Without sacrificing safety or quality

Speed to market is a crucial part of medical device success. Our employee experts drew upon their experience with hundreds of medical device products for proven tips and recommendations that increase medical device speed to market without sacrificing safety or quality.

Read on to discover how to understand the intended market, focus the development process, and pay early attention to regulatory requirements and design transfer can speed the medical device commercialization journey.

Culture

Foster a culture of collaboration and empowerment to encourage creativity and innovation, further enhancing efficiency without sacrificing standards.

Kick things off right, ensure you’re meticulous about team composition, making sure you have the right blend of skills and experience. Establish how the project will be run outlining communication channels, decision-making rules, and defined roles and responsibilities. If you skip these steps, your team might not gel well, leading to lower performance and missed opportunities. Building a high-performing team from the start ensures everyone knows their role, fostering better collaboration and achieving project goals more effectively.

Understand Your Target Market

Focus on Target Product Profile (TPP).  Understand what the key market differentiator is and focus on that.  Also, look for opportunities to enter a market (or adjacent market) with a lower barrier to entry.  A classic example in antimicrobial development is when going for a disinfectant claim that requires a new drug submission, start with a sanitization claim.  This strategy is less risky, builds the collateral required for the larger (more TPP focused) market, identifies potential risks, forces production and scales up development with potential to generate early revenue wins that can fund the heavier regulatory lift.

Reimbursement strategy. When looking to sell a device, make sure there is a good and clear way of getting paid for it, and confirm that there is sufficient demand. This is especially important in the US market. Devices need to have a reimbursement strategy established and a good sense whether there are codes for the device and whether doctors can clearly charge for it. Have that strategy in mind before even thinking about launching the product.

Test assumptions with users before diving into technical problem solving. Gather feedback from the market and users. Assess initial design assumptions. And once they are formalized, don’t limit development to traditional modes like batch testing. Consider analysis as rudimentary as hand calculations to help de-risk. Or use computational modeling which allows good scalability for parametric studies to optimize timelines and bring down development costs. Not everything has to be assessed on the bench. It’s all about de-risking the approach through the lowest bar.

Efficient Development Process

Review product requirements and question what is necessary and what can wait for post launch. Eliminate product requirements that do not affect device performance, safety, or quality. Specifically, product features that are software based that add nice to have features and can be added as a future software release. Doing this can decrease the complexity and effort of getting a device to market.

Value and incorporate User Experience (UX) design principles to ensure the device is not only technically effective, but user-friendly, intuitive and will delight clinicians and patients alike. Create an intuitive interface – whether physical, digital or a combination of both – that minimizes the learning curve for clinicians – reducing training and customer service costs.

In early stages of development build proof of concept prototypes that de-risk only the highest risk elements of the architecture, preferably one design element at a time. That helps determine quickly, early, and cheaply whether architecture elements of concern will meet device needs so development plans can be changed to solve or mitigate those risks in parallel with less risky development aspects.

De-risk any technological uncertainties as early as possible and work through risks starting from the most impactful and going down to less impactful ones. This gives evidence and confidence that the core technologies will work before spending a lot of time and money going down the path of detailed development with the possibility of needing to change course if risks not checked, ultimately manifest themselves.

Break down projects into smaller, manageable tasks and continuously gather feedback from stakeholders. Teams can identify and address issues early on, ensuring both safety and quality are maintained throughout the development process.

Invest in automation wherever possible. Automation streamlines repetitive tasks, reducing manual errors and freeing up time to focus on more complex challenges. By automating processes such as testing, deployment, and monitoring, organizations can achieve faster and more reliable product releases. Automation facilitates consistent adherence to safety protocols and quality standards by eliminating human error and ensuring thorough and repeatable testing procedures.

Early Regulatory Strategy

Clearly define intended markets with sales and marketing so the supply chain team can understand applicable regulatory requirements. For example, is the region the entire United States or just California? It is important to make sure during the transfer phase that everything is checked out; the suppliers process is up to date and all the documentation is completed. Figuring the markets out later will require a complete review of the Bill of Materials (BOM) and waste a lot of time. So, understand the intended market(s) first.

Include regulatory professionals early. The earlier the better. In the past I’ve seen smart engineers with great ideas that haven’t thought of regulatory requirements early enough and slowed time to market.

Don’t forget about labels! It’s amazing how many projects go full speed ahead to reach a finish line, only to be delayed by labels that do not meet the regulatory requirements for the intended use of the device. Don’t be afraid to make different labels to cover each step of the device development from proof of concept, to clinical, to CE mark. A clear label plan that aligns to the product road map will ensure a smoother (faster) path to the market.

Plan Early for Design Transfer

Allocate sufficient time for commercialization and the design transfer. A lot of times, there is a temptation to think, “we have a working device, so we can start to complete the commercialization phase very quickly. But most times, that is not very realistic. Allocate enough time for the transfer phase and try to incorporate design for manufacturability and assembly as early as possible during development. Once proof of concept risk is mitigated and technology is mature, try to factor in manufacturability. Because even if there is a working device, if it’s not manufacturable, or easy to assemble or test, then it will be a headache in the transfer and commercialization phase.

Engage the engineering manufacturing team with key suppliers so the suppliers can develop suggestions for the development team. This can speed the process and get the unique identifier (UID) to the market sooner.