Our Track Record
Here at Keystone Scientific, we are proud of our work. The following examples are provided so that you can formulate the questions that will allow us to provide solutions specific to your company's needs.
Hardware and Software Medical Device Prototype DevelopmentThe company: A start-up medical device company.
The challenge: Musculoskeletal assessments are qualitative and time-intensive. Detection and tracking musculoskeletal conditions is disconnected and inconsistent. The Keystone Solution: Management of 15-person cross-functional product development team consisting of market researchers, clinicians, physical therapists, full stack developers, UX, UI, hardware engineers, and vendors to collect patient data for integration into electronic health record. Implementation of design for manufacturing and assembly (DFMA) methodologies during prototype development. Benefits delivered: Musculo-skeletal care, once standardized, can support diagnosis, prognosis, and post-surgical treatments. Physicians can spend more quality time with patients, and patients will have access to their own, portable data. |
Healthcare IT Platform Development
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Defining global requirements for an operations capacity planning modelThe company: A Fortune 500 medical products company.
The challenge: Capacity models needed to be more robust and consistent to meet increased production demands. The Keystone Solution: Designed and facilitated workshops and conducted interviews to gather and prioritize requirements for capturing and analyzing capacity planning model inputs and data. Benefits delivered: This information will be utilized by enterprise software products to generate reports and decision making tools to drive improvements in capacity models and resource planning. |
Managing the delivery of innovative manufacturing aidsThe company: A Fortune 500 medical products company.
The challenge: Current molding components are expensive, require many operator hours to maintain, and cause bottlenecks in production. The Keystone Solution: Project managed the design and material selection of new, disposable mold drop-in components. Facilitated knowledge transfer of requirements with mold vendor. Benefits delivered: Disposable mold drop-in components will lower the cost of goods, reduce operator touch time and cycle time, eliminate a bottleneck source, and increase the capacity of the molding process, thus enabling greater capacity on downstream processes. |
Molding process improvements to enable future automation
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Assessing a concept for an advanced surgical patch (ASP) to prevent surgical site infectionsThe company: A medical technology collaborator.
The challenge: The client needed to know whether the ASP design concept could meet product requirements and be viable for prototyping. The Keystone Solution: Analyzed the ASP design concept and initial development activities with regards to preliminary product requirements, identified potential solutions to address where the concept does not meet product requirements, and developed a high level plan to move towards a first prototype. Benefits delivered: This analysis will be used by the client and their manufacturing partner to mitigate design and development risks. |
Development and validation of replacement medical grade polymerThe company: A mid-sized medical device company.
The challenge: The raw material for a key component of the client's disposable hematology line went obsolete. The Keystone Solution: Sourced and validated new compound to meet color match, brittleness, static dissipation, shrinkage, and light transmittance requirements. Developed and coordinated IQ/OQ/PQ protocols. Coordinated validation of new material. Benefits delivered: Development of a replacement material that met all specifications. Additionally, the new manufacturing process lowered labor costs by approximately $25,000 annually and raw material and processing costs were lowered by almost 33%. |
Manufacturing process and supply chain quality control improvementsThe company: A mid-sized medical device company.
The challenge: A malaria determining stain product was not working properly with a client located in Asia. The Keystone Solution: Assessed production and supplier criteria. Developed new production protocols. Benefits delivered: Determined that one of the 10 product components did not meet acceptance criteria, pre-existing production and quality procedures were insufficient, and production personnel were not trained properly. Systemic organizational concerns were corrected. |
Strategic Program Management of Cardiovascular Device Development |
Marketing and Regulatory Strategy Development for a First-To-Market Physical Exam Station |
The company: An early-stage medical product company.
The challenge: Leadership needed to focus on fundraising and clinical trial preparation, and the manufacturing development partner needed management and documentation support. The Keystone Solution: Developed an end-to-end program road map plan, identified key risks and work stream hand-offs, and established program communication tools. Benefits delivered: Supported the transition between design freeze and design verification, identified opportunities to drive the device development program, bringing in critical path milestone dates and mitigating risks. |
The company: A start-up healthcare venture in orthopedics.
The challenge: Orthopedic assessments are qualitative, labor-intensive, and clinician-dependent. Reproducible, accurate data collection that allows for the ability to track orthopedic conditions and physical therapy progress is currently not possible. The Keystone Solution: Conducted market assessment, including competitive landscape, regulatory and reimbursement pathways. Benefits delivered: This research led to the development of the market plan, marketing materials, investor pitch decks, and strategic implementation plans. |