Social Connection

"I would rank AMxTek LLC as one of
the most insightful and focused
teams with whom I've partnered.
"

~ Ross Ian Garrett, Ph.D.
Sr. Director of Research
Zimmer Biologics

CLIENTS OF AMXTEK LLC

AMxTek Corporate Clients have included:
> Orthopedic Implant Companies
> Hospital & Medical Supply Companies
> Wound Care Product Companies
> Specialty Chemical Companies
> Early-Stage Medical Device Companies
> SBIR/STTR Awardees
> Food Industry Companies

TESTIMONIALS

“Jim is an excellent strategic planner with a very successful track record of identifying and executing on key product development opportunities in the medical device and drug/device combination fields. I had the privilege of working for and with Jim in the forward looking application of effective infection control technologies applied to a wide variety of medical devices. His leadership drove technology development matched to given product platforms, vital efficacy testing and key support of successfully addressing emerging regulatory requirements in the antimicrobial field. A key example is Covidien’s Kendall AMD wound care platform; Jim first identified this need as an opportunity to markedly reduce the risk of infection in open wounds. His team identified a novel disruptive technology, effectively applied that to a wide variety of wound care products at a cost well below emerging competition and steadily built the clinical evidence that established it’s benefit in improved clinical outcomes. The result has been a market-leading platform that has covered 10’s of millions of wounds with revenues far exceeding $ 100 million."

~ David Fink
[Formerly] Director of R&D
Covidien



"I had the pleasure of personally interacting with Jim whilst we both worked at an orthobiologics company.  Jim is one of those rare individuals with unquestionable moral ethics, character and above all honest.  He is a trustworthy and creative individual who performed a pivotal role in bringing our orthobiologics products to market with unprecedented swiftness.  Unreservedly, I would highly recommend and personally utilize Jim’s expertize to spearhead projects where measurable expectations and extraordinary results are mandated.   If you would like to further discuss Jim’s qualifications, I welcome the opportunity to share a plethora of positive experiences that will undoubtedly impact the success of your organization."

~ Jesus Hernandez, CEO
CellRight Technologies


 

I've worked with many, many consultants over the years, and I would rank AMxTek LLC as one of the most insightful and focused teams with whom I've partnered. James Walls of AMxTek effectively challenged our thinking on anti-infectives for orthopedics, and his insights played a critical role in moving an anti-infective project forward at Zimmer.  With Jim's extensive knowledge of both the science and regulatory pathways in this area, AMxTek was able to effectively guide this project forward resulting in a major progression of this internal program. I would recommend AMxTek LLC to any company that is challenged to make a difference in the device related anti-infective space.

~ Ross Ian Garrett, Ph.D.
[Formerly] Sr. Director of Research
Zimmer Biologics


 

“I have known and worked with Jim for 15 years in my capacity as President of Surface Solutions Labs Inc. The medical device field demands a wide variety of technical disciplines and expertise. Jim and I have interacted on several anti-infective coating, combination product medical devices. Jim not only has a good understanding of coatings but one of the best understandings of infection control and antimicrobial technologies of anyone in the business. He has also championed the regulatory strategy and pathway for some groundbreaking FDA submissions. If I ever need expertise or guidance regarding infection control, antimicrobial technologies, combination products, or the regulatory process for such medical devices, Jim is the first person I contact. He simply knows more about this field than anyone I know.” May 1, 2010

~ Margaret (Opolski) Palmer
President, CEO & Owner
Surface Solutions Labs Inc.


 

“Jim’s experience in antimicrobial technology development and his regulatory understanding especially FDA’s expectation in relation to 2007 draft guidelines for combination devices were very useful for us at a crucial time of the project.  His involvement and guidance brought right focus back on the project.” 

~ ‘Anonymous’
R & D Manager
Major Medical Device Company