Medical Device Development with Strategic Manufacturing
July 18, 2023Establishing our dedicated Strategic Manufacturing facility equipped with a Cleanroom means Rev.1 Engineering can offer a more comprehensive solution for medical device startups.…Join REV.1 Engineering at MedTech Innovation Summit Dublin 2023
April 20, 2023We are looking forward to attending the MedTech Innovation Summit Dublin 2023, the premier conference series for startups, strategics, and investors…Medical Device Engineering Updates for 2022 and 2023
February 23, 2023It’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),…MedTech Innovator 2023 Cohort Deadline Approaching
January 26, 2023Rev.1 Engineering and ASAHI-Filmecc are proud to announce we are once again a sponsor for the 2023 MedTech Innovator accelerator program. The…M2D2 Announces Next Accelerator Cohort
December 20, 2022REV.1 Engineering® is pleased to announce the next cohort for UMass Lowell’s M2D2 Impact program is forming! ASAHI Intecc, REV.1’s…ASAHI INTECC AND REV.1 ENGINEERING® Support Medical Device Startups at AdvaMed and The MedTech Conference
November 14, 2022Representatives from ASAHI INTECC and REV.1 Engineering were proud participants in this year’s combined AdvaMed and The MedTech Conference in…MedTech Innovator Panel Discussion ~ Engineering, Manufacturing and Supply Chain Management
October 10, 2022Eric 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…The Importance of Speed to Market: Launching a Medical Device Startup
July 19, 2022Launching a medical device startup is a complicated process and many factors can contribute to its success. One key factor…Sales & Marketing for Medical Device Startups
June 2, 2022I recently had the pleasure of presenting a one hour training session on Sales and Marketing, specifically tailored to the…REV.1 Engineering to Exhibit with ASAHI Intecc at MD&M West
April 12, 2022The ASAHI Intecc and REV.1 Engineering teams would like to invite you to visit them at booth #2455 at this…Are We Entering The Age of Intrapreneurship?
March 30, 2022Those readers that are familiar with this blog know we often look back in order to discern where we’re going…An Introduction To Strategic Manufacturing
September 21, 2021Managing a medical device startup is not for the faint-of-heart. After moving heaven and earth to secure funding, you’re finally…Rev.1 Engineering® Announces Acquisition by ASAHI INTECC While Attending MD&M West
August 11, 2021While attending MD&M West today, Rev.1 Engineering (Murrieta, CA) announced it has been acquired by ASAHI INTECC and will operate…Have Medical Device Startups Turned the COVID Corner?
June 3, 2021It’s been over a year since the first COVID-driven shut downs hit the United States, so what is the current…The Implications of Alternative Payment Methods on Medical Device Development
January 27, 2021Part One in a Series Exploring Medical Device Development Strategies Under Alternative Payment Methods With the inauguration of a new…When Uncertainty Becomes Certain – A Rev.1 Engineering White Paper
November 19, 2020While the recent vaccine news from Pfizer and Moderna is promising, we, as an industry, still have some turbulent waters…Managing Risk Beyond the Critical Chain
September 16, 2020Our clients are intimately familiar with REV.1’s well established incorporation of Design for Risk Management Throughout the Critical Chain. This…Comparing Apples to Apples – Identification of Strategic Development Dollars
July 16, 2020At Rev.1 Engineering®, we specialize in the design and commercial development of complex, minimally invasive, medical devices. Very often, these…Rev.1 Promotes Virtual Medical Device Startup Model In Response to Pandemic
May 7, 2020The global pandemic will undoubtably depress equity investments in medical device startups. In response, Rev.1 announces a nimble, efficient and…Is It Time For A New Startup Business Model?
May 6, 2020Those of us working in the medical device industry are experiencing unprecedented times. Often insulated from periodic downturns in the…Rev.1 Operations During COVID-19 Pandemic
March 20, 2020As you have likely heard, the Governor of California has issued an Executive Order in response to the COVID-19 global…The Medical Device Industry ~ Our First Line of Defense
March 18, 2020During the go-go ‘90s, I had the pleasure of working for STERIS Corporation. At the time, our tag line was, “The Global…The Strategic Potential of Rapid Operational Improvement
February 7, 2020A REV.1 Engineering White Paper Several years ago, a startup company developed an innovative, reduced profile, coronary stent-on-a-wire device. The…The REV.1 Team Discusses Design for Risk Management
January 28, 2020Scott Huter, Kim Wehde & Phillip Burke discuss how REV.1 Engineering manages risk in the design, development and innovation of…REV·1 Engineering® Launches New Website
January 15, 2020World-class medical device design & development firm reformats website to support growing client base. REV.1 Engineering announced today the launch…The Critical Elements That Drive Efficiency Of Development
December 10, 2019I recently had the opportunity to read Greenlight Guru’s “State of Medical Device Product Development and Quality Management - 2020…Navigating the Challenges of Developing First of Kind Medical Devices
November 11, 2019Eric Johnson and Andy Denison discuss the challenges unique to developing First of Kind medical devices (3 minutes).Exit Horizon ~ M&A Activity and Private Equity Going into 2020
November 8, 2019I recently had the opportunity to read Bain & Company’s annual Global Healthcare Private Equity and Corporate M&A Report - 2019. While…Rev.1 Engineering® Takes Early Phase Medical Device Development To The Next Level
September 18, 2019It’s been a while since my last blog, as it’s been a busy summer here at REV·1 Engineering®. Things have been…Rev.1 Engineering® Named As Exclusive Development Partner For Valvublator
July 29, 2019Leonhardt Ventures taps REV·1 Engineering to design and develop Valvublator's heart valve regeneration technology platform. REV·1 Engineering has been selected…How Design For Manufacturing Can Effect Company Valuation At Exit
July 29, 2019Throughout a medical device’s Life Cycle, few opportunities ever afford themselves to the organization to initiate a strategic approach to…Are You Missing The Low Hanging Fruit?
June 25, 2019As medical device company executives, it can be challenging to identify opportunities for performance improvement that can quickly and efficiently…Developing Medical Devices in an Age of Reimbursement Uncertainty
May 30, 2019Developing advanced medical devices is challenging enough even during the most predictable of times. Today, we’re still in mid-migration, from the…The High Cost of Trying to Develop Medical Devices on the Cheap
April 24, 2019Having worked with investor-driven, medical device startups over the past two decades, I’ve learned, often the hard way, what works and…Identifying and Managing Strategic Dollars in Device Development
March 26, 2019Developing a medical device to commercialization is a complex, multi-faceted endeavor. It’s also an expensive undertaking fraught with risk factors at…Strategic Engineering and Speed to Revenue
February 27, 2019Strategic Engineering is a comprehensive approach to medical device development that drives speed to revenue while simultaneously scrubbing away risk…Identifying Meaningful Metrics For Strategic Engineering & Development
January 4, 2019It’s often, and rightly said, if you can measure it, you can manage it. Yet, performance metrics are applied in a…Innovating The Business Of Innovation
December 18, 2018In my last blog, I discussed how technologies that I witnessed on the lab bench some thirty years ago are…Can Business Keep Pace With Innovation?
November 28, 2018The Thanksgiving holiday is a contemplative time. A time to reflect back on the passing year and to look forward to…Accelerating Development in a World of Growing Complexity
October 17, 2018Recently, I’ve been surveying a number of reports and articles forecasting the future of medical devices. Specifically, the future trends emerging…The Financial Impact of Strategic Innovation
September 24, 2018Market intel firm CB Insights recently published results from its survey of corporate strategy executives, illustrating the fact that 41%…The Coming Age of Strategic Innovation in Medical Device
August 28, 2018Efficient and effective engineering and new device development have always been central to the success of medical device companies. Under the…Leveraging a Culture of Innovation in Device Development
August 9, 2018While innovation may simply be the next buzz word resonating throughout industry, it’s a competitive imperative in medical device. Yet, identifying…Notes From the Field – The Drug/Device Combination Product Summit
June 29, 2018We recently had the opportunity to speak at the Combination Product Life Cycle Management Summit, which was held in Boston…Rev.1 Engineering To Speak at Drug/Device Combination Product Summit
June 19, 2018Phil Burke to Present "Best Practices" for Device Development with Drug/Device Combination Products at Boston Summit. Combination products integrate a…Is Your Innovation Strategy Incremental or Transformational?
June 11, 2018I recently had the opportunity to read CB Insights’ 2018 State of Innovation report on the perspectives of nearly 700 senior strategy…The Strategic Risk of Engineering Talent Turnover
April 25, 2018Do You Have Contingencies in Place to Counter Disruption from the Coming Talent Wars? It’s a topic that’s been front…De-Risking the Development of Drug/Device Combination Products
April 12, 2018Navigating the Critical Path with Combination Products A market research study, published earlier this week by Market.Biz, illustrates the promise…Strategic Risk Management in Medical Device Development and Innovation
March 29, 2018Employing Clinical Pathway Impact Analysis™ to drive efficacy at launch. While large medical device corporations have long looked to startups…Convergence, Innovation and the Future of Interventional Cardiology
March 13, 2018Having spent the past two days walking the exhibit hall at this year’s American College of Cardiology Conference, I got…A Culture of Innovation
February 18, 2018In our last blog, we spoke about the source of innovation – human creativity. If human creativity is the seed…The Role of Health Technology Assessments in High Performance Development & Innovation
January 30, 2018Other than pharmaceutical and technology companies, no other industry invests a greater percentage of revenue into R&D than medical device…The Multiplier Effect of the Time Value of Cash Flow
January 17, 2018It’s perhaps the most commonly heard value proposition in the contract engineering market space…we’re faster than our competition. What isn’t…The Innovation Conundrum
January 12, 2018A current theme is buzzing throughout the medical device development community. It has to do with innovation, and more importantly,…Rev.1 Engineering Medical Device Client Closes on $77 Million Series D Round
January 3, 2018Ablative Solutions (Kalamazoo, MI) announces major investment in support of their innovative device technology intended for the treatment of hypertension.…Rev.1 Engineering Launches Development & Innovation Solutions
December 15, 2017Celebrating its 10th year anniversary, Rev.1 Engineering is expanding to deliver comprehensive, strategic development and innovation solutions for its medical…10 Years of Innovation and Development
December 5, 2017As 2017 winds to a close, we at REV.1 Engineering will be celebrating our 10th year in business. As this…10 Heads for the Price of 2: Medical Device Development on Hyperspeed
August 15, 2017Whether you have an established medical device business or are starting up a new company, staffing efficiently is always a…Speed Your Medical Device Development with In-House Machining
August 10, 2017When in-house machining is not an option, medical device engineers are forced to use outside companies for quotes and machining.…Irvine Medical Device Development: The Choice Is Yours
August 8, 2017You’re located in Irvine and you have sketched out a great new medical device idea. Maybe you are a start-up, but more…Attention Carlsbad Medical Device Companies: Discover Murrieta Research & Development Services
August 3, 2017If your company is based in Carlsbad, CA and you are looking to outsource your medical device development, look no…Foothill Ranch Medical Device Development: Rapid Transformation from Prototype to Commercialization
July 31, 2017Getting a new medical device product to market is a challenge. If your company is located in Foothill Ranch, read…The Third Pillar of Medical Device Engineering: Compliance Certification
July 27, 2017So far we’ve discussed two of the three key pillars of quality medical device engineering: Design Control and Quality System.…Medical Device Development: Five Risks
July 25, 2017In the feasibility phase, all aspects and options for design should be researched and explored, which will avoid wasting time…Speed Up Your San Clemente Medical Device Development
July 20, 2017When it comes to finally getting that idea for a great new medical device into production, the faster you can…Low Fixed Rate Bid: Lost Opportunities in Medical Device Development
July 17, 2017Selecting your R&D team will make or break your medical device development project. And whether you’re a start-up or an…Time to Market: 2x Faster with Rev.1 Engineering
July 14, 2017REV.1 Engineering makes an astonishing claim: We can get you to market 2x Faster than building an in-house team. Whether…The Second Pillar of Medical Device Engineering: Creating an Effective Quality System
July 11, 2017In our last blog, we explored Design Control – the first of three pillars that support quality medical device development.…What to Expect: Medical Device Development with Rev.1 Engineering
July 5, 2017Companies unfamiliar with using outsourced R&D for medical device development are often hesitant because they are uncertain about how the…Rev.1 Engineering: Your Brick & Mortar Medical Device Engineering Office
June 30, 2017Whether you’re running a start-up or are an established company looking for an outsourced medical device engineering solution, REV.1 Engineering…Rev.1 Engineering: Your Diverse Medical Device R&D Team
June 27, 2017At Rev.1 we talk about “2 heads equals 10,” meaning our diverse team members bring a surprising range of skills…The First Pillar of Quality Engineering for Medical Devices
June 21, 2017One aspect of REV.1 Engineering that sets us apart from many product design firms is the experience we have working…Rev.1 Engineering’s Program Management
June 20, 2017Rev.1 Engineering’s program management team is inseparable from the engineering team. They have worked together for years in our unique…Why Rev.1 Engineering is a Top Choice for Your Medical Device Development
June 15, 2017We’re so confident and ready to roll, that when you say “yes,” we begin working on your innovative medical device…Rev.1 Engineering and Your Medical Device Funding Plan
June 11, 2017Rev.1 Engineering’s medical device development typically gets clients to CE and FDA approvals before it is necessary to build a…Your Medical Device Development … 2x Faster
June 6, 2017Are you hunting for an outsourced medical device R&D firm? Concerned that you won’t find a company that’s as dedicated…Client Collaboration in Outsourced Medical Device Development
June 1, 2017We were thinking about the expression, “When I tell you to jump, you say, ‘How high?’” The intent of this…Rev.1 Engineering: The Flexible R&D Team You Need
May 30, 2017If you are intrigued by the concept of running your start-up company as a “virtual entity” with low fixed costs…Medical Device R&D: The New Outsourcing Paradigm
May 26, 2017The flow of money from large venture capital firms into the medical device space slowed in 2008 and has never…Contract Manufacturing: 4 Reasons to Just Say “No”
May 23, 2017Many start-up CEOs are seduced by the low cost development offered by some contract manufacturers. But as they say, you…7 Realities of Building an In-House Medical Device Development Team
May 17, 2017In-house medical device development requires dedicated, highly skilled and experienced talent; acquisition of necessary equipment and facilities to build to…Medical Device Design Case Study: FEA Modeling Techniques Support R&D
May 11, 2017We recently assisted a Southern California biotechnology company that is developing a novel immunotherapy for treating cancer. Immunotherapy is an…Medical Device Development with Advanced Materials
May 4, 2017REV.1 recently had a client with a highly specialized wound care product which combined molded and converted parts. Careful sourcing…The Value of 2x Faster Medical Device Development
April 27, 2017You have that special “spark” of an idea, the one that excites and drives you and your colleagues to lay…Medical Device Funding Confidence
April 24, 2017Regardless of your stage or current structure, continued funding sources for medical device development are difficult to find. According to…Rev.1 Engineering CEO Quoted in Forbes
April 21, 2017Rev.1 Engineering’s CEO, Eric Johnson, was recently quoted in a Forbes magazine article about artificial transplants: “By quickening the procedure…Medical Device Design Case Study: Communication is Key
April 18, 2017At REV.1 Engineering, we work with many types of teams looking to bring their product to feasibility. Recently we worked…Medical Device Design Case Study: Achieving the Un-Achievable
March 30, 2017At REV.1 Engineering, we’ve handled medical device product development for more than 120 products for 60+ clients. We specialize in…Developing to Your Medical Device’s Character
March 16, 2017We have clients with a wide range of products who knock on our door and request our help. Every project…Bending Medical Device Regulations?
February 22, 2017At Rev.1 we pride ourselves in getting you to your project goals 2x Faster. Typically, when we meet with clients…Managing the Contract Manufacturer: Is Your Product Ownership at Risk?
January 31, 2017Product development with a contract manufacturer can seem like a good choice for a start-up company. Low or no-cost engineering…6 Smart Ways to Spend Money and Create Value for Your Medical Device
December 20, 2016Every start-up company is looking for a successful endpoint: Bringing their product to market; or acquisition. In either case, the…Acquisition Transition: The Benefits of Outsourced Medical Device R&D
October 27, 2016Once you’ve sold your medical device company, the work of transition begins. What does your R&D team need to do…Due Diligence: Funding & Acquisition of Your Medical Device Company
October 11, 2016You have developed a spectacular product. You have a good idea of the value of your company. You’ve worked hard…The 3 R’s of Medical Device Development: Research, Regulation, Reimbursement
September 22, 2016In our last blog, we laid out 5 pre-funding essentials for early start-ups. Today we want to delve further into…5 Pre-Funding Essentials for Early Medical Device Start-Ups
September 8, 2016When you are geeked about your medical device idea, it can be challenging to focus on the less-exciting parts of…Stories of Medical Device Success: The Opportunity in Failure
August 23, 2016“Don’t bury your failures, let them inspire you.” – Robert Kityosaki As we all know, medical device development is not always…5 Ways Skilled Technicians Speed Medical Device Product Development
August 1, 2016Often the medical device product design team is disconnected from the technicians and machinists who tackle the nuts and bolts…5 Ways to Create a Medical Device Development Contractor Partnership
July 14, 2016“REV.1 Engineering gets involved and puts skin in the game. They are very good problem solvers who take ownership. It…Designing Medical Devices with Finite Element Analysis
June 30, 2016You’re likely already familiar with finite element analysis (FEA) and its use in medical device development. From stress-strain to thermal…5 Steps: Critical Chain Methodology in Medical Device Development
June 15, 2016Most project managers use software that provides basic Gantt chart and cascading waterfalls of activities. Key milestones are laid out…Increase Speed with Parallel Pre-Clinical Modeling
May 31, 2016In a recent blog, we discussed the benefits of rapid prototyping with on-site 3D printing and machining capabilities. The same…4 Questions to Ask About Medical Device Development Consulting Transparency
May 16, 2016A key factor in selecting a medical device development consulting firm is transparency of data and information. From billing to…5 Benefits of On-Site Rapid Prototyping for Medical Devices
May 2, 20163D printing is much in the news right now, and yes, it’s an astonishing technology that we at REV.1 Engineering…From Feasibility to Design Freeze: 5 Key Risks in Medical Device Development
April 20, 2016Moving a medical device from “napkin sketch” to commercialization is a complex business requiring a wide variety of skills. Most…When 2 Heads Equal 10: FTEs in Medical Device Development
April 1, 2016Efficient staffing for medical device research and development can be a logistical nightmare, especially if you are trying to build…Top 5 Challenges in Building a Start-up Engineering Team
March 16, 2016As CEO of a start-up medical device company in search of engineering and development talent, it’s important to keep in…3 Hidden Costs of the Low Fixed-Rate Bid for Medical Device Development
March 1, 2016You’ve got a great idea for a new medical device sketched out. A successful implementation could mean acquisition of your…Which Barriers-to-Speed Slow Down Your Product Development?
February 16, 2016In all my years working with start-up CEOs who have an innovative medical device sketched out on a napkin, I…