How to become A Biomedical Entrepreneur

• Clinical Entrepreneur

What do Biomedical Entrepreneurs do?

A Biomedical Entreprenuer would typically need to:

• Pursue opportunities with scarce resources under conditions of uncertainty to create user-defined value by deploying biomedical or clinical innovation
• Streamline the discovery/creation, development, and commercialization of drugs, medical devices, biologics, vaccines, diagnostics, or a combination thereof
• Play diverse roles in the value creation pipeline, such as a technopreneur, intrapreneur (employees acting like entrepreneurs), social entrepreneur, investor, or small-medium size business owner
• Discharge diverse responsibilities, ranging from scientific discovery to delivery of proof of concept and intellectual property; from analysis of market opportunities and competitive intelligence to creation of timelines and business plans for a first product
• Validate your concept, pitch to potential investors, argue value, build a team, engage advisors, and then, with funding in hand, launch an entirely new research and development (R&D) enterprise
• Drive state-of-the-art research using multidisciplinary skills, either as a leader or as part of a team; share responsibilities, knowledge, and research results
• Improve the quality of outcomes while making them available worldwide through efficient operational processes
• Enhance the stakeholder/student and clinician/teacher experience; reduce administrative waste
• Present ideas and strategies to a cross-section of disparate groups; report to colleagues and potential investors; defend tough decisions to stakeholders
• Set the “culture” or style of management of your enterprise to motivate and encourage those whom you have enlisted
• Engage in strategic & financial planning, networking, negotiating, and managing both projects & personnel
• Adhere to the highest ethical standards in business practices and personal interactions; build and uphold an exemplary reputation

Biomedical Entrepreneurs may spend their time between the office, the field, and meetings with investors and clients. The dress code is smart casual unless specified otherwise.

At the initial phase of the business, you may not get a lot of free time. Working weekends may be necessary, in addition to meeting with clients and investors. As a Biomedical Entrepreneur, your work schedule will consist of long irregular hours.

Most Biomedical Entrepreneurs are self-employed. Biomedical engineering is one of the fastest-growing fields of engineering, and the knowledge and skills of persons with advanced degrees are in high demand. Students from diverse biomedical sciences and engineering fields can find high impact careers following a graduate degree.

If the prospect of beginning your career at a start-up seems high-risk, you can apply to more extensive and better-established biotech or pharmaceutical companies. Finding a new job might seem challenging. Biomedical Entrepreneurs can boost their job search by asking their network for referrals, contacting companies directly, using job search platforms, going to job fairs, leveraging social media, and inquiring at staffing agencies.

Biomedical Entrepreneurs are generally employed by:

• Start-Ups
• Conglomerates
• Small & Medium Business Enterprises

Professional associations and organizations like the Institute for Biomedical Entrepreneurship (IBE) are crucial for Biomedical Entrepreneurs. They need specialized know-how and the funding required for translational development success. Translational Development is the phase where a company forms multidisciplinary teams to implement a solution that best solves a critical unmet market need.

Academic, commercial translation occurs at the interface of business and science when an “asset factory” like the IBE converts large numbers of early-stage theoretical innovations into well-defined, significantly de-risked commercialization opportunities.

Organizations like the Biotechnology Innovation Organization (BIO) provide unparalleled networking and educational opportunities. Affiliated Biomedical Entrepreneurs may attend conventions, seminars, and dinners frequented by peers, mentors, and other industry leaders. The events help them keep up with the newest breakthroughs and latest developments in the field.

• Intellectual property protection is of utmost importance but might be complicated to navigate
• The need to scale quickly to achieve a dominant market position and the speed of the market might prove barriers to entry
• Reliance on rapid technological innovation and quick adaptation and penetration
• Long, risky, and expensive regulatory approval for drugs and devices
• The relatively high amount of capital needed to release a health product
• Target customers vary depending on the type of product you wish to release
• Expensive and time-consuming clinical trials essential to prove the clinical efficiency of products might fail

Presenting a resume that reflects a broad range of competencies will help Biomedical Entrepreneurs attract investment or potential employers. Engage in activities that will expand your expertise, even while studying. You can conduct research with faculty, undertake an internship or co-op program, study abroad, attend and present your results at scientific meetings, and plan conferences within your institution.

Take courses that focus on practical experience or spend a year in industry on research or business placement. Industry placements may help develop your skills in innovation, biotechnology, and marketing. They will enhance the opportunities you have to be at the cutting edge of the biomedical industry.

Start-ups often offer unpaid internships and opportunities to test the culture and contribute to their investor value creation. Writing for the university newspaper, explaining recent advances in your department, or starting a student journal will enhance your ability to communicate with the non-scientific population.

The field of bioengineering is vast. For example, tissue engineering is very different from cardiac device engineering. Figure out what you want to do first. Then choose the core classes to gain additional knowledge in that realm.

A bachelor’s degree in medically-related disciplines such as physiology, pharmacology, neuroscience, cell biology, microbiology, anatomy and histology, genetics, biochemistry, and immunology will work to your advantage. Some universities offer foundation courses that help students who do not have the right educational qualifications enter one of their biosciences degree programs.

Look for courses that teach biological sciences and entrepreneurship in a judicious mix of lectures, tutorials, practicals, and research projects. These hands-on courses allow the students to study multiple facets of venture creation and gain experience in the entrepreneurial process using real-world projects ripe for commercialization. The program should offer a solid foundation in entrepreneurship in the context of the medical device industry. It should ideally provide access to mentors with extensive experience in bringing biomedical innovation to life.

Some universities offer a two- to three-year part-time or full-time MBA/Biomedical Entrepreneurship program. It seeks to develop trailblazers who can guide health care, science, and business into a new entrepreneurial age. Hands-on biomedical experience in moving novel drugs and devices from the laboratory to clinical practice work adds considerable value to the program. Students will acquire knowledge in research techniques, literature review, drug and device commercialization processes, institutional regulatory bodies, clinical trials, and funding opportunities. Entry requirements usually include either the Graduate Management Application Test (GMAT) or the Graduate Record Examination (GRE).

Another option is to go for a four-year bachelor’s degree in Biomedical Sciences with Entrepreneurship. It will allow you to learn how to apply biology-based science for medical use through research, health monitoring, or treatment.

A master’s degree will further your knowledge and offer you better options for employment. A one-year MS in biomedical innovation, design, and entrepreneurship provides the interdisciplinary training required to break into a career at engineering and business interface.

Forward-looking Biomedical Entrepreneurs may enroll in unique combined MD/PhD programs that educate the next generation of clinical leaders through training in medicine and engineering research. Start building on your writing and communication skills, even while at school.

Voluntary certification from a reputed organization in the processes necessary to translate promising discoveries into well-defined product opportunities attractive to the commercial ecosystem can help promising Biomedical Entrepreneurs gain professional credibility.

You can also opt for an immersive graduate certificate program in biomedical innovation and entrepreneurship designed to avoid building a product that no one wants; the number one reason startups fail. Graduate students of science, technology, engineering, and management validate potential applications of their technology via online instruction, classroom discussion, and customer discovery interviews.

If expertise in entrepreneurship, business development, and personnel or financial management is not part of your graduate training program, enroll yourself in programs that will certify you capable of leadership in an academic research laboratory as well as a corporate setting.

Successful certification programs protect public welfare by incorporating a Code of Ethics. The reassurance that members who practice outside the Code will be investigated and held accountable earns the community’s trust and respect, which are the most critical elements in securing a Biomedical Entrepreneurs future.

Performance, experience, and acquisition of professional qualifications drive career progression. Entrepreneurs can emerge from different career levels.

Future-oriented Biomedical Entrepreneurs, who join recognized pharmaceutical or biotech firms, will learn how to research in a more traditional company setting and seek opportunities to develop and manage the business. This early tenure will provide valuable and instructive experience to determine how you wish to proceed in your career path. It will transfer to and enhance your position should you choose to move to a smaller setting.

A research position in a large or small company will enable you to continue research as a Senior Scientist or Project Manager. You will be able to take on the management and operations side of a new venture. The first-hand information will equip you with the wherewithal necessary to launch and maintain your start-up. Potential investors may view this exposure as a value addition. Progression to the position of CEO or entrepreneur leaves open the opportunity to serve as an Analyst for venture investors or Consultant/Advisor to corporations, universities, and government scientific councils.

Some Biomedical Entrepreneurs come out of academia to form a company within the university or leave to create an independent company. Success in working in or starting a company provides a smooth transition to roles with greater responsibility in higher education and government.

If your experience, vision, and personality are well suited to tolerating the possible lack of stability, you will enjoy a challenging and exciting career as a Biomedical Entrepreneur.

Continuing professional development (CPD) is especially important in the healthcare sector as it has important implications for public wellbeing. Ideal career progression happens when Biomedical Entrepreneurs expand their skill-sets and meet the requirements of regulatory bodies like the IBE.

The central concern of CPD is that of lifelong learning with its application to professional lives. CPD is more than just a policy or some form of bureaucratic procedure. It is not just a set of boxes to be ticked mindlessly. It is value-laden and embraces new learning objectives, educational methodologies, and novel technological developments, especially in education, management, and IT.

Reflective learning, interaction with peer groups, comprehensive inclusion, workshops, and professional publications serve to educate, influence, support, and foster lifelong enlightenment in all career-grade Biomedical Engineers.

Reach out beyond your immediate circle of colleagues to become acquainted with those who may serve as mentors or role models. Identify those at your institution who have had some success with inventions, entrepreneurship, and start-up efforts and set up meetings with those individuals. Speak at professional meetings, join local biotechnology associations and professional societies, and use their career services.

Biomedical Entrepreneurs can expect support and additional training from the academic institution or from Vitae, a non-profit global leader with over 50 years’ experience in enhancing researchers’ skills. In partnership with governments, funders of research, academies, professional bodies, trusts & foundations, universities, and research institutes, Vitae offers training, resources, events, consultancy, and membership.

Along with medical technologies, healthcare information technology, and the pharmaceutical industry, biotech forms one of the four sectors of biomedical industries. A rapidly evolving bioscience sector is generating new opportunities for small start-ups and biotechs.

The Road Less Traveled

Diverting from the relatively defined and secure path of research in academics or established biotechnology/pharmaceutical institutions to dive into a new venture comes with its risks and rewards. Academia demands a narrower focus that fosters understanding, while a start-up aims to develop an application, service, or product with medical or commercial value.

However, to gather team support, you need to bolster even the most brilliant research idea for a novel product by analyzing how the customer differentiates it, its delivery cost and time, patenting prospects, and regulations that may cause hiccups.

Driving Innovation

Pinpoint a start-up, and the chances are that it drives risky but innovative experimentation. If your experience, vision, and personality are conducive to a likely lack of stability, you can look forward to a challenging and exciting career as a Biomedical Entrepreneur. The need for innovation in research is continuously expanding and being fulfilled by various original and imaginative approaches.

Strategies of Large Companies

As large pharmaceutical companies downsize their R&D workforce in response to pricing and regulatory pressures, they seek to invest in and/or acquire smaller companies and focus their efforts on product marketing, sales, and distribution. This strategy supports large companies in their development efforts as their older products lose patent protection.

Another corporate strategy is to move the research efforts from the company R&D departments into academic settings, anticipating greater efficiency, and lower costs. In this model, universities generate and explore new ideas and innovative concepts, whereas the companies focus on funding and supporting clinical trials and other developments.

Other Routes to Biomedical Entrepreneurship

Individually or in collaboration with colleagues, principal investigators may form small satellite companies based on an idea or finding emerging from their laboratories or conversations. Some universities also produce their own companies to meet the demands for healthcare information technology or advances in personalized medicine. Cutbacks in state funding also kindle a start-up culture, as faculty spin out their very early technology to access different types of federal funding, such as small business grants.

Roles in a Small Biotech Company

A small start-up may be the perfect launching pad to gain experience in the successful establishment and operation of a company. The positions may vary, depending on the maturity and the nature of the company and its focus, and you may need to take on multiple roles.

Bench Scientists

They usually work on various projects such as target or assay development, chemical analysis or synthesis, data mining and prediction, instrumentation improvement, or systems optimization. Companies typically hire individuals with subject matter expertise (e.g., microbiomes and obesity) rather than generalized skills (e.g., protein chemistry).

While researching, bench scientists may also analyze data, publish results, and file patents, as part of a team. With increasing success, the bench scientist will decide whether to continue at the bench as a senior research scientist or move into a managerial or leadership position.

Group Leaders

Armed with the experience in leading a small group of researchers working together as a team, group leaders coordinate team efforts, evaluate results, and assign specific tasks to be undertaken. They must be experts on data and able to articulate the research findings clearly to senior managers.

Managers & Directors

Entrusted with overseeing the activities of multiple research teams, managers & directors typically set the goals of a project and monitor their achievement in terms of direction, budget, and timelines.

Effective and contextual data presentation to senior management is a crucial responsibility concerning business strategy and customer needs. They must also lead individuals through dramatic shifts in project funding or corporate strategy.

Personnel managers hire, supervise, and create an encouraging environment for the research groups. They liaise with external advisors/scientists or speak to investors, depending on the company’s size.

C-Level Positions

The leadership team of the company typically comprises the chief executive officer (CEO), the chief financial officer (CFO), and the chief scientific officer (CSO), or chief operating officer (COO).

Reporting to the board of directors, they establish the strategy for the company’s overall direction, formulate and revise business plans, fundraise, and respond to general market shifts and demands. Companies often receive the credit for success, but CEOs need to shoulder the blame for problems and failures, making the position highly visible and risky.

Founding Your Startup

An idea for a potential business venture may take root while you are employed in an academic setting or a company. As the founder and CEO of a startup, you must discharge wide-ranging responsibilities to see your venture through its various stages. You will also play many roles, beginning as the finance and operations officer as well as the primary “human resource.” You can decide whether to venture alone or bank on a savvy colleague or two.

Idea Evaluation

Your first step is to assess your idea for how competitive and fundable it is. To help you do this, you may seek the expert and objective counsel of a mentor, who may be a distinguished professor or supervisor and experienced entrepreneur.

Pitch Development

Using the support available, developing a compelling business strategy or pitch, and proposing it to potential team members and investors is your next step. The pitch is often a logical and engaging PowerPoint presentation that explains to potential stakeholders how you plan to implement your idea, making it profitable and worthwhile for each group.

The presentation may also support your application for a small business grant from the government. Ensure your business story (the special sauce) is sound and original and allows your enthusiasm and vision to shine through as they are critical to raising support for your startup.

Proof-of-Concept

Undertaking proof-of-concept activities helps validate your business concept. These activities are business-dependent and may include building prototype software, testing marketing hypotheses, continuing biological assays on drugs, developing patents, and accessing key people.

The overall goal is to win the confidence of investors and potential customers by demonstrating the proposal’s value, validity, and likely outcomes. Often, small angel investors or the state offer sums of money to support proof-of-concept work.

From Vision to Reality

Your venture will genuinely have begun when you acquire successful capital investment, enabling you to attract participation and begin to form a team that can make your vision a reality. Your investors may often serve as business advisors or board members to track budgets and progress against corporate goals. Putting together a scientific advisory board to provide technical balance and expertise will help you monitor and guide your research.

Give Back to Move Forward

Every Biomedical Entrepreneur should create research and education partnerships and facilitate collaborations among universities, companies, and investors. Make sure to help universities and start-ups identify talent and assess business strategies to promote entrepreneurship and innovation and improve the quality of life.

Serve as an advisor, mentor, or consultant for students, companies, and organizations. Join a local angel organization, scientific society, or entrepreneurial group that invests in creating and driving the biomedical community.

Follow Your Heart but Take Your Brain With You

Spend time with a diverse team of mentors in diverse settings. Ask for input on issues, pressure testing your assumptions, and leveraging their connections. Take advantage of local business or entrepreneurial networking and educational forums. Selective, quality, industry-focused conferences can also be valuable.

Learn how to introduce yourself in an engaging manner to valuable mentors and connections. Offer a contact or an idea of your own. Consider a transparent communication style. Investors, colleagues, mentees, and teammates often appreciate knowing your thought process.

Nothing Ventured Nothing Gained

Take that career risk. Choose a company offering broad opportunities rather than a large salary. Step out of your comfort zone to widen your knowledge and expertise. Appreciate that your first company is a start and not necessarily your destination.

Stay Optimistic...and Persevere

Optimism is the secret to staying motivated. A new venture will face numerous challenges, but a successful entrepreneur perseveres to meet them, focusing on the vision and pushing ahead despite obstacles. Keeping the big picture in mind keeps distractions at bay.

Remain Flexible...and Adapt

Confronted with setbacks, successful entrepreneurs flexibly adapt the venture to the changed circumstances with a new positioning, a different market, a revised business model, a new source of funding, and an alternative technology application. Seeking a challenging and conflicting inputs from advisors, investors, and colleagues is critical.

Stay Focused...and Balanced

When demoralized, the trick is not to force yourself to work but to figure out what it takes to get you back to a state where you want to work. Take a step back when you need it. Create a discipline around balancing friends/family and a passion for entrepreneurship.

Regulatory Rigors

Regulatory approval can be a long, expensive, and risky process for drugs and devices. However, traditional regulatory boards and authorities may not have jurisdiction over many health innovations. For example, a digital health app is not deemed a medical device but rather something that provides information and education to users. Internet neutrality plays a significant role in the design, development, and deployment of digital health technologies such as telemedicine, remote sensing, and medical information portals.

Money Matters

Reimbursement and payment for biomedical innovations often depend on getting high enough appropriate payment codes and third-party fees to generate a profit. Business models differ between the two and are continually changing. The amount of capital necessary to get a drug or device to market is frequently higher than that needed for health innovation.

Validate Your Business Model

The targeted customers vary depending on whether you are offering a biomedical or health product. The ability to validate your business model using the Lean Startup method (a scientific approach to creating and managing startups and getting the desired product to customers' hands faster) will vary and can be more challenging for biomedical innovators.

Many a Slip Between the Cup and the Lip

Biomedical entrepreneurship is risky., Unlike most digital health products and services, medical tech and biotech entrepreneurs must demonstrate clinical efficacy, involving expensive and time-consuming clinical trials, which fail in a substantial number of cases. A failed trial can sink the prospects of a product ever making it to the shelf.

An Entrepreneur’s Toolkit

Biomedical entrepreneurship often requires different skills than health entrepreneurship. For example, Biomedical Entrepreneurs must navigate intellectual property, regulatory, and reimbursement hurdles much higher than others, so they need the knowledge, skills, and abilities in those domains to confront the issues.

Digital health physician entrepreneurs rely on rapid technological innovation, speed to market and quick adoption and penetration, scaling quickly, to achieve a dominant market position. Consequently, medical marketing and social media skills are critical.

Ambition, confidence, and passion for your ideas & your company are vital to promoting your cause. You may need to deal with numerous questions or problems across the broad spectrum of the business (from science to personnel to workplace operation failures) - be strong-willed, resourceful, resilient, and even optimistic in the face of discouragement. Strategic planning and negotiation skills are indispensable. Consider enlisting a partner (perhaps a business partner) whose expertise complements your own and fills the gaps.

Potential Pros & Cons of Freelancing vs. Full-Time Employment

Being a freelance Biomedical Entrepreneur offers freedom regarding flexible schedules, working hours, and location. They have full ownership of the business and can afford selectivity in terms of the variety of projects and clients presented. While it has unlimited earning potential, it also has less stability and security, with inconsistent work and cash flow. There is more responsibility, effort, and risk involved. No paid holidays; sick/maternity/paternity leaves are almost unaffordable. There is the added pressure of a self-employment tax and no eligibility for unemployment benefits.

However, a full-time Biomedical Entrepreneur has access to company-sponsored health benefits, insurance, and retirement plans. They have job security with a fixed, reliable source of income and guidance from their bosses. However, they are susceptible to potential boredom and inability to pursue passion projects due to their lack of time or effort. With a lack of flexibility, ownership, and variety, there is also a need to budget extra money for commuting and attire costs.

When deciding between freelancing or being a full-time employee, consider the pros and cons to see what works best for you.

A flexible patch uses ultrasound waves to penetrate the skin to measure central blood pressure. This advance may allow heart problems to be detected sooner.

While scientists, engineers, and clinicians continue to invest incredible effort into conceptualizing, producing, and marketing innovations that treat diseases and improve health, lack of access to capital and a burdensome and uncertain regulatory environment continuously threaten the growth of this knowledge-intensive industry. Biomedical Entrepreneurs act as a bridge across this abyss between research and commercialization.

No solution is complete unless it results in something practical that humanity wants.