insights
Innovation in the medical device industry drives ideas that lead to improved patient safety and better outcomes. However, successfully bringing the next life-changing medical device to market is complex.
The interrelationship of research & development, regulatory affairs, manufacturing, marketing, and legal requirements within medical device development often challenges, and may ultimately change, the scope of innovation. It may even halt production if issues aren’t properly identified and addressed — a costly message no device manufacturer wants to hear.
Partnering with an experienced, single-source medical device design consultancy from the earliest stages of concept development in medical devices is beneficial, regardless of OEM size or project scope. Leveraging their expertise and collaborative guidance helps ensure every aspect of the project is holistically considered, aligns with defined device and cost goals, and supports innovative initiatives.
The advantages of working with a medical device consultant can vary based on the company’s experience, depth of specialized knowledge and team members, and willingness to function as an extension of an OEM’s team.
Kapstone Medical has earned a reputation for helping OEMs launch successful devices and drive innovation in the medical industry by:
1. Helping OEMs overcome internal challenges
It’s common to want to keep a medical device project in-house, perhaps to protect breakthrough innovations and intellectual property, or maintain control over the entire process. While understandable, it can also be somewhat counterproductive. Internal red tape might delay progress, or maybe your team lacks capacity to dedicate time and resources to another project.
Whatever the reason, your project stalls out.
There’s too much at stake to risk losing forward momentum. The Kapstone approach to partnerships is intentional and dynamic. We plug into a project as an ancillary team member, engaging at every touchpoint to ensure any gaps are filled, questions are answered, and communication remains fluid and transparent to promote solid decision-making.
2. Asking the right questions
Medical device innovation is centered around challenging the status quo to arrive at the best possible solution for patient safety and wellbeing.
A responsible medical device consultant supports innovation, but not without due diligence. Asking questions that verify and further the process are essential, but so is challenging certain assumptions about the design, materials, testing, etc. that might otherwise complicate engineering and production, or introduce unnecessary time and cost impediments.
3. Offering project-specific guidance
Some medical device consultancies are set up to provide feedback based on a formula. You provide certain information about your device, and answers are returned about how your device can or should be produced. It’s equivalent to a best guess using input and output, with no comprehensive understanding of the whole project, or real-world testing and prototyping.
Kapstone doesn’t believe in a cookie cutter approach to medical device innovation. In addition to deep dives into understanding the impetus behind the need for the device, its regulatory pathway, and its market fit, we spend hours in practical application of engineering methodologies and testing such as Design for Manufacturability, usability testing, and feasibility studies.
We also prototype devices in-house to physically interface with a part in three dimensions, and also provide prototypes to medical professionals for feedback on product design and development, as well as intuitive use.
Objectively gathering and evaluating project-specific information puts us in the best position to act as your true consultant partner and guide you to desired outcomes.
4. Working in multidisciplinary teams to finalize and market the device
Kapstone experts are specialized and diverse. It gives our team the flexibility to plug into your project at one, many, or all touchpoints, leading or supplementing development, regulatory affairs, quality assurance, manufacturing, testing, and more.
Our single-source approach means your project is streamlined and efficient. We eliminate the need for juggling multiple suppliers and also get rid of potentially duplicative work or documentation. That means confidence in the final device, faster time to market, and smoother post-market surveillance and support.
Go From Medical Device Concept to Clearance with Kapstone
Did you know that working with a consultant on a medical device innovation can be up to 75% faster than in-house handling? It’s a statistic that underscores the value of partnering with external experts such as Kapstone, and speaks to the effectiveness of our single-source approach to inspire, equip, and guide OEMs to successful outcomes.
Explore more Kapstone actionable insights for OEMs in US FDA 510(k) From Concept to Clearance: A Guide for Medical Manufacturers. Click below to download your copy!
