LEARN. PREPARE. SUCCEED.

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LEARN

Our coaching program provides in-depth analysis, along with an educational overview, of your company's digital health or mobile health product current and potential posture within the FDA and the costs associated with regulation

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PREPARE

The Tenzing Group's expertise is in carefully creating product and end-goal specific regulatory strategies that will help you prepare for any future costs or challenges that could arise from working in a regulated environment

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SUCCEED

Once you have learned about the regulatory process and prepared for the future, you can showcase your knowledge to potential investors and use our strategies to help ensure future success in this growing market

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FDA Regulatory Coaching

Our comprehensive analysis begins with a consultation meeting to review your application’s benefits, your target market, business and marketing strategy and language, and your development process. We will then look to current, pending, proposed, and rumored regulations to determine if and/or when your product will fall under FDA jurisdiction. We will provide detailed definitions and background to help you to better understand why your product falls within a specific category and class. Most importantly we will inform you of your obligations as a medical device including registration and reporting requirements as well as what the 510(k) process entails. Since many medical devices can fall under differing regulations, we will also inform you of changes you can make, both short and long term, to limit your regulatory burden. All of these tools can be the propelling force that allows you to separate your product from the competition

Start-Up Counsel

Because we are a start-up ourselves, we understand the need for early legal help during the initial stages of a company's formation. As an extension of corporate legal and regulatory departments we often provide advice and assistance on matters outside of FDA regulation and more tailored to common legal issues facing start-up healthcare companies. Because an in-house counsel is sometimes an expensive initial expenditure we can provide outsourced advice on a range of issues both healthcare focused and business focused. On the healthcare front we offer HIPAA and privacy law analysis, anti-kickback and Stark law interpretation, BAA agreements, and Medicare and Medicaid reimbursement overviews. On the business side our additional offerings include contract creation, review, and interpretation, partnership and client negotiations, and corporate governance review. We also provide employment contract review and stock options and vesting plan creation as well. Having a legal counsel in the early stages of development can help ensure compliance with the relevant laws and save you time and money in the future.

Helping with Additional Product Strategies

Our background includes more than 20 years of combined health information technology, digital health, and mobile health experience. Our advisors have education and practical experience in a number of fields including marketing, finance, economics, and law. We leverage our knowledge to provide additional product strategies on top of our regulatory coaching. We can help you and your company with domestic and international market research, customer acquisition and retention, appropriate pricing strategies, product development and functionality, branding, and go-to-market strategies. We also have cultivated an extensive network of strategic partners to better help our clients with any issue that may lie outside of our areas of expertise. We provide only the highest quality advice and pride ourselves on offering the best solutions while incorporating any end-goals that you and your company might have. Using us will definitely help you learn, prepare, and succeed in this thriving market.

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Consult. Research. Develop. Inform.

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Once you determine that our program is right for you, we will meet with your team, either online or in person, to get the necessary background information on your mobile medical application. This includes your product’s objectives, past and present business practices, development strategy, and marketing techniques, all covered by a complete NDA. These are all critical factors that go into your FDA classification

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Once we have the necessary information we will conduct extensive research on how the FDA has or will view your unique product. We look to current, pending, and proposed regulations as well as market trends to adequately predict what classification and definition your healthcare product will meet. We will also examine the requirements for each classification and compare those with your current business practices

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Next we will create a uniquely tailored and easy to read report that outlines the FDA’s classification process for medical devices and the subsequent requirements. We will include a spreadsheet overview for quick reference of the traits that are important for your MMA as well as a definition list and executive summary. The report is yours to give to anyone that might be interested

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Lastly, we will meet with you again to go over the report and highlight its most important aspects while answering any questions you might have. We will pinpoint the exact changes that should be made and how they relate to total costs and FDA regulation in general. Having us there to go over your analysis is key as a complete understanding of the regulatory process is necessary to adequately prepare

The Inspiration Behind our Founding

To travel, to experience and learn: that is to live.
Sherpa Tenzing Norgay
  Tenzing Norgay

 

Tenzing Norgay

Tenzing Norgay, one of TIME Magazine’s 100 most influential people of the 20th century, was an experienced mountaineer and Sherpa who holds the great distinction of guiding Sir Edmund Hillary on the first successful ascent of Mt. Everest. Norgay started his climbing career at 20 when he seized upon the opportunity to join an English reconnaissance mission studying Mt. Everest in 1935. After numerous expeditions and attempt to summit Everest, Norgay joined John Hunt’s team in 1953. The group set up base camp in March 1953 and Hunt directed two climbers to try and reach the summer. Unfortunately their oxygen system failed forcing them to turn back but not before coming within 300 feet of the summit. Norgay and Hillary were the next pair to try the ascent and on 11:30 a.m. May 29th, 1953 the two became the first people to reach the top of the world. Norgay would go on to receive world-wide praise for his role in guiding the expedition to the top of Everest

Creating Pathways to Success

 
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His role as Sherpa for the successful expedition took immense courage, fortitude, and most importantly a vast knowledge of the dangerous Himalayan terrain. We chose the name Tenzing Group as homage to this great and inspiring guide. We view our role as one that is very similar to that of a mountaineering Sherpa. Our goal is to guide new companies through the treacherous terrain that is governmental regulation by informing these companies of the best possible paths that will provide them with the easiest and most cost effective paths through the regulatory process. By imparting our knowledge of FDA regulation to these start-ups they can successfully transition from product development to regulated entity with the least amount of risk and the greatest chance of success. Our company started in October 2012, but we have been interested in health information technology, specifically the laws behind its adoption and regulation for years prior. 

We want this industry to continue to thrive and benefit the public, so we made it our mission to study healthcare regulation and equip these companies with the tools necessary to achieve success. Our goal is decrease the amount of companies that are doomed to failure because of regulatory costs and maximize those that can make the transition so the MMA market can thrive and the public can continue to benefit.

Ryan Minarovich J.D., Hunter Hawkins J.D., Vijay Bal J.D., M.B.A

 

Partners

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Ryan Minarovich, J.D.
CEO & Co-Founder

Ryan has extensive experience in health information technology and has a passion for helping MMA entrepreneurs understand the regulatory laws

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Hunter Hawkins, J.D.
CFO & Co-Founder

Hunter uses his expansive educational background in business and finance to help start-ups merge their regulatory and business strategies.

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Vijay Bal, M.B.A
VP of Business Operations and Analysis

Vijay’s experience, including his MBA and JD, help clients to identify and solve problems in finance, operations, and marketing

Interested in working together? Here's our contact info.

 

The TENZING GROUP, LLC

9245 Twin Trails Dr. Ste. 207
San Diego, CA 92129

858.449.9106