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Managing Risk Beyond the Critical Chain

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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 & program management as well. Combined with our disciplined (and documented) execution, our approach is proven to scrub away risk and significantly compress developmental timelines.

As First-of-Kind devices make up a disproportionate amount of our Design & Development work, we believe we’ve evolved to deliver a unique combination of benefits for our clients that support the successful navigation of broader, business risk factors, in addition to managing their Design & Developmental risk.

Here are some additional areas where partnering with Rev.1 Engineering contributes to your company’s strategic strengths and ongoing, sustainable success.

Manufacturing Risk

Our experience with Design for Manufacture is extensive and drives immediate profitability upon commercial launch (by addressing parts count, cycle times, assembly times, yield rates, scrap rates, etc.). This, combined with our approach to Design Transfer, ensures a seamless transition into commercial manufacturing. Perhaps most importantly, however, is the benefit of when our clients get to make their decision on their contract manufacturer (CM). Working with Rev.1 Engineering enables our clients to choose the best fit CM for their device…based upon the actual design of their device. Together, we will have gone through several iterations of design options, placed fabricated prototypes and/or critical components into peoples’ hands, and engaged potential manufacturers for their input, prior to design freeze and before deciding who the best fit CM is for the device. This alleviates significant unknowns and addresses potentially, albeit unwitting false assumptions that, years down the road, could lock a company into a less than optimal relationship with a CM with little recourse or options going forward.

Strategic Risk

After the past several months, we all fully appreciate how an “unanticipated or unprecedented” event can disrupt the best of plans. This is the third such disruption I’ve experienced while being an executive operating within the Med Device industry (9/11, The Great Recession, COVID-19), so I greatly appreciate having contingencies in place and the flexibility to quickly pivot if the company needs to do so.

We believe working with REV.1 provides you with the best of both worlds (a dedicated, world-class Design & Development firm and a best fit contract manufacturer). Because we build, install, test & validate (IQ/OQ/PQ), document and train the CM on your manufacturing line (all machines, processes, fixtures, etc.), you own it. You’re not captured in a long-term manufacturing contract that could be impacted by forces well outside your control. With REV.1, your manufacturing line is plug & play; you can take it to any CM that best suits your strategic needs, at the time and for the future. And we’ll always be there to support you throughout your device’s life cycle.

Regulatory Risk

As we build out your project plan, we will work with you (or your regulatory vendor) to ensure we’ve accurately incorporated your regulatory strategy. From this vantage point, we capture critical design/performance features (e.g., substantially equivalent to a predicate device) establish bench testing protocols and ensure we’re preparing a meticulous Design History File.

In addition, we train to and work within your Quality System, ensuring seamless documentation and a clean audit trail.

Adoption Risk

This is always a challenge with First of Kind devices. There’s a constant balance between achieving strategic, beneficial differentiation (patient outcomes/experience, cost, CMS quality goals, haptic feel, handle balance, intuitive interface, hand fatigue) and not moving so far outside of the standard of care delivery model as to have to reinvent the wheel. This is where we strongly believe we’re far superior to the engineering departments working within and in support of contract manufacturing. Our talent combined with our vast experience designing First of Kind, complex, interventional technologies places us within the best-in-class category for medical device design & development. Upon hitting the market, our designs are quickly embraced and broadly adopted.

Financial Risk

Because of the investments we continue to make in our knowledge workers, talent management and developmental/fabrication capabilities, no one is faster when it comes to speed to revenue and cash flow. Pulling in dollars sooner rather than later, from farther out in your 3 to 5 year forecasts, has an enormous impact on company valuation and company performance.

Topera is a great example of this phenomenon (IRR/NPV calculations available upon request). Working exclusively with Rev.1, Topera went from a concept and a license for an algorithm to a $250 million cash exit, in just 4.5 years. Topera raised $30 million, payed REV.1 ≈ $4.75 million for Design & Development, and used the balance for clinicals, manufacturing and SG&A. With Rev.1 providing the kernel of value creation and our partnering closely with them throughout the commercialization process, Topera delivered an Internal Rate of Return of 329%, a Present Value of ROI of 686%, and achieved a Net Present Value of $160,387,000 on their total investment. This isn’t our only example. In fact, we have two previous clients, serial entrepreneurs, that are back with us again working on their next projects and companies.

Operational Risk

Acting as a natural extension of your team, Rev.1 delivers the personnel and expertise that enables our clients to de-leverage internal resources in support of strategic priorities. Building in this level of flexibility, without any carrying costs, affords executives expansive options to meet the challenges of today’s volatile world. Additional operational benefits include strategic sourcing for your sub-assembly and component needs, helping select your best fit contract manufacturer, as well as document management and quality system support.

HR Risk

Engaging Rev.1 Engineering immediately delivers the capabilities and expertise of our 25 engineers and technicians. All without introducing the risk and expense associated with recruiting, onboarding and training new, often hard to find, engineering talent. This greatly expands your operational bandwidth without introducing any additional HR risk.

As you can see, partnering with Rev.1 delivers benefits that go well beyond the critical chain!