THE BUSINESS
Kashyap Malkan founded Advasaf in 2021, in Brookfield, WI. Advasaf is operated by Kashyap, and Vikram Malkan plays a key role in supporting the business. He is a University of Wisconsin–Madison–certified cybersecurity professional and assists with implementing process controls, quality systems, and internal audits, which are critical requirements in an FDA-regulated manufacturing environment.
Advasaf provides services to help manufacturers meet FDA and quality-system requirements, so their products can safely reach the market. The small business provides these capabilities locally in Wisconsin, reducing cost, lead time, and logistical complexity.
Advasaf combines novel technical capabilities with lean manufacturing practices, allowing faster turnaround times and greater flexibility for customers. Their processes are designed to be efficient and scalable, supported by decades of combined experience in FDA regulation, quality systems, cybersecurity, and manufacturing operations.
THE GROWTH
Since launching, Advasaf added commercial-scale, medical-grade sterilization capability, one of the first contract-based offerings of its kind in Wisconsin. Historically, companies either maintained this capability in-house or shipped products out of state.
As the company grew, it expanded into:
- Medical packaging design consulting
- Packaging validation and testing coordination
- Final assembly, labeling, and packaging services
The business is currently operating at capacity and is planning to expand its physical footprint In the future. Growth includes additional sterilization technologies, expanded manufacturing capabilities, and strengthened export partnerships.
THE ASSISTANCE
As a startup, there were many operational and regulatory unknowns. Ron Chisholm, a consultant at the Small Business Development Center (SBDC) at UW-Whitewater, provided guidance on business planning, funding pathways, supplier diversity programs, and minority-owned business registration.
Accomplishments with SBDC
- Advocacy
- Export Readiness
- Financials
Kashyap said, “What stood out most about SBDC’s assistance was having an experienced advisor who genuinely cared about the success of my business. That level of advocacy and support made a meaningful difference in helping Advasaf progress to its next stage.”
He also worked with Chris Wojtowicz at the SBDC’s Go Global Initiative. Through its ExportTech program, Advasaf received guidance on export readiness topics such as Harmonized Tariff Schedule (HTS) codes, market diversification, and international risk considerations.
Hear how ExportTech offered by SBDC’s Go Global Initiative helped this small business
Kashyap said, “The grant component was valuable, but the greatest benefit was access to Chris as an experienced export professional. Discussions with him focused on avoiding common export mistakes were especially impactful, as small manufacturers do not have the margin to learn through costly trial and error. Programs like ExportTech provide structured our confidence for expanding internationally.”
Vikram describes some steps they take to enable exporting to the EU.
Through the Main Street Bounceback Technical Assistance program, this small business also participated in QuickBooks and financial reporting classes offered by the SBDC at UW-La Crosse.
He also worked with Deb Reibold at Thrive, who helped the business expand in the Milwaukee- Madison corridor.. Kashyap said, “The support was highly effective because it was hands-on and problem-specific. We worked closely with Michelle Halverson who took time to understand our exact challenges and walked us through solutions step by step, which is extremely valuable for small businesses needing timely and practical assistance.”
He said of the obstacles to starting the business, “Building a medical manufacturing business requires navigating regulatory compliance, quality systems, cybersecurity, capital investment, and operational scaling simultaneously. While challenging, access to experienced advisors and structured programs helped us address these complexities in a disciplined manner.”
THE FUTURE
Advasaf is expanding into owning and developing proprietary product lines, beginning with simulation-based training products for injectable medical devices, hosted through www.mycaha.com.
Kashyap said, “Many clinics and medical practices face challenges training staff on injectable products, particularly higher-viscosity and particulate-based injectables such as Calcium Hydroxylapatite. These materials require greater injection force and precise technique to ensure accurate placement in the intended tissue plane. Our initial focus is developing non-clinical training and simulation products that replicate the handling characteristics of real injectable materials. These allow clinicians to safely practice injection technique, force control, and material placement using mannequins or training models, without patient risk.”
Their approach improves practitioner confidence and consistency, supports responsible adoption of advanced injectable technologies, and leverages Advasaf’s existing manufacturing, sterilization, quality, and cybersecurity infrastructure.
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Published February 2026