Built for Startups. Designed to Scale.
We partner with early-stage medical device teams to manage complexity, reduce risk, and create a clear path from concept through commercialization.
Flexible early-stage development with manufacturing in mind from day one
Bringing a medical device to market is both inspiring, and rigorously complex.
Early-stage teams often need to move quickly, navigating design decisions, balancing limited resources, and trying to achieve milestones, often while facing real pressure from investors and strategics.
At Sage Product Development, we work almost exclusively with medical device startups. We understand the need for flexibility, transparency, and responsiveness with a constant focus on budget and timeline constraints, and have developed our business model to best meet and serve those needs.
Our focus is to help our client companies move forward with clarity, confidence, and momentum on time and within budget.
Transparency,
Responsiveness
How We Work with Startups
At Sage, it is important for us to engage with our customers as a development partner, not just a transactional vendor. We focus on the partnership and want our client companies to see us as an extension of their team.
What to expect when working with Sage:
Flexibility, transparency, and responsiveness:
We align with our customers’ pace, priorities, and evolving technical needs.
Milestone-driven execution:
Our project plans are structured around the technical and business milestones that matter most to our partners, while following FDA guidelines and creating an auditable package required for market approvals and transfer to manufacturing and commercialization.
Cost-conscious decision-making:
We guide design choices that work today and scale efficiently for manufacturing. To manage risk and prevent scope creep, we use structured tools such as Earned Value Analysis (EVA) which provides transparency around progress, scope, and budget while still allowing the agility early-stage development requires.
Distribution Capabilities:
Sage will distribute commercialized product, providing a complete turnkey solution for our customers.
Supporting Investor and Strategic Due Diligence:
Many of our startup partners are preparing for financing, partnerships, or an acquisition. We routinely support due diligence and reduce perceived execution risk by:
- Providing clear, well-organized technical documentation
- Demonstrating manufacturability and scalability
- Clarifying technical risks and mitigation plans
- Showing a credible path from prototype to production
Designed for startup success
From Concept to Commercialization — A Turnkey Partner
Sage offers an integrated, turnkey solution for comprehensive program management.
We act as an extension of your team, and can support our client companies throughout the entire journey, including:
- Concept development and feasibility
- Detailed engineering design
- Design for Manufacturability (DFM) and Design for Assembly (DFA)
- Prototyping and iterative testing
- Regulatory support
- Quality integration and documentation
- Sterilization validations
- Packaging design and development
- Pilot builds and scale-up planning
- Transition to manufacturing
- Commercialization and distribution
- Supply chain management
Rather than working with multiple vendors, our customers gain continuity, accountability, and speed by working with one integrated partner.
We don’t just help you develop your device; we help you build a robust, scalable program.
Let’s Talk Before Your Next Milestone
Whether you’re refining a prototype, preparing for funding, or planning your path to commercialization, an early conversation can make a meaningful difference.
Connect with Sage before your next milestone to move forward with clarity and confidence.
Working with Sage
Sage Product Development brings decades of experience bringing novel ideas and early stage prototypes through to commercialization.
The earlier, the better. Sage often partners with startups at the concept or feasibility stage to help de-risk design, regulatory, and manufacturing decisions early, saving time, cost, and rework as development progresses.
Yes, Sage can provide a turnkey comprehensive development/manufacturing solution for your entire project, but we are open to supporting at any phase of development, no matter how large or small the work. Sage offers end-to-end support, including design and development, prototyping, testing, regulatory guidance, and manufacturing. Our team can support individual phases or manage the full lifecycle through commercialization.
Absolutely. Many of our partners are early-stage startups preparing for funding, clinical milestones, or market entry. We understand the unique challenges startups face and tailor our approach accordingly. We can also help support customers fundraising efforts.
Yes. Sage supports regulatory strategy and execution throughout development, including design controls, risk management, and preparation for FDA submissions. Sage partners with AlvaMed to support our customers regulatory and clinical needs. We work collaboratively to align technical development with regulatory requirements from the start.
Sage follows design controls according to ISO 13485 and FDA guidelines including Design Inputs, Risk Management, Good Manufacturing Practice (GMP), and Verification and Validation planning and execution. Sage partners with AlvaMed to support regulatory submissions and FDA and EU notified body correspondence.
Yes. Sage is structured to support startups as they grow whether that means early prototypes, low-volume builds, or scaling into full production. Our goal is to be a long-term partner, not just a project vendor. Sage’s niche is low – mid volume manufacturing. We will transfer your project to manufacturing and grow with you as your quantities ramp. Once you hit a level where you are looking for economy of scale with lowest labor and component cost, we support a seamless transition to one of our higher volume manufacturing partners.
We understand that startups operate within defined funding stages and milestones. Sage works with clients to scope projects strategically, prioritize critical work, and align development efforts with funding and growth objectives whenever possible. Sage will meet you where you are on your project and we pride ourselves on being flexible and adaptable to our client companies funding milestones and budget constraints.
Sage has experience in clinical areas including Arthroscopy, Cardiology and Cardiac Surgery, Dermatology, ENT, Gastroenterology, General Surgery, Interventional Radiology, Laparoscopic Surgery, Neurology, Ophthalmology, Orthopedics, Pulmonology, Peripheral Arterial Disease, Robotics, Urology, Vascular Access, and Women’s Health.
Our clients retain ownership of their intellectual property. Sage respects and protects IP and operates under strict confidentiality and contractual agreements to safeguard proprietary information.
Sage combines deep technical expertise with a partnership mindset. Sage’s values and over a decade of experience are what separate us from our competitors. We focus on being responsive, flexible, and transparent with our client companies, while maintaining a strong quality system and catering to startups manufacturing needs for initial lower volume quantities, while preparing to ramp to high volumes, all while keeping our pricing competitive by keeping our overhead low.
Still have questions?
Commitment
Sage is an ISO 13485:2016 certified company. We are committed to employing quality principles to provide the best possible medical device product development and manufacturing value to client companies.
Other Sage Services
We work side-by-side with our clients to develop the most effective solution for each unique product.
