NDA’s are legally binding documents so we should read it carefully before signing. We need to be aware of the terms in the document and clarify any vague statements before signing. NDAs should provide clear and specific terms to detail…   Read more»

Alternative Dispute Resolution (ADR) can be effective because they are speedy than going to courtroom and also reduces the cost. Moreover the result can be kept confidential in ADR whereas most court trials and are open to the public.  Another…   Read more»

Consultants usually have experience of working in the domain of the developed Medical device and they can provide a viewpoint which the company realises to see. Consulting an physician expert in the field will surely increase the chances of obtaining…   Read more»

My preference would be to work in a matrix structure because it can increase efficiency to meet the demands of the project by collaboration with various teams. This structure can also help to increase skills of employees.

When I worked as a Research assistant, there was matrix structure where I reported to immediate supervisor and project manager. As long as there was proper communication between the team member and supervisor there wasn’t any issue with the structure….   Read more»

The important trait of upper management in any industry is leadership quality. They foresee the future of company and set the vision for everyone to work towards it.Their leadership role can extend over the entire organization and they are responsible for…   Read more»

The risk register is an important document in the product life cycle and it has to be updated continuously with the following information –  Prioritised list of quantified risks which were resolved Trends in quantitative risk analysis which had significant…   Read more»

Like everyone suggested in the previous posts, Information Gathering techniques are proven for Risk identification. These techniques involve sessions like Checklist analysis where risks in previous devices have been ticked out. Also Assumption analysis help identify any new risks which…   Read more»

Some of the basic tools used are  1. SWIFT Analysis – Standing for “Structured What-If Technique” where the project members apply a systematic, team-based approach in proposal environment, where the team investigates how changes from an approved design, or plan,…   Read more»

In combination products design controls, the clinical trials takes place as three constituents – for drug constituent part, the device constituent part and the combination product as whole. The implication from each part help change the impact on the combination…   Read more»

Drugs trials are conducted in three phases, starting with an introduction on a small number of healthy subjects, and then in large populations and then in population with the disease or condition indicated for treatment. And in devices, trials are…   Read more»

Document control is very essential in device changes. It helps maintain a quality system or a device. An example of device change that is controlled is device specification which will be be usually updated with the arrival of better specification…   Read more»

Randomization is used to reduce the bias in assigning patients to study treatment groups and it provides unbiased assessment of the effects of different medical treatments. Both randomization and blinding are important tools in determining the effectiveness of a clinical…   Read more»

As of January 2020, it has been reported that one patient with amyotrophic lateral sclerosis, or ALS, has received an investigational drug from BrainStorm Cell Therapeutics and seven patients have received an immunotherapy vaccine under evaluation for glioblastoma under the…   Read more»

Although I have never experienced Adverse effect during clinical trials, I agree to the possibly of incorporating wearable technologies into the protocol for effective physiological monitoring. AE’s are unanticipated and the wearable sensors provide supporting documentation which can be used…   Read more»

According to me, In order to create an organisation that is both dynamic and responsive to the market while still generating revenue, the relationship between sales and product management needs to go hand in hand. However sales is armed with…   Read more»

During this Covid-19 pandemic crisis time, Companies around the world have come up with innovative advertisements to sell their products. Trying to create ads that seek to capture the emotions and feelings generated by large crisis can be very tricky….   Read more»

As discussed in previous posts, Product management’s responsibility is to prototype and develop a product that fulfils customers need and eventually gets purchased.  It is based on the market requirements, and a good team will consistently adapt to recent feedback…   Read more»

I very well agree with the previously mentioned posts that successful partnership can be formed based on the size of the business and number of people who wish to be the partners. Once the agreement addresses how decision-making power will…   Read more»

I agree with the previous posts. There are many benefits in DBA compared to a LLC. The benefits are listed in the below link are – Compliance, Business banking and Flexiblity.  https://exitpromise.com/what-is-a-dba/ Another advantage is the low-cost and easy to…   Read more»