Boulder BioMed Secures FDA Clearance, Market Launch for Embolization, Inc.

Case Study Boulder BioMed Secures FDA Clearance, Market Launch for Embolization, Inc. Integrated family of services takes multi-year struggle to successful product launch   Boulder BioMed is a vertically integrated medical device development company. The family of expert contract consulting businesses provides life sciences companies all the resources they need to bring products to market, […]

The Truth Behind Investor-Investee Relationships – Part 5

The Truth Behind Investor-Investee Relationships On the hunt for funding? Step 5: Know the importance of real-world testing Fifth in a five-part series   In the fourth part of our series on helping early-stage med device companies that are seeking funding, we talked about the advantages of external involvement in the early stages of product […]

The Truth Behind Investor-Investee Relationships – Part 4

The Truth Behind Investor-Investee Relationships On the hunt for funding? Step 4: The advantages of external involvement from the beginning Fourth in a five-part series In the third part of our series on helping early-stage med device companies that are seeking funding, we examined what really happens once a funding agreement is in place and […]

The Truth Behind Investor-Investee Relationships – Part 3

The Truth Behind Investor-Investee Relationships On the hunt for funding? Step 3: The celebration – and the end of the honeymoon Third in a 5-part series In the second part of our series on helping early-stage med device companies that are seeking funding, we talked about common investee perspectives and expectations on the process. Here, […]

The Truth Behind Investor-Investee Relationships – Part 2

The Truth Behind Investor-Investee Relationships On the hunt for funding? Step 2: The investee’s perspective Second in a 5-part series   In the first part of our series on helping early-stage med device companies that are seeking funding, we talked about the importance of understanding investors’ perspectives. Balancing that with the typical investee’s perspective can […]

The Truth Behind Investor-Investee Relationships

The Truth Behind Investor-Investee Relationships On the hunt for funding? Step 1: Understand investors’ perspective First of a 5-part series   The funding process is full of excitement, anticipation, expectation – and trepidation. Understanding the investor’s perspective can make all the difference in how you approach and tailor your efforts, and ultimately in how well […]

MPO Summit 2025

MPO Summit 2025 Sept. 24, 2025 MPO Summit describes itself as a boutique-style event that provides an environment for in-depth discussions on issues relevant to those involved with the development and manufacture of medical devices. Based on my recent experience in San Francisco, the Summit lived up to its description in a big way. At [...]

Boulder iQ Leads Embolization, Inc. to 501(k) Clearance for Non-Metal Coil Device

Boulder iQ Leads Embolization, Inc. to 501(k) Clearance for Non-Metal Coil Device June 25, 2025 Embolization, Inc., is the latest company to receive 510(k) clearance with the development and regulatory work provided by Boulder iQ and its sister company, Boulder Regulatory and Quality. Embolization’s Nitinol Enhanced Device (NED) is a vascular embolization device intended for […]

Speed-to-Market Focus Prevails at MD&M West 2025

Speed-to-Market Focus Prevails at MD&M West 2025 March 17, 2025 Boulder iQ once again exhibited at the MD&M West show in Anaheim, California, this year. Described as an event where industry professionals can “advance their knowledge, contacts, and progress in the rapidly accelerating world of advanced manufacturing,” MD&M lives up to its promises. More than […]

BIOMEDevice 2024: Innovation in Med Device Development

BIOMEDevice 2024: Innovation in Med Device Development December 6, 2024 BIOMEDevice claims to be a “one-of-a-kind” expo and education event that “brings together the brightest minds in the industry to demonstrate and discuss emerging trends, innovation, and disruptive tech changing the future of the medical device industry.” Its claims are true, if my experience is […]