Venture Analysis

We assist product startups in developing a strong business case by identifying strategic opportunities, achieving prototype milestones, mitigating risk through our risk-analysis process, and validating business models to help entrepreneurs attract capital.

 

Regulatory

A clear and actionable regulatory strategy can speed the time-to-market, support fundraising efforts, and assist in obtaining FDA clearance. Our team of experts can help develop a plan for navigating the regulatory process whether it’s a home health product, medical device, surgical tool, or lab instrument.

Learn more about our ISO-13485 certification >

 
 

Root Cause Analysis

Isolating and analyzing the root cause of problems, at different stages of a product life cycle, are crucial for a product's long-term success. Our team can help identify problems, analyze solutions, and help you pave the way for the future of your innovation.

 

Quality Management

Our PCS+ Quality Management System underscores our commitment to continually improve our processes and ensure no issues are overlooked. This helps us reduce risk, meet regulatory requirements, improves time-to-market, and enhances product safety and effectiveness.

Learn more about our PCS+ Quality Management Policy Benefits >

 
 

Industry Expertise

 

Medical

Our experience spans home health, wearable tech, pharmaceutical delivery, point-of-care diagnostics, imaging and therapeutic ultrasound, photobiomodulation, and more.

Learn more about our Medical Device Development process >

Industrial

With experience ranging from industrial grade furnaces, to powered ascenders, to ocean-going mil-spec transceivers, we bring innovative design thinking to industrial products.

Consumer

From wearable fitness devices to crash-detection systems, we’ve successfully tackled a wide range of technical development challenges for consumer-facing products.

Lab Instruments

Mission-critical equipment is safe, efficient, durable, and easy to use. Product Creation Studio brings innovative design thinking to industrial products, developing equipment that impacts your bottom line.

Learn more about product development for your lab and test instruments >

Home Health & Wellness

Properly delivered, digital health experiences feel like magic. We combine medical expertise with consumer product development to help you deliver a home health and wellness device that is as easy to use as everyday digital products.

Interventional & Surgical Devices

We can help you maximize procedural success. Earn the trust of both medical professionals and patients alike with precision design, exceptional quality, and unwavering reliability with our medical device design expertise.

Learn more about our process for Interventional and Surgical Devices >

 

Resources

 

Newsletter

 

Latest Blog Posts

 

Case Studies

 

Ready to get started on your product?

Let Product Creation Studio show you how to bring your idea from concept to prototype to launch with a free consultation and technology analysis.