You don’t want to spend millions of dollars only to find out at launch that your product has reliability issues or only solves part of your customer’s needs. That’s why our team analyzes every inch of your product; to ensure it meets the mark.
We conduct a detailed analysis of your product and market to predict the future path it will follow, then cater our workflow to increase potential customer use, optimize performance and extend the product lifespan.
The way healthcare professionals and their patients interact with your product is very important. Our human factors analysts and digital designers ensure your product is novel, intuitive and is easy to understand and use.
We stay up to date with all relevant global regulations, and research country and state-specific ones as required by your product. This guarantees your product complies with all regulations and avoids delays in approval, costly remediations, recalls and safety issues.
Sometimes, unexpected challenges can send even the best-laid plans off the rails. Our client-focused remediation services help combat this by recalibrating struggling projects and keeping your current ones on track.
Our process places an emphasis on collaboration, both between ourselves and with our clients. We don’t just get your products across the finish line on time, we make sure it’s the best possible version of your product too.
Each increment produces a useable product and set of deliverables needed for the next milestone in development. Since clear objectives are defined upfront and constant feedback is provided during execution, the risk of delivery is significantly reduced.
We execute in increments defined upfront so we can demonstrate progress, validate assumptions, obtain feedback and allow time for refinement before the product is too far along. The increment approach promotes focused development which is clearly defined and allows for flexibility as the future needs become clearer.
Once the team is defined, we hold collaborative deep dive sessions jointly with your team to share and refine the objectives, strategy, technological approaches and associated risks. Together we define our short-term goals and success criteria. We believe working together increases success by building trust, increasing visibility, leveraging each other’s strengths, fostering creatively and promoting progress.
We define the technology, tools and the team as part of the strategy. Once we agree on a set strategy for the next phase of the program, we create a custom team of experts and select tools utilizing your existing framework while considering your long-term staffing plans. We believe the right team is a mix, utilizing our domain and software expertise, your existing strengths and skillsets and leveraging tools that are best suited for the product.
Once the initial assessment is complete, we will create a detailed strategy with clear deliverables, activities and product functionality that supports your next milestone while still achieving your final delivery. This strategy provides the framework for the program and helps establish the team and their long-term understanding of the product journey. This enables the team to drive the short-term objectives and make sound technical decisions without jeopardizing the subsequent milestones.
Before we embark on a new a project with you and as a continuous part of our process, we work with your team to conduct a thorough assessment covering various aspects of the program and product. This assessment is used to identify the needs, gaps, risks and opportunities that are critical for the success of the company. You cannot define a path to your destination without honestly knowing where you are today.
Quality / Compliance / Regulatory Updates – 16 March 2021
Mar 17th, 2021
FDA / Regulatory Updates Abbreviated 510(k) Regulatory Pathway (Overview) The Abbreviated 510(k) submission program relies on the use of guidance documents, special controls, and FDA-recognized consensus standards to facilitate 510(k) review. The most important difference is that a medical device manufacturer shall demonstrate substantial equivalence with a guidance, standard or special control. Traditional 510(k) submission […]
Quality / Compliance / Regulatory Updates – 2 March 2021
Mar 4th, 2021
Coronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a […]
Quality / Compliance / Regulatory Updates – February 2021
Feb 17th, 2021
Clinical Trials Requirements for Medical Devices (Overview) The determination of whether or not a device clinical trial is required is largely based upon a FDA classification of the device, as illustrated in the table below: Class I Class II Class III Example Reusable Scalpel Elastic bandage Infusion Pump Powered wheelchair Implantable pacemaker IVD test […]
Every business is different, and we adjust our approach to suit your market-specific and team-specific needs. The way we deliver our services may differ on a case by case basis, but our commitment to our clients remains consistent.