Practice Group
Medical Devices and Biotechnologies
Experienced experts supporting strategic objectives while strengthening leadership, operations, cultures and reputations.
Addressing Needs and Challenges
Our trusted advisors are recognized authorities in their areas of expertise, many with more than three decades of medical device and biotech industry experience working inside enterprises similar to yours. They’ve sat in your seat and have known what it’s like to address concerns from inside an organization. We use that experience to work hard to find great solutions that benefit you.
- We communicate frequently and transparently with you and your team about goals and progress.
- Our strategies help leadership and staff to succeed, and to hold themselves accountable for that success.
- We measure and monitor progress regularly and offer reports that let you change course and redirect resources when necessary to eliminate processes that aren’t working and amplify those that are.
- We help you to streamline operations for greater efficiencies that can improve the effectiveness, quality, speed and customer focus of your teams, and so much more.
“With over 100 years of combined leadership experience inside international medical device and biotech companies our team of skilled professionals understand the dynamics of your position, your goals and your challenges, and work closely with you to support your success.”
– from Jeffrey Miller, Director-in-Charge
Products & Services
- Risk assessment, measurement, and mitigation
- Compliance controls and programs, assessments, and benchmarking
- Information privacy controls, and programs, assessments and benchmarking
- Product development and access, including clinical research, regulatory engagement, coverage,
and coding and reimbursement strategy and execution - Product marketing and promotion
- Professional compensation and relationships
- Customer contracts and relationships
- Interactions with government officials
- Education and educational support
- Charitable donations
- Third party contracted research, manufacturing and sales organizations
- Open payments and transparency
- Mergers and acquisitions
- FDA and notified body regulatory quality system compliance
- Government audits and inquiries
- Internal investigations and audits
- Litigation support
- International business compliance
- Remote, part time, and interim Compliance and Privacy Officers
Success Stories
As a specialized medical device company, we commit ourselves to fully compliant business and regulatory practices in the US and in each market we serve around the world. The experts at Granite GRC have the scope and depth of experience to meet our needs in an informed, efficient, and timely manner. The Granite GRC team gives us personal – and scalable – attention in support of our strategic objectives, while helping strengthen our culture and reputation.
– from Steven F. Murray, Chief Executive Officer, Centinel Spine
I’m fortunate to have worked with Clivetty Martinez and Jeff Miller, two highly effective compliance and privacy professionals at Granite GRC. Together with them, my organization and I were able to effectively grow our business while fully complying with country-specific laws and internal company directives across Latin America. The key to their impact lies in their understanding of the business, their knowledge of laws and regulations, but above all in their ability to relate to, and communicate with the organization in a way that helped us all understand how to operate correctly and effectively in a highly competitive market. I recommend their work to any company seeking to establish or improve their compliance related activities around the world.
– from Alfredo R. Granai, Former President DepuySynthes LatAm, Companies of Johnson & Johnson
Meet the Medical Devices and Biotechnologies Team Leads
Jeffrey Miller, Esq.
Director-in-Charge
Jeffrey B. Miller, Esq. is a trusted advisor for clients across the business spectrum, with an emphasis on businesses involved in healthcare and the life sciences, and their supporting service providers and suppliers. Working with clients that range from start-up organizations to large, complex international conglomerates, Jeff collaborates with organizational owners, board members, financial backers (including private equity), executive management and staff of all levels to strategically address corporate governance matters and challenges, risk identification, mitigation and management, information privacy, cyber security, payment, reimbursement and revenue integrity, and corporate ethics and compliance. Jeff’s services focus on improving the effectiveness, quality, integrity, compliance, speed, and efficiency of organizational operations, while enhancing company value.
Ken Geskes
Director, Quality Systems and Compliance
Ken Geskes, Director, Quality Systems and Compliance, is an experienced life sciences executive and consultant, who brings more than 40 years of skills and insight to the Quality Systems and Compliance practice group. In addition to having expertise in quality system design, implementation, assessment, and remediation experience, Ken has managed operational activities associated with initial design concept through production, labeling, marketing, distribution, and post-distribution activities. This includes on site experience across the US, Canada, Europe, the Middle East, Latin America, and Asia and includes firsthand experience with both face-to-face and behind the scenes activities associated with regulatory and notified body audits.
