www.delve.com Open in urlscan Pro
76.76.21.142  Public Scan

Form analysis
0 forms found in the DOM

Text Content

Sectors
Services
Case Studies
Blog
About Us
Partner with Delve




MEDICAL DEVICE DEVELOPMENT

Product innovation for Class II and Class III devices



Access to multidisciplinary medical device experts

We assist from concept to launch of Class II and Class III medical devices. From
creating user requirements and handling regulatory compliance, to developing
medical device designs, selecting materials and supply chains, and assisting
with FDA submissions.



Manage the risks of healthcare
Delve is ISO 13485:2016-certified, a testament to the quality practices we have
and our team's abilities to develop the industry's most complex medical devices.
Read more

Be more than clinically effective
Medical devices today need to be developed to be intuitive, reliable, and
cost-effective. Our products balance the needs of the whole ecosystem.
We’re not only a medical firm.
Users expect medical devices to behave like consumer devices. We design and
develop those, too, and your device will benefit from what else we know.

55+
Years
Trust our longevity
200+
Awards
Delight your users
1,500+
Patents
Secure your edge
10,000+
Projects
Rely on our experience

MEDICAL DEVICE DEVELOPMENT EXPERTISE


Imaging
Surgical Instruments
Diagnostic Equipment
Wearables
Single-Use Devices


OUR WORK


'They bring skills we don't have'
A complex screening procedure is brought out of the lab and onto a chip.

Baebies' sought our expertise in user research, industrial design, and shaping
the user experience. We immersed ourselves in the NICU and turned Baebies'
technology into a diagnostics device that's saving lives.

Read More

Award
Winner
Medical Devices
Dexcom G6
While users of the previous Dexcom system greatly valued its enhanced ability to
monitor their glucose levels, applying the subcutaneous Dexcom sensor to their
bodies was an obvious pain point that was a barrier to wider adoption.
Read more

Award
Winner
Medical Devices
REAL™ Immersive System
The first virtual reality system that is purpose-built from the ground up for
rehabilitation in a healthcare environment.
Read more

Award
Winner
Medical Devices
BD Diagnostics
Strategic, actionable branding guidelines bring BD Diagnostics into the future
and provide a roadmap as they develop and acquire more products.
Read more

Medical Devices
ProNova SC360
Imagine being strapped into a large machine, completely immobilized, for an hour
while it delivers high doses of radiation to treat your cancer - every day for
six months.
Read more

Award
Winner
Medical Devices
BK Ultrasound Sonic Window
Delve helped BK Ultrasound bundle its game-changing technology into a widely
adopted, easy to use, award-winning medical device.
Read more

Medical Devices
Alcon Cataract Surgery Scalpel
Delve developed a new scalpel that skirts competitors’ overly broad patents and
keeps costs low.
Read more


Not just for enterprise. For startups, too.

Your concept has already attracted backing, but to get to the next level you
need design, technical expertise, and prototyping capacity. Our strategists,
designers, and engineers have guided many startups to the next round. Or to an
exit.


END-TO-END PRODUCT DEVELOPMENT

All the experts in one place means a more cohesive experience.



Read More About Our Capabilities

MEET THE EXPERTS


Kent Kallsen
VP of Engineering

Kent helps clients turn concepts into products that are differentiated,
elegantly functional, and practical to manufacture. He leads mechanical,
electrical, human factors, software, quality management, and prototype
development engineers who apply their deep expertise on projects across multiple
industries, including medical device, consumer, and commercial.


Mathieu Turpault
VP of Design

Mathieu helps clients evoke emotion through design. He believes emotional appeal
can be rationally and analytically designed. Mathieu taps into his extensive
experience, finding the best possible approach within the client’s constraints.
He has been published in many leading design journals and speaks frequently
about multisensory and immersive design, front end innovation, brand building,
integrated design methods, and sustainability.


Meet All Our People

OUR RECENT THINKING


Get Inspired
3 Surprising Findings from Our Latest MedTech Industry Survey
While reviewing the early data from our ongoing research on trends in the
medical device industry, three unexpected findings caught our eye.
Read more

Be More Innovative
How to Design a Medical Device as Safe as an MRI and as Intuitive as a Nest
Medical device manufacturers need to design for a new kind of user. This has big
implications not just for the devices they design but also for how they do
business.
Read more

Design an Experience
Four Ways to Win the Future of MedTech Wearables
Soaring demand for wearables has created a market saturated with the
things—prompting an 18.1 percent year-over-year growth worldwide, according to
Gartner.
Read more

Predict the Future
How to Design Health Products of the Future, Part 1: Everyday Wellness
Future healthcare products need to be designed to embody a proactive and
preventive mindset. This new paradigm is focused on enhancing our well-being and
health in all areas of our life, all of the time.
Read more

Get Technical
Design for Sterilization of Medical Electronics
Learn design techniques to maximize device reliability for common sterilization
processes — autoclave, ethylene oxide, and ionizing radiation.
Read more

Be More Innovative
How the Consumerization of Healthcare is Transforming Medical Device Design
Patients are becoming empowered consumers of healthcare. They bring to medical
devices the high expectations formed from their experiences with highly
intuitive consumer products—as well as greater risk.
Read more


Let's build a breakthrough medical device.
Reach Out Today


--------------------------------------------------------------------------------




MEDICAL DEVICE DEVELOPMENT

We are deeply rooted in human-centered medical product design.

Over 55 years we've developed thousands of medical products, including surgical
instruments, drug delivery devices, home health and rehabilitation devices, and
complex medical diagnostic systems.

They are safe, effective, innovative, and successful in the marketplace. They're
used by everyone from healthcare professionals to patients to lay caregivers.

Whether we’re developing new products or improving existing ones, our
cross-disciplinary project teams of human factors and usability specialists,
researchers, designers, and engineers tap into their experience with multiple
industries and technologies to spark cross-pollination.


This is especially important as medical devices continue to look and act more
like consumer products.

Healthcare professionals’ expectations for usability are growing, and more lay
caregivers and patients are administering their own treatments and medications.

We nimbly bridge this narrowing gap between the consumer and medical sectors
throughout every development phase: Product Design and Definition, User Research
and Human Factors, and Engineering Development and Verification.


MEDICAL DEVICE PRODUCT DESIGN AND DEFINITION

We assist from concept to launch—evaluating user requirements, studying
competitive patents, finding patent opportunities, handling regulatory
compliance issues, selecting approved materials and processes for manufacturing,
processing documentation for FDA submissions, and designing the Product Brand
Language.

Cross-disciplinary project teams pull from our seven in-house disciplines:
design and innovation strategy, user research, industrial design, interaction
design, mechanical engineering, electrical engineering, and software
engineering.

Our consumer and commercial work enhances our larger understanding of user
needs, materials, and processes, along with design trends and emerging
technology.

With more products featuring digital interfaces, design doesn’t end with the
physical product. Our interaction designers and electrical engineers are often
part of the project team. Their contributions may include user interface
architecture and visual design for embedded touchscreens as well as the
underlying electronics hardware and firmware.

The development of mobile apps as companions to medical devices often comes into
play. (Learn more about our integrated Digital-Physical Design expertise.)


USER RESEARCH AND HUMAN FACTORS

Human factors and usability engineering not only help maximize the ease of use,
efficiency, and user satisfaction of any product, but they are FDA-required
components of medical device design.

Medical device designers must conduct human factors validation testing to
demonstrate that the intended users of a device can use the product to perform
the intended uses in the intended use environment.

This effort is commonly referred to as usability engineering, and the goal is to
ensure that the device has been optimized to eliminate, or reduce to the
furthest extent possible, use errors that could cause harm to a patient.

Delve employs a wide array of user research techniques to help clients navigate
through the human factors regulatory process, from initial product design to
final validation testing.

We have extensive experience executing user research aligned with regulatory
guidance and are well-versed in standards requirements, including

 * FDA Guidance 1757: Applying Human Factors and Usability Engineering to
   Medical Devices
 * AAMI/ANSI HE75:2009 Human Factors Engineering—Design of Medical Devices
 * AAMI/ANSI/IEC 62366-1:2015, CE marking (Europe)
 * Medical Devices Directive 93/42 EEC (Europe)


FORMATIVE TESTING

Formative studies are typically conducted to help inform the design refinement
of product concepts and prototypes.

They will typically include evaluations with representative users to answer
design questions, identify strengths, probe for weaknesses, and detect potential
use errors that may occur while using a product.

Conducting formative testing early and regularly throughout the design process
can help medical device companies save time and money before final products or
prototypes have been created.

Formative testing can be done in a wide variety of forms, including qualitative
interviews, quantitative testing of one or more prototypes, and statistical
analysis of observational data across multiple usability studies to investigate
improvements in safety and usability over time.

Delve helps clients define the optimal formative testing plan to align with
their product, development plans, and regulatory pathway. Then, our researchers
efficiently and effectively execute the studies, providing clients with the
timely answers needed to assess if a product is safe and effective.

For those who plan to sell their product across international markets, Delve
collaborates with national and international partners to help clients connect to
relevant users across the globe.


HUMAN FACTORS VALIDATION TESTING

Human Factors Validation Testing, also called “Summative Testing” or “Simulated
Use Validation Testing,” is required by some regulatory bodies—specifically the
FDA—to demonstrate that the production-ready product can be used by the intended
users, for the intended uses, and under the expected use conditions, without
causing harm or degrading medical treatment.

A minimum of 15 users per user group (i.e., a set of users with distinct
characteristics) must use the final product to perform critical tasks (i.e.,
tasks that could lead to medical harm) in a representative use environment.

Delve's team of human factors experts can help companies execute all stages of
validation testing, from defining the user groups, uses, and use environments,
to creating a risk analysis, to conducting the simulated-use validation testing.


EUROPEAN MEDICAL DEVICES REGULATION (MDR)

Medical device manufacturers who have a device with a CE mark or who are looking
to submit a CE Marking Technical File need to ensure they are up to date with
the new EU Medical Devices Regulation (MDR), which went into effect May, 2020.

The EU MDR regulations will place greater scrutiny on the history of the
research that has been conducted to ensure the “safety and health” of users and
patients, as well as on the information to be included with your product
[instructions for use (IFU), implant card, labeling, etc.].

This regulation is four times longer than its predecessor, the Medical Device
Directive (MDD). To meet these new requirements, additional labeling and IFU
comprehension studies and usability studies may be necessary.

A gap analysis of your Design Dossier may be an ideal starting point to identify
the needs to be addressed. Read more about how the MDR relates to human factors
and usability.


USABILITY ENGINEERING FOR RISK MANAGEMENT

To ensure that a device has been designed such that critical tasks can be
performed safely and effectively, medical device manufacturers must conduct a
risk analysis to identify the risks associated with device use and the measures
that have been implemented to reduce those risks.

A well-crafted usability engineering plan ensures that user research efforts
directly consider the use tasks identified as critical by risk management
efforts.

Delve has considerable experience working with companies to create risk
analyses, including defining the tasks necessary to safely and effectively use
the product, identifying potential use errors and the associated clinical
consequences, and assigning severity levels (highlighting critical tasks that
must undergo validation testing).


ETHNOGRAPHIC RESEARCH

Products for which development is informed by user research are safer, make
fewer cognitive and physical demands on users, are easier to learn, and simpler
to use.

More and more often, companies are realizing the potential return on investment
of early integration of user research-driven insights and human factors into
their product experience design process.

This early-stage research often takes the form of ethnographic research or
contextual inquiry.

We routinely go into the field to observe surgeons, healthcare consumers,
patients, and other users in a broad range of contexts from homes to hospitals —
and in U.S. to overseas markets.

Our researchers identify design opportunities informed by the real-world
eco-systems where the products are expected to perform.

When we can’t be there, we use current and emerging technology to gather and
analyze data.

Go to Design & User Research to learn more about our generative research methods
(ethnography and observation, interviews, benchmarking, and competitive
analyses) and evaluative research methods (human factors evaluation, simulated
use, and comparative testing).


MEDICAL DEVICE ENGINEERING DEVELOPMENT AND VERIFICATION

Medical devices deliver some of our toughest development challenges.

Our robust team of mechanical and electrical engineers use advanced tools to
design medical products with complex mechanical and electromechanical systems.

Our highly experienced and skilled team of degreed engineers is equally
proficient leveraging hand calculations as they are the most advanced CAD-based
analysis tools.

These help us identify and solve for issues in the early stages of the design
process — and shave precious time off of project schedules.


PROTOTYPING AND TESTING

As described in Engineering Analysis and Optimization, we build and test
prototypes to put all design options through their paces both virtually and
physically.

We’re frequently developing proof of principal models and building subsystems to
remove risk from the process.

With the tools in our engineering lab, we have the ability to simulate, test,
and optimize for many factors.

Ultimately, our engineers will conduct failure mode and effects analysis (FMEA)
with advanced CAD tools to determine design performance.

This rigorous testing proves that each medical product meets the safety
standards put in place by various governing bodies, such as the FDA, CSA, CE,
and UL.


GETTING TO PRODUCTION READY

We work in parallel with client and production partners to make sure everything
is ready to roll into efficient production.

This process consists of: material and processes specification, vendor
selection, detailed part design, software fine-tuning and testing, failure mode
analysis, tolerance analysis, additional expert reviews to ensure compliance and
effective manufacturing, and building and testing a beta prototype.

Though we’re capable of managing production, more typically we act as a
consultant to the process and address opportunities for improvements as they
arise.

Unlocking the power of product innovation

What We Do
ServicesIndustriesCase StudiesBlog
Who We Are
About UsOur PeopleWork at DelveNewsroom
Our Studios
BostonMadisonPhiladelphiaSan Francisco
Contact
Partner with Delve
LP

© Delve 2023
 * Privacy Policy
 * FCOI Policy