Pivot Medical
Steering Medical Device Development toward Better Patient Outcomes

The medical device industry is witnessing a remarkable transformation, where the convergence of clinical insights, end-user needs and engineering excellence is guiding medical device development toward a singular, profound goal of improved patient outcomes.

At the vanguard of this shift stands Pivot Medical, a company committed to guiding medical device manufacturers from the initial spark of an idea to the final product.

“We take on the task of translating user requirements into the precise engineering specifications and product performance criteria needed to ensure that the devices we are designing will truly make a positive impact in clinical settings,” says Jeff Larson, CEO of Pivot Medical.

Serving a broad range of clients, from startups to multinational corporations, Pivot builds strong connections with partners. Its approach involves thoroughly exploring the product’s clinical applications by understanding and translating client needs into precise specifications through continuous and interactive communication. This close engagement helps it gain a comprehensive understanding of project requirements.

Pivot brings field-specific expertise spanning various devices, including neurovascular interventional devices and large implant delivery systems. It takes on many projects, from prototype development to extensive engagement in full-scale product development, for products subject to FDA oversight. Regulated products follow a structured development process that includes various ‘phase gates’, to ensure product efficacy, safety, and plan adherence.

When it comes to project acceptance, Pivot adopts a highly selective approach. Instead of becoming overwhelmed by many projects, it focuses on a select few that offer substantial advantages to clients. This allows it to dedicate equipment and resources to its selected projects, avoiding the challenges of conflicting project priorities and the constant juggling of tasks. It also leads to speedy progress and the flexibility to implement swift adjustments, resulting in multiple design iterations.

A notable aspect of Pivot’s work involves devising and validating testing methods for products. Testing is done within its facility to closely emulate the clinical environment without resorting to expensive, intricate simulations or animal studies. This enables the company to work swiftly, enhance product quality and manage costs effectively.

In a specific instance, Pivot embarked on a project involving a neuro-interventional device, initially conceived as a basic concept at the feasibility level. Within a relatively short period of about six months, the initial concept was transformed into a fully functional device that surpassed the performance of the leading device in the neuro-intervention market. All of this was accomplished within a tight budget and a short timeframe, making it a remarkable accomplishment.

Pivot’s inventory management is a key factor that sets it apart. By maintaining a well-stocked inventory of materials and components tailored specifically for these development efforts, it eliminates the time that would be spent procuring materials for each, new project. This allows them to initiate projects promptly and iterate rapidly, all more cost-effectively than industry peers.

Another point of pride for Pivot is its financial independence and ownership structure. Pivot is debt-free and founders-owned, which provides security for clients, assuring them that their technology and ideas will remain protected from exposure to parties not involved in its business operations.

A different approach is adopted from the industry norm of assigning projects to less experienced engineers, with senior personnel oversight. True to its name, Pivot strongly emphasizes hands-on involvement by its top staff throughout an entire product development process, ensuring a more engaged and experienced approach to project execution.