Progressive Gating
About Us
Tools provided by Progressive Gating are geared toward delivering key product lifecycle management (PLM) safeguards tailored to help medical device start-ups and smaller organizations in their journey through product development. These safeguards are primarily meant to drive sound business decisions along the rigorous PLM journey.
Our founder’s extensive experience in medical device product development and operations has provided unique perspectives on how best to avoid critical mistakes while navigating PLM stages. Progressive Gating’s Business Product Lifecycle Management (B-PLM) Process* and Tools are designed to address the unique challenges faced by start-ups and smaller businesses today. They have been developed from decades of experience and made further comprehensive by the emergence of artificial intelligence.
All large companies in the medical device industry (and in many other industries) utilize rigorous PLM stage gate processes. These processes provide ways to adhere to regulatory requirements, are typically comprehensive, and design control focused (technical reviews and decisions). These large company processes are often very complex from a process and deliverables standpoint, with business-side process deliverables included to safeguard spending, drive confidence in launch readiness, among many other critical needs.
Business-sided PLM processes are often deficient, or even absent, early in the life of an emerging company. This deficiency creates risk of financial failure, with this risk growing through every stage of the PLM journey. As each PLM stage advances to the next, capital spending increases. Capital spending especially grows as product development enters transfer to operations and readiness for launch.
Progressive Gating is here to assist emerging medical device companies place business-sided safeguards in the product development efforts in the form of B-PLM Process and Tools, easily deployed through every stage of product lifecycle management.
*B-PLM Stages and Gate Reviews are not associated with design control. Please review the B-PLM Process
What We Do
The B-PLM Process and Tools that Progressive Gating provides, key pillars such as Business Case, Value Proposition, and a project Charter, and a variety of other comprehensive organizational plans, provide critical support and pathway to increase the probability of successfully launch a new medical device product. Deployed early in a new organization’s life, their biggest value is keeping your emerging organization adapting to an ever-evolving marketplace, ensuring that spending is strategic and under control, utilizing a process where the key pillars and organizational plans are reviewed through each stage.
End-to-end, Progressive Gating's B-PLM Process & Tools deployed into your organization, at the tier aligning with your organization’s growth condition, provide business-minded safeguards that independently sequence with design control efforts*. Deployment of the B-PLM process help ensure that your emerging products enter the market with a predicted position, providing confidence of returned value to internal stakeholders, early investors, and prospective investors.
*B-PLM Stages and Gate Reviews are not associated with design control. Please review the B-PLM Process
Who We Help
Our products are meant to support innovators, start-up organizations, and smaller emerging organizations, primarily in the medical device industry. The B-PLM Process and Tools have been designed specifically for the medical device industry but may be applicable to other industries.
The best part of Progressive Gating is that the B-PLM Process is provided FREE of charge. It is our pleasure to offer this important process to all emerging companies as our founder has understood its importance in bringing new products to market. The regulatory process is challenging enough! Progressive Gating strongly feels that internal process and tools that can help ensure an emerging company's financial stability and success is an important cornerstone worthy of offering to the industry!
Other highly regulated life science segments that could benefit from Progressive Gating products are Pharmaceuticals, Biotechnology, Diagnostics, and Cell & Gene Therapy. Emerging companies focused on consumer products can also benefit by incorporating the B-PLM Process* and Tools.
*B-PLM Stages and Gate Reviews are not associated with design control. Please review the B-PLM Process
Meet Our Founder!
Jason Rinehart is a highly experienced engineering professional with over 25 years of experience in the medical device industry and similar industries such as pharmaceuticals, biotech, and diagnostics.
Primarily skilled in Research & Development, his skills and capabilities have been further developed over a wide-ranging career, through functional ownership and collaborations with Process Development, Manufacturing Engineering, Production Operations, Regulatory Affairs, Facilities, QA/QE/QC, Marketing, Legal, Finance, and Supply Chain.
Jason has been the principal designer of several Class 3 devices, including drug-coated stent delivery systems, balloon dilatation catheters, resorbable stents, atherectomy catheters, RF tissue ablation devices, and silicone implants. Additional medical device product development experience includes AAA stent graphs, program leadership of a spine scoliosis system of implant and surgical tools, and gastric balloon systems.
Operationally, Jason has supported several organizations in capital expenditure projects such as bioreactor installations; operational readiness of a viral vector production line; pilot line development of a next-generation gene sequencing consumable product; design, engineering, and construction of cleanrooms, analytical and microbiology labs.
Jason has spent significant time in the field working shoulder-to-shoulder with medical device industry KOLs, suppliers, and CMOs. Jason has served on several collegiate industrial advisory boards, including five years as the chair of Cal Poly SLO's Biomedical Engineering program advisory board.
Jason's education: BSME from Cal Poly SLO and an MS in BioEngineering from Clemson University.
Please feel free to review Jason’s LinkedIn page for more details about his experience, capabilities and competencies.