketplace. If you are an early-or growth-stage company, you need to capitalize on all opportunities, commercialize technologies, and secure funding to get your feet off the ground. We can help with the formation and planning stage of your new enterprise and work with you through the structuring and negotiation of investment transactions. We have a strong network of investors and can provide introductions when needed to help your business grow –and to help build your human capital and strategic connections, too. As your business expands and grows, we can help advance your long-term vision and work with you on transactions with private equity and venture capital groups. When it comes to fund representation, we provide transactional support and advice on financing issues from the investor’s prospective. We have experience working with seed funds, private equity groups and venture capital firms.
In the capital markets arena, our attorneys are experienced in a wide range of matters, including the planning and formation of:
- Business start-ups
- Joint ventures
- Private offerings
- Mergers and acquisitions
- Compensation and benefits programs
- Outsourcing relationships
- Acquisition and development of intellectual property rights
- Creation and implementation of investment strategies and structures
Startup and venture capital
We take pride in our ability to understand the complex technologies and financial strategies that drive our clients’ businesses. Our wide-ranging industry knowledge allows us to represent startups’ cutting-edge areas of technology, including software-SaaS, e-commerce, biotech, cybersecurity, data analytics, social media, and many others.
At all stages of the startup life cycle, we focus on our client’s ultimate goal and take a practical, commercial approach to meeting our client’s goals, so the client (whether the founders or investors) can focus its most valuable resource –time and energy –on the collaborative work of building the next great startup. Moreover, we have dedicated M&A and capital markets practices that are ready to advise clients when exit and liquidity event opportunities arise.
We have an extensive network of founders, investors and established companies, and will often make value-additive connections to foster relationships, growth, investment and strategic opportunities.
For over 50 years, our firm has provided legal service to individuals and entities in the healthcare industry. Today, our diverse, national practice enables us to provide a unique perspective on the issues you face in the rapidly changing healthcare environment. We utilize our knowledge of the business, financial and operational components of your industry to deliver value beyond traditional legal services.
We work with a wide variety of individuals and entities in the healthcare field, such as:
- National, state and specialty healthcare societies and associations
- Clinical testing companies
- Concierge medicine
- Drug and pharmacy companies
- Dialysis centers
- Healthcare billing and management companies
- Healthcare product vendors and distributors
- Healthcare technology and biotech companies, including start-up ventures
- Home health providers
- Hospitals and hospital systems, including specialty hospitals
- Imaging centers
- Private equity and venture capital sponsors in healthcare transactions
- Banks and other financial institutions involved in healthcare ventures
- Long-term care providers
- Medical device companies
- Medical staffs
- Multi and single specialty clinics and groups
- National, state and specialty healthcare societies and associations
- Occupational medicine providers
- Pathology groups
- Physicians in all specialties (private practice and academic) and other healthcare professionals, including dentists, optometrists, podiatrists, and veterinarians
- Provider-owned managed care organizations
- Rural healthcare facilities
- Surgery centers, urgent care centers, and other free-standing medical centers
- Technology and IT healthcare facilities
- Dental service organizations and dental management practice companies
Our services to individuals and entities in the healthcare field include:
- Affordable Care Act counseling
- Antitrust issues
- Advice on the formation, acquisition, sale or merger of healthcare entities
- Counsel regarding antitrust litigation, including civil and criminal price fixing matters
- Assistance with Hart-Scott-Rodino filings and other interactions with regulatory agencies
- Corporate law
- Counsel with regard to accreditation and licensing issues
- Data privacy and cybersecurity
- Health Information Technology for Economic and Clinic Health Act compliance
- Design, drafting and compliance requirements of benefits and qualified retirement plans
- Estate planning
- Food and drug administration compliance and filings
- Fraud and abuse services
- Assistance with compliance with Medicare and Medicaid anti-kickback laws and Stark laws and regulations
- Representation in civil and/or criminal investigations of potential violations of fraud and abuse laws
- Representation and assistance in connection with Medicare, Medicaid or private payor audit investigations
- Development of arrangements that fulfill your business objectives while eliminating or minimizing fraud and abuse risk
- HIPAA compliance
- Healthcare business restructuring
- Joint venture, mergers and acquisition assistance
- Labor and employment advising
- Litigation representation
- Managed care contract review and negotiation
- Medical staff relation matters
- Medical staff bylaw requirements
- HCQIA and Joint Commission requirements
- Disciplinary proceedings and appeals
- Network affiliation assistance
- Developing or affiliating with other systems or networks
- Negotiation of financial arrangements, governance issues, antitrust review, licensure, representation and regulator compliance
- Real estate
- Advise on Medicare, Medicaid, TRICARE and commercial payor reimbursement
- Assist in the review and negotiation of hardware/software and billing contracts
- Tax-exempt matters
- Structuring of business relationships with private individuals or taxable entities
- Limitations imposed on contracts
- Transaction services
- Deal execution, with experience on transaction sizes ranging from $2 million to almost $400 million
- Overpayment demands, audits, appeals, internal investigations, prepayment reviews, payment suspensions
- Payor disputes
- Served as lead counsel, Biotech startup in $390M Series D Financing and $300M Series C Financing, and as point associate for the startup’s $900M Series B Financing
- Served as lead counsel in Medical Device startup’s $5M financing
- Assisted multiple medical device startups in an outside GC capacity (including several that have previously raised over $9M)
- Assisted Health Tech AI Platform in its formation, c-corp conversion and seed financing
- Represented Multiple Medical Device startups in commercial contract
- Served in outside general counsel capacity for startup providing physical and online-based Autism learning for children
- Served in outside general counsel capacity for startup creating an innovative software platform for dental practices, also assisted with formation, intellectual property
- Assisted a startup creating an innovative content-based software platform for cancer survivors in seed financing and outside GC capacity
- Assisted in patent, open source software, and agreement due diligence review of laboratory management technology and products.
- Assisted in patent due diligence review of next-generation sequencing technology and products.
- Assisted in patent, open source software, and agreement due diligence review of genetic testing technology and products.
- Assisted in due diligence patent and agreement review of medication delivery system “five-rights” checking technology and products.
- Patent clearance and prosecution for major healthcare companies in the infusion pump, blood collection / separation, and medication delivery system “five-rights” checking technology and products space.
- Advised client on FDA and regulatory compliance issues related to telemedicine dermatology services.
- Provided FDA and FTC compliance review of medical device product sales.
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