Market Access Plan | Consulting | Colombia
Offer for Skyline Medical, Inc. (the "Offer") | Prepared by: bioaccess.™
April 3, 2019
Offer No. SKY0012019
Attn.: Kevin Hungerford, Vice President of Sales and Marketing
Thank you for considering bioaccess.™ for your market access needs in Colombia and the rest of Latin America. This Offer will enable bioaccess.™ to assist Skyline Medical, Inc. ("Skyline") with its interest in significantly increasing sales of its STREAMWAY System (the "Product") in Latin America.
This Offer has been customized to address the challenges for Skyline in Latin America that we identified during our most recent conference call, and they include,
With this Offer, we will research the Colombian market and develop for Skyline a strategic and tactical market access plan; this plan will position Skyline for success in Colombia (the "Plan").
The Plan will require a comprehensive market access analysis after conducting face-to-face interviews with key stakeholders. This will give us the ability to propose strategies and tactics to have Skyline successfully penetrate the Colombian market.
After delivery of the Plan, Skyline will be able to thoroughly understand the Colombian market for the Product, will know the right pricing, the reimbursement landscape (if applicable), how to generate demand, and the candidate in-country distribution partners.
We look forward to getting started on this exciting project for Skyline.
Thank you for your trust,
Julio G. Martinez-Clark, bioaccess.™ CEO
email@example.com | +1 (954) 903-7210
The Offer is subject to a mutually executed confidentiality agreement or clinical services agreement specifying full terms and conditions. By accepting this document, you agree that the information in this proposal shall not be disclosed, duplicated or used for any purpose other than to evaluate the Offer.
All of the information contained in this document is provided on the basis of strict confidentiality for only your exclusive use and must not be disclosed to any other party. You should exercise no lesser security measures than those applied to their own confidential material including restricting the circulation of the information on a need to know basis.
Why do you need a market access plan?
Emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical and medical technology companies
Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical and medical technology companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders.
The stagnant developed markets have forced pharmaceutical and medical technology companies to focus more on the emerging markets, which are touted as being the next engines of growth. Thus, growth for pharmaceutical and medical technology company will depend on its performance in these markets. A customized market access strategy integrated with the right processes and talent can help mitigate these challenges, allowing effective commercialization and increased drug or medical device accessibility for patients.
Market access consulting in Colombia
A turn-key solution for your market access needs in Colombia
Many foreign medical technology companies are dependent primarily on local distributors to sell into the Latin American countries. Most of these companies poorly choose their distributors, don't conduct the necessary due-diligence on them. Most distributors in Latin America are small operations that are thinly capitalized; they may be good at accepting orders and service clients but are unable to invest in demand creation on your behalf.
bioaccess.™ market access experts identify why certain companies succeed in a given market while others fail, pinpointing the forces that drive the market so we can make the best possible strategic recommendations. This market wisdom is the most valuable component of our medical device market access plans and is designed to bring our clients a competitive edge.
Benefit to Skyline
Lack of understanding of the risks and opportunities that Colombia has to offer for medical capital equipment vendors in the fluid disposal segment.
If Skyline doesn't address this, it will likely enter the market with the wrong information, and will make many mistakes along the way.
A thorough market access plan to enter the Colombian market —one of the top Latin American economies and the door to the Pacific Alliance.
Access to updated verifiable information to make decisions, project revenue, and lower Skyline's risks in Colombia.
Lack of local contacts to guide the company in a market access initiative in Colombia.
If Skyline doesn't address this, it will have ill-prepared, inexperienced, and culturally-insensitive staff interacting with a different culture, in a different language, and will likely fail communicating its value proposition.
Latin American market access experts, key opinion leaders, and other key stakeholders contributing to creating Skyline's market access plan in Colombia.
Lack of access to qualified distributors that are aligned with Skylines's values and business objectives.
If Skyline doesn't address this, it won't conduct due diligence on its distributors, and will poorly choose them. This will mean wasted time and money in the process —the wrong distributor in a Latin American country costs a Medtech company about three years in lost sales.
Skyline will have market access experts objectively conducting local research from primary and secondary sources to formulate a market access plan for Skyline in Colombia.
Skyline will have access to a pool of qualified candidate distributors so that it can make the best decision as to its best partner to have in Colombia.
With this Offer, we are focused to reaching the following objectives:
The Scope of Work
This Offer includes the following scope of work/activities:
We will know we are successful when the following are manifested:
(1) bioaccess provides regulatory product registration services in Colombia (and also in Brazil, Mexico with the help of a local partner).
Access to this market [Colombia] is not easy for newcomers. The market is mature and competitive, with many foreign firms selling medical equipment and medical products.
— U.S. Department of Commerce, Colombia Export Guide
bioaccess.™ is a US-based contract research (CRO), regulatory, and market access consulting company that delivers a full spectrum of offerings from bench to commercialization so that foreign medical device companies can have long-term success in Colombia and the rest of Latin America.
Our promise is for US or EU medical device companies that believe that Latin America offers untapped potential to test and sell their products. We focus on forward-looking medical device companies that want to conduct first-in-man clinical trials and want to have long-term sales growth in the region.
We promise that by engaging with us as your CRO, regulatory, and market access consultants, your company will cost-effectively get the clinical data it needs and will be able to increase its sales in Colombia and the rest of Latin America.
bioaccess.™ has helped companies like Avinger, Mitralign, and MitraSpan, SANUWAVE, ClarVista Medical, CeloNova BioSciences, Abiomed, Volcano, Mount Sinai's Center For Personalized Cancer Therapeutics, Libella Gene Therapeutics, Medimaps Group, WEP Clinical, Hancock Jaffe Laboratories, Omron Healthcare, IDx, LumiThera, and Biomerica —among others— conduct trials, register their products, and/or formulate a winning market access strategy in Colombia.
Omron Selects bioaccess.™ for its Market Access Plan in Colombia
[ORLANDO, FL, July 6, 2018] - Omron Healthcare, Inc. ("Omron") has appointed bioaccess.™ as its market access consultants in Colombia. bioaccess.™ will help Omron formulate a market access strategy and implementation plan in Colombia so that more hypertensive patients have access to Omron's automated home blood pressure (BPM) monitors in Colombia; thus, making it easier for patients to monitor their blood pressure at home and reducing their risk of heart attacks and strokes.
Proven methods to deliver results!
The execution strategy must incorporate proven methodologies, extremely qualified personnel, and a highly responsive approach to managing deliverables.
We first need to craft your problem statement in Colombia. A problem statement is a concise description of an issue to be addressed or a condition to be improved upon. It identifies the gap between the current (problem) state and the desired (goal) state. Focusing on the facts, the problem statement should be designed to address the 5 W’s – who, what, where, when, and why.
The first condition of solving a problem is understanding the problem, which can be done by way of a problem statement. Only after the problem statement is written and agreed upon should the solution(s) be discussed and the resulting course of action determined.
Before the problem statement can be crafted, the problem must be defined. It is human nature to want to begin working on a solution as soon as possible and neglecting the definition of the true problem to be solved. However, a poorly defined problem increases the risk of implementing a solution that does not fully meet the expected results. A problem cannot be solved if it is not completely understood.
The process of defining the problem is often a group effort. It starts with meeting with the stakeholders, customers, and/or users affected by the issue (if possible) and learning about their pain points. Once the problem is understood and the circumstances driving the project initiation are clear, it is time to write the problem statement.
A poorly crafted or incorrect problem statement will lead to a faulty solution, as well as wasted time, money, and resources. A good problem statement will address the following areas: a) the ideal situation, the reality, the consequences of not solving the problem, and the potential solutions.
There is an underlying problem related to access to the Colombian medical device market that we need to find and address that will prevent the Device from being sold in Colombia (the "Problem").
Skyline needs a thorough market research/analysis that will help us identify its problem statement, identify Skyline's opportunities, and provide it with a well-thought-out and effective Plan.
Once we find the Problem, then we will be able to come up with the right solutions (strategies and tactics) as part of the Plan for Skyline in Colombia.
In order to find the Problem and achieve the objectives of this Offer, we strongly believe that we need to obtain insights from multiple stakeholders. This will allow us and Skyline evaluate and validate multiple access alternatives in Colombia that will contribute to a stronger Plan with more probability of being implemented with a successful outcome.
In order to gather the information needed to create the Plan, we must diligently take action under the following framework:
The bioaccess.™ Framework
Our framework to guide our clients consists of three phases to ensure a successful market entry in each Latin American country.
Market Access Plan Research
You will have insights, key opinion leaders, potential buyers of your product, and distributors.
Market Access Plan Creation
To create a document outlining the research findings and recommend strategies and tactics to solve the Problem.
You will know exactly what strategies and tactics you need to implement to succeed in the local market.
Data analysis and formulation of strategies and tactics to create a thorough market access plan.
Market Access Plan Implementation
To operationalize the strategies and tactics in the market access plan that solve the Problem.
You will have a local team of experienced medical device business development, marketing, and sales experts driving your business in Colombia.
Implementation of the market access plan and management of the local business.
We will need several team members to execute this project simultaneously in the top four (4) Colombian cities (Bogota D.C, Medellin, Cali, and Barranquilla). This project will need a team of experts engaged for the time indicated below.
Market Access Plan (90 days)
Juan J. Muñoz
Project Leader/In-Region Market Access Expert
Monica C. Mora
Project Manager/General & Administrative
Julio G. Martinez-Clark, M.B.A.
The benefits that our solution will provide Skyline
Due diligence on a pool of qualified distributors in Colombia
A foothold on the Pacific Alliance (Mexico, Colombia, Peru, and Chile) —a market with over 210 million people that represents the 7th economy in the world
A thorough understanding of market drivers of the Colombian medical equipment business
A team of qualified experts taking you by the hand and guiding you to make the right decisions on the challenging Latin American market
London-based WEP Clinical Selects bioaccess.™ As Market Access Consultant to Enter the Colombian Market and Provide Patients Access to Life-Savings Drugs
[Orlando, FL, August 22, 2018] — WEP Clinical —a London-based drug sourcing, and distribution company— has selected bioaccess.™ as its market access, regulatory and business development consultant to enter the Colombian market for hard-to-find drugs. For hospitals or health management organizations (HMOs) that want to provide a life-saving and hard-to-find drug to their patients, WEP Clinical offers an efficient, end-to-end product distribution model. From the required regulatory filings, through to product handling and delivery, WEP Clinical is well positioned to support patient's needs.
Our team is comprised of international senior market access, healthcare, health economics, business development, sales & marketing, and regulatory professionals specialized in the life science industry with extensive experience in Latin America. They have a proven record of developing and implementing market access, healthcare, regulatory and business strategies in the region.
This engagement will be led by,
Orlando, FL USA
Julio has been working with US medical device companies for about 10 years helping them design and implement successful clinical trial, regulatory, and market access strategies. Julio is a recognized medical device expert, and his insights on the medical device industry have been featured on the industry-leading Med Device Online publication. Julio is also the host of the LATAM Medtech Leaders Podcast: A weekly conversation with Medtech leaders who have succeeded in Latin America. Julio has a B.S. degree in electronics engineering and a masters in business administration (MBA).
Miami, FL USA
Project Leader, Senior Market Access Expert
Alejandro is a global senior executive with over 30 years of experience in healthcare including P&L management, go to market strategy, setting up new operations and building organizations overseas. He has a unique background in international markets for pharmaceuticals, generics, medical devices and nutritional products. He also has experience managing a large generics and medical devices business in the US.
Prior to founding Procursum Medical, he held the position of President of International with Hill-Rom where, as a member of the executive leadership team, he managed a $500M business with focus on improving profitability in Europe and driving sustained and profitable growth in emerging markets.
Before joining Hill-Rom, Alejandro had several executive positions with Hospira including President of the Americas where he was responsible for the medical device and specialty pharmaceutical segments with a total revenue of $2.5B; he also held the positions of Vice President and General Manager of International Commercial Operations and Regional Director for Hospira in Latin America. Prior to joining Hospira, at the time of the spin off from Abbott Laboratories, he held numerous management roles within Abbott, including General Manager in Mexico and Poland.
Alejandro has extensive experience building multifunctional organizations in international markets for both direct and indirect operations. He develops successful go to market strategies and build effective teams based on strong leadership and a diverse background in various segments of healthcare products and geographies. Read more.
Bogota, D.E., Colombia
In-Region Senior Market Access Expert
Juan is an experienced international life sciences and healthcare business development, sales, marketing, and management executive. Juan had leadership positions at Baxter Laboratories and Boston Scientific creating, managing, and leading profitable sales operations in Colombia, Venezuela, Ecuador and Peru. Juan is an expert at formulating market access strategies that allow foreign Medtech companies successfully penetrate the challenging Latin American market. Juan has a B.S. in microbiology from Javeriana University and an M.B.A. degree from ICESI; both leading universities in Bogota, Colombia. Learn more.
Orlando, FL USA
Vice President of Operations
Monica leads the company's operations including project management, logistics, accounting, human resources and general corporate and project-related administrative matters. Monica has worked for global companies including Alcatel-Lucent and Toshiba. She has a B.S. degree in computer sciences from Universidad del Norte —the leading university in Colombia's Caribbean coast— and graduate studies in business management. Learn more.
United States dollars (USD)
Terms & Conditions
Terms and Conditions
Colombia is the third largest health market in Latin America.
Healthcare expenditure in Colombia
Source: Business Monitor International
The Colombian medical equipment market is complex and challenging; it relies overwhelmingly on imports, which made up about 93% of the market during 2017. BMI Research estimates that Colombia imported USD $1.2 billion worth of medical equipment in 2018. Since the implementation of the U.S.-Colombia Trade Promotion Agreement (TPA) with the United States in 2012, 96% of U.S. medical equipment exports to Colombia receive duty free treatment.
The country’s healthcare infrastructure is adequate in the larger urban areas but is generally in need of modernization and expansion. The Colombian government provides a universal medical system known as the “General System of Social Security in Health” (SGSSS, or Sistema General de Seguridad Social en Salud), which currently covers about 95% of the population thanks to Law 100 of 1993, whereby all citizens, irrespective of their ability to pay, are entitled to a comprehensive health benefit package.
At this moment, the most cost-effective way for Skyline to sell the Product in Colombia is through a financially-solid distributor with experience selling hospital capital equipment preferably in the fluid disposal segment.
The Colombian market is desirable, is unique in terms of favorable legislation for patients’ rights, and has ample coverage of the population. Colombia may represent millions in sales for Skyline. It is critical for Skyline to identify the limitations that may prevent the sales of the Product in Colombia and to find ways to successfully enter the market.
A market access plan for Skyline in Colombia will require comprehensive analysis including face-to-face interviews with the right stakeholders including key opinion leaders, distributors of medical equipment, and select insurance companies (if applicable for the Product.
The market access plan for Skyline should explore topics such as pricing, reimbursement landscape, distribution network, market size, competitive differentiation, key sales drivers, technology preferences, patient needs, packaged services, etc.; it must identify Skyline's challenges in Colombia, identify Skyline's opportunities, and provide Skyline with a well-thought-out and effective Plan.
bioaccess.™ has a team of expert market access consultants that can help Skyline conduct primary and secondary market research, and design and implement cost-effective strategies and tactics —as part of the Plan— to help Skyline reach its sales goals in Colombia.
Let's get started!
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