Medical Device Consulting
Sullivan Cole provides tailored medical device consulting services to help you achieve your business objectives.
From product inception through ongoing post-market support, we partner with you to meet your needs while maintaining the highest standard of quality and regulatory compliance.
SERVICES
LEADERSHIP & ORGANIZATIONAL DEVELOPMENT
Regardless of the scope of your project or the size of your organization, building the right team is the foundation for achieving success. Defining your strategy for talent to compliment your business plan is essential. This involves understanding your resource needs, identifying the unique qualifications and experience that are necessary, and planning for when specific talent is required. Timelines and budgets are tight, while compliance is an ever-present responsibility that cannot be ignored. Establishing a diverse and cross-functional team sized to meet the demands of the business at just the right time is the only way to foster success.
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If your organization needs an experienced leader, to support building your team, to advise on reorganization needs, to lead a specific project, or to step into an interim functional role Sullivan Cole will provide the leadership and management services you need.
PRODUCT DEVELOPMENT
The goal of Product Development is to deliver a safe and effective device that efficiently achieves its intended use while meeting user needs.
For your organization Product Development must also achieve business goals. Market acceptance, introduction timing, and resource demands are critical factors in whether the Product Development effort is ultimately a success.
A robust and formal Product Development approach should support both the business need and the quality and regulatory requirements. Sullivan Cole will help you establish and follow an effective, repeatable, and compliant process to meet your business goals while achieving compliance.
QUALITY MANAGEMENT
As a medical device company, you have a responsibility to ensure that your products are safe, meet the requirements you claim, and are compliant with the regulatory standards governing the countries in which you market, sell, and distribute product.
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Defining and documenting your organization's Quality Management approach and commitment is essential to ensuring that you design, produce, and distribute product(s) that are safe and effective.
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Sullivan Cole will help you establish and/or refine a Quality Management System (QMS) that is appropriate for your organization and its operation.
PROCESS ENGINEERING
Production processes must be monitored and controlled such that resulting product conforms to the predetermined design specifications. The scope of the production process is quite large, including the environment, facilities, personnel skill level, raw material compatibility, cleaning steps, etc. which are all in addition to the manufacturing steps themselves.
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Sullivan Cole will help you evaluate the production process, define process specifications and determine the required process controls. We can also support all aspects of process validation and establishment of calibration and maintenance programs.
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ABOUT
Tina Hudson
Tina is a twenty-plus year veteran of the Life Sciences industry. Having spent her career initially within Fortune 500 companies and then moving to start-up and smaller focused businesses, she has gained unique insight into the different perspectives and challenges that exist across our industry landscape.
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Leading across a broad spectrum of focus areas and diverse company structures has cemented her passion for meeting people where they are and adapting her experience and knowledge to steer organizations through their unique journey.
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During her twelve-year tenure at Roche, Tina held a range of operational engineering roles with progressive scope and leadership responsibilities. Her teams were responsible for product and process design, design transfer, manufacturing, partner relations and ongoing product lifecycle management. She led a Project Management Office (PMO) that launched over 150 new product introductions spanning across multiple life science areas (assays, instruments, software and point-of-care devices).
Tina has led PMO, engineering, quality and operational departments at start-up and small diagnostic companies. She has product development experience with in-vitro diagnostics, software and a variety of devices, leading multi-functional teams from product concept through successful FDA clearance. Her expertise also includes cGMP manufacturing and process validation (prospective and retrospective) for high volume automation and low volume batch manufacturing. She has established and audited Quality Management Systems (QMS), wet-lab operations and supported CLIA lab accreditation.
Throughout her career Tina has been a strong champion of continuous improvement methodologies (DMAIC, LEAN) resulting in improved quality, waste reduction, and increased efficiency. She is also an advocate for a risk-based approach to operations. Utilizing risk management principles and tools (FMEA, PHA, Ishikawa) to systematically identify and mitigate the impact of potential product hazards and business and manufacturing related risks.
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Ultimately the work is about the people and Tina is most proud of those experiences where she was able to assemble the talent necessary to build a cohesive and successful team. She has multiple times been asked to build functional departments from inception, honing the skills of assembling the right mix of talent and personality to achieve results. Whether launching a new product or taking manufacturing to a new level, it requires a team that will persevere through the most challenging of obstacles, be relentless in the pursuit of their goals, and be humble to continuously learn and grow with each step forward or backward.
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Tina has a BS degree in Chemical Engineering and spent the first part of her professional career with Eastman Chemical Company.