We share values with our client innovators who have an outcome-driven mindset to improve lives through their products. Our partnership model aligns with business outcomes as a supportive partner that guides the client as we navigate together through the regulatory and business environment.
Shared service for companies of any size
Medical device companies need the full breadth of expert services over the different stages of the regulatory process, but find it infeasible to have a full-time in-house team. This is specifically challenging for small to medium size companies who end up either underutilizing expensive in-house resources or find themselves lacking the right level of expertise.
The shared service model provides the perfect level of expertise that’s constantly updated based on the experience of multiple clients. The pool of experienced resources available offers higher quality and a quicker response time. The shared service model ensures that different skill sets are available for different periods to match the needs of the client. In this model, the cost for the pool of resources is shared between different clients, and results in cost efficiency for individual clients.
Meet the Team
Our team brings together extensive experience, rich skill sets and specialized qualifications. The team adopts an approach of continuous learning through research and interactions with ecosystem partners. The team is efficiently integrated through the experience of working together on multiple projects along with a shared understanding, culture and processes.
Bright. Specialized in program management of complex engineering, software, or clinical research projects. Her ability to translate business objectives to engineering specifications is what sets her apart. University of Connecticut, BS – Chemical Engineering, Purdue University, Ph.D. – Biomedical Engineering
Meticulous. The key to success for most things is twofold, attention to detail and resounding grit. These skills complemented with Jennifer’s ability to lead multi-function teams with ease, make her the ultimate project manager. University of Minnesota, BS – Biomedical Engineering and Physiology
Astute. Able to assess the whole picture of a complex problem, Janice can quickly find the most subtle details and create clever solutions that work for the client. Her willingness to explore any solution and build upon it, is perfectly suited to the fundamental nature of start-up companies. University of Memphis – Biomedical Engineering
Friendly. Karla is eager to work with your team to tackle the complex challenges that come with running a medical device company, and no matter how difficult the problem, she will approach it with a solution and a smile. The University of Texas at Dallas, BS – Biochemistry
Experienced. He has led several start-up teams to successful business exits valued from $50 to $100 million. Bill has served in executive management roles for Fortune 500 companies and start-ups. He understands your needs and situation because he has lived them. Texas A&M University, BS – Biomedical Engineering
Service-Oriented. Her relentless passion for excellence in customer service and strong technical knowledge, make Elisabeth a valuable resource for any client team. Michigan Technological University, BS – Biomedical Engineering and Polymer/Plastics Engineering
Adaptable. Blending complex processes and regulatory requirements and adding the right degree of business understanding creates success. Sarah embraces innovative solutions while applying the needed regulatory compliance to create real world solutions for clients. Texas A&M University, BS – Biomedical Engineering
Proactive. Consistently takes initiative, moving projects forward and implementing solutions to reach final success for the project. Passionately devoted to her clients’ needs, Logan ignites connections and delivers remarkable value. University of Toledo – Biomedical Engineering