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Table of Contents
1. Introduction…………………………………………………………………………………………………….2
2. Assignment……………………………………………………………………………………………………..2
3. Methodology…………………………………………………………………………………………………..3
4. Market Trends…………………………………………………………………………………………………4
A. Growth Drivers…………………………………………………………………………………………..5
B. Target Audiences………………………………………………………………………………………..6
C. Product Sales……………………………………………………………………………………………10
a. Retail Sales……………………………………………………………………………………..10
b. Commercial Sales……………………………………………………………………………10
i. Who Does the Selling……………………………………………………………11
ii. To Whom Do You Sell……………………………………………………………13
5. Trade Associations…………………………………………………………………………………………15
6. Trade Shows………………………………………………………………………………………………….17
7. Competitive Products…………………………………………………………………………………….20
A. Introduction……………………………………………………………………………………………..20
B. Competitive Analysis………………………………………………………………………………..22
a. 3M.…………………………………………………………………………………………………22
b. Medline Industries……………………………………………………………….…………25
c. Smith & Nephew…………………………………………………………………………….26
d. Coloplast…………………………………………………………………………………………29
e. Santus………………….…………………………………………………………………………31
f. Moberg Pharma…..…………………………………………………………………………33
C. Additional Competitors………………….…………………………………………………………36
8. FDA……………………………………………………….………………………………………………………39
A. Who is Considered the Manufacturer.……………………………………….……………40
B. Can the Product be Classified as Both a Drug and Medical Device……..42
C. Best Route to Register a Product as a Medical Device……………….……………45
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Introduction
Benchmark Skincare Ltd (Benchmark) is a producer of a skincare product branded Derma Shield, which
has been sold in the UK since 1994. Derma Shield is currently also being sold in the US by Delta Kits. In
the US Derma Shield is registered with the Federal Drug Administration (FDA) as a “skin protectant
monograph” and is sold primarily to retail customers. It is promoted as protecting the skin from a
comprehensive range of skin irritants; treating dry, cracked or damaged skin; and staying effective
despite repeated washings.
In an effort to make the product more appealing and marketable to the healthcare industry, the product
was officially registered as a Class 1 Medical Device with the MHRA in March 2018 and gained an ISO
certificate so it is now marketed in the UK as a medical device. The product is also CE marked and is
available for sale in the rest of the US.
Benchmark has advised us that it believes that if the product’s FDA classification is expanded to medical
device, Benchmark may be more successful in marketing to the healthcare and other industries in the
US. Derma Shield’s current distributor, Delta Kits, is not interested in selling to healthcare and other
industrial customers. As a consequence, Benchmark is considering rebranding the product and finding
new ways to sell Business to Business (B2B). The intent is to keep the same formulation, register it as a
medical device, and have it sold commercially.
Assignment
The FDA regulatory process and rules are complex. Benchmark has a few preliminary questions, the
answers to which will help it decide how to proceed in the US.
• Who would be considered the manufacturer of the medical device, Benchmark or the product’s
mixer?
• Can the product be classified both as a drug and a medical device?
• What is the best route to register the product as a medical device?
Benchmark wants to better understand the competitive landscape in the US should it register and
launch the rebranded product as a medical device. Once it can review an analysis of its competitive
products in the US; understand the size and trends in the healthcare market; determine the best ways to
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reach its target customers; and identify organizations that will help it enter the market, it will be better
positioned to plan how it will proceed.
Methodology
In the performance of the market study and FDA inquires, Parter International performed the following
activities:
Market Study
We have conducted both primary and secondary research to prepare this study. It included an analysis
of incontinence from a macro perspective, which includes the skin care and wound care markets. We
carefully studied the potential competitors to obtain a deeper insight into the market. In addition, we
collected data and information about commercial and retail sales processes and opportunities to
provide recommendations regarding how Benchmark might introduce, distribute and promote a
rebranded product in the US.
1. Primary research
• Collected rival products’ information by communicating and speaking directly with the
companies via online chat, calls and emails
• Visited pharmacies and interviewed medical consultants to learn more details about
competitors' products
2. Secondary research
• Analyzed market trends by collecting data from healthcare industry reports, and magazine
articles
• Collected competitive company information from official websites, financial reports, Bloomberg
articles, and Amazon
• Collected information about FDA classification of competitors’ products
• Collected and compared information about trade associations and trade shows
• Reviewed different distributors’ capabilities
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FDA Inquires
With respect to the FDA issues our research included.
1. Primary research
• Made calls and sent emails to FDA staff
• Spoke with FDA lawyer
2. Secondary research
• Reviewed on the FDA website considerable regulations, definitions, rules, etc.
• Read articles about related to FDA issues
To help Benchmark expand upon the information provided in this report, we have whenever possible
provided links that can be accessed by Benchmark to show the source of much of our information and to
allow it to investigate further.
Market Trends
In studying market trends, we have determined that the most appropriate category is incontinence care,
which is grouped under two genetic categories: skin care and wound care. The skin care product
categories include antifungals and antimicrobials, liquid skin protectants, moisture barriers, skin
cleansers, therapeutic moisturizer, and other skin care products. Items included in the wound care
product section are alginates, antimicrobials, collagens, composites, contact layers, drugs, foams,
hydrocolloids, hydrogels, negative pressure wound therapy, specialty absorptive, surgical dressings,
transparent films, wound fillers, and other devices and products.
Two categories apply to Derma Shield in the skin care products section:
1. Liquid skin protectants (also called skin sealants): products that protect the skin by forming a
transparent protective barrier
2. Moisture barriers (also called skin protectants): ointments, creams, or pastes that protect the skin
from urinary and fecal incontinence by shielding the skin from irritants or moisture (e.g.,
dimethicone, petrolatum, and zinc oxide)
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North America was the leading market for incontinence care products with a global share of over 30% in
2015. It is expected to continue to grow, as the number of people with incontinence is reaching around
30 million.
*Data is based on market data and SCA’s estimates (2015)
According to statistics from Euromonitor International, unit retail volume of adult incontinence products
in North America grew 6% between 2015 and 2016, and the market tracker predicts the region will
register a compound annual growth rate of 7.5% during the 2016-2021 period.
Growth Drivers
Aging population, increasing acceptance for incontinence products, and increasing awareness about the
products are the major factors that have been driving the growth of global incontinence care products
market.
As the population booms and seniors live longer than ever before, the increasing number of patients
with medical conditions related to incontinence is anticipated to boost the growth of the incontinence
care products market. According to the Pew Research Center, 10,000 people turn 65 years old every day
and this will continue until 2029.
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The innovations in the customization of incontinence products are expected to generate demand from
patients with specific incontinence conditions. Patients are now more aware of their health issues and
are actively seeking physician’s advice at an early stage. As consumers are becoming better educated
about their options, prevention products and other supplies is a growing market segment. These
products include advanced skin care moisturizers and protectants, offloading devices and cushions and
dressing for protection as well as for wounds that simply do not meet criteria for insurance or Medicare
reimbursement but fit nicely into the retail space.
Outside of aging, incontinence can also stem from childbirth, pregnancy, obesity and other causes—
people who still have active lifestyles—and these sufferers don’t want incontinence to hold them back.
Target Audience
Institutional care as well as the home care distribution channels segments dominates the global
incontinence care products market with 60% market share over the retail segment.
This institutional care market is highly competitive and dynamic in nature with several big players
competing to gain revenue share in the market. The increase in demand for branded and high-quality
products in the market also favors the companies operating in this market. Recently these companies
have been involved in strategic initiatives such as mergers & acquisitions (M&A) to gain and maintain a
competitive edge in the market.
Set forth below are several product company mergers and acquisitions that will provide Benchmark with
an idea of how the products companies are rapidly changing and increasing in size to compete in this
market.
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Closing Date
Buyer Target Transaction Description Total Trans.
Value
03.26.2018 Scapa Group
plc.
BioMed Laboratories
LLC
The Board believes the acquisition of BioMed brings the following advantages to Scapa: - Allows Scapa Healthcare to better serve the ancillary accessories market for advanced wound care and ostomy segments - Expands its turn-key value proposition in consumer wellness, including OTC and Health & Beauty - Offers the opportunity to leverage Scapa Healthcare’s global infrastructure to further drive BioMed’s growth - Enhances Scape Group earnings in the first full year
$19 million with a further cash consideration of up to USD$13million payable depending on performance in calendar years 2018 and 2019.
02.02.2018 Celularity
Inc.
Alliqua BioMedical
Inc.
Celularity will acquire all of the property, assets, and rights relating to the company’s advanced biologic wound care business including Biovance amniotic membrane allograft, Interfyl Human Connective Tissue Matrix, the UltraMist Therapy System, and other therapeutic ultrasound platform products.
$29 million
12.07.2017 Medline
Industries Inc.
Centurion Medical Products
Corporation
Centurion gives a complete product offering in the vascular access market and brings more depth to Medline's Infection Prevention solutions for customers.
N/A
05.22.2017 Avery
Dennison Corp.
Finesse Medical Ltd.
Finesse Medical’s innovative portfolio of silicone gels and polyurethane foam dressings builds on and complements Avery Dennison’s existing products in wound care. And Finesse Medical’s converting and packaging capabilities will enable Avery Dennison to offer expanded manufacturing services to our customers.
N/A
8
Closing Date
Buyer Target Transaction Description Total Trans.
Value
03.28.2017 Organogene
sis Inc. NuTech
Medical, Inc.
Organogenesis Inc., a commercial leader in the field of regenerative medicine, is expanding beyond wound care with the acquisition of NuTech Medical. The newly-combined company will offer a portfolio of advanced and next generation products for the wound care and surgical biologics markets.
N/A
02.24.2017 Integra
LifeSciences, Plc.
Derma Sciences,
Plc.
The transaction will accelerate Integra advanced wound care strategy through the addition of the amniotic tissue-based products of Derma Sciences, a tissue regeneration company focused on advanced wound and burn care.
$205 million
10.03.2016 Domtar
Home Delivery
Incontinent Supplies Co.
Home Delivery Incontinent Supplies has a successful high-touch service model, as direct-to-consumer engagement and interaction is growing and provides unique consumer and customer insights that are critical to continuously improve the value of Domtar.
$45 million
07.12.2016 RestorixHeal
th, Inc. Wound Care Specialists
This complementary combination of wound care management companies will position RestorixHealth to meet the needs of integrated hospital systems and their patients in all markets.
N/A
06.28.2016 Domtar Butterfly Health
Domtar’s Personal Care segment manufactures and sells a wide range of incontinence solutions for adults, children and infants under leading brands like ATTENDS, ATTENDS DISCREET and COMFEES. The acquisition will facilitate the company to strengthen its position in the market.
N/A
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Closing Date
Buyer Target Transaction Description Total Trans.
Value
12.01.2015 Acelity
SNaP® (SNaP® Therapy
System, a disposable negative pressure wound
therapy line of products
from Spiracu)
The acquisition of the SNaP® business accelerates Acelity’s plans for disposable NPWT and increases access to the post-acute market by strengthening the company’s portfolio of offerings for customers in need of comprehensive wound care solutions. This transaction amplifies the largest range of disposable negative pressure solutions while expanding patient access to these devices through Acelity’s more than 1,800 sales professionals across North America and other developed markets.
N/A
03.02.2015 Healogics,
Inc.
Accelecare Wound
Centers, Inc.
This combination will leverage Healogics and Accelecare’s strengths including talented team members, an extensive network of wound care physicians, advanced training opportunities and an innovative wound care technology platform.
N/A
03.02.2015 First
Water Limited
Scapa Group plc (AIM:
SCPA)
The acquisition of First Water helps Scapa enhance its offerings in advanced woundcare and expand its global footprint. First Water designs, develops, manufatures, and markets wound dressings and skin adhesives for OEMs in the United Kindom and internationally.
$23.5 million
01.26.2015 Convidien
plc
Medtronic, Inc. (nka:
Medtronic plc) (NYSE:
MDT)
The acquisition of Covidien, a leading global health care products company and manufaturer of medical devices/supplies, creates significant tax advantages for Medtronic by shifting its domicile to Dublin, Ireland.
$48,056.4 million
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Product Sales
Retail Sales
Since Derma Shield has been sold in the United States for a number of years, its distributors understand
the channels and processes to sell the product directly to customers.
Should Benchmark classify the product with the FDA as a medical device and rebrand its product to
target the healthcare industry it can still sell directly to customers via a retail route. For instance,
doctors may tell their patients to buy the product directly or home health care workers may use retail
outlets to purchase the product. As a result, the new product should continue to be sold online and at
physical retail stores.
Online sales have become increasingly popular and Benchmark can sell directly through its own website
or through third parties, including comprehensive online suppliers such as Amazon and Walmart, and
online medical stores, such as AliMed and VitalityMedical. In terms of physical retail stores, Benchmark’s
distributors should attempt to sell into the major pharmacy chains such as CVS, Walgreens, Rite Aid,
Walmart, and Kroger’s, as well as to independent pharmacies. Advantages of selling retail are that the
product benefits from the credibility and customer association with the stores selling the product,
helpful and supportive store staff could help Benchmark build customer loyalty, attracting customers to
return again over time, and positive reactions by the public can lead to positive word of mouth
marketing, which is one of the best and cheapest ways to market.
Commercial Sales
Benchmark has expressed an interest in selling the potentially newly branded product directly to the
healthcare and other industries. The healthcare industry has by far the greatest potential but there are
other industries, such as those mentioned in the US Derma shield website, which are also potential
markets. There are two issues to be discussed when selling Business to Business (B@B) rather than
Business to Customer (B2C); who does the selling, distributors or the company sales force; and to whom
do you sell.
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i. Who Does the Selling
• Distributors / Agents / Brokers vs. Company Sales Force
Manufacturers have the option of having independent companies sell their products (distributors /
agents / brokers) or they can develop their own sales force, employed by them, to sell their products.
Unless a company is quite large or has a specific service component, it is rarely economical to build its
own sales force until substantial sales have been achieved. Distributors / Agents / Brokers often have
the capability to warehouse, assist with financing, provide considerable manpower, and purchase the
products themselves for resale. Establishing a partnership with distributors / agents / brokers can
benefit Benchmark in several ways:
• Establish a customer base quickly by drawing upon existing relationships between them
and their existing customers
• Provide expertise in sales & marketing in the US environment
• Provide different geographical storage facilities and independent logistics to deliver
product quickly and cost effectively
• Decrease labor cost
• Introduce new products to market based on distributors’ reputation
We have identified a number of distributors that Benchmark may want to research and contact to
determine whether they are appropriate for the new product market entry. Each represents skin and
wound care products. Since 3M owns such a large market share in skin care industry, a number of these
distributors already have partnerships with 3M. We do not know whether these are exclusive
partnerships or whether the distributors will also represent competitive products.
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Distributor Name
Wound&Skin Care
Order Online
Logistics Partnership
with 3M Geography Website
Gericare Medical Supply
Y Y Own truck
or UPS Y All states
http://www.gericaremedicalsupply.com
Medical Supplies Depot
Y N Own truck
or Third party
Y All states http://www.msdepot.com
McKESSON Y Y Own truck
or Third party
Y All states https://mms.mckesson.co
m
Nurse Rosie Y Y Own truck
or Third party
N All states
https://nurserosie.com/?SID=h5qfumvivjb1gpdtjuk7jrtk
o4
Performance Health
Y Y Own truck
or Third party
N All states https://www.performanceh
ealth.com
TwinMed Y Y FedEx Y All states https://www.twinmeddirect.
com
Turenne Phar Med
Company Inc Y Y N/A Y All states
https://www.turennepharm
edco.com
Preferred medical
Y Y
Called company but don’t provide answer
Y
Called company but don’t provide answer
https://www.preferredmed
ical.com
Finnegan Medical Supply
Y Y UPS Y All states https://finneganmedicalsup
ply.com
Resource Services
Y Y Third Party
Y All states www.resourceservices.net
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ii. To Whom Do You Sell
• Individual Entities:
B2B sales can be made directly to the companies or institutions. With the trend toward hospital
mergers and aging care facilities referred to in the earlier trends section, some of the individual
institutions have become quite large and could purchase considerable quantities. However, because
there are so many different potential buyers throughout the country, for instance there are 5,564
registered hospitals and15,600 nursing homes in the US, you may want to target specific geographic
regions or sectors within the healthcare industry – hospitals, nursing homes, ambulatory care facilities,
physician practices, and home health care agencies. The expertise and relationships of the distributor /
agent / broker that you choose will determine how you approach the individual institutions or
companies.
• GPO’s
In the United States, group purchasing organizations (GPO) have been created to leverage the
purchasing power of a group of business in order to obtain discounts from vendors, distributors and
manufacturers. In addition, GPOs can save time and money for manufacturers by helping to make the
sales process more efficient, easier, faster, and cost-effective. The healthcare industry uses GPO’s a
great deal.
When a company looks for customers for their new products or wants to enter U.S. market from abroad,
it needs to spend considerable time to identify customers and negotiate with them. GPO’s, however,
can assist the company to match potential customers through their network and membership database,
helping products enter a new market efficiently. In addition, healthcare product manufacturers, often
face regulatory and legal issues when they promote new products or enter US market. GPO’s
procurement professionals often regulatory compliance expertise which is beneficial to both the
supplier and buyer.
We have identified for Benchmark a number or GPO’s that work within the healthcare industry:
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Name Information Contact Information
Vizient
Vizient, with offices in Irving, Texas, and Chicago, serves a membership consisting of a little more than 50 percent of the nation's acute care providers. The company also serves more than 20 percent of the nation's ambulatory market. Vizient members include academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute healthcare.
Website: https://www.vizientinc.com/what-we-do Phone number:(972) 830-0000
Premier
Premier members account for 76% of U.S. community hospitals, around 3750, and more than 130,000 other provider organizations. Premier provides data analytics, supply chain and pharmacy solutions, and advisory and other services based on clinical data on 40% of U.S. hospital discharges.
Website: https://www.premierinc.com Phone number: (877)777-1552
HealthTrust
Health Trust members consists of 1,600 hospitals and more than 26,000 non-acute care sites in the U.S. and U.K. The company includes several business lines, including HealthTrust insight Advisory, providing the largest integrated delivery networks with operator-informed guidance, and HealthTrust Workforce Solutions, providing vender-neutral, healthcare contingent labor managed services program solutions in North America.
Website: https://healthtrustpg.com Phone number: (615)344-3000
Intalere
Intalere has memberships with 3,734 hospitals and morthan 85,000 non-acute healthcare providers. Among Intalere's core strategic business drivers are value-added services beyond contracting, as well as a committed portfolio product with best pricing.
Website: http://www.intalere.com Phone number: (877)711-5600
Cardinal Health
Cardinal Health offers clinically-proven medical products and pharmaceuticals and cost-effective solutions to strengthen efficiency and effectiveness of supply chain from hospital to home by connecting patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management.
Website: https://www.cardinalhealth.com/en.html Phone number: (614)757-5000
McKesson Pharmaceut
ical
McKesson Pharmaceutical offers branded, generic and OTC pharmaceuticals to more than 40,000 customers. The channels that McKesson uses include retail chain, independent retail pharmacies and institutional providers such as hospitals, health systems, integrated delivery networks and long-term care providers.
Website: http://www.mckesson.com Phone number: (415) 983-8300
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Trade Associations
As you well know, trade associations are organizations founded and funded by businesses that operate
in specific industries to assist in helping their members in a number of ways. As you would expect, there
are a great many trade associations in the healthcare industry. These organizations targeted within
specific sectors of the health care industry: produce conferences; provide advocacy support; develop
educational, training, and certification programs; and provide networking opportunities for the
exchange of ideas, discussion of best practices, and building of relationships with customers, regulators,
and competitors. Often these associations are non-profit organizations governed by bylaws and
directed by officers who are also members.
We have provided Benchmark with contact information on several Trade Associations that might prove
valuable to it.
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Name Address Contact Information
Advanced Medical Technology Association
701 Pennsylvania, Avenue, NW, Suite 800
Washington, DC 2004-2654
Phone: (202)783-8700 Fax: (202)783-8750
https://www.advamed.org
National Association for Home Care & Hospice
228 Seventh Street, SE Washington DC, 20003
Phone: (202) 547-7424 Fax: (202) 547 3540
https://www.nahc.org
International Association of Medical Equipment
Remarketers and Servicers
719 Catalpa Avenue Teaneck, New Jersey 07666
Phone: (201) 833-1157 Fax: (201) 833-2021
http://www.iamers.org
Medical Device Manufacturers
Association (MDMA)
1350 I Street NW, Suite 540 Washington, D.C. 20005
Phone: (202)354-7171 Fax: (202)496-7756
https://medicaldevices.site-ym.com
BIOCOM 4510 Executive Drive, Plaza
One San Diego, CA 92121
Phone: (619)455-0300 Fax: (619)455-0022
https://www.biocom.org/s/
The Society for Biomaterials
15000 Commerce Parkway, Suite C
Mount Laurel, NJ 08054
Phone: (856)439-0826 Fax: (856) 439-0525
https://www.biomaterials.org
Consumer Healthcare Products Association
1625 Eye Street, NW, Suite 600 Washington, DC 20006
Phone: (202) 429-9260 Fax: (202) 223-6835
https://www.chpa.org/Default.aspx
Medical Alley Association 4150 Olson Memorial Hwy,
Suite 430 Golden Valley, MN 55422
Phone: (952)542-3077 Email: [email protected]
https://medicalalley.org
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Trade Shows
Benchmark is already familiar with the value of Trade Shows as it has already attended Medica in
Germany and will be attending FIME in Orlando, FL. American based trade shows in the healthcare
industry can prove valuable but because there are so many, it is important to choose ones that are
appropriate for your product. By choosing the right trade shows Benchmark will be able to: meet
industry partners and potential customers; study activities of rivals; learn about sector specific issues,
trends, and opportunities; and potentially exhibit its product.
Set forth below are some trade shows that might be of interest to Benchmark.
Name Introduction Date and Location
Website
THE REGULATORY
CONVERGENCE: 2018 RAPS
RAPS' Regulatory Convergence addresses today’s biggest challenges for regulatory professionals and regulators. Join your colleagues and peers for two action packed days of educational sessions you'll find nowhere else, led by renowned experts and inspiring thought-leaders from across the globe. Network and make contacts with Regulatory's who's who -p all in one place. Plus, two extra days of deep-dive workshops, where you'll roll up your sleeves and take your foundational knowledge to the next level. You'll leave with the tools to do your job better and strengthen your organization’s regulatory prowess.
October 1-4, 2018
Vancouver, BC
https://www.raps.org/con
vergence-2018/home
BIOMEDEVICE SAN JOSE
Silicon Valley's Premier Event for Medtech Professionals. Whether it's mHealth or the Internet of Things (IoT), BIOMEDevice San Jose showcases emerging trends and innovations that will set the tone for the biomed industry in 2017 and beyond. The conference offers training on digital device trends and exploring effective ways to overcome barriers to market entry, all in a two-day Connected Health Device Development Summit. With thousands of attendees, more than 300 leading exhibitors, and numerous thought leaders set to meet face-to-face, BIOMEDevice San Jose is a must-attend opportunity for medtech professionals to accelerate industry knowledge and network.
December 5-6, 2018 San Jose,
CA
https://biomedevicesj.mddionline.com
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Name Introduction Date and Location
Website
Medtrade Home
Medical Equipment Exposition
The Medtrade conference program brings together hundreds of HME industry experts. Our education programs cover a variety of topics such as: Regulations & Compliance, Retail and Cash Sales, Sales & Marketing, Legal Issues, Business Operations, Executive Leadership and Strategic Planning. As retail continues to be a focus for today’s HME provider, this is one of the most popular tracks at Medtrade. Compliance is another hot-topic for education as DME audits continue to burden providers. The education sessions at Medtrade provide knowledge and training in virtually every aspect of the HME industry. Medtrade also offers intensive workshops on Monday before the expo begins. These full-day workshops provide training on topics such as DME Certification, Sales & Marketing, Reimbursement, and more.
October 15-17, 2018
Georgia World Congress Center •
Atlanta, GA
https://www.medtrade.com/index2/
American Academy of Dermatolog
y Annual Meeting
Year-after-year, attendees rate the AAD exhibit hall as one of the most important aspects of their Annual Meeting experience! The AAD’s Annual Meeting exhibition hall offers an innovative, lively environment filled with key decisions makers from across the world. This is also the prime venue for any exhibitor to showcase new products, meet new customers and touch base with existing ones.
March 1-5, 2019
Washington, D.C.
https://www.aad.org/meetings/a
nnual-meeting
MPO SUMMIT
Focusing on the world of outsourcing for medical device manufacturing coupled with a keen awareness of innovation in the space, Medical Product Outsourcing’s conference series—the MPO Summit—has provided the medtech industry with the most comprehensive programs for more than 10 years. These highly informative symposiums address critical issues impacting multiple stakeholders within the industry. In 2018, the MPO Summit arrives in Colorado—home to the sixth largest medical device sector according to the Colorado Office of Economic Development and International Trade. Graciously hosted by the Omni Interlocken Resort, this year’s Summit will simultaneously highlight the appeal of the region for medtech while tackling a number of the most significant issues for today’s medical device companies.
October 11-12, 2018
Denver, CO
http://mposummit.co
m
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Name Introduction Date and Location
Website
AMERICAN MEDICAL DEVICE
SUMMIT 2018
Join the discussion with over 175 of your industry peers as we explore the challenges and opportunities in product development, quality management, speed to commercialization, and regulatory harmonization. Hear first-hand case studies and walk away with strategic insights to streamline processes, reduce costs, and remain compliant in an ever evolving environment. This October we encourage you to join us for two days of thought provoking content and exceptional networking at the 2018 Generis American Medical Device Summit.
October 24-25, 2018
Chicago, IL
https://amdsummit.com
THE MEDTECH
STRATEGIST INNOVATION
SUMMIT
Innovation Summit San Francisco will be a top-tier forum for innovative emerging medical technology companies seeking investment, joint venture or other relationships to gain exposure to venture capital, investment bankers and large medical device companies for the purpose of potential investment and/or strategic partnership. It is organized as a two-day business partnering and networking event, featuring 40+ pre-screened start-up medical technology companies that will deliver 10-minute presentations, followed by meetings in private breakout rooms. The Summit will also feature thought-leading guest speakers, and plenary and panel sessions, all providing candid insight on topics of utmost importance to all stakeholders in the rapidly evolving global device marketplace.
November TBD, 2018
San Francisco,
CA
https://www.innovationinmedtech.com/conference/medtech
-strategist-innovation-summit-san-
francisco-november-
2017/
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Competitive Products
Introduction In depth research was conducted regarding five major companies and 21 individual products in the skin
protectant / liquid bandage category. In addition we reviewed over 100 other similar products sold in
pharmacies and e-commerce platforms in U.S. market. We have provided substantial information for the
products of the following companies:
• 3M
• Medline Industries
• Smith & Nephew
• Coloplast
• Santus
• Moberg Pharma
In addition we have provided a few other companies whose products Benchmark may want to research
itself.
• DermaRite
• Touchless Care
• Gloves in a Bottle
• Wedmedix Home Care Pro
• BSN Medical
• Derma Sciences
• Insight Pharmaceuticals
For the competitive analysis, we chose the leading companies and the products we considered most
similar to Derma Shield. We investigated the various companies’ history, market share, financial reports,
partnerships, and community relationships.
For the individual products, we have set forth information relating to price, active ingredients, FDA
classification, target audience, OTC/Prescription Use, and a description of how they promote
themselves. To collect this information we studied the companies FDA registration messages, spoke
directly with pharmacists, reviewed company websites, and other information relating to the companies
manufacturing, distribution, and customers.
21
We expect that the competitive product information will be helpful for Benchmark to understand how
its products would fit into the competitive landscape and how its competitors operate. It should also
help Benchmark make decisions about pricing and promotion.
Whenever possible, we have included links to the sources of our information in other to allow
Benchmark to conduct additional research on its own.
22
Product Type
Product Name
Size/each
Price/each
Price/ml
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
• Barrier Film
• Skin Care Condition Type: Incontinence-Associated Dermatitis,
Maceration, Moisture-Associated Skin Damage, Peri-Tube Skin Irritation,
Radiation Dermatitis, Tracheostomy Site Trauma, Trauma from Tapes and
Dressings
• Wound Care Condition Type: Abrasions, Closed Intact Surgical Wound,
Donor Sites, Friction, Laceration, Neuropathic Ulcers, Open Surgical
Wounds, Skin Tear, Superficial Partial Thickness Burns, Venous Leg Ulcer
$11.53
$0.41/ml
Liquid Bandage
3M™ Cavilon™ No Sting Barrier Film
(4 products 3343-3346)
(3346 spray) 28ml
The 3M Company
Product Information
Prescription Use
Hexamethyldisiloxane; Isooctane; Acrylate Terpolymer;
Polyphenylmethylsiloxane Copolymer
Class 1 Medical Device
PART 880.5090 -- General Hospital and Personal Use Devices
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
• For skin is frequently or continuously exposed to moisture and caustic
irritants such as feces, digestive fluids, wound drainage and urine
• Forms a film barrier intended to protect intact or damaged skin
• Can be used in areas exposed to friction and shear from bedding,
clothing, shoes or any other material that would rub against the skin
Liquid Bandage
3M™ Cavilon™ Advanced Skin Protectant 5050
0.1 fl oz
$11.59-$21.38
$115.9-$213.8
5%-10% Acrylate Polymer;
5%-10% 2-Octyl Cyanoacrylate; 80%-90% Hexamethyldisiloxane
Class 1 Medical Device
PART 880.5090 -- General Hospital and Personal Use Devices
Prescription Use
23
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Liquid Bandages
Nexcare™ Liquid Bandage
Hexamethyldisiloxane; Isooctane; Acrylate Terpolymer;
Polyphenylmethylsiloxane
Class 1 Medical Device
PART 880.5090 -- General Hospital and Personal Use Devices
• First aid solution to cover minor cuts, scrapes and minor irritations of the
skin and help protect them from infection.
• No-sting formula
0.61 fl oz
$5-$9
$8.2-$14.7/fl oz
• Temporarily protects and helps relieve chapped or cracked skin
2% Miconazole Nitrate
PART333C. Topical Antifungal Drug Products
• Proven clinically effective in the treatment of most athlete's foot (tinea
pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
• For the treatment of superficial skin infections caused by yeast (candida
albicans)
• For effective relief of redness, irritation, scaling, itching, discomfort and
burning
Skin Protectant
3M™ Cavilon™ Durable Barrier Cream Fragrance Free
3.25oz
$9.43
OTC Use
OTC Use
OTC Use
$2.9/oz
1.3% Dimethicone
PART347 Skin Protectant Drug Products for Over-The-Counter Human Use
$4.95-6.58
The 3M Company
Product Information
Skin Protectant
3M™ Cavilon™ Antifungal Cream
2oz
$2.48-3.29/oz
24
*Liaised with 3M customer services and representitives for FDA, OTC related information, relationship with other communities , activte indegredients, distributors, etc. Websites: https://www.3m.com/3M/en_US/company-us/all-3m-products/~/3M-Cavilon-Advanced-Skin-Protectant-5050/?N=5002385+8711102+3291589704&rt=rud http://s2.q4cdn.com/974527301/files/doc_financials/2017/Annual/2017_3M_Annual_Report.pdf https://www.3m.com/3M/en_US/company-us/about-3m/ https://csimarket.com/stocks/competitionSEG2.php?code=MMM https://www.nexcare.com/3M/en_US/nexcare/products/catalog/~/Nexcare-Liquid-Bandage/?N=4326+3294529207+3294631568&rt=rud https://www.accessdata.fda.gov/scripts/cdrh/Cfdocs/cfrl/rl.cfm?lid=467579&lpcd=KMF https://www.pharmapacks.com/products.php?product=Nexcare-Liquid-Bandage-Spray-0.61-oz https://www.healthykin.com//p-5328-3m-cavilon-advanced-skin-protectant.aspx?gclid=CjwKCAjwr-PYBRB8EiwALtjbz2-Q7rgZc2yrpvvsfjSoeqR-0iA7dbC8A1M4s79XWro8Wi-FLCd0choCoWMQAvD_BwE https://www.accessdata.fda.gov/cdrh_docs/pdf15/K153571.pdf https://www.accessdata.fda.gov/scripts/cdrh/Cfdocs/cfrl/rl.cfm?lid=467579&lpcd=KMF https://www.accessdata.fda.gov/cdrh_docs/pdf5/K050757.pdf
Headquarter
Phone
Website
Market Share
National / Medical
community
Sales force /
Distributor
The 3M Company
Company Information
Contact Information
Saint Paul, Minnesota, USA
+1(888)364-3577
https://www.3m.com/3M/en_US/company-us/
Background
• 3M Company is an American multinational conglomerate corporation based in Northern Minnesota, formerly known
as the Minnesota Mining and Manufacturing Company
• 3M Company operations in 70 countries and sales in 200 countries, it has $30 billion in annual sales with 90,000+
emplyees around the world
• 3M™ Cavilon™ Advanced Skin Protectant is the key product to a skin care regimen that protects patients, even in cases
of moderate to severe IAD
Revenue
• Net Sales 31.7 Billion; US net sales 12.37 Billion;
• Health Care sales 5.8 Billion increased by 4.4%;
MISC
3M products occupied 4.56% market share in Health care in USA market (first quarter in 2018)
American Red Cross; Direct Relief (U.S.); MAP International (Global Christian health and relief
organization); GlobalGiving (U.S.); Member of State Government Affairs Council;
Government; Hospitals; Stores; Online retailers; 3M distribution centers; Company website
25
Type
Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Type
Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Type
Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
PART347 Skin Protectant Drug Products for Over-The-Counter Human Use
OTC Use
• Provides an effective, long-lasting moisture barrier against incontinent
episodes while relieving dryness, abrasion or denuded skin
• Helps prevent diaper rash, dry and cracked skin, such as those associated
with venous leg ulcers
• Offer protection even after multiple washings
Remedy-Nutrashield
4oz
$9.67
$2.4/oz
1% Dimethicone
25% - 50% Methane, oxybis
50%-75% Ethyl alcohol
Class 1 Medical Device
PART 880.5090 -- General Hospital and Personal Use Devices
OTC Use
• A quick and flexible seal for minor cuts and scrapes
• Creates a water-resistant, transparent film to seal out dirt and germs
• Portable and convenient for mom's purse or any athlete's gym bag
1.35oz
Curad Flex Seal Bandage
Medline Industries
Product Information
$6.79
$5.02/oz
Remedy-Calazime
4oz
$9.75
$2.44/oz
1.5% Dimethicone
PART347 Skin Protectant Drug Products for Over-The-Counter Human Use
OTC Use
• Ideal for normal to broken-down skin and peristomal areas
• For skin protection against moisture, itching and minor irritation
• For the relief of discomfort associated with diaper rash caused by
wetness, urine and/or stool and other macerated skin conditions
• Menthol cools irritated skin and calms inflamed tissue
Liquid Bandage
Skin Protectant
Skin Protectant
26
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ed8a08a7-594c-46e2-b70f-b75b2960141f https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1295cfcc-5b61-481b-964b-f53ffd0cb58e https://www.medline.com/ https://en.wikipedia.org/wiki/Medline_Industries https://en.wikipedia.org/wiki/Providence_Health_%26_Services https://www.medline.com/media/assets/pdf/Medline-Coporate-Capabilities-Brochure.pdf https://www.amazon.com/Medline-MSC094853UNSC-Nutrashield-Protectant-incontinence/dp/B0797DK6XB/ref=sr_1_2?ie=UTF8&qid=1528402549&sr=8-2&keywords=Remedy-Nutrashield https://www.amazon.com/Medline-MSC094544-Protectant-incontinence-dermatitis/dp/B07BSX6PZP/ref=sr_1_1?s=industrial&ie=UTF8&qid=1528402617&sr=1-1&keywords=Remedy-Calazime https://www.amazon.com/Curad-FlexSeal-Spray-Bandage-1-35/dp/B00A4RX27W/ref=sr_1_3?s=industrial&ie=UTF8&qid=1528402662&sr=1-3&keywords=Curad+Flex+Seal+Bandage
Headquarter
Phone
Website
Market Share
National / Medical
community
Sales force /
Distributor
Commercial uses
https://www.medline.com/
Company Information
Medline Industries
MISC
Contact Information
Three Lakes Drive, Northfield, Illinois 60093
United States
(847)949-5500
Background
• Medline Industries, Inc. is a private American company founded in 1966, it is the largest privately held manufacturer
and distributor of medical supplies providing products, education and services across the continuum of care with offices
in 20 different countries and 15,000+ employees.
• In 2001, Medline started manufacturing private label wound care products for CVS, Walgreens, Target, Dollar General
and Family Dollar.
• In 2007, Medline acquired first-aid brand, CURAD, entering the retail market. Since the acquisition, CURAD has
introduced innovative solutions including Truly Ouchless™ Silicone Adhesive technology, rugged Performance Series™
bandages and hydrocolloid and antibacterial bandages.
• Today, Medline operates 42 U.S. distribution centers.
Revenue
9.6 billion USD in overall company sales in 2016, with an increasing trend
Dominance in following medical product categories in USA market (2010)
• Rank 1: Exam Gloves; Textiles; Durable Medical Equipment; Plastic Patient Utensils; Skin Care;
Disposable Incontinence Care; OR Kits
• Rank 2: Protective Apparel; Gauze; Packs and Gowns; Bathing Sustems; Surgical Trays
• Rank 3: Advanced Wound Care
• Providence Health & Services (U.S.)
• Partnership with Project C.U.R.E., under Benevolent Healthcare Foundation (U.S.)
Stores; Online retailers; Medline distribution centers; Company website
Hospitals, Extended care facilities, Surgery centers, Supportive housing, Educational services,
Physician offices, Home care agencies and providers, and Retailers
27
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
$4.69/oz
1% Dimethicone
PART347 Skin Protectant Drug Products for Over-The-Counter Human Use
OTC Use
• Provides superior protection from exposure to urine and feces on the
skin in the perineal area
• Protects minor skin irritation associated with diaper dermatitis and helps
protect from wetness
• Helps prevent and temporarily protects chafed, chapped, cracked or
wind burned skin and lips
Skin Protectant
Proshield Plus
3.2oz
$15.00
• Provides a high level of protection for patients with severe diarrhea
• Will not wash away after repeated exposure to urine and feces.
• Contains karaya to absorb moisture and adhere to weepy, macerated
skin. Soothing Non-sensitizing
$12.64
$1.63/oz
30.6% Zinc Oxide
PART347 skin protectant drug products for over-the-counter human use
OTC Use
Product Information
Smith & Nephew
OTC Use
• Helps treat and prevent incontinence associated dermatitis, seal out
wetness and prevent and temporarily protect chafed, chapped, cracked or
wind-burned skin or lips
• Safe and effective; Easy to apply; Lanolin free
Secura Dimethicone Protectant Tube
4.8oz
$9.29
$1.9/oz
5% Dimethicone
PART347 Skin Protectant Drug Products for Over-The-Counter Human Use
Skin Protectant
Skin Protectant
Extra Protective Cream
7.75oz
28
http://www.smith-nephew.com/global/assets/pdf/corporate/2017%20ar%20-%20strategic%20report.pdf https://en.wikipedia.org/wiki/Smith_%26_Nephew https://www.drugs.com/otc/434397/secura-extra-protective.html https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=83f92ac9-4114-4192-926d-be2854a84106 https://en.wikipedia.org/wiki/Ambulatory_Surgery_Center_Association http://www.smith-nephew.com https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=83f92ac9-4114-4192-926d-be2854a84106 https://www.amazon.com/Healthpoint-Proshield-Plus-Protectant-Ounce/dp/B000TLUSX4
Headquarter
Phone
Website
USA Office
Market Share
National & Medical
community
Sales
force/Distributor
Commercial uses
Stores; Third-party pnline retailers; Company website
Leaf Healthcare; MolecuLight i:X (2017)
Background
Revenue
• By geographical segment:
$2.306 billion in US market (2017), which represented 48% of its total revenue
• By product:
$720 million in Advanced Wound Care Product (2017);
$342 million in Advanced Wound Bioactives (2017);
$194 million in Advanced Wound Devices (2017)
MISC
Smith & Nephew represented 15% in advanced wound management in global market (2017)
• Smith & Nephew plc is a British multinational medical equipment manufacturing company headquartered in London,
United Kingdom.
• It is an international producer of advanced wound management products, arthroscopy products, trauma and clinical
therapy products, and orthopedic reconstruction products.
• Its best sellers in advanced wound management products are mainly wound care products (dressing products):
ALLEVYN LIFE; ACTICOAT; ALLEVYN AG; OpSite; IV3000
• In advanced wound bioactives SANTYL Ointment (IODOSORB Gel) is the best seller focused on debriding chronic
dermal ulcers and and severely burned areas
Hospitals, Nursing home, office-based physicians, Retails, non-acute facilities, supportive housing,
educational services
Smith & Nephew
Company Information
Contact Information
Group Head Office: 15 Adam Street, London, WC2N 6LA UK
+44 (0)20-7401-7646
https://www.3m.com/3M/en_US/company-us/
USA Office
USA Office
Andover, MA
150 Minuteman Road, Andover, Massachusetts 01810 USA
Andover, MA: +1 (978) 749-1000
Memphis, TN
1450 Brooks Road, Memphis, Tennessee 38116 USA
Memphis, TN: +1 (901) 396-2121 or +1 (800) 821-5700
Fort Worth, TX
5600 Clearfork Main Street, Suite 600, Fort Worth, Texas 76109 USA
Ambulatory Surgery Center Association (USA)
29
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Type
Product Name
Price/Size
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
• Diaper Rash Skin Protectant
• Helps treat and prevent minor skin irritation due to diaper rash
• Helps seal out wetness
$12.91
Coloplast
Product Information
Skin Protectant
Baza Protect
5oz
$2.5/oz
12% Zinc oxide; 1% Dimethicone
PART 356 Nonmonograph Ingredients Products For Over-The-Counter Human
Use
OTC Use
• Provides everyday wetness protection and aids in the prevention and
treatment of diaper dermatitis
• Provides effective relief from the inflammation caused by diaper rash
• Moisture barrier cream helps treat and prevent minor skin irritation due to
diaper rash and incontinence, and helps seal out wetness
Skin Protectant
Critic-Aid® Clear
6oz
$18.20
$3.03/oz
71.5% Petrolatum
PART347 Skin Protectant Drug Products for Over-The-Counter Human Use
OTC Use
Prescription Use
• For management of low to moderately exuding wounds, including leg ulcers,
pressure ulcers, superficial burns, superficial partial-thickness burns, donor sites,
postoperative wounds and skin abrasions
• Can stay on for up to 7 days depending on the specific wound characteristics
• Can be used as primary as well as secondary dressing; bacteria- safe and
waterproof top film and forms a viscous gel that absorbs exudate; not adhere to
the wound
Comfeel® Plus Ulcer Dressing
$3.09 / 4*4 inch, $8.19 / 6*6 inch, $16.0 / 8*8 inch
12% Zinc oxide; 1% Dimethicone
Class 1 Medical Device
PART 878.4020 -- General and Plastic Surgery Devices - Occlusive Wound Dressing
Skin Protectant
30
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ed63df26-3879-46df-8e09-10be569b25be https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ed63df26-3879-46df-8e09-10be569b25be https://en.wikipedia.org/wiki/Coloplast https://www.coloplast.com/Documents/Investor%20Relations/Annual%20reports/GB/Annual%20Report%202016-17.pdf https://www.coloplast.us/Global/US/Wound%20Care/New%20MSDS%20Sheets%20-%20Wound%206-2017/Comfeel(R)%20Plus%20Ulcer%20Dressing.pdf https://en.wikipedia.org/wiki/Coloplast https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=75182cb7-840a-423a-9c20-10840d6e1d65
Headquarter
Phone
Website
Market Share
National & Medical
community
Sales
force/Distributor
Coloplast
Company Information
Contact Information
Contract with the U.S. Department of Veterans Affairs;
SUNA - Society of Urologic Nurses and Associates (Annual Conference);
Association of Rehabilitation Nurses
Stores; Online Retails; Government; Hospitals
• Headquarters in Humlebæk, Denmark.
• US headquarters is in Minneapolis, Minnesota
+1(855)745-8544
https://www.coloplast.us
Background
•Founded in 1954, with 10,000+ employees, Coloplast is registered on the Danish Stock Exchange
•Business includes Ostomy Care, Continence Care, Wound & Skin Care and Urology Care
Revenue
Revenue: 15,528 million DKK;
Global market growth is 4-5%;
MISC
• 7%-9% market share of skin care in USA
• 7-9% market share of global wound care market, which is expected to increase by 2-4% due to
the increasing life expectancy, the growing diabetic population and a growing number of patients
receiving preventive treatment
31
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Santus
Product Information
OTC Use
• Protects chafed or ulcer-prone skin, promote the healing of skin injuries
and serve as a first aid treatment
• Formulated to encourage the proper moisture balance of the skin,
thereby supporting the body's natural healing process
• Treats skin conditions including diaper dermatitis, ulcer-prone skin,
incontinence associated dermatitis, reddened or cracked skin and burns or
other skin injuries
Lantiseptic Skin Protectant Ointment
4.5oz
$9.99
$2/oz
50% Lanolin
PART347 Skin Protectant Drug Products for Over-The-Counter Human Use
OTC Use
• Suited for skin irritation resulting from urine, diarrhea, hemorrhoids,
minor burns, and others
• Helps promote relief, by temporarily alleviating pain and itch
• A moisture barrier that prevents and helps heal skin irritation from:
urine/diarrhea/hemorrhoids/minor burns/cuts/scrapes
Skin Protectant
PART347 Skin Protectant Drug Products for Over-The-Counter Human Use
OTC Use
• Provides a temporary therapeutic relief for dry, cracking skin
• Help optimize skin hydration
• Its non-greasy formula leaves the skin feeling smooth and soft.
Skin Protectant
Lantiseptic CaldaZinc Ointment
4oz
$6.95
$1.73/oz
0.45% Menthol
18% Zinc Oxide
PART 346 Anorectal Drug Products for Over-The-Counter Human Use
Lantiseptic Nourishing Skin Cream
4oz
$9.95
$2.5/oz
Skin Protectant
1.5% Dimethicone
32
https://www.lantiseptic.com https://www.lantiseptic.com/find-lantiseptic/ https://www.healthedgepartners.com/blog/healthedge-completes-investment-in-santus http://www.buzzfile.com/business/Santus,-LLC-844-772-6887 http://www.santuslabs.com
Headquarter
Phone
Website
National & Medical
community
Sales
force/Distributor
Commercial uses
http://www.santuslabs.com
Background
• Santus,LLC was formed in 2015 simultaneous with its acquisition by HealthEdge Investment Fund II (under HealthEdge
Investment Partners)
• HealthEdge owned Santus jointly with Ambassador Enterprises, has acquired substantially all the healthcare assets
from Summit Industries, Inc., primarily consisting of the Lantiseptic® and Boroleum® brands
• HealthEdge acquired control or significant minority ownership in both public and private companies with enterprise
values between $10 and $100 million
• HealthEdge Investment Partners targets companies in niche segments where the partners have extensive expertise in
the following sectors: specialty medical products; healthcare services; healthcare information technology; selected
pharmaceutical segments; and specialty distribution
Santus
Company Information
Contact Information
3575 Koger Blvd., Suite 240, Duluth, Georgia 30096 USA
US: +1 (844) 772-6887
MISC
CFIM - Central Florida Inpatient Medicine;
Below is the list of its Stores; Online Retails and Wholesale Distributors:
https://www.lantiseptic.com/find-lantiseptic/
Hospitals
33
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
$2.32/oz
0.2% Benzethoniuim Chloride
20% Benzocaine
Moberg Pharma
Product Information
Skin Protectant
Liquid Bandage
Dermoplast First Aid Spray
2.75oz
$6.39
OTC Use
• Helps relieve and prevent rashes and irritation due to wetness from
incontinence
• Protects chafed skin due to irritation and helps seal out wetness
BALMEX ADULT CARE RASH
3oz
$3.51
$1.17/oz
11.3% Zinc Oxide
PART347 Skin Protectant Drug Products for Over-The-Counter Human Use
PART333 Topical Antimicrobial Drug Products for Over-The-Counter Human
Use
OTC Use
• Provides fast relief of pain and itching from scrapes, minor cuts and burns
• Maximum OTC strength of the pain relieving ingrediant, benzocaine,
which helps fight off infection
• Aloe and vitamin E to moisturize the skin
• No-touch spray application lessens pain to sensitive and tender areas
• Safe and effective for children ages 2 and older
34
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Type
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
New Skin Liquid Bandage Spray
Liquid Bandage
New Skin Liquid Bandage
1fl oz
$6.02
$6.02/fl oz
0.2% Benzethonium Chloride
• Protects larger cuts and scrapes;
• Helps prevent and protect blisters;
• Helps prevent the formation of calluses;
• Covers painful hangnails and chapped and cracked fingertips
• Excellent for racers, runners, athletes, bikers, and outdoor activities
1oz
$5.57
$5.57/oz
0.2% Benzethonium Chloride
PART 333 Topical Antimicrobial Drug Products For Over-The-Counter
Human Use
OTC Use
PART 333 Topical Antimicrobial Drug Products For Over-The-Counter
Human Use
OTC Use
• Helps prevent and protect blisters
• Helps prevent the formation of calluses
• Covers painful hangnails and chapped and cracked fingertips
• Excellent for doctors, nurses, EMS, fire & police, fishing, forestry,
construction, and maintenance
Liquid Bandage
Moberg Pharma
Product Information
35
http://www.mobergpharma.com/about-moberg/ceos-comment http://d1q0gh225dp9f5.cloudfront.net/sites/default/files/eng_ar_moberg_2017_mellan_0.pdf http://www.mobergpharma.com/press-releases/2016-07-08/moberg-pharma-completes-acquisition-us-otc-brands-prestige-brands http://www.mobergpharma.com/press-releases/2018-02-28/moberg-pharma-divests-balmexr-425-million
Headquarter
Phone
Website
Market Share
National & Medical
community
Sales
force/Distributor
Commercial uses
USA Office
Moberg Pharma North America LLC
7 East Frederick Place, Suite 100, Cedar Knolls, NJ 70927 USA
+1 (973) 946-7550
Moberg Pharma
Company Information
Contact Information
Moberg Pharma AB (Publ),Gustavslundsvägen 42, 5 tr. 167 51 Bromma, Sweden
+46.8-522-307-00
http://www.mobergpharma.com
Background
• Swedish pharmaceutical company which was founded in 2006
• Market OTC brands in U.S.
• Sell products through distributors in more than 35 countries
• 40 employees
• Divested Balmex to Randob Labs at $4.25 million, Balmex is a brand to prevent and treat diaper rash
• On June 30 2016, Moberg Pharma acquired New Skin, Fiber Choice and PediaCare from Prestige Brand at $40
million
Revenue
Liquid Bandage brand New Skin's revenue grew 31% in 2017 and 90% comes from US
MISC
Brand New Skin Occupy 75% market share in liquid bandage
• The Association of Women’s Health, Obstetric and Neonatal Nurses U.S.
• FootHealth UK
• CHPA (the Consumer Healthcare Products Association)
Major retail chains: Walmart, Wahlgreens, CVS, Rite Aid and others; Third party online store
Office-based physicians, Retail
36
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
PeriGuard® Ointment
3.5oz; 7oz
$5-$6/ 3.5oz;
$14.36/ 7oz;
PART347 Skin Protectant Drug Products for Over-The-Counter Human Use
$1.5-$2.1
3.8% Zinc Oxide
PART347 Skin Protectant Drug Products for Over-The-Counter Human Use
OTC Use
• A petrolatum-based barrier ointment and Leave skin soft and supple
• No heavy residue – it goes on clear and removes easily even from
sensitive skin
• Use to treat skin irritations associated with incontinence or as part of a
comprehensive prevention program
Touchless Care Zinc Oxide Protectant Spray
2oz
$10
$5/oz
25% Zinc Oxide
2oz
$11.99
$6/oz
Other Competitors You May Study
Touchless Care Antifungal Spray
DermaRite
Touchless Care
OTC Use
• Helps treat and prevent diaper rash associated with
incontinenceassociated dermatitis.
• Protects minor skin irritation due to excess moisture, urine or stool.
• Helps seal out wetness.
10% Dimethicone
10% Zinc Oxide
2% Miconazole Nitrate
PART333C. Topical Antifungal Drug Products
OTC Use
• Treats jock itch, ringworm and athlete's foot
• For the treatment of most superficial skin irritations caused by yeast
(Candida albicans).
37
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
$9.93
$4.97/oz
Other Competitors You May Study
$3.5/oz
Petrolatum + Zinc Oxide
PART347 Skin Protectant Drug Products for Over-The-Counter Human Use
OTC Use
• temporarily protects and helps relieve chapped or cracked skin
• helps protect from the drying effects of wind and cold weather
• helps treat and prevent diaper rash
• protects chafed skin associated with diaper rash and helps protect from
wetness
• temporarily protects: • minor cuts • scrapes • burns
Welmedix Home Care PRO
4oz
$14.01
Gloves In A Bottle Shielding Lotion
2oz
Gloves In A Bottle
Welmedix Home Care PRO
7% Octinoxate;
5% Octisalate;
3% Homosalate;
(Contains Dimethicone)
PART 352 Sunscreen Drug Products for Over-The-Counter Human Use
OTC Use
• Relief from psoriasis & eczema; Heals dry or cracked skin.
• Protects from sanitizers, soaps & cleaning products.
• Prevents skin allergies & irritations
• Effective on feet - Diabetic friendly
• Does not wash off - naturally exfoliates.
38
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Product Name
Size/each
Price/each
Price/oz
Active Ingredient
FDA Classification
OTC / Prescription
Promotion
Description
Other Competitors You May Study
Cutimed® PROTECT Spray
2oz
$20.81
$10.4/oz
-
Substantially Equivalent
Prescription Use
PART 878.4018 General and Plastic Surgery Devices. Hydrophilic Wound
Dressing
Unclassified
PART 878.4018 General and Plastic Surgery Devices. Hydrophilic Wound
Dressing
Prescription Use
• Protects wound margins
• Preserves and maintains intact skin
• Prevents maceration and peri-wound skin breakdown
• Promotes dressing adhesion and pain free dressing removal
MEDIHONEY Wound and Burn Dressing Gel
Derma Sciences
1.5oz
$12.96
$8.64/oz
80% Active Leptospermum Honey
BSN medical
Insight Pharmaceuticals
SKIN SHIELD- benzethonium chloride and dyclonine hydrochloride liquid
0.45oz
$3.12
• can be used for: diabetic foot ulcers; leg ulcers (venous stasis ulcers,
arterial ulcers and leg ulcers of mixed etiology); pressure ulcers / sores
(partial and full thickness)
• 1 st and 2nd degree partial thickness bums
• donor sites, and traumatic and surgical wounds
$6.93/oz
0.2% Benzethonium chloride
0.75% Dyclonine hydrochloride
PART 333 Topical Antimicrobial Drug Products For Over-The-Counter
OTC Use
• First aid for the temporary relief of pain and to help protect against
infection in minor cuts, scrapes and burns.
39
Federal Drug Administration
With headquarters in Maryland, 223 field offices and 13 laboratories located throughout the 50 states
and five countries including the UK, the FDA is a massive and complex organization. It has
approximately 15,000 employees and regulates more than $2.4 trillion worth of consumer goods, about
25% of the consumer expenditures in the US. In addition to Drugs, Biologics, and Medical Devices, it
also regulates: foods; veterinary products; tobacco products; cosmetics; and electronic devices that give
off radiation. Since many of these consumer goods expenditures are for items imported into the US, the
FDA is also responsible for monitoring imports. With the size and complexity of the organization, it is
easy to understand why there are many service companies and law firms in the US that are devoted
exclusively to working with the FDA and interpreting its rules and regulations.
During the course of this assignment we reached out, by e-mail and phone call, to many offices and
individuals at the FDA. In addition, we had a conversation with an attorney at a law firm whose practice
is entirely FDA related. Since the issues dealt with in this assignment span a number of different
regulations, the FDA officials often referred us to other offices.
Set forth below are the divisions within the FDA with whom we have had e-mail correspondence and /
or direct phone conversations.
FDA Office Email Tel
OCP-Office of Combination Products [email protected] (301)796-8930
DICE-Division of Industry and Consumer Education
(800)638-2041 (301)796-7100
CDER-CDER Small Business and Industry Assistance- Division of Drug Information
(866)405-5367 (301)796-6707
DSMICA-Division of Small Manufacturers, International and Consumer Assistance
(800)638-2041 (301)796-7100
Division of Import Operations Management [email protected]
[email protected] (301)796-3668
Center for Medical Devices and Radiological Health
[email protected] (612)7587198
Office of International Programs [email protected] (301)796-4600
40
Who is Considered the Manufacturer?
We have been advised by Benchmark in response to our written questions that Benchmark:
• Owns the IP rights to its products
• Specifies and purchases all raw materials which are then sent to appropriate subcontractors all
of whom are based in the UK
• Employs a mixing subcontractor who mixes the product to Benchmark specifications
• Employs an aerosol filing subcontractor who fills Benchmark cans with bulk product
• Labels and does the final packaging for the aerosol cans
• Fills and labels consumer containers at their own premises for non-aerosol products
We have also been advised that the intent for any rebranded product, which will be using the same
ingredients, is that it will be classified as a medical device, and that the above listed items will remain
the same.
The Derma Shield product now being sold in the US is classified as a drug under the skin protectant
monograph category and the current mixer, Fillcare, is listed as the manufacturer and that Benchmark is
designated as the market authorization holder. Benchmark wants to know who would be considered
the manufacturer for the rebranded product which is expected to be classified as a medical device.
The Code of Federal Regulations, title 21, Volume 8 (revised April 1, 2017) sets forth definitions
regarding medical devices. Sec. 820.3 contains the definition for manufacturer.
(o) Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a
finished device. Manufacturer includes but is not limited to those who perform the functions of contract
sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and
initial distributors of foreign entities performing these functions.
There are also definitions for other activities related to the production and distribution of medical
devices.
41
Contract Manufacturer
Manufactures a finished device to another establishment's specifications.
Contract Sterilizer
Provides a sterilization service for another establishment's devices.
Foreign Exporter
Exports or offers for export to the United States (U.S.), a device manufactured, prepared, propagated, compounded, or processed in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.
Initial Importer
Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations.
Manufacturer
Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Repackager
Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).
Relabeler
Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.
Remanufacturer
Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.
Reprocessor of Single Use Device
Performs remanufacturing operations on a single use device.
Specification Developer
Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.
U.S. manufacturer of export only devices
Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries.
42
Our research indicates that the determination of who is the manufacturer is not the same for medical
devices as it is for drugs. While it is unclear why there is a difference, we have learned from our
conversation with an FDA representative at the Division of Industry and Consumer Education (DICE) that
there is a difference. When we described Benchmark’s situation, we were told that regarding medical
devices, the developer of the product, in this case Benchmark, would be considered the manufacturer.
The mixer would be considered a Contract Manufacturer. Both the manufacturer and the contract
manufacturer would need to be FDA compliant.
We were also told by the DICE representative that with respect to labeling, Benchmark as the IP owner,
developer, and the entity causing the product to be put on the market, would be listed as manufacturer.
Can the Product be Classified as Both a Drug and Medical Device?
The FDA regularly receives questions from medical product sponsors concerning the classification of
their products. This often occurs in cases in which a product may be classified as a drug, device or both.
Our explanation of the process for obtaining a formal classification determination for a product is
described below in answer to the Best Route to Register a Product as a medical device. In this section
we will deal with whether Benchmark’s potentially rebranded product with the same ingredients can be
classified as a medical device as well as a drug.
What does FDA consider in determining whether to classify a product as a drug or device? FDA’s
determination of whether to classify a product as a drug, device, or both is based on statutory
definitions. Medical product classification determinations often focus substantially on whether a
product that meets the definition of drug also meets the statutory definition of device. While the FDA
wording is often difficult to understand, we believe it is important to make it available to you together
with a few explanatory paragraphs that relate to Benchmark’s situation. Set forth below from a Final
Guidance Memorandum dated September 2017 is the relevant information:
Statutory Definitions
1. Drug
Section 201(g) of the FD&C Act (21 USC 321(g)) provides that the term "drug" means:
43
(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia
of the United States, or official National Formulary, or any supplement to any of them; and (B) articles
intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other
animals; and (C) articles (other than food) intended to affect the structure or any function of the body of
man or other animals; and (D) articles intended for use as a component of any articles specified in clause
(A), (B), or (C). . . .
2. Device
Section 201(h) of the FD&C Act (21 USC 321(h)) provides that the term "device" means:
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or
related article, including any component, part, or accessory, which is--
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement
to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment,
or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does
not achieve its primary intended purposes through chemical action within or on the body of man or other
animals and which is not dependent upon being metabolized for the achievement of its primary intended
purposes.
Conceptually, all FDA-regulated medical products meet the definition of “drug” under section 201(g) of
the FD&C Act, due to the broader scope of the drug definition. For a medical product also to meet the
more restrictive device definition under section 201(h) of the FD&C Act, it must (i) be “an instrument,
apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,”
and (ii) “not achieve its primary intended purposes through chemical action within or on the body of man
or other animals” and (iii) “not [be] dependent upon being metabolized for the achievement of its primary
intended purposes”.
“Similar or related article” - The first clause of the device definition provides that the term “means an
instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or
related article . . .” (emphasis added). The issue of whether a product may be considered a “similar or
related article” under this clause can arise, for example, with regard to products in liquid, semi-liquid, gel,
gas, or powder form. In some cases, such products are appropriately considered “similar or related
articles,” and may be classified as devices, so long as they also satisfy the remainder of the device
44
definition under section 201(h) of the FD&C Act, including the chemical action exclusion discussed in
section III.B.3 below. This could be the case, for example, for gels or powders put on the skin as a barrier,
gases used as space fillers, or liquids used to clean either surgical instruments or contact lenses.
“Primary intended purpose” - Most often, in determining whether a product meets the device
definition, questions arise concerning the exclusionary clause of the definition, which provides
that a device is a product “which does not achieve its primary intended purposes through
chemical action within or on the body of man or other animals . . . .” 11 A product that has
chemical action could be a device if it does not achieve its primary intended purposes through
that chemical action.
“Chemical action” - FDA frequently receives questions from product sponsors concerning the
Agency’s interpretation of the term “chemical action.” This term must be read in the context of
the statutory definition of “device” as a whole. The determination of whether a product meets
the device definition does not depend solely on whether the product exhibits “chemical
action.” In particular, as explained in section III.B.2 and 4, a product that exhibits chemical
action will still meet the device definition if the product “does not achieve its primary intended
purposes through” that chemical action “within or on the body,” and otherwise satisfies the
device definition.
In addition to our review of this Final Guidance Memorandum and other FDA written materials, we
communicated directly with the FDA Office of Combination Products. In their response to our specific
question detailing the Benchmark situation, the OCP advised us by e-mail as follows:
“Classification for a medical product is dependent on many factors. One important parameter to consider
is the intended use of a product. For example, if Product A’s ingredients is identical to Product B’s
ingredients but the intended use (includes claims) for Product A and B are distinctly different they might
be 2 different products. So, OCP would evaluate Product A and Product B separately. Therefore,
depending on the intended use of Product A and Product B, the classification for Product A and Product B
may differ.”
45
Best Route to Register a Product as a Medical Device
Registration or Pre-Registration
In order to register a medical device, a Request for Designation (RFD) must be prepared and filed. If
there are any questions concerning the classification and jurisdiction of a product, a Pre-RFD process is
available to provide informal, non-binding feedback regarding the regulatory identity or classification of
a human medical product as a drug, device, biological product, or combination product.
A Pre-RFD is a clear and concise written submission that a sponsor may make to OCP to request FDA’s
preliminary, nonbinding assessment. OCP will provide a written preliminary classification and / or
jurisdictional assessment of the product based on the information provided in a specific Pre-RFD within
60 calendar days and will communicate with the sponsor during the review as needed. Differences
between the RFD and Pre-RFD process include length of submission and depth of regulatory analysis
that a sponsor must provide. A Pre-RFD is especially beneficial when the classification of a product or
the Agency Center to which it should be assigned is unclear.
Since Pre-RFD is an easier, simpler, more flexible option than going directly to the RFD process and we
would recommend following this route in order to get initial confirmation that the goals Benchmark
hopes to achieve can be accomplished. When preparing a Pre-RFD particular attention should be paid
to:
• A complete description of the product, including the product’s composition (the application will
identify who the manufacturer is)
• The intended use/indications of use – (this will be a key element of why the rebranded product
should be a medical device rather than its current classification as a drug)
• The methods of action of the product (how does your product work)
• If the product may be a combination product, information you may have regarding the relative
contribution of each of its components to the overall intended therapeutic effects.
• Any claims that will be made about the product.
As Benchmark proceeds, the premarket requirements will be:
• To classify the Device
• To choose the correct premarket submission
• To prepare the FDA information for the premarket submission
46
• To send the required documents to the FDA and interact with the staff during the review
• To complete Registration and Device Listing
Product Classification
Medical product classification contains the name, associated information and product code, which
identify the generic category of a device for FDA. Below is an example of the format and type of
information for medical device category Bandage, Liquid, Skin Protectant should Benchmark obtain a
formal classification in the near future.
Device Bandage, Liquid, Skin Protectant
Regulation Description Liquid bandage.
Regulation Medical Specialty General Hospital
Review Panel General & Plastic Surgery
Product Code NEC
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch One - Implants and Tools
(PRSB1)
Submission Type 510(K) Exempt
Regulation Number 880.5090
Device Class 1
Total Product Life Cycle
(TPLC) TPLC Product Code Report
GMP Exempt? No
Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket
notification requirement, including those devices that were exempted by final regulation published in the Federal
Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any
limitations that apply with 21 CFR Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-
892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S.
however, these manufacturers are required to register their establishment. Please see the Device Registration and
Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
47
Third Party Review
• Eligible for Accredited Persons Program
Accredited Persons
Device Registration and Listing
Owners or operators of places of business (also called establishments or facilities) that are involved in
the production and distribution of medical devices intended for commercial distribution in the United
States (U.S.), are required to register annually with the FDA. This process is known as establishment
registration. Most establishments that are required to register are also required to list the devices and
the activities performed on those devices at that establishment. (Title 21 CFR Part 807).
1. Foreign Establishments
Congress has authorized FDA to collect an annual establishment registration fee for
device establishments. The schedule of annual registration user fees for fiscal years
2017 through 2018 follows:
Year FY 2017 FY 2018
Fee $3,382 $4,624
2. U.S. Agents
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or
processing of a device imported into the United States must identify a United States agent (U.S. agent)
for that establishment.
Information about a foreign establishment’s U.S. Agent is submitted electronically using the FDA Unified
Registration and Listing System (FURLS system) and this is part of the establishment registration process.
Each foreign establishment may designate only one U.S. agent.
3. Establishment Registration & Device Listing
There is a FDA searchable database, which contains establishments (engaged in the manufacture
preparation, propagation, compounding, assembly, or processing of medical devices intended for
human use and commercial distribution) and listings of medical devices (classification as Bandage,
48
Liquid, Skin Protectant) in commercial distribution by both domestic and foreign manufacturers. Set
forth below are some medical device companies registered with the FDA that are related to
Benchmark’s product.
Establishment Name Registration
Number Current Registration Yr
Arrow Internacional de Chihuahua S.A. de C.V.
MEXICO 9680794 2018
Bandage, Liquid, Skin Protectant - Bandage, Liquid, Skin Protectant Foreign Exporter;
Repackager/Relabeler
Bandage, Liquid, Skin Protectant - Not Applicable Foreign Exporter
Arrow Internacional de Chihuahua S.A. de C.V.
MEXICO 3003737899 2018
Bandage, Liquid, Skin Protectant - Bandage, Liquid, Skin Protectant Foreign Exporter;
Repackager/Relabeler
Arrow International, Inc. NC/USA 1036844 2018
Bandage, Liquid, Skin Protectant - Bandage, Liquid, Skin Protectant Repackager/Relabeler
BSN MEDICAL GMBH GERMANY 9710608 2018
Bandage, Liquid, Skin Protectant - Cutimed Protect Foreign Exporter
BSN medical inc. NC/USA 1043537 2018
Bandage, Liquid, Skin Protectant - Cutimed Protect Complaint File Establishment
BSN MEDICAL, INC. NC/USA 1038963 2018
Bandage, Liquid, Skin Protectant - Cutimed Protect Specification Developer
Synergy Health Sterilization UK Ltd UNITED KINGDOM
3002807310 2018
Bandage, Liquid, Skin Protectant Contract Sterilizer
Most establishments that are required to register with the FDA are also required to list the devices that
are made there and the activities that are performed on those devices. The registration for SKINSTITCH
LLC is set forth below as an example.
49
Establishment information of SKINSTITCH LLC
Establishment:
SKINSTITCH LLC
56 Center St
Massena, NY 13662
Registration Number: 2438948
FEI Number: 3003396642
Status: Active
Initial Distributor/Importer: Yes
*Note Firm May Have Additional Establishment Types.
Please Review Listings For Further Information.
Date Of Registration Status: 2018 Owner/Operator:
SKINSTITCH LLC
56 Center St.
Massena, NY 13662
Owner/Operator Number: 9046146 Official Correspondent:
Venkat Kakani
56 Center St.
Massena, NY 13662
Phone: 866-2543900
Registered Products of SKINSTITCH LLC
Registration
NumberCurrent Registration Yr
SKINSTITCH LLC NY/USA 2438948 2018
Repackager/Relabeler
Repackager/Relabeler
Repackager/Relabeler
Repackager/Relabeler
Bandage, Liquid - Gluseal 90
Tissue Adhesive For The Topical Approximation Of Skin - GluStitch Twist
Registered Owner Information
Bandage, Liquid, Skin Protectant - SkinStitch
Bandage, Liquid - Skinstitch
Establishment Name
50
Registration information of product SkinStitch
Proprietary Name:
Classification Name:
Product Code:
Device Class:
Regulation Number:
Medical Specialty:
Registered Establishment Name:
Registered Establishment Number:
Owner/Operator:
Owner/Operator Number:
Establishment Operations:
9046146
Medical Device Registration Information
Repackager/Relabeler
1
880.509
General Hospital
SKINSTITCH LLC
2438948
SKINSTITCH LLC
SkinStitch
BANDAGE, LIQUID, SKIN PROTECTANT
NEC