News and Other Events
May 5, 2025 – Regulatory Considerations: The Landscape
When starting a life science company, navigating the regulatory landscape is an early and important step. Regulatory authorities play a heavy role in approving and monitoring products — impacting how quickly you can reach the market and even shaping your business model. Because regulatory requirements demand significant time and investment, they are often seen as a key risk by investors. Being clear about them from day one not only builds confidence but can guide your fundraising efforts effectively.
Understanding the Regulatory Path
Each product type has its own pathways and rules. For biotech startups, knowing which agencies govern your specific category — drugs, biologics, devices, diagnostics, dietary supplements, animal therapeutics, or GMO crops — helps you plan realistic timelines and budgets.
Drugs, Biologics, and Vaccines
Generic drugs: Approved via an Abbreviated New Drug Application (ANDA). Generics rely on patents of innovator drugs having expired, and they mainly prove their product is like the original with proper manufacturing controls. ANDAs shorten time to market and cut costs dramatically.
Biosimilars: The FDA is developing standards for biologic “generics,” but achieving interchangeability (exact matching) for biologics is more complex than for small-molecule drugs. As of now, clear paths are evolving.
Medical Devices and Diagnostics
The FDA divides devices into three classes based on risk:
Class I: Low-risk (e.g., sunglasses); often exempt from full FDA review.
Class II: Moderate-risk (e.g., blood glucose meters); usually require pre-market review via a 510(k) clearance or sometimes PMA.
Class III: High-risk (e.g., heart valves); always require Pre-Market Approval (PMA), which demands evidence of safety and effectiveness.
A less stringent 510(k) clearance may apply if your device is substantially equivalent to a previously approved “predicate” device. The Investigational Device Exemption (IDE) allows clinical trials before final FDA approval.
Diagnostic Tests and CLIA
Some diagnostics reach the market as Laboratory Developed Tests (LDTs), created within CLIA-certified labs. CLIA certification is a non-trivial process that lets labs develop and use their own diagnostic tests. Startups sometimes partner with or build CLIA labs to use this approach.
Stay tuned for the next post where I’ll cover regulatory aspects for dietary supplements, animal therapeutics and devices, feed additives, veterinary biologics, and GMO crops.
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April 25, 2025 – Why Research the Market?
“If you build it, they will come.” It’s a nice thought, but in business, things rarely work that way. Many good ideas fail because entrepreneurs didn’t take customers into account. Before you invest time and money, ask yourself: If I build it, will they come?
Market research helps you find the answer by figuring out whether people will pay for your product or service and whether the market is big enough to support your business.
What Is Market Analysis?
Broadly, market analysis evaluates your product’s or service’s chance of success. It focuses on:
Market Size: This means how many units of a product are sold and at what price over a period. For example, in March 2025, about 1,525,200 new cars were sold in the US at an average transaction price of about $47,462 each, resulting in a total market value of roughly $72.4 billion for that month. Not all cars are alike. A luxury electric vehicle, for example, does not compete directly with an economy sedan. Tesla, however, once a niche player targeting a small segment of high-tech, eco-conscious buyers, now operates in a rapidly expanding and increasingly competitive market.
Customer Research: Once you know your relevant market, dig deeper to find out who your customers are, what they want, why they buy, and how they decide. Learning what motivates customers and what features they value helps you tailor your product and messaging. Trends here can tell you if demand will grow or fade.
Competitor Research: Know who else sells similar products or services. What are their strengths? Where do they fall short? This helps you refine your unique offering or decide if the market is too crowded.
Barriers to Entry: Some challenges make it tough to enter a market—like regulations (more on this later), customer habits, or big sales forces. Identifying these up front lets you prepare strategies to overcome them. Plus, these barriers can protect you from future competitors once you’re in.
Key Questions to Answer in Your Market Analysis
What product or service am I offering? How does it meet a specific customer need?
Who exactly are my target customers? What do they want or need?
What value does my product or service provide?
How big is the total market? More importantly, how big is the relevant accessible market now and later?
Who are the competitors? How do their offerings compare? How many customers do they serve?
What barriers exist to entering the market? How will I overcome them? How might these barriers protect me later?
Answering these helps you focus on real opportunities, reshape your product to fit the market, and avoid wasting effort on ideas that won’t take off.
In Short
Market research isn’t just data — it’s knowing your customers, your competition, and the real market you want to enter. It gives your business a much better chance to succeed.
So, before you build anything, start by asking: Will they come? Then do the work to find out.
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April 18, 2025 – Join Me at the INCubator Open House – A Hotspot for Entrepreneurs, Small Businesses & Investors!
I’ll be hosting a booth at the INCubator Open House on Wednesday, May 8th, 2025, from 9:30 AM to 11:30 AM at the INCubator in Chattanooga, TN. This event is a cornerstone of Chattanooga Entrepreneurship Week, bringing together bold entrepreneurs, growing small businesses, and savvy investors—all under one roof.
Why This Event Is a Can’t-Miss for You
Whether you’re starting your first business, scaling up, or scouting for your next investment, the INCubator Open House offers a unique chance to:
Meet Chattanooga’s vibrant entrepreneurial community and explore the innovative products and services they’re building.
Network with industry leaders, resource partners, and investors eager to connect and collaborate.
Showcase your company’s strengths—whether through a booth or simply by making powerful new connections.
Support and fuel the growth of Chattanooga’s startup ecosystem by forging meaningful partnerships.
What to Expect at My Booth
I’ll be there ready to chat, share insights, and explore how we can work together to drive growth and innovation. Whether you’re curious about intellectual property, technology and law, or just want to say hello, swing by—I’d love to connect!
Mark your calendar, get ready to network, and let’s celebrate what’s next for Chattanooga’s business scene together!
#INCubatorOpenHouse #ChattanoogaStartups #EntrepreneurshipWeek #SmallBusinessGrowth #InvestorConnections
https://chattanoogachamber.com/may-8th-incubator-open-house/
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April 17, 2025 – Business Formation: Choosing the Right Entity for Your Startup
Forming a company officially under State and Federal IRS rules is the first step to becoming a recognized legal entity. This entity shields the founders’ personal assets from liabilities, such as debts or lawsuits, that may arise from business activities. In this roadmap, we focus on two popular business types for startups: the Limited Liability Company (LLC) and the Corporation. Note, the term “C-Corp” refers to a tax status, not an entity type, though corporations are taxed as C-corps by default unless they opt for S-corp status.
LLCs and Corporations: What’s the Difference?
LLCs offer flexible tax options. A single-member LLC is generally ignored for tax purposes (a “disregarded entity”) unless it opts for corporate tax treatment (C-corp or S-corp). Multi-member LLCs typically face partnership taxation but can elect corporate taxation if they prefer. Corporations taxed as C-corps face what’s called “double taxation,” where both the company profits and the individual dividends are taxed.
Which Entity to Choose?
Startups often debate whether to form an LLC or a Corporation. Corporations are typically favored by professional investors, such as venture capitalists. However, LLCs may offer tax advantages to startups planning to generate early profits with minimal investment. Transitioning from an LLC to a corporation is feasible and, when handled by legal professionals, can be done within about a week.
Why Form a Corporation?
Corporations exist as independent legal entities owned by shareholders. This setup protects owners from personal financial risk if the business fails or faces lawsuits. This “limited liability” is the main protection corporations provide — your personal assets remain separate from business debts and obligations.
Why Opt for an LLC?
LLCs also offer limited liability akin to corporations but have the appealing feature of “pass-through” taxation. This means the company’s income is taxed only once at the owner level, avoiding the corporate tax layer. LLCs can also pass losses through to investors, which can be attractive to angel investors.
Tax Elections: C-Corp vs. S-Corp
Both LLCs and corporations can choose tax treatment as C-corporations or S-corporations. C-corps pay corporate taxes and are subject to double taxation — company profits taxed at the corporate level and again at the shareholder level when distributed as dividends.
S-corps pass income directly to shareholders, avoiding double taxation, but have limitations: Only one class of stock and up to 200 shareholders. Despite these perks, many investors prefer C-corps because the tax filing and compliance duties rest with the corporation itself, not the individual shareholders. Also, C-corps can issue multiple classes of stock — an important feature for financing flexibility.
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March 21, 2025 – Midtown IP featured on the Mountain Echo Podcast
Please check out my new podcast interview with Will Newberry at the Mountain Echo. In it, I share my journey from a space-loving youth in Huntsville to becoming a chemistry PhD and a leading IP attorney in Chattanooga. Tune in to hear how I'm using my expertise at Midtown Intellectual Property, PC, to support the industry and commerce of Chattanooga and its surrounds.
➡️ Listen now: www.themountainecho.org, Apple Podcasts