The lesser known spin-off strategy is when the original parent company breaks off to form a new company. The primary reason for this, is that companies may want to market a new product under a different name, or divert attention to R&D projects that languish due to not fitting into current strategies of the parent.

Start-ups are small, newly created and in a phase of development seeking growth and entry into markets. The entire concept is considered quite risky as business outcomes are unknown and high amounts of resources and time are required by the founder. Arguably, more than any industry, medical device and biotechnology companies have the potential to

Joint ventures are a form of strategic alliance where a temporary partnership is formed between two or more parties, seeking to leverage shared markets, IP, knowledge and, of course, expenses and revenue. The degree of ownership is dependent on the agreement. Partnerships and joint ventures are quite similar; however the underlying difference is that partnerships

Licensing agreements are contractual arrangements that allow a licensee to use, manufacture or sell particular assets with permission from the contractual owner. Licensing has been integral for smaller companies to gain access to resources, including specialist regulatory expertise or manufacturing and marketing capabilities. These are usually only resources that larger pharmaceutical partners or medical device

Go To Market Strategies

Determining the best market strategy can go a long way for the profitability and commercialisation of your technology. The following are the most common ‘go to market strategies’ for biotechnology and medical device companies. Licensing Licensing agreements are contractual arrangements that allow a licensee to use, manufacture or sell particular assets with permission from the

IP – Asset or Liability?

A patent is a legally enforceable right granted for a new or inventive device, substance, method or process that provides exclusive right for the holder to commercially exploit their invention for the life of the patent (IP Australia). We all have ideas, and as the late Robin Williams once stated ‘no matter what people tell

Defining Value Propostion

Defining your technology’s value proposition is pivotal for successful commercialisation. It’s the promise of value and the belief that value will be delivered and experienced by the end users of your technology. In the case of medical devices and biotechnology, value may extend further into national and international benefits, solving problems that can have a

Generics vs Branded Drugs

A generic drug is considered identical or bioequivalent to its branded cousin. Upon patent expiry of the branded version (generally 20 years), other pharmaceutical companies jump on the opportunity to create a cheaper, generic version. As the drug is not developed from scratch, the cost of commercialisation is significantly reduced. As such, generic drugs are

During the commercialisation process, entrepreneurs may consider developing a presence in various international markets. Before embarking on this journey, it’s crucial for the foreign company to understand a specific country’s culture, market need and customs, that will ultimately assist a new medical device to be tailored and distributed within a new jurisdiction. Even if both

Patent Law Basics 101

Patent law can be a complex topic that leaves entrepreneurs perplexed and out of pocket. It can be a costly exercise, but is absolutely necessary in protecting your invention or medical device for successful commercialisation. Here are some basic principals in patent law. What is a patent? It is a property right granted by a

A clinical trial is a scientific study involving medicines, new treatments and new medical devices involving patient and non-patient human volunteers. They are necessary for collecting clinical data to demonstrate the safety and effectiveness of a new therapeutic, an existing therapeutic or a medical device. Before commencing clinical trials on human subjects, extensive pre-clinical testing

Interdisciplinary research can be an essential driver for innovation in the medical device and pharmaceutical space. The opportunities are positive where collaboration between researchers or soon to be entrepreneurs can result in an idea that eventually leads to commercialisation. Interdisplinary research involves bringing together inventors or researchers from separate disciplines. By drawing upon the unique

Licensing agreements are contractual arrangements that allow a licensee to use, manufacture or sell particular assets with permission from the contractual owner. Licensing has been integral for smaller medical device companies to gain access to resources, including specialist regulatory expertise or manufacturing and marketing capabilities. Compensation to the licensor can consist of a combination of

There are important things entrepreneurs need to consider before commercialisation. The fundamental question is whether your medical device is a sustaining technology or is it a disruptive one? Sustaining Technology A sustaining technology is one that relies on incremental improvements. For medical technology, this may be a diagnostic test that has improved sensitivity or accuracy

Rapid advances in biotechnology have posed challenges for legislators and biotechnology companies as legal systems struggle to determine the patentability of biological matter. Key issues include the ownership of genes, the law of nature in diagnostic methods, GMOs and biopharmaceuticals. Litigation that has reversed decades of US precedent is best demonstrated by the ‘Myriad’ case.

A confidentiality agreement, also known as a non-disclosure agreement (NDA) is a legal contract between two parties. It restricts the sharing of confidential information outside of the parties involved. An NDA should be drafted and signed before commencing any discussion with third parties. This is particularly useful when discussing your medical device or idea with

Finding a business partner is merely a small step in the commercialisation journey. From here on, the relationship needs to be managed to ensure it is a mutually beneficial one. Wasting time with mismatched partnerships is particularly harmful to those looking to commercialise medical devices or any technology device for that matter. It may significantly

For three years running, Australia has ranked in the top 5 in biotechnology in the world with 140 ASX- listed biotechnology companies with a market capitalisation of $50 billion (Ausbiotech, 2017). CSL remains the largest biotechnology company in Australia with Medical Technology and devices also surging forward. The big guns in this area include Cochlear

Making a Pitch

By now, you would have heard of the show Shark Tank. This television series based on hopeful entrepreneurs, pitching their idea to a group of millionaire investors, is an inspiring watch. The panelists on the show are an impressive line: Naomi Simson, founder of Red Balloon, John McGrath of McGrath Partners Real Estate, Andrew Banks

Approaching Partners

Many start-up medical device companies face hurdles in lack of resources, expertise or capital. Many inventors choose to support the initial development phase of their technology with their personal resources, but soon find that they run out of time and money. The project may also be too early in the development phase to attract external

If you have ever studied Marketing 101, the concept of the four P’s is one that you will be familiar with. Before successful commercialisation, inventors need to consider how to position their medical device in the market. The 4P’s of marketing is a simple tool for determining how to put the right product in the

Developing a Business Plan

Planning is always the first step in developing a business. A good business plan will provide direction and foresight as to future barriers that need to be overcome throughout the commercialisation process. A business plan should be a living document which evolves over time as you research your market, your IP position and understand your

Distribution Strategy

One of the crucial parts of the commercialisation process is implementing a distribution strategy for a new product. The inventor has put in the hard- yards (both in capital and time) and now it’s time to determine how and where the consumer will buy your product through the most appropriate distribution channels. Reaching your target

The Achilles heel to any great invention is obtaining sufficient levels of capital to fund different phases of commercialisation. With medical devices and therapeutics, costs can skyrocket as regulatory fees, legal fees and the most costly of all – running clinical trials, build up. How you finance your business can be the difference between success

The Value of an Idea

Everyone has ideas, but few people have the tenacity to convert their idea into a commercial product. How many times have you come across a product thinking ‘ Hey… I thought of that idea?’ Commercialisation is a long and complex process, particularly for medical devices and pharmaceuticals that face the additional challenge of dealing with regulatory authorities. Medical

Commercialisation is a long and arduous process. Inventing a medical device or new technology is just the first step. The ultimate goal may be to license your idea to a larger company, sell your company or raise more capital for even more inventions. The journey is a rollercoaster ride, and many inventors fail to persist

The Role of Venture Capital

The lack of seed funding in early technology development is a key barrier for many medical device inventors during the early stages of commercialization. This equity gap is something that only a few specialist investors have been able to bridge, but leading universities have found developing relationships with venture capitalists invaluable as a source of

The commercialisation process is an arduous and complex one. You invest your heart, energy and your finances, funding an invention hoping to be the next popular innovation in medical devices. Before implementing a market entry strategy, however, it is crucial that extensive market research is performed on potential competitors and whether similar products already exist.

What is Commercialisation?

Commercialisation is the process of introducing a new technology or idea to market. The path to successful commercialisation can be a complex and challenging one, with medical devices facing the additional challenges of R&D expenses and regulatory hurdles. For instance, a surgeon may have an idea for a new surgical device or a researcher might

A partnership is an association of people who carry on a business as partners and receive income jointly (ATO). The partners are all joint owners of a business and equally responsible for decisions made on behalf of the company. In other words, all profits, losses and responsibilities are equally shared, unless specified otherwise in a