Arthur Spalding, TAMM Net, Inc., contract research organization, on FDA Approval, Clinical Trials, and Reimbursement for Medical Devices and Biotech (North Fulton Business Radio, Episode 944)
On this episode of North Fulton Business Radio, host John Ray welcomes Arthur Spalding, President of TAMM Net, Inc., a boutique contract research organization that helps biomedical inventors and companies navigate the final steps from laboratory to clinic. TAMM Net works with medical device, diagnostic, and pharmaceutical developers to conduct clinical trials, gain FDA authorization, and secure reimbursement from payers, addressing all three stakeholder needs under one roof.
Spalding brings more than 30 years of industry experience, including time at major firms like Pfizer and Parke-Davis, and now applies that large-company perspective to startups and emerging companies that often have brilliant science but limited commercial roadmaps. He shares a vivid example of a neurosurgeon who developed a device to safely rotate heavy patients during surgery, only to discover through Medicare claims data that over 30% of those procedures were performed by plastic surgeons, a market he had never considered. Knowing where the real market is, Spalding explains, is as important as the invention itself.
The conversation also covers the “lone wolf” problem, inventors who try to go it alone too long, and why investors in this space back the jockey, not the horse. Spalding describes how bringing in fractional C-suite executives early can dramatically improve an inventor’s odds of securing funding and completing the development journey before a patent expires.
John Ray is the host of North Fulton Business Radio. The show is produced by John Ray and North Fulton Business Radio, LLC, an affiliate of Business RadioX®, and is recorded inside Renasant Bank in Alpharetta.
Key Takeaways from This Episode
- TAMM Net serves as the “last mile” bridge for medical device and pharmaceutical inventors, integrating FDA strategy, clinical trial design, and insurance reimbursement planning in a single engagement rather than leaving each to a separate specialist.
- Inventors frequently overestimate how far along they are in the development process. Spalding’s team conducts gap assessments to help clients understand where they actually stand and what specific steps remain before they are ready to engage the FDA or enter clinical trials.
- Investors in the biomedical space back the jockey, not the horse, meaning the team matters more than the invention. Statistically, having one experienced team member who has successfully commercialized a product before can more than double an inventor’s odds of success.
- Rushing to get a device cleared through the FDA’s lowest-barrier pathway can backfire if the product requires stronger reimbursement or clinical evidence to succeed in the market. Strategic planning before going near the FDA often saves significant time and money by ensuring that all necessary documentation, clinical evidence, and reimbursement strategies are in place to meet market demands.
Topics Discussed in this Episode
00:20 John Ray introduces the show and guest Arthur Spalding of TAMM Net
02:11 Arthur Spalding describes TAMM Net and its role in medical device and pharmaceutical development
03:07 Spalding’s background and the “patient is waiting” mission that drives his work
04:10 TAMM Net as the “last mile” for inventors: bridging from lab to clinic
05:08 Why integrating FDA, clinical trial, and reimbursement strategy together matters
06:05 Lessons from a career spanning Pfizer, Parke-Davis, and hundreds of products
06:35 The neurosurgeon case: how Medicare claims data revealed a 30% plastic surgery market he had overlooked
08:19 The lone wolf problem and why no successful product has ever been built by a single person
10:45 What separates inventors who succeed from those who don’t, and the limits of ChatGPT for FDA reimbursement questions
12:24 Why AI tools can’t reliably answer CPT reimbursement questions: the AMA owns and licenses that data
13:00 Georgia’s biotech ecosystem and what’s missing to retain locally-developed innovations
15:23 When inventors need to start building their team and what that team should look like
16:28 Why investors back the jockey, not the horse, and how experienced team members change the funding calculus
17:20 The value of fractional C-suite executives for startups that can’t afford full-time leadership
18:11 Manufacturing timelines: why pharmaceutical manufacturing is often the longest bottleneck in the FDA process
19:17 TAMM Net’s gap assessment process and why inventors often misjudge how far along they are
21:13 The Texas client case: how a pharma-style clinical development strategy reshaped a medical device approach
25:07 Why thinking about reimbursement and strategy early, not just before approval, is critical
26:19 The most common mistake: rushing to clear a device without considering whether it will actually be used or paid for
28:03 When inventors should pick up the phone and call TAMM Net
30:06 A 2025 success story: helping a radiation-emitting device client get FDA authorization faster than expected
Arthur Spalding, President, TAMM Net, Inc.
Arthur Spalding has over 30 years of experience in pharmaceuticals and medical devices, with expertise spanning market access, reimbursement, clinical trials, distribution, regulatory affairs, market research, hospital sales, forecasting, and sales operations. He held management and director-level positions at companies including Parke-Davis, Pfizer, Solvay, and Columbia Laboratories.
In 2009, he founded TAMM Net, Inc., a boutique contract research organization serving biomedical manufacturers. Spalding holds a B.S. in Chemistry from Union College in Schenectady, New York, and an MBA in Health Administration from Temple University in Philadelphia. He also serves as a mentor at the Texas Medical Center, Georgia Tech, and Emory.
TAMM Net, Inc.
TAMM Net, Inc. is a boutique contract research organization offering comprehensive reimbursement and regulatory consulting services to biomedical manufacturers. The firm conducts clinical trials, including CMS-approved trials with health economics and outcomes research (HEOR) components, helps clients secure appropriate insurance reimbursement, including Hotline and Prior Authorization pathways, and gains FDA marketing authorizations and clearances, including QMS hosting and auditing. With an average of more than 20 years of experience per team member across multiple disease states, TAMM Net works with clients across North America, Europe, South Korea, and beyond.
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About North Fulton Business Radio and host John Ray
With over 900 episodes and having featured over 1,400 guests, North Fulton Business Radio is the longest-running podcast in the North Fulton area, covering business in our community like no one else. We are the undisputed “Voice of Business” in North Fulton!
The show invites a diverse range of business, non-profit, and community leaders to share their significant contributions to their respective markets, communities, and professions. There is no discrimination based on company size, and there is never any “pay to play.” North Fulton Business Radio supports and celebrates businesses by sharing positive stories that traditional media ignore. Some media lean left. Some media lean right. We lean business.
John Ray is the host of North Fulton Business Radio. John and the team at North Fulton Business Radio, LLC, an affiliate of Business RadioX®, produce the show, which is recorded inside Renasant Bank in Alpharetta.
The studio is located at 275 South Main Street, Alpharetta, GA 30009.
You can find the entire archive of shows by following this link. The show is accessible on all major podcast apps, such as Apple Podcasts, Spotify, Google, Amazon, iHeart Radio, and many others.
John Ray also operates his own business advisory practice. John’s services include advising solopreneurs and small professional services firms on their value, their positioning and business development, and their pricing. His clients are professionals who are selling their expertise, such as consultants, coaches, attorneys, CPAs, accountants, bookkeepers, marketing professionals, and other professional services practitioners.
John is the author of the five-star-rated book The Generosity Mindset: A Journey to Business Success by Raising Your Confidence, Value, and Prices, praised by readers for its practical insights on raising confidence, value, and prices.
