About Prime Path Medtech™
A supportive partner for innovators
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 to navigate smartly through the regulatory and business environment.
Shared service for small and medium sized companies
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.
WHY Prime Path Medtech™?
Prime Path Medtech™ brings together extensive experience, a cost effective model and a business outcome based approach that balances the need for regulation, business efficiency and cost effectiveness. We customize our approach so that our clients’ business goals are met.
- Prime Path Medtech™ has extensive domain knowledge through hands-on experience, industry insight and interaction. This is combined with a deep understanding of the client’s vision, technology, challenges, and plans. This sets the right context for meeting business goals.
- We can anticipate the challenges faced by a small or mid-sized company and provide smart solutions that are effective and cost efficient.
- We have worked at every stage. Our offerings include all the specialized services needed to launch to market. We can advise on high-level strategies, develop and execute projects, complete everyday activities, or anything in between.
- We have driven success for our clients with deliverables that match their business goals and timelines. From FDA approvals to ISO 13485 certifications and other regulatory, clinical and product development milestones - we have proof of outcome.
- We combine a professional and focused approach with a friendly, open and accommodating mindset.
- We are a good match with innovative companies who want to create new products or enhance existing product lines. We offer the flexibility and expertise needed for innovators to achieve their goals.
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
Studious. Just as she has relentlessly pursued both her Bachelor’s and Master’s degrees in Biomedical Engineering, Laura will study the ins and outs of your company. University of Hartford, BS – Bioengineering and Biomedical Engineering, Hochschule Furtwangen University, MEng – Biomedical/Medical 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
VP Buisness Development
Reliable. With over 20+ years of experience in customer-oriented solutions, Steve always puts the customer first. He understands that long-term relationships are built every day by understanding our client needs and by designing cost-effective quality solutions. University of Northern Colorado
Adaptability. 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 patients. Texas A&M University, BS – Biomedical Engineering
Creative. Combining state-of-the-art applications, digital design and her own ingenious talents, Katherine creates trainings and digital design for both Prime Path Medtech™ and Clients. She has a passion for storytelling, the original training format for ages. University of Oklahoma, BA – Creative Media Production
Have questions on what Prime Path Medtech can do for you?
What Our Clients Say
“What makes Prime Path Medtech truly exceptional is their business thinking mindset. Prime Path Medtech works as your true partner, takes interest in your business objectives and finds the right solutions for your needs.
I have lost count of the times Prime Path Medtech’s counsel was invaluable. Especially, when working with start-up ventures.
If there is such a thing as a resounding endorsement, look no further, this is it.”
CEO, Ortho FX
Prime Path Medtech’s vast industry knowledge and years of experience gives us the confidence we need when working with strict regulatory agencies.
They seamlessly worked with our team members from engineering to production to design to ensure we had the right quality systems in place. They treat us a partner and truly believe that our success is their success.
As we continue to take on new endeavors we will make sure to have the team at Prime Path Medtech with us every step of the way.
The Prime Path Medtech team are experts in the industry and really care about the companies that they work with. They are problem solvers and will work with you from start to finish to get results.
The breadth and depth of Bill’s industry knowledge has been hugely valuable to my company over the last year.
Choosing to work with Prime Path Medtech is choosing to have the best people in your corner. I highly recommend them-you will not find a better group of people to work with.