Contact Us

Simplifying
Drug Delivery

With Biolark’s deep expertise in drug delivery and drug-device combination products, we create alternative solutions that simplify development and product support for pharmaceutical companies and improve the patient experience when self-administering their medications at home.

Contact Us
A woman wears a compact drug delivery patch on her lower abdomen

Simplifying
Drug Delivery

With Biolark’s deep expertise in drug delivery and drug-device combination products, we create alternative solutions that simplify development and product support for pharmaceutical companies and improve the patient experience when self-administering their medications at home.

Contact Us

Addressing An Unmet Need

medical professionals developing a large volume subcutaneous delivery device in a clinical environment

Evolution of Biologics from IV to Sub-Q

Subcutaneous delivery offers the convenience of self-administration, enhancing patient experience, lowering healthcare costs and reducing infusion reactions.

High Volume & High Viscosity Formulations

Many new and in-development therapies are not suitable for autoinjector delivery due to the high dose volumes required and/or higher viscosities of the drug/biologic formulations.

The Challenges of Patch Pumps

Patch pumps face significant challenges including a lengthy development process, regulatory hurdles, high costs, usability issues, reliability concerns, the need for custom containers, and sustainability hurdles.

Hyaluronidase Out of Reach?

Hyaluronidase is expensive, can be challenging to formulate, and may not be accessible for some products due to exclusivity agreements.

Introducing the Ness HVDS

Biolark is developing the Ness HVDS (High Volume Delivery System).

The Ness HVDS is a subcutaneous drug delivery system that allows the user to self-administer higher volumes (5-40ml) of a range of viscosities of drug/biologic.

The system is entirely mechanical without any electronics or software.

Ness HVDS Vs. Patch Pumps

The table below shows how the Ness HVDS compares to traditional patch pumps.
_
Time & Complexity to Develop
Cost to Develop & Support
Cost of Goods Sold (COGS)
Regulatory Pathway
Primary Container
Usability
Reliability
Sustainability
Patch Pumps
Years / complex & unpredictable
$$$
$$$
Complex regulatory challenges
Often custom, exotic
Confusing ‘black box’
Questionable
Mixed electronic waste
Ness HVDS
Short / simple & predictable
$
$
Combination product or 510(k)
Standard vial (any size)
Intuitive & transparent
Simple & reliable mechanical system
No electronics
Patch Pumps
Ness HVDS
Time & Complexity to Develop
Years / complex & unpredictable
Short / simple & predictable
Cost to Develop & Support
$$$
$
Cost of Goods Sold
$$$
$
Regulatory Pathway
Complex regulatory challenges
Combination product or 510(k)
Primary Container
Often custom, exotic
Standard vial (any size)
Usability
Confusing ‘black box’
Intuitive & transparent
Reliability
Questionable
Simple & reliable mechanical system
Sustainability
Mixed electronic waste
No electronics

Ness Advantages For The Pharmaceutical Company

Standard Vial

Primary container is a standard vial.

Simple Production

No combination product assembly.

Cost Efficient

Low development costs and low cost of goods sold (COGS).

Support & Maintenance

Simple to support post-launch, minimizing user issues and complaints.

Efficient Manufacturing

The design is easy to scale for large volume production.

Low hold-up volume minimizes required overfill.

Regulatory Flexibility

Options for 510(k) device or combination product.

Ness Advantages For The User

Self-Administration​

Designed for self-administration by patients, or administration by nurses or caregivers.

User-Friendly​

Simple and intuitive operation with minimal steps: attach vial, attach device, deliver drug.

Pre-Assembled​

Requires only vial attachment, eliminating complex setup.

Intuitive Control & Feedback​

Users can control delivery rate and receive clear feedback throughout the delivery process.

Environmental Benefits​

Reduced environmental impact compared to traditional patch pumps. No electronic waste produced.

Ness Development Status

a human factors engineer developing a subcutaneous drug delivery device in a bright test lab

Benchtop Testing

Extensive component testing has been performed with multiple design iterations.

System Testing

System characterization and performance testing underway with product-like prototypes.

Design Finalized

Low production volume device design has been finalized for use in Verification and Validation (V&V) testing.

Human Factors

Several rounds of human factors user studies have been conducted.

Design Controls

Following ISO 13485 standards for design controls & documentation.

Next Step

Order injection mold tooling for low volume production (thousands).

About Us

After decades of experience bringing drug delivery products to the global market, the Biolark team realized that significant challenges remained unaddressed.

Meet The Team

profile picture of peter krulevitch looking positive and optimistic

Peter Krulevitch, PhD

CEO
28 years medical device and microfluidics experience.

18 years at J&J and Janssen Pharma.

Senior Director and Fellow, led Janssen’s Device, Primary Container, and Human Factors Group.

Developed products from concept to commercialization across Janssen’s portfolio, large & small mol.
profile picture of nick foley smiling by the sea

Nick Foley

CTO
Managing Director and Founder of Shore.

Over 20 years of experience in leading the development of successful medical devices for a wide range of blue chip Pharma and MedTech clients.

Involved in all stages of development from early concept through to commercial launch.
profile picture of leif bowman looking positive and optimistic

Leif Bowman

CEO and Co-Founder of Allez Health.

Has held senior leadership positions in marketing at LifeScan (J&J) and Dexcom.

Was Director of Infusion Products at SpectRx, and Senior Manager in Marketing at Medtronic.

Powered By Shore

Shore is a medical device design consultancy with over two decades of experience and a strong track record of developing drug delivery and combination products, including infusion pumps, autoinjectors, and pre-filled syringes.
Visit Shore
an array of medical devices developed by shore group consultancy including drug delivery devices

Interested In Learning More?

Get in touch for more information.
Contact Us