The Blog
Rev.1 Engineering Announces Newly Appointed CEO, COO, and CTO
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…...Read more
Rev.1 Engineering Achieves ISO 13485:2016 Certification
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…...Read more
Medical Device Development with Strategic Manufacturing
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…...Read more
Join REV.1 Engineering at MedTech Innovation Summit Dublin 2023
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…...Read more
Medical Device Engineering Updates for 2022 and 2023
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…...Read more
MedTech Innovator 2023 Cohort Deadline Approaching
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…...Read more
M2D2 Announces Next Accelerator Cohort
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…...Read more
ASAHI INTECC AND REV.1 ENGINEERING® Support Medical Device Startups at AdvaMed and The MedTech Conference
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…...Read more
MedTech Innovator Panel Discussion ~ Engineering, Manufacturing and Supply Chain Management
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…...Read more
The Importance of Speed to Market: Launching a Medical Device Startup
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…...Read more
Sales & Marketing for Medical Device Startups
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…...Read more
REV.1 Engineering to Exhibit with ASAHI Intecc at MD&M West
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…...Read more
Are We Entering The Age of Intrapreneurship?
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…...Read more
An Introduction To Strategic Manufacturing
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…...Read more
Rev.1 Engineering® Announces Acquisition by ASAHI INTECC While Attending MD&M West
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…...Read more
Have Medical Device Startups Turned the COVID Corner?
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…...Read more
The Implications of Alternative Payment Methods on Medical Device Development
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…...Read more
When Uncertainty Becomes Certain – A Rev.1 Engineering White Paper
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…...Read more
Managing Risk Beyond the Critical Chain
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 &…...Read more
Comparing Apples to Apples – Identification of Strategic Development Dollars
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…...Read more
Rev.1 Promotes Virtual Medical Device Startup Model In Response to Pandemic
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…...Read more
Is It Time For A New Startup Business Model?
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…...Read more
Rev.1 Operations During COVID-19 Pandemic
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…...Read more
The Strategic Potential of Rapid Operational Improvement
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…...Read more
Navigating the Challenges of Developing First of Kind Medical Devices
Eric Johnson and Andy Denison discuss the challenges unique to developing First of Kind medical devices (3 minutes)....Read more
Exit Horizon – M&A Activity and Private Equity Going into 2020
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…...Read more
Rev.1 Engineering® Named As Exclusive Development Partner For Valvublator
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…...Read more
How Design For Manufacturing Can Effect Company Valuation At Exit
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…...Read more
Are You Missing The Low Hanging Fruit?
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…...Read more
Developing Medical Devices in an Age of Reimbursement Uncertainty
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…...Read more
The High Cost of Trying to Develop Medical Devices on the Cheap
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…...Read more
Identifying and Managing Strategic Dollars in Device Development
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…...Read more
Strategic Engineering and Speed to Revenue
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…...Read more
Identifying Meaningful Metrics For Strategic Engineering & Development
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…...Read more
Innovating The Business Of Innovation
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…...Read more
Can Business Keep Pace With Innovation?
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,…...Read more
Accelerating Development in a World of Growing Complexity
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.…...Read more
The Financial Impact of Strategic Innovation
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…...Read more
The Coming Age of Strategic Innovation in Medical Device
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…...Read more
Leveraging a Culture of Innovation in Device Development
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…...Read more
Notes From the Field – The Drug/Device Combination Product Summit
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…...Read more
Rev.1 Engineering To Speak at Drug/Device Combination Product Summit
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…...Read more
Medical Device Innovation Strategy: Incremental or Transformational?
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…...Read more
The Strategic Risk of Engineering Talent Turnover
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…...Read more
De-Risking the Development of Drug/Device Combination Products
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…...Read more
Strategic Risk Management in Medical Device Development and Innovation
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…...Read more
Convergence, Innovation and the Future of Interventional Cardiology
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…...Read more
A Culture of Innovation
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…...Read more
The Role of Health Technology Assessments in High Performance Development & Innovation
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…...Read more
The Multiplier Effect of the Time Value of Cash Flow
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…...Read more
The Innovation Conundrum
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…...Read more
Rev.1 Engineering Medical Device Client Closes on $77 Million Series D Round
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,…...Read more
Rev.1 Engineering Launches Development & Innovation Solutions
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…...Read more
10 Years of Innovation and Development
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…...Read more
10 Heads for the Price of 2: Medical Device Development on Hyperspeed
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…...Read more
Speed Your Medical Device Development with In-House Machining
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,…...Read more
Irvine Medical Device Development: The Choice Is Yours
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…...Read more
Attention Carlsbad Medical Device Companies: Discover Murrieta Research & Development Services
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…...Read more
Foothill Ranch Medical Device Development: Rapid Transformation from Prototype to Commercialization
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…...Read more
The Third Pillar of Medical Device Engineering: Compliance Certification
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…...Read more
Medical Device Development: Five Risks
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…...Read more
Speed Up Your San Clemente Medical Device Development
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…...Read more
Low Fixed Rate Bid: Lost Opportunities in Medical Device Development
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…...Read more
Time to Market: 2x Faster with Rev.1 Engineering
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…...Read more
The Second Pillar of Medical Device Engineering: Creating an Effective Quality System
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.…...Read more
What to Expect: Medical Device Development with Rev.1 Engineering
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…...Read more
Rev.1 Engineering: Your Brick & Mortar Medical Device Engineering Office
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…...Read more
Rev.1 Engineering: Your Diverse Medical Device R&D Team
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…...Read more
The First Pillar of Quality Engineering for Medical Devices
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…...Read more
Rev.1 Engineering’s Program Management
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…...Read more
Why Rev.1 Engineering is a Top Choice for Your Medical Device Development
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…...Read more
Rev.1 Engineering and Your Medical Device Funding Plan
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…...Read more
Your Medical Device Development … 2x Faster
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…...Read more
Client Collaboration in Outsourced Medical Device Development
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…...Read more
Rev.1 Engineering: The Flexible R&D Team You Need
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…...Read more
Medical Device R&D: The New Outsourcing Paradigm
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…...Read more
Contract Manufacturing: 4 Reasons to Just Say “No”
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…...Read more
7 Realities of Building an In-House Medical Device Development Team
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…...Read more
Medical Device Design Case Study: FEA Modeling Techniques Support R&D
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…...Read more
Medical Device Development with Advanced Materials
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…...Read more
The Value of 2x Faster Medical Device Development
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…...Read more
Medical Device Funding Confidence
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…...Read more
Rev.1 Engineering CEO Quoted in Forbes
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…...Read more
Medical Device Design Case Study: Communication is Key
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…...Read more
Medical Device Design Case Study: Achieving the Un-Achievable
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…...Read more
Developing to Your Medical Device’s Character
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…...Read more
Bending Medical Device Regulations?
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…...Read more
Managing the Contract Manufacturer: Is Your Product Ownership at Risk?
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…...Read more
6 Smart Ways to Spend Money and Create Value for Your Medical Device
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.…...Read more
Acquisition Transition: The Benefits of Outsourced Medical Device R&D
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…...Read more
Due Diligence: Funding & Acquisition of Your Medical Device Company
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…...Read more
The 3 R’s of Medical Device Development: Research, Regulation, Reimbursement
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…...Read more
5 Pre-Funding Essentials for Early Medical Device Start-Ups
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…...Read more
Stories of Medical Device Success: The Opportunity in Failure
“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…...Read more
5 Ways Skilled Technicians Speed Medical Device Product Development
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…...Read more
5 Ways to Create a Medical Device Development Contractor Partnership
“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.”…...Read more
Designing Medical Devices with Finite Element Analysis
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…...Read more
5 Steps: Critical Chain Methodology in Medical Device Development
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…...Read more
Increase Speed with Parallel Pre-Clinical Modeling
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.…...Read more
4 Questions to Ask About Medical Device Development Consulting Transparency
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…...Read more
5 Benefits of On-Site Rapid Prototyping for Medical Devices
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…...Read more
From Feasibility to Design Freeze: 5 Key Risks in Medical Device Development
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…...Read more
When 2 Heads Equal 10: FTEs in Medical Device Development
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…...Read more
Top 5 Challenges in Building a Start-up Engineering Team
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…...Read more
3 Hidden Costs of the Low Fixed-Rate Bid for Medical Device Development
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…...Read more
Which Barriers-to-Speed Slow Down Your Product Development?
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…...Read more