insights
Whether the innovation of an established industry manufacturer or that of a newly formed startup, taking a medical device to market is challenging. Even the most thorough understanding of the concept behind the medical device and its intended use can fall short when faced with real-life product development issues, ever-changing regulations, continual quality needs, cost management challenges, and supply chain issues.
It’s a lot. It’s also why manufacturers often seek external medical device consulting. There are many capable and qualified companies available to help, but finding a true partner requires careful consideration of the following factors.
Narrow the Scope
Choosing your medical device consulting partner is a big decision. Therefore, it’s common to want to extensively sort through dozens of prospects — which can be time-consuming and sometimes frustrating.
Instead, a simple exercise can be a great way to arrive at a handful of top-notch candidates relatively quickly. Before starting in-depth analysis, have your team weigh in on the type(s) of expertise required for your project. It could be any or all of the following:
- Medical device strategy consulting
- Medical device development consulting
- Medical device regulatory consulting
- Medical device quality assurance consulting
You may not be completely dialed in on what a partnership needs to provide, and that’s okay. Identifying what you know to be true about your project from the outset helps eliminate prospects that don’t align with expectations – and gives you more time to spend on those that do.
5 Focus Areas that Define a Medical Device Consulting Partner
Understandably, their industry reputation likely held some sway in advancing consultants to your short list of prospective partners. Known and proven success is a powerful qualifier, but now’s the time to dig deeper.
Objectively evaluate each prospect in these 5 focus areas:
1. Industry Experience & Specialization
Medical device experience is an obvious requirement for a medical device consultant, but demonstrated results in your specific area of device innovation — such as orthopedics — is a difference maker. A partner immersed in the nuances of your niche can provide impactful go-to-market strategies for a competitive advantage and knows the not-so-obvious pitfalls to avoid.
2. Technical Expertise & Resources
Technical capabilities underpin the effectiveness of a medical device consultancy. The depth and breadth of engineering expertise in testing, equipment, qualification, support, and follow-through speaks directly to partnership potential. The same holds true for the consultant’s understanding and early adoption of emerging technologies and trends that improve outcomes.
3. Centralized Support
Taking a medical device from concept through commercialization is a multi-faceted process. The required disciplines are numerous: regulatory, quality, engineering, marketing, manufacturing, compliance, reimbursement, supply chain, inspection, customer service, sales, and more. Involving and managing many outsourcing partners is complicated enough, let alone taking on the challenge of coordinating work and timelines among them.
There is another option. A medical device consultant with the expertise and in-house capabilities to address all of the needed disciplines provides a hub of centralized support. The single-source convenience optimizes time and resources without sacrificing process or product quality.
4. Effective Collaboration
Finding a consultant that’s compatible with your company’s culture, team, and values is crucial. A natural synergy strengthens collaboration, communication, and mutual investment in goals. It also reflects a consultant’s willingness to provide ongoing support and guidance throughout and after the conclusion of a project.
5. Value vs. Cost
There’s a financial aspect to investing in a medical device consulting partnership. However, there is cost and there is value. The expertise and seamless responsiveness of a full-service consultant regarding all aspects of a medical device project provides a return on investment in tangible and intangible ways.
Using this set of criteria provides helpful insights in two important ways: First, it serves as an apples-to-apples comparison of key competencies. Second, the answers will reflect the strongest choices and guide prioritization.
The Single-Source Solution
When a medical device consulting company is built around exceeding partnership expectations, there’s much to be gained.
Niche intelligence and practical experience refine the Kapstone Medical team’s holistic approach to medical device development and regulatory process. Our diverse team of specialized experts works toward one goal — being the single-source solution for medical manufacturers from project concept through commercialization.
What does a Kapstone Medical partnership look like for medical device manufacturers? Explore the possibilities using the Kapstone Medical New Product Development (NPD) Roadmap. Click the button below to download your copy now.
