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Kinetic Compliance Solutions

Kinetic Compliance

Kinetic Compliance Solutions, provides legal and regulatory services in the highly regulated health technologies industry, specializing in medical devices. From healthcare compliance and contract negotiations to regulatory strategy and FDA submissions, our combined 20 years of in-house experience provides clients with a continuum of services as they grow. Our mission is delivering flexible, pragmatic and cost-effective legal and regulatory solutions via a modern service model to give our clients a competitive edge. Also, we partner with our clients to provide the personalized attention and responsiveness that they need in order to free them up to focus on innovation and growth.


BizStarts of Milwaukee is excited to present the January 2017 Featured Entrepreneurs, Jana Gerken and Robin Martin. Each month, BizStarts highlights an entrepreneur and their company to provide inspiration to other Milwaukee entrepreneurs.

 

What is your professional background?
Robin Martin – I have been in the medical device industry for ten years, including eight years of regulatory experience with a variety of medical devices (U.S. FDA Class I – III). I worked at GE Healthcare in a variety of regulatory roles / businesses and before that a small device company that had IDE clinical trial, premarket approval (PMA) and 510(k) submission work. Through my previous work I’ve been fortunate to gain experience in working with FDA as well as global submission experience (CE mark, Brazil, China, Japan, Russia and rest of world). Previously My educational background is in biomedical engineering from Marquette University.

 

Jana Gerken – I have practiced law for over twenty years, including in the medical device and life sciences industries. I started out at major law firms in New York City, where I represented clients of all sizes and in a variety of industries. I then went in-house to join GE Healthcare, where I worked in both in the life sciences and the medical device businesses. My last position at GE Healthcare was General Counsel of the diagnostic imaging businesses (X-Ray, CT & MR)). In that role, I was the primary point of contact for the business on all global strategic matters. I have a law degree from Seton Hall University and am admitted to the bar in New York, New Jersey and Wisconsin
What product/service does your organization sell?
We are a boutique consultancy specializing in the highly-regulated health technology space – our unique combination of legal and regulatory services provides wholistic solutions covering a the many and often gray areas in this highly-regulated compliance continuum.

 

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What challenges have you experienced professionally, and how did you overcome them?
Like many entrepreneurs, we left stable jobs and took leap of faith to follow our passion. Despite the inevitable ups and downs we have no regrets and are more committed than ever to our mission.
What has been the most rewarding about running your own business?
The personal and professional growth has been extremely rewarding. Starting a business has been both challenging and invigorating. We are learning every day and are continuing to meet many inspiring people who are equally passionate about making a positive difference and helping to bring life-saving technologies to market. Our value-add is to help our clients build a strong foundation from the start in order to proactively manage risk and enable sustained, long-term growth. We want to be their trusted advisors of choice in order to support them in reaching their goals.
What are your goals for 2016? How do you plan on achieving your goals?
At this point, we are looking more at the goals for 2017, which include continuing to build relationships and our client base. We rely on word of mouth referrals and have invested a good amount of time into spreading the word about our new business to let people know that we are here to help. We are already starting to see the fruits of our labor on that front and are excited about continuing on this trajectory in 2017.
Where do you see your company in 5 years?
Achieving and surpassing our growth targets while staying true to our core values of supporting innovation with personalized and cost-effective solutions – always with unyielding integrity. And at the right point in time, we hope to be able to expand our team of experts.
How has BizStarts helped you and/or your organization grow?
We were honored to be part of this article. When we contacted BizStarts, they immediately wanted to understand our business so as to connect us with others operating in the health technology space. That type of support is necessary and truly appreciated during the critical start-up phase we are currently experiencing.
What advice would you give to other entrepreneurs?
Passion and patience. The latter is something we realized quite early into this adventure that both of us lack! Always remember why you decided to take the leap of faith in the first place. Try not to sweat the small stuff and remember to “pay it forward.” And most importantly, be flexible to adjust and adapt while always staying true to your values

 

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