HOW WE WORK
We partner with our clients’ to build value and reduce risk as we develop new medical products.
We leverage our team’s technical, regulatory, clinical, and manufacturing expertise to develop comprehensive product development strategies that fit with our clients business objectives.
This process starts with developing efficient methods to address key risk factors early. Through this risk-focused development approach, we help our clients achieve their milestones and build value in their enterprise.
Our Business Models
We partner with clients in three types of business relationships to accelerate the growth of new medical technologies. Our primary model is Fee-for-Service.
- Contract Product Development (Fee-for-Service)
- SBIR/STTR Collaboration
- Company Incubation
Read more about our business models in the FAQ section below.
Our Innovation Networks
Archimedic participates in a number of programs and initiatives to help new companies advance or assist established companies in bringing new medtech products to market.
- J&J Innovation JLABS The premier life science incubator empowering and enabling innovators to deliver life-enhancing health and wellness solutions to people around the globe.Archimedic offers a discount to JLABS companies through the vendor Resource Hub.
- Ben Franklin FabNet and PRIMA A partnership for rapid prototyping and fabrication utilizing advanced manufacturing technologies, offered through Ben Franklin Technology Partners of Southeastern Pennsylvania.Regional companies may apply for matching funds from FabNet to work with members of the partner network, including Archimedic.
- FDA Pediatric Device Consortia The goal of the FDA’s Pediatric Device Consortia (PDC) Grants Program is to facilitate the development, production, and distribution of pediatric medical devices through funding of nonprofit consortia.Archimedic participates as an official design partner of the Pennsylvania Pediatric Medical Device Consortium and the National Capital Consortium of Pediatric Device Innovation.
Archimedic leverages a proven design process to deliver high quality deliverables while reducing clinical, technical, and commercial risks
• Prior Work Review • Need Clarification
• Value Proposition • Phase 1 Goals
• Team Alignment • L10 Meeting Pulse
Engineering Concepts / Ergonomic Concepts
• Brainstorming • Concept Refinement
• IP Review & Filing • Early Prototypes • Functional Testing • HF / Usability Testing • Prelim. Hazard Analysis
• User Needs • Design Inputs
Production Design and Specifications / Alpha and Beta Prototyping
• Design for MFG • Design for ASM • Supply Chain Dev
• Alpha/Beta Protos • Testing • 2D Documentation
• Design Control • Risk Management • DHF/DMR
Testing and Documentation / Regulatory
Submission and Approvals
• Protocol Development • Pre-Production Build • Hardware Verification • Software Validation
• Biocomp. Validation • Sterilization Validation
• Final Risk Report • Regulatory Submissions
Design Transfer / Manufacturing Launch
• Design Transfer Mtg • Assembly Fixture Dev
• IQ, OQ, PQ • Pilot Builds
• Sustaining Engineering • Monitor Production
Often, customers approach us with specific deliverables in mind. Below are some of the common outputs of our process, delivered at key milestones throughout the development journey.
Clinical Study Builds
Breadboards & PCBs
Breadboards (or electronic test beds) are often generated early in the development process to evaluate functionality of key components. Additionally, these early breadboards can be a platform on which to load firmware. For clinical and production-focused builds, our team creates Printed Circuit Boards (PCBs) that address system performance and safety requirements. Our medical electronics are developed in compliance with IEC 60601, 3rd Ed. and our hardware is verified to ensure safety and consistency in performance.
Prototype & Production Code
Software is developed at varying levels of maturity depending on the risks being address. For proof-of-concept prototypes, we rapidly generate prototype code that can demonstrate system functionality. For clinical and commercial builds, we develop software using robust risk management and quality focus to ensure that software meets user, technical, and design requirements. In these clinical and commercial builds, our team ensures safety and efficacy through full software validation and documentation in compliance with IEC 62304.
Nearly all of our customers require Design History Files (DHFs) for quality management and regulatory filings. We utilize a flexible quality system to meet the needs of Class I, II, and III medical products. Read more about our QMS here.
Manufacturing Launch Plans
Our ultimate goal is to help client companies enter manufacturing with a well-vetted design that meets commercial requirements. Throughout development, we engage strategic suppliers for component fabrication, contract manufacturing, packaging, sterilization, and other processes to ensure a smooth and comprehensive transfer to production.
Archimedic Product Development Process
Download our process map to see more about our approach to developing new medical technologies.
Frequently Asked Questions
As you evaluate partners for your project, you likely have a lot of questions. Here are the answers to several of the most common ones.
Have a different question?
What are your business models?
Typically, our business model is fee-for-service. In these projects, we are contracted for product development services and we operate on either a fixed-fee or a time-and-materials basis.
With select clients seeking additional funding support beyond our initial engagement, SBIR/STTR funds are often pursued. If our clients secure these grants and list Archimedic as a subcontractor, we continue on a fee-for-service basis. There may be often restrictions on the portions of grants funds that can be subcontracted, limiting our scope of work. If Archimedic secures SBIR/STTR funds directly as the prime contractor, we receive these funds directly from the agency and are able to apply the full amounts toward the activities that most efficiently advance a product toward commercialization.
In select cases, we license assets and incubate them within Archimedic. This can be an efficient model, since our team already has in place the full capabilities and infrastructure needed to accelerate new medical technologies. For incubated technologies, our team may seek sources of funding from grants and investors. Under this model, Archimedic is responsible for securing the funding and advancing the product toward a future financial transaction, which may be in the form of a sublicense or an asset sale. Agreements are put in place with the asset licensors to share in future financial successes.
Who owns the intellectual property at the end of a project or development phase?
Our project collaborations often result in new intellectual property that form the foundation for patent filings.
In fee-for-service relationships, we typically assign intellectual property rights to our clients as part of our service agreements. We expect that our team members are listed as inventors on related patent filings in accordance with patent law.
When Archimedic directly secures grants and/or equity investments to facilitate product development and commercialization (see “What is your business model?” question above for more details), we structure joint intellectual property agreements.
Can you assist my company with an SCIR/STTR grant application?
After entering into a business relationship with a client seeking funding to advance their technology and who may be a good candidate for SBIR/STTR programs, Archimedic may support companies in securing additional grant funding. (See “What is your business model?” question above for related details.) There are two ways we collaborate with organizations through the SBIR/STTR process.
The first and most straight-forward collaboration is for Archimedic to operate as a subcontractor. In providing support as a subcontractor, companies leverage our track record of developing successful devices, qualified development team, quality management system, and facilities and equipment. For these types of subcontractor relationships, we provide a letter of support capturing our qualifications and specifying the details (timelines, budgets) for the project.
The second mode of collaboration is for Archimedic to operate as the prime contractor in securing the SBIR/STTR funding. Under this mode, Archimedic files with the agency directly and obtains letters of support from the contributing academic institutions and other organizations part of the grant process. A team member from Archimedic operates as the Principal Investigator (PI) for these types of grants. We collaborate with partnering organizations and institutions to generate many of the grant application components and Archimedic completes the filing and communications with the SBIR/STTR agency. Typically, we pursue this prime contractor route only if a prior fee-for-service engagement with an organization has been completed.
What does it take to incubate my technology at Archimedic?
We work with many clinical innovators and academic hospitals that have limited resources to drive business operations, product development, project management, fundraising, and the other functions necessary to build a medical device business. In select cases, Archimedic will license a technology from an academic institution or an individual and incubate the technology internally, leveraging our team members, quality system, supply chain, facilities and equipment.
Due to the investment of resources required, Archimedic is very selective regarding the technologies we pursue for this incubation program.
How much does it cost to develop a new medical device?
Developing even a simple medical device often requires multiple years of dedicated effort. This is due to the many technical, regulatory, clinical, quality management, and manufacturing processes that must be simultaneously managed to achieve market approval. From napkin sketch through regulatory approval, companies can usually anticipate seven- to eight-figure investments. For this reason, we primarily work with organizations that are seeking or have successfully secured external financing.
While the overall funding requirements for commercializing a new medical device are significant, the vast majority of our clients obtain smaller rounds of funding to achieve early technical and clinical milestones. We structure development programs to fit within these smaller rounds of capital, helping companies map out the longer-term development processes, timelines, and budgets needed to unlock future funding rounds.
Can your team work within my QMS?
Yes. Archimedic’s quality system allows for flexibility in our approach to each project. As an alternative to utilizing our internal quality system, our can work within your quality system when requested.
Do you only work on products from start to finish? Can you work only on certain project phases or product components?
We pride ourselves on flexibility and ensuring our team members are being utilized to their optimal abilities. We often work with clients that drive one disciplinary area. For companies simply seeking a single part to be designed within a much larger system, we are generally not the best fit.
What sets you apart from the competition?
We’re distinct from many other product development firms in three key areas.
- Medtech expertise – this goes beyond product development. Our knowledge of regulatory, clinical, payment, IP, and business factors are leveraged throughout the development process to help our clients determine what product to build and how to optimally structure the development roadmap.
- Technical expertise – our broad array of technical disciplines, including mechanical and electrical engineering, software development, industrial design, and human factors, allows us to deploy the right disciplines on the appropriate tasks.
- Program management – changes in new medical device projects are inevitable, but our goal in program management is “no surprises.” We work hard to ensure that our internal teams and client teams are in lockstep throughout the development path.
Should we put a Non-Disclosure Agreement in place prior to meeting?
We typically start each conversation with a high level, 30 minute, non-confidential phone call. If we both determine that there is a strong fit for collaboration, we put a mutual NDA in place and dive into the project details during a follow-up meeting.
Our Commitment to Quality
We take quality seriously and hold ourselves to a rigorous standard in all that we do.
Archimedic is committed to assisting clients with the development of safe and effective medical devices. Our commitment to excellence is reflected in a robust Quality Management System compliant with 21 CFR 820 FDA Quality System Regulation and ISO 13485:2016.
For details, please read our Quality Statement.
EPISODE 11 - Data Flow & Medtech InnovationIn this episode, Seth Goldenberg, VP of Vault Medical Device & Diagnostics at Veeva Systems, covers data flow throughout the product lifecycle and how advanced data management can speed devices along the path to market....
EPISODE 10 - Securing Funding, Part IIIn Part II of this two-part episode, Adam Dakin, Managing Director of Dreamit Health, covers funding trends in medtech and how to pitch to institutional investors. (Part I available here!) Adam and Dan discuss: Medtech funding...
This article originally appeared on Med Device Online. By Matthew R. Maltese, The Pennsylvania Pediatric Medical Device Consortium, and Daniel Henrich, Archimedic As a society, we seem to regard the lives of children as more innocent, precious, and worthy of...