Tensentric has only one focus, the design and development of medical devices.
We don’t design industrial or consumer products. We don’t do volume manufacturing. Our technical and management staffs have been carefully selected based on their passion for medical-device design. Period.
Keeping our focus narrow has helped make us experts in all of the applicable standards and regulatory requirements. No one understands the very unique process and the uncompromising controls better than we do.
That’s why we developed our own, proprietary ISO13485-certified quality system. It’s easily tailored to meet the specific needs of each of our clients and lets us design as efficiently as possible.
Requirements change. Specifications change. Even the end users change. And if any of those changes happen after you’ve begun the formal design process, the impact on your budget and your schedule can be staggering. But there’s a way to avoid the cost and delays imposed by our industry’s stringent design controls. And that’s to start before you officially start. What we call that is Phase Zero.
Phase Zero is everything that happens from the moment your idea is conceived to the beginning of the formal design development process.
What makes this phase so critical?
A recent study showed that “the average total cost to bring a low- to moderate-risk 510(k) product from concept to clearance was approximately $31 million; $24 million was spent on FDA dependent and/or related activities.
For a higher risk PMA product, the average total cost was approximately $94 million, with $75 million spent on stages linked to the FDA. And these estimates don’t include the cost of obtaining reimbursement or any sales and marketing activities.1
With so much on the line, no one can afford to make these types of investments without a rock-solid business case right from the start. One that includes a thorough assessment of the opportunity, the technology, and the ability to deliver a product to market in a known time frame.
That’s why we developed Phase Zero. So you have zero doubt that the design-and-development process will go as smoothly as possible. And that your device will truly meet the needs of your end user.
References 1. “FDA Impact on U.S. Medical Technology Innovation.” Josh Makower, M.D., consulting professor of medicine, Stanford University; CEO, ExploraMed Development, LLC; venture partner, NEA. Aabed Meer, M.D.-MBA candidate, Stanford University. Lyn Denend, research associate, Stanford University. With support from Medical Device Manufacturers Association (MDMA), National Venture Capital Association (NVCA), and multiple state medical industry organizations. Independent data analysis and verification by PricewaterhouseCoopers LLP.
It’s your idea. It will always be your idea. We’re just the ones who will give it life.
We’ll make sure it’s a design that can be manufactured at your target unit cost. And at your target unit volume. And that the transition from design to manufacturing will go off without a hitch.
That kind of smooth transition doesn’t happen by itself. So we have a full-time transition manager. All during the design process, the transition manager’s sole focus is to gather manufacturing input to ensure that the early prototypes and controlled V&V builds all contribute to the development of sustainable manufacturing processes.
We also have a Manufacturing Confidence Prototype Build that parallels the Engineering Confidence Prototype Build. By incorporating the manufacturing process with the documentation package, issues with manufacturing can be identified and addressed early in the design process.
Although we aren’t a contract manufacturing facility, we know the ultimate goal is to bring your concept to life. And to the market.
When you talk to our clients, you hear it over and over again. They don’t consider us just another approved vendor. We have become a trusted design partner.
That level of trust doesn’t just happen. It has to be earned.
It starts with clearly communicating a project’s scope and underlying assumptions right from the very beginning. That’s the time to put financial and schedule incentives into place, when they can promote the best possible outcome.
It comes from the long hours we spend working together to identify technical challenges and risks. And finally, it’s earned by exceeding our client’s expectations at every turn.
Because we understand just how connected the medical-device community really is. So we don’t merely design medical devices, we built long-term relationships.
A trusted partner wouldn’t have it any other way.