The Blog

We are excited to announce the appointment of Scott Huter as Rev.1 Engineering's new Chief Executive Officer, Kevin Magrini as the Chief Operations Officer, and Andy Denison in the newly…...

Rev.1 Engineering has officially received the ISO 13485:2016 certification for our robust quality management system. This certification is a testament to our commitment to upholding the highest standards in the…...

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…...

We are looking forward to attending the MedTech Innovation Summit Dublin 2023, the premier conference series for startups, strategics, and investors in the medical device industry. As a leader in medical…...

It’s been a year-and-a-half since we’ve expanded into our new Design & Innovation lab and Strategic Manufacturing site (Temecula and Murrieta, CA), geared towards first-of-kind medical device development and its early, flexible…...

Rev.1 Engineering and ASAHI-Filmecc are proud to announce we are once again a sponsor for the 2023 MedTech Innovator accelerator program. The application deadline for this year's cohort of medical device startups…...

REV.1 Engineering® is pleased to announce the next cohort for UMass Lowell’s M2D2 Impact program is forming! ASAHI Intecc, REV.1’s parent company, is a sponsor of M2D2’s accelerator programs. The…...

Representatives from ASAHI INTECC and REV.1 Engineering were proud participants in this year’s combined AdvaMed and The MedTech Conference in Boston. REV.1 Engineering is a wholly owned subsidiary of ASAHI…...

Eric Johnson, Co-Founder & CEO of REV.1 Engineering® (https://rev1engineering.com/), joins Jim Warren, head of medical device at Jabil (https://www.jabil.com/), and Joshua Magnuson of Fujikura (https://www.fujikura.com/), to discuss the unique challenges…...

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…...

I recently had the pleasure of presenting a one hour training session on Sales and Marketing, specifically tailored to the unique needs of medical device startups. The event was hosted…...

The ASAHI Intecc and REV.1 Engineering teams would like to invite you to visit them at booth #2455 at this year's MD&M West. The event will run from today through…...

Those readers that are familiar with this blog know we often look back in order to discern where we’re going in the future. As we emerge from two years of…...

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…...

While attending MD&M West today, Rev.1 Engineering (Murrieta, CA) announced it has been acquired by ASAHI INTECC and will operate under ASAHI’s Solution Device Division (Filmecc). “As a Strategic Supplier…...

It’s been over a year since the first COVID-driven shut downs hit the United States, so what is the current status of the medical device startup industry? To get some…...

Part One in a Series Exploring Medical Device Development Strategies Under Alternative Payment Methods With the inauguration of a new administration in Washington, D.C., I thought it was a good…...

While the recent vaccine news from Pfizer and Moderna is promising, we, as an industry, still have some turbulent waters ahead of us. Leveraging lessons learned from the spring and summer months…...

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. The…...

The global pandemic will undoubtably depress equity investments in medical device startups. In response, Rev.1 announces a nimble, efficient and accelerated approach to new device development and commercialization. Rev.1 Engineering…...

Those of us working in the medical device industry are experiencing unprecedented times. Often insulated from periodic downturns in the normal business cycle, the COVID-19 pandemic has landed squarely in…...

As you have likely heard, the Governor of California has issued an Executive Order in response to the COVID-19 global pandemic. The California Department of Public Health has ordered all…...

A REV.1 Engineering White Paper Several years ago, a startup company developed an innovative, reduced profile, coronary stent-on-a-wire device. The design promised to streamline Percutaneous Coronary Interventions (PCI), improve Cath…...

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

I recently had the opportunity to read Bain & Company’s annual Global Healthcare Private Equity and Corporate M&A Report - 2019. While the current report looks back to 2018, it provides some…...

Leonhardt Ventures taps Rev.1 Engineering to design and develop Valvublator's heart valve regeneration technology platform. Rev.1 Engineering has been selected as the exclusive design and development partner for the commercialization…...

Throughout a medical device’s Life Cycle, few opportunities ever afford themselves to the organization to initiate a strategic approach to Design for Manufacturing in order to optimize product profitability. This is…...

As medical device company executives, it can be challenging to identify opportunities for performance improvement that can quickly and efficiently drive incremental profits to the bottom line. New product development…...

Developing advanced medical devices is challenging enough even during the most predictable of times. Today, we’re still in mid-migration, from the traditional, fee-for-service system to a value-based reimbursement system. Simultaneously, a noteworthy…...

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. Here, we examine the value of…...

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…...

In my last blog, I discussed how technologies that I witnessed on the lab bench some thirty years ago are now finding their way into the clinic...yet the business model…...

The Thanksgiving holiday is a contemplative time. A time to reflect back on the passing year and to look forward to the next. This Thanksgiving was a bit more resonant for me,…...

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.…...

Market intel firm CB Insights recently published results from its survey of corporate strategy executives, illustrating the fact that 41% of executives say their firms are extremely at risk, or very at risk of…...

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…...

While innovation may simply be the next buzz word resonating throughout industry, it’s a competitive imperative in medical device. Yet, identifying the causal inputs that drive sustainable, efficient innovation remain elusive…...

We recently had the opportunity to speak at the Combination Product Life Cycle Management Summit, which was held in Boston earlier this month. Our co-founder and COO, Phil Burke, presented…...

Phil Burke to Present "Best Practices" for Device Development with Drug/Device Combination Products at Boston Summit. Combination products integrate a medical device for the delivery of a therapeutic drug. Examples…...

In a recent review of CB Insights' 2018 State of Innovation report, a comprehensive analysis reflecting the perspectives of nearly 700 senior strategy executives worldwide, a significant revelation emerged. This…...

Do You Have Contingencies in Place to Counter Disruption from the Coming Talent Wars? It’s a topic that’s been front and center since our recovery from the Great Recession: How…...

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…...

Having spent the past two days walking the exhibit hall at this year’s American College of Cardiology Conference, I got to thinking about convergence, innovation and the direction of new…...

In our last blog, we spoke about the source of innovation – human creativity. If human creativity is the seed of innovation, organizational culture is the soil in which it…...

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…...

It’s perhaps the most commonly heard value proposition in the contract engineering market space…we’re faster than our competition. What isn’t necessarily offered up is faster at what? There’s a place…...

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…...

Ablative Solutions (Kalamazoo, MI) announces major investment in support of their innovative device technology intended for the treatment of hypertension. Rev.1 Engineering is pleased to announce one of their long-standing,…...

Celebrating its 10th year anniversary, Rev.1 Engineering is expanding to deliver comprehensive, strategic development and innovation solutions for its medical device and life science customers. Rev.1 Engineering announced today it…...

As 2017 winds to a close, we at REV.1 Engineering will be celebrating our 10th year in business. As this milestone approaches, we have been reflecting on our first decade…...

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…...

When in-house machining is not an option, medical device engineers are forced to use outside companies for quotes and machining. Typical turnaround times can run from 2 to 6 weeks,…...

You’re located in Irvine and you have sketched out a great new medical device idea. Maybe you are a start-up, but more than likely you have an established company and your current…...

If your company is based in Carlsbad, CA and you are looking to outsource your medical device development, look no further than REV.1 Engineering in Murrieta. You are invited to…...

Getting a new medical device product to market is a challenge. If your company is located in Foothill Ranch, read on to learn more about Rev.1 Engineering, a top outsource…...

So far we’ve discussed two of the three key pillars of quality medical device engineering: Design Control and Quality System. The third, Compliance Certification, is the audit of the design…...

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…...

REV.1 Engineering makes an astonishing claim: We can get you to market 2x Faster than building an in-house team. Whether you are a start-up in need of medical device R&D…...

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.…...

Companies unfamiliar with using outsourced R&D for medical device development are often hesitant because they are uncertain about how the process should work. Here’s what to expect when you work…...

Whether you’re running a start-up or are an established company looking for an outsourced medical device engineering solution, REV.1 Engineering is the turnkey medical device R&D team you are looking…...

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…...

Rev.1 Engineering’s program management team is inseparable from the engineering team. They have worked together for years in our unique medical device product development ecosystem. As a well-oiled team, they…...

We’re so confident and ready to roll, that when you say “yes,” we begin working on your innovative medical device that very day. While REV·1 always creates a plan to…...

Rev.1 Engineering’s medical device development typically gets clients to CE and FDA approvals before it is necessary to build a commercialization team. Most of our successful clients have not needed…...

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…...

If you are intrigued by the concept of running your start-up company as a “virtual entity” with low fixed costs and low capital expenditure, you need a medical device development…...

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…...

In-house medical device development requires dedicated, highly skilled and experienced talent; acquisition of necessary equipment and facilities to build to feasibility and beyond; and sourcing and management of reliable partners…...

We recently assisted a Southern California biotechnology company that is developing a novel immunotherapy for treating cancer. Immunotherapy is an exciting emerging field and we were happy to be involved…...

REV.1 recently had a client with a highly specialized wound care product which combined molded and converted parts. Careful sourcing was necessary to find the advanced materials necessary. The client…...

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…...

Regardless of your stage or current structure, continued funding sources for medical device development are difficult to find. According to Price Waterhouse Coopers, funding for medical device companies dropped by…...

Rev.1 Engineering’s CEO, Eric Johnson, was recently quoted in a Forbes magazine article about artificial transplants: “By quickening the procedure of manufacturing and design, 3D printing helps lower the costs…...

At REV.1 Engineering, we work with many types of teams looking to bring their product to feasibility. Recently we worked with a physicians’ group that found our approach a refreshing…...

At REV.1 Engineering, we’ve handled medical device product development for more than 120 products for 60+ clients. We specialize in complex, new-to-market products that require our innovative engineering approach. It’s…...

We have clients with a wide range of products who knock on our door and request our help. Every project we review has its own character. And the product development…...

At Rev.1 we pride ourselves in getting you to your project goals 2x Faster. Typically, when we meet with clients for the first time, there are dozens of ways to…...

Product development with a contract manufacturer can seem like a good choice for a start-up company. Low or no-cost engineering in exchange for the manufacturing contract is an attractive incentive…...

Every start-up company is looking for a successful endpoint: Bringing their product to market; or acquisition. In either case, the degree of success is determined by the company's perceived value.…...

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…...

You have developed a spectacular product. You have a good idea of the value of your company. You’ve worked hard to attract four potential buyers. And now the day has…...

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…...

When you are geeked about your medical device idea, it can be challenging to focus on the less-exciting parts of your start-up plan. Most start-up clients we work with initially…...

“Don’t bury your failures, let them inspire you.” – Robert Kityosaki As we all know, medical device development is not always a smooth process. In fact, we like to say that…...

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…...

“REV.1 Engineering gets involved and puts skin in the game. They are very good problem solvers who take ownership. It wasn’t just ‘the client’s’ project, it was always ‘OUR’ project.”…...

You’re likely already familiar with finite element analysis (FEA) and its use in medical device development. From stress-strain to thermal heating to fatigue, FEA is an indispensable part of the…...

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.…...

A key factor in selecting a medical device development consulting firm is transparency of data and information. From billing to IP assignment to day-to-day operations, how can you know if…...

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…...

Efficient staffing for medical device research and development can be a logistical nightmare, especially if you are trying to build an in-house R&D team. Many start-ups only have funding for…...

As CEO of a start-up medical device company in search of engineering and development talent, it’s important to keep in mind some of the time and money challenges you may…...

You’ve got a great idea for a new medical device sketched out. A successful implementation could mean acquisition of your start up company. But first you need engineers to bring…...

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…...