about ampulis
Ampulis is committed to developing safe, user-focused, and reliable combination products in partnership with pharmaceutical organizations.
EXPERT DRUG DELIVERY TEAM
At Ampulis, we have assembled a world-class team with deep experience in drug delivery design, operations, human factors, and manufacturing.
Eric Sugalski, mba
Chief Executive Officer
Eric Sugalski has over 2 decades of experience in design, regulatory, and commercial aspects in medical devices. At Ampulis, Eric leads corporate strategy and pharma partnerships while keeping a hand in operational activities.
Michael baratta, mba
Operations Lead
Michael Baratta has over 30 years experience leading combination product teams in engineering, supply chain, and operations. At Ampulis, Michael leads product management and works with supply chain and manufacturing partners to execute with precision and control.
Lynn brown, cpa
Director of Finance & Administration
Lynn Brown has over 25 years experience leading financial operations and administrative functions within various organizations. At Ampulis, Lynn leads financial and administrative operations collaborating closely with leadership on strategic decisions.
joseph jackson
Engineering Lead
Joseph Jackson has over 2 decades of hands-on experience developing drug delivery and other medical devices. At Ampulis, Joe leads the detailed design process ensuring that functional, manufacturing, and cost targets are being achieved.
AIDAN HYDE
Human Factors Lead
Aidan Hyde has over 25 years experience optimizing medical devices for usability. At Ampulis, Aidan leads the human factors process gaining insights from customers that drive design decisions and confirming that user related risks have been mitigated.
JAMES CURTIS, Pharmd
Pharmacy Lead
James Curtis has over 20 years experience as a pharmacist and pharmacy manager at major healthcare institutions. At Ampulis, James advises on critical pharmacy operational issues that drive design and labeling decisions.
Craig Steiner, MD
Emergency Med Lead
Craig Steiner has over 30 years experience as an anesthesiologist, heavily involved in emergency medicine. At Ampulis, Craig advises on clinical and operational issues that drive design decisions to optimize clinical safety and effectiveness.
James Scull, phd
Drug Stability Lead
James Scull has over 30 years of experience at the intersection of drug-device interactions. At Ampulis, James manages extractables & leachables testing, particulate analysis, and other analytical tests to address regulatory and commercial needs.
HOW WE WORK WITH PHARMA
We offer unique drug delivery device platforms at Ampulis, but our REAL job is to help you develop a user-focused and reliable combination product. That means considering the essential requirements for your drug, implementing device changes, and performing the testing to meet regulatory, clinical, and commercial requirements. Below are the steps we’ll take to develop the right combination product in partnership with you and your team.
PHASE 1: ASSESSMENT
The first part of this process is to define the unique needs of your drug and application to determine if AFS is an appropriate fit. This process includes understanding dose volumes, drug viscosities, filling processes, sterilization methods, and human factors requirements. Through this initial phase we provide feasibility assessments, preliminary costing, timeline estimates, and an executional plan. This assessment phase is aimed at providing you the critical information to efficiently make a go / no-go decision.
> Phase Timing: 4-6 weeks
phase 2: CUSTOM DEV
After gaining alignment on strategic fit, we will customize the AFS for the unique needs of your drug and use case. This involves updating the design, generating design control documentation in accordance with ISO 13485 requirements, building single-cavity molds, assembling prototype devices, and performing characterization testing. By the end of this phase, we will have custom tailored the AFS to your unique functional needs while integrating branding, labeling, and other elements to make it uniquely yours.
Timing – 6-8 months
Phase 3: DESIGN VERIFICATION
After characterization testing has been completed, a cGMP build will be produced. Formal mechanical testing, analytical testing, process validations, and summative human factors testing will be completed. The output of this process will be a comprehensive test report package, suitable to support your regulatory filings.
> Timing: 4-6 months
phase 4: CLINICAL BUILDS
Following design verification testing (DVT), a suitable quantity of units will be produced under cGMP conditions to support your clinical testing needs. Device History Records (DHRs) will be generated through this process for full traceability for your combination product process.
> Timing: 2-3 months
phase 5: SCALE UP
At the appropriate time, we will determine the pathway and supply chain to support your scale-up initiatives. Depending on expected quantities, this may involve engaging one of our contract manufacturing partners to establish a custom line for your future production needs. Automation and process controls will be established through this process.
> Timing: 8-12 months
CONTRACT Manufacturing Partners
Our operations at Ampulis are aimed at helping you get to design freeze and clinical builds rapidly. When you are ready to scale, we have aligned ourselves with best-in-class contract manufacturing organizations (CMOs) to help you achieve your production volumes under strict quality controls.
LEARN MORE
The best way for us to tell you more about Ampulis and the AFS platform is through our email series. If you are interested, please subscribe through the form below. Thanks!