Category: Development Process

Establishing our dedicated Strategic Manufacturing facility equipped with a Cleanroom means Rev.1 Engineering can offer a more comprehensive solution for medical device startups. This state-of-the-art Cleanroom is a significant milestone for us, enabling…...

Launching a medical device startup is a complicated process and many factors can contribute to its success. One key factor is speed to market. Startups that have a positive exit come…...

Managing a medical device startup is not for the faint-of-heart. After moving heaven and earth to secure funding, you’re finally moving through your formal development process, sprinting towards V&V, animal…...

Our clients are intimately familiar with REV.1’s well established incorporation of Design for Risk Management Throughout the Critical Chain. This philosophy extends to our meticulous approach to project planning &…...

At Rev.1 Engineering®, we specialize in the design and commercial development of complex, minimally invasive, medical devices. Very often, these are First of Kind technologies, requiring as much invention as development. I…...

Scott Huter, Kim Wehde & Phillip Burke discuss how REV.1 Engineering manages risk in the design, development and innovation of complex medical devices (3 minute video)....

I recently had the opportunity to read Greenlight Guru’s “State of Medical Device Product Development and Quality Management - 2020 Report”. I highly recommend giving it a look. The comprehensive…...

Eric Johnson and Andy Denison discuss the challenges unique to developing First of Kind medical devices (3 minutes)....

Having worked with investor-driven, medical device startups over the past two decades, I’ve learned, often the hard way, what works and what doesn’t work, in attempting to bring a new device…...

Developing a medical device to commercialization is a complex, multi-faceted endeavor. It’s also an expensive undertaking fraught with risk factors at each stage of development. While maintaining a meticulous attention to…...

Strategic Engineering is a comprehensive approach to medical device development that drives speed to revenue while simultaneously scrubbing away risk along the critical, developmental path. This White Paper sets forth to…...

It’s often, and rightly said, if you can measure it, you can manage it. Yet, performance metrics are applied in a somewhat uneven manner throughout most businesses. Commonly used in manufacturing (yield…...

Recently, I’ve been surveying a number of reports and articles forecasting the future of medical devices. Specifically, the future trends emerging in interventional cardiology, structural heart, neuromodulation and drug/device combination products.…...

Efficient and effective engineering and new device development have always been central to the success of medical device companies. Under the traditional, Fee-For-Service reimbursement landscape, companies could identify costly or marginally…...

Navigating the Critical Path with Combination Products A market research study, published earlier this week by Market.Biz, illustrates the promise of what is perhaps the most dynamic technology segment emerging…...

Employing Clinical Pathway Impact Analysis™ to drive efficacy at launch. While large medical device corporations have long looked to startups for new technologies and devices, there are additional, innovative benefits…...

Other than pharmaceutical and technology companies, no other industry invests a greater percentage of revenue into R&D than medical device (holding steady at an average of 6.7%). The returns on…...

A current theme is buzzing throughout the medical device development community. It has to do with innovation, and more importantly, how organizations create and drive innovation. In product pipelines, standards…...

Whether you have an established medical device business or are starting up a new company, staffing efficiently is always a challenge. There is always a limit on how many engineers…...

In the feasibility phase, all aspects and options for design should be researched and explored, which will avoid wasting time and spending more money in the back end when problems…...

When it comes to finally getting that idea for a great new medical device into production, the faster you can move, the better. Even if you are an established San…...

Selecting your R&D team will make or break your medical device development project. And whether you’re a start-up or an established company looking to supplement an existing team, cost is…...

In our last blog, we explored Design Control – the first of three pillars that support quality medical device development. The second pillar is the creation of a Quality System.…...

At Rev.1 we talk about “2 heads equals 10,” meaning our diverse team members bring a surprising range of skills and resources to your medical device project. On average you…...

One aspect of REV.1 Engineering that sets us apart from many product design firms is the experience we have working within medical device quality systems. With years of experience at…...

Are you hunting for an outsourced medical device R&D firm? Concerned that you won’t find a company that’s as dedicated to your project as you are? Look no further. REV·1…...

We were thinking about the expression, “When I tell you to jump, you say, ‘How high?’” The intent of this expression is clearly “Do what you’re told,” and we often…...

The flow of money from large venture capital firms into the medical device space slowed in 2008 and has never rebounded. Large medical device companies have always relied on start-ups…...

Many start-up CEOs are seduced by the low cost development offered by some contract manufacturers. But as they say, you get what you pay for. First off, you will be…...

You have that special “spark” of an idea, the one that excites and drives you and your colleagues to lay it all on the line to make it happen. Now…...

Once you’ve sold your medical device company, the work of transition begins. What does your R&D team need to do to meet your acquiring company’s needs and fulfill your contractual…...

In our last blog, we laid out 5 pre-funding essentials for early start-ups. Today we want to delve further into three critical topics. Each has special significance not just at…...

Often the medical device product design team is disconnected from the technicians and machinists who tackle the nuts and bolts of product development. Working with highly skilled technicians who are…...

Most project managers use software that provides basic Gantt chart and cascading waterfalls of activities. Key milestones are laid out and the dependencies for reaching those milestones. Critical chain methodology…...

In a recent blog, we discussed the benefits of rapid prototyping with on-site 3D printing and machining capabilities. The same “need for speed” applies to pre-clinical modeling and bench testing.…...

3D printing is much in the news right now, and yes, it’s an astonishing technology that we at REV.1 Engineering use frequently. We’re very proud to have state-of-the-art FDM and…...

Moving a medical device from “napkin sketch” to commercialization is a complex business requiring a wide variety of skills. Most risk should be mitigated in the feasibility phase, where all…...

In all my years working with start-up CEOs who have an innovative medical device sketched out on a napkin, I watch certain issues show up again and again. I’ve never…...